New data shows the KCC Model is producing strong clinical outcomes—but the financial payoff hasn’t arrived yet. New policy changes coming in PY26 have altered the math for participants. Time will tell how they respond. This brief breaks down what’s changed, what’s working, and what’s still to come.

What Happened

CMS released summary results from the Kidney Care Choices (KCC) Model’s second performance year (PY2023), and the data tells a story of clear clinical momentum—but rising financial pressure. Providers participating in the model made measurable gains on nearly every front: optimal dialysis starts rose 31%, home dialysis use increased 10%, and preemptive kidney transplants jumped by an eye-catching 69%. Living donor transplants also rose by 22%, and preemptive waitlisting—often a precursor to better outcomes—increased by 40%.1

But the progress came with a price. Total net Medicare spending increased by more than $300 million in 2023, driven in large part by incentive payments—like transplant bonuses and capitation for CKD care coordination—that are core to the model’s design. CMS didn’t find statistically significant increases in Parts A and B service costs alone. Rather, the increase came from adding in model-specific investments meant to change how kidney care is delivered and rewarded. Again, as designed.

In short: the KCC Model is working as intended—but it’s “expensive.” And with new policy changes coming in 2026, the tension between spending today and saving tomorrow is playing out in ways we’ve long described but rarely seen so clearly. The question is: Are we prepared to follow through and accept the cost of transformation? Will an additional year of CKCC be enough to show policy makers the return on investment it’s after when it comes to addressing chronic illness?

Why It Matters

The KCC Model wasn’t designed to cut costs overnight. It was designed to realign incentives: to reward earlier, better, and more coordinated care. And like any shift of this scale, it comes with a price tag. The incentive payments driving this year’s spending increase—transplant bonuses, capitation for CKD care, and shared savings—are not excess. They are the mechanism. They represent a deliberate bet that upfront investment—both financial and operational—can produce long-term value through fewer emergency dialysis starts, more transplants, and better patient outcomes.

That investment doesn’t live on paper. It lives in the daily work of providers who’ve taken on new responsibilities, often without the systems or staff they need. Nephrology practices participating in the KCC Model have built new modality education workflows, hired transplant coordinators, and expanded outreach to patients long before they ever reach a dialysis clinic. And in many cases, it’s private practice nephrologists leading the way.

As Katie Kwon and I wrote in Kidney News, “Nephrology has become a laboratory of sorts for alternative payment models… The business sense and nimbleness of private practice nephrology are assets to the specialty and to the medical system as a whole; if we cannot make something work, it is unlikely to succeed at scale.” But that flexibility has its limits. Medicare compensation has declined 29% since 2001 (adjusted for inflation), and many private groups are stretched thin. Asking them to deliver coordinated, multidisciplinary care while absorbing financial risk is a high bar—even with bonuses.

One nephrologist put it plainly:

VBC is resource intensive. Although only 33% of our patients are aligned with our current model, we have hired kidney care coordinators and expanded our educational and outreach programming to address the needs, depending on risk factors, of 100% of our patients. The revenue we earn back from participating in the Kidney Contracting Entity (KCE) in the form of quality incentives, the Advanced Alternative Payment Model (or AAPM) bonus, and shared savings helps subsidize the cost of this care for our patients who are not KCE-aligned.2

That’s the paradox at the heart of the model: the incentives work—but only when providers are resourced to meet the moment. And with key incentives set to change in 2026, the future of that support is uncertain.

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What’s Changing in PY26

CMS has announced several updates to the Kidney Care Choices Model that will take effect in Performance Year 2026. While the program itself will continue—and CKCC will be extended through 2027—the financial mechanics are changing in ways that many consider significant. Candidly, I hope this piece helps open a dialogue around how these changes might impact participants of all types and sizes in the years ahead.

Here’s a snapshot of those updates:

Among the most notable changes:

• Capitated payments for CKD care (QCP) will be reduced by 50%, even as care coordination remains a central goal of the model.

• The $15,000 transplant bonus, previously paid out over three years per transplant, will be eliminated.

• Benchmark discounts of 1% will be added for both CKD and ESRD populations, effectively lowering the ceiling on potential shared savings.

• The Kidney Care First track will end one year early, while CKCC options will be extended through 2027, consolidating participation under one track.3

Some see these changes as expected course corrections to control spending. Others view them as potentially disruptive—especially for smaller or newer participants who are still scaling their operations (see comments above). Larger organizations that have fully committed to the model may be better positioned to adapt. What’s clear: These changes reshape the economics of participation, and reactions will likely vary by size, structure, and risk appetite.

It’s also worth noting what isn’t yet clear. The public evaluation offers limited detail on which incentives drove the $304.8 million in added Medicare spending. Without that detail, it’s difficult to assess the net policy value—or the longer-term consequences of pulling back incentives just as outcome trends are improving.

The good news: the program continues. The extension of CKCC gives current participants more time to realize the benefits of their early investments (albeit not as much time as they perhaps would have liked). But the questions going forward are big ones—and we do hope this brief offers a starting point for those conversations.

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The Bigger Picture

The story of KCC is still being written. Providers are playing their part—but they’re not writing the script. Still, this model is one of the most ambitious value-based payment models CMS has launched to date—and like many of the Innovation Center’s earlier experiments, it’s being actively reshaped in response to early data and feedback.

In a January 2025 Health Affairs essay, CMMI leaders outlined their evolving approach to model innovation. Success, they argued, doesn’t always come from getting everything right at launch. It comes from learning, adapting, and designing successor models that can carry forward what works—and leave behind what doesn’t. “Most models require active management and modification to become successful,” they wrote. “Successor models build on what came before—not just in structure, but in timing and strategy.”

KCC fits squarely into that vision. It builds on lessons from the earlier ESRD-focused CEC Model, expands the scope to include advanced CKD and transplant recipients, and gives nephrology providers new tools to manage population health in ways the traditional Medicare program rarely supports.

But like any model that blends clinical innovation with financial risk, KCC faces a dual challenge: showing results quickly enough to satisfy policymakers, while giving participants enough time and stability to realize the full return on their investments. That’s the balance CMS seems to be after with the PY26 changes—and it’s where much of the tension lies.

For now, the core idea remains intact: reward what matters, support what works, and let the data guide what comes next.

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What’s Next

More detail is coming—and it will matter. While the topline results offer a glimpse of progress, individual provider-level data will be critical to understanding what’s really working, where variation exists, and how different approaches are translating to outcomes and cost performance.

Meanwhile, the next phase of CMS kidney innovation is starting to take shape. The forthcoming Increasing Organ Transplant Access (IOTA) Model may absorb some of the goals previously supported by KCC transplant incentives. And future iterations of value-based kidney care—whether successor models, regional pilots, or something else entirely—will likely be informed by the KCC data and the community’s response to these 2026 changes.

For now, providers remain in the model. CKCC has been extended, and early outcome trends are encouraging. But as the policy shifts take effect, all eyes will be on what happens next: who stays in, what changes on the ground, and how CMS interprets the signals from this next round of data.

We will continue listening, learning, and sharing what we find out as things progress. When individual provider-level data is released (hopefully soon), we will summarize, synthesize, and publish our findings. In case you missed it, we also published our summary of Year 1 results and the VBKC Directory earlier this year as part of that ongoing effort.

One day at a time. Keep exploring,

This brief is meant to inform—and to invite conversation. The upcoming changes to the KCC Model are substantial, and their impact will likely vary depending on your role, organization, and experience within the program. We’d love to hear how you’re thinking about what’s ahead. Please share your thoughts below or join us in Slack to keep learning.

Discussion

1. Can CMS afford to scale back incentives just as outcomes begin to improve?

2. What happens to transplant growth once the bonus disappears?

3. What will happen to kidney care coordinators once KCE subsidization ends?

4. What role should Medicare Advantage play as federal APMs shift?

5. What can we learn from high-performing KCEs, and how should those lessons shape future models?

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2

From Volume to Value: Nephrology's Tough Transition: “Our nephrology practice has been involved in Medicare value-based care (VBC) models since 2017. We were drawn to the alignment of higher quality care with shared savings incentives. Despite our successes, we find the programs difficult to navigate due to year over year changes in quality metrics, delayed data reporting, surprises in the shared savings waterfall (i.e., the retrospective trend adjustment and normalization factor), as well as overall program complexity...”

It’s been a busy few weeks, and I’m just back from Washington, DC, where I had the chance to join an incredible group of peers at the 2025 Kidney Innovation Conference. This year’s theme—Innovation through Collaboration—set the tone for two days of listening, learning, and leaning in. From workshops on pediatric trials and APOL1 roadmaps to patient stories and a powerful keynote from Dr. Robert Montgomery, it left me energized about what’s possible. I’ll be putting together a series of posts on ideas that bubbled to the surface and the people behind them, so stay tuned. It was also a week of firsts: the World Health Assembly passed the first-ever global resolution on kidney health, and researchers completed the world’s first personalized CRISPR therapy given to baby with genetic disease.

Meanwhile, just a few blocks west of the conference, the policy landscape continued to shift. CMS rolled out an aggressive new strategy to accelerate Medicare Advantage audits—adding thousands of coders and expanding reviews to all eligible plans by 2026. The Trump administration and its ‘MAHA’ commission also released a new report on chronic disease in children, raising questions over its framing of trends in cancer, obesity, and aging— and what it left out.1

We’re also testing a shorter recap format this week—fewer words, same Signals. If you make it to the end, I’d love your feedback. Thanks for being here.

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In this issue

• Global milestone: WHA resolution on kidney health

• CMS reboot: New RFI + Medicare Advantage audits

• Medicaid overhaul: What the House bill could mean

• Breakthroughs in AKI recovery & AI-led discovery

• CLTI awareness & new patient-centered resources

• Highlights from the Kidney Innovation Conference

• Community voices on dignity, advocacy & access

• 20 new roles across Sanofi, Bayer, Vantive, & more…

Signals

This week’s top stories reveal a moment of reckoning—and opportunity—in kidney and chronic care: from kidney disease finally earning global health recognition, to CMS opening the door for bolder value-based models, to a sweeping House bill that could upend Medicaid for millions. Here’s what’s happening and why it matters.

1. Kidney Disease Makes Global Health History

The World Health Assembly has officially passed the first-ever global resolution on kidney health, recognizing chronic kidney disease as a growing public health issue. Led by Guatemala and co-sponsored by several Member States, the resolution urges countries to integrate kidney care into national health strategies, prioritize early detection and prevention, and strengthen kidney services through primary care systems. This landmark move places kidney disease alongside other major noncommunicable diseases (NCDs) in global health policy for the first time. While the resolution is non-binding, it sets a precedent for funding, program design, and global collaboration. As universal health coverage efforts expand, advocates hope this resolution will drive more visibility, research investment, and equitable access to care for the 850+ million people affected by kidney disease worldwide.2

2. CMS Asks Us How to Unblock Care Innovation

On May 13, CMS unveiled a new strategic direction for the Innovation Center, emphasizing evidence-based prevention, consumer engagement, and tech-enabled care. The 2025 strategy—aligned with the Trump administration’s “Make America Healthy Again” agenda—marks a notable shift from broad participation to performance-focused models with greater downside risk. Accompanying the strategy is a Request for Information, seeking input on how federal law can better support digital health, data sharing, and patient-driven care. Future CMMI models are expected to focus on site-neutral payments, Medicare Advantage redesign, and stronger alignment across payers. Critically, all models will now require downside risk participation. Stakeholders should anticipate more stringent benchmarks, reduced state-level rate setting, and a stronger role for private sector partnerships. While the Innovation Center has not yet set a coverage goal akin to past “100% ACO” mandates, the tone is clear: innovation must be fiscally accountable, consumer-centered, and digitally enabled.3

3. GOP Medicaid Cuts and Budget Bill Updates

In a razor-thin 215–214 vote, the House passed Republicans’ sweeping reconciliation bill—marking the most significant attempt to restructure Medicaid since its founding. The legislation cuts an estimated $700 billion from Medicaid over 10 years, primarily by requiring beneficiaries to meet new work-reporting mandates starting in 2026. The Congressional Budget Office estimates 7.6 million people would lose Medicaid coverage, with another 4 million losing ACA plans—reversing nearly half the coverage gains since 2010. The bill also extends Trump-era tax cuts, which the CBO projects will add $3.8 trillion to the federal deficit over the next decade. Republicans argue the cuts combat fraud and preserve benefits for the neediest, while Democrats and health leaders warn the bill will gut safety-net programs, close hospitals, and worsen health outcomes. For kidney patients—nearly half of whom rely on Medicaid—these proposals represent a potentially massive disruption in coverage and care continuity.4

Visual of the Week

Biobanks and kidney research. This global snapshot of genomic biobanks and studies reflects both the scale and complexity of modern data infrastructure in healthcare—and the conversations at last week’s Kidney Innovation Conference made clear that we still have work to do. In the pediatric trials workshop, researchers, industry, and patients discussed the challenges of consent, data sharing, and alignment between foundations and commercial stakeholders. A major theme: patients want follow-through—”tell us where the data went, how it went, and who it helped.” We’ll be exploring this topic further in an upcoming Signals brief.

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News

• Medtronic to spin off its diabetes business: The company will separate its insulin pumps and glucose monitors unit into a standalone firm amid broader portfolio streamlining. The diabetes unit employs more than 8,000 people worldwide and represented 8% of Medtronic’s fiscal year 2025 revenue (Press, Becker’s, MedTech Dive).

• Lupin launches generic tolvaptan for ADPKD with 180-day exclusivity: The FDA-approved launch offers a lower-cost alternative to Jynarque for slowing kidney decline in adults with autosomal dominant polycystic kidney disease (ADPKD), entering a $1.4B U.S. market with first-to-file status (BW Healthcare World).

• Hinge Health pops 17% in public debut, but at half its 2021 valuation: The digital physical therapy firm closed its first trading day at $3B—down from its $6.2B Series E valuation in 2021—joining a wave of down-round IPOs reshaping expectations in digital health (CNBC, TechCrunch).5

• Dialysis giants DaVita and Fresenius face antitrust lawsuit: A union health benefits fund is suing the companies for alleged collusion and price inflation in dialysis services to the tune of billions of dollars (Reuters, Bloomberg, Denver BJ).

• DaVita hit by ransomware attack: On April 12, DaVita reported a ransomware breach that encrypted parts of its network; while patient care was unaffected, the Interlock gang has since claimed responsibility and allegedly leaked 700,000 files to the dark web. The attack follows similar breaches at Fresenius (500K patients) and UnitedHealth (100M affected) in recent years, highlighting escalating cybersecurity threats across third-party healthcare networks (Healthcare Brew, Reuters).

• CMMI releases new strategy to advance MAHA agenda: The CMS Innovation Center's 2025 strategy focuses on prevention, patient empowerment, and competition—signaling a shift toward site-neutral payment, broader provider inclusion, and upcoming model redesigns aligned with these pillars (CMMI, AAMC, Fierce).6

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Research

• First-in-human base editing therapy shows early success in rare metabolic disorder: NIH-funded scientists just achieved a major milestone in the evolution of personalized therapies for rare & ultra-rare inborn errors of metabolism (NEJM).

• USC engineers develop kidney-targeted gene therapy platform: Researchers created a nanoparticle-based delivery system for gene therapies using engineered extracellular vesicles to target kidney and cardiovascular disease (USC Viterbi).

• Deep learning predicts lupus nephritis treatment response: A multistain pathology-based AI model showed potential for personalized risk stratification in LN patients (LinkedIn post).

• New review highlights complexity of kidney recovery after AKI: A systematic review synthesizes evidence on the biological, clinical, and environmental factors influencing AKI recovery, revealing both progress and persistent uncertainty in how these factors interact—offering guidance for improving outcomes in post-AKI care (Cardiorenal Medicine).

• New insights on CLTI awareness and amputation prevention: Leaders in PAD and vascular care emphasize the need for culturally competent, community-driven outreach built on experience, exposure, and education—highlighting models like Get a Pulse on PAD that center patient voices and scalable storytelling approaches (EV Today, h/t Terry Litchfield).

• AI agents identify novel dry AMD treatment in 10 weeks: FutureHouse’s “Robin” system—using a closed-loop of AI agents—discovered Ripasudil as a candidate for dry age-related macular degeneration, marking a milestone in automated scientific discovery (FutureHouse).

• Deloitte explores “build-to-buy” as a rising model in medtech: A new report highlights the growing appeal of milestone-triggered acquisition deals between strategics and startups—offering early-stage medtech companies financial stability and R&D leverage, but often with capped upside and no guaranteed buyout (Deloitte).

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Community

• Full house at the Kidney Innovation Conference pediatric trial workshop: Researchers and advocates came together to explore how data extrapolation can unlock new therapies for kids with kidney disease (LinkedIn).

• Reflections on CMS’s open call for feedback: Value-based care advocates celebrated CMS’s new RFI as a rare chance to shape the regulatory future of coordinated, tech-enabled chronic care (LinkedIn).

• A must-read dialogue on dignity and dialysis: A powerful essay by Dr. Jeffrey Gold sparked an in-depth public conversation with Jeff Parke, a dialysis patient of 30 years, about why U.S. kidney care continues to lag behind global peers—and what meaningful reform must look like; Tom Mueller calls it “essential reading” for anyone serious about change in kidney care (LinkedIn).

• A family story of shared sacrifice and living donation: STAT published a moving personal piece on two sisters who each donated a kidney to their brother—a powerful testament to love and the life-changing impact of living organ donation (STAT).

• Healthy.io hits 300,000 test milestone: The company announced over 300,000 at-home urinalysis tests performed through its digital health platform, a major step in expanding kidney screening access outside the clinic (LinkedIn).

• Milestone moment for nephrology authorship: The 6th edition of Handbook of Dialysis includes four new chapters co-authored by rising leaders in kidney care—described as a “full-circle” moment by Dr. Tushar Vachharajani (LinkedIn).

• A must-bookmark VBC lecture series: Dr. Paulius Mui spotlighted a free set of educational videos covering the finer points of value-based contracts, risk adjustment, attribution, and bundled payments—essential context for anyone navigating VBC from the outside in (XPC Courses).

• What exactly is a “patient advocate”: In a recent post, Dr. Macey Levan asks the community to reflect on the meaning of the term “patient advocate” and many ways people identify with the goals, actions, and experiences of each (LinkedIn).

Events Calendar

• European Nephrology Conference (May 26-27 in Rome, Italy)

• European Renal Association (June 4-7 in Vienna, Austria)

• AMGA Value Roundtable (June 9-10 in Washington, DC)

• LSI Asia Summit (June 10-13 in Singapore)

• International Podocyte Conference (June 11-13 in Hamburg)

• Benesch Nephrology & Dialysis Conf (June 26 in Chicago, IL)

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Jobs

• Director, Generative AI — Natera

• Sales Manager – Digital Health — Vantive

• Lead Data Scientist - Healthcare Delivery — Oak Street Health

• VP, Member Experience Ops & Innovation — Cityblock Health

• Director, Process Development — ProKidney

• Manager, Patient Access — Intermountain Health

• Health Economic Policy & Reimb Analyst — Medtronic

• Director, Global Logistics — Akebia Therapeutics

• Assoc Dir, Market Access Data Specialist — Bayer

• Principal Reimbursement Analyst - RDN — Medtronic

• Transplant Medical Science Liaison — Sanofi

• Director, Digital Engagement & Innovation — Travere

• Global Program Clinical Head - Renal — Novartis

• Biostatistics Leader - CVRM — Roche

• Director of Drivers of Health — Blue Cross NC

• Browse 100+ more at jobs.signalsfs.com…

Find your next role

This newsletter brings together 15,000 kidney professionals in 50 countries every month around topics in kidney health and innovation. Please consider sharing it with your colleagues and friends. Thank you.

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Thoughts?!

Welcome to one of the busiest months for U.S. health policy, maybe ever. In the span of just a few days, we’ve seen a House GOP proposal that would dramatically cut Medicaid funding (Sunday), a sweeping new executive order on drug pricing (Monday), and launch of CMS Innovation Center’s “Make America Healthy Again” strategy (Tuesday). This week’s deluge follows last week’s leadership changes at two key agencies: Chris Klomp, a former health tech CEO known for his frugal, data-driven approach, is now overseeing Medicare—and Vinay Prasad has officially taken the reins at the FDA’s Center for Biologics. Suffice it to say: this Sunday newsletter became a Tuesday limited edition.

Each of these stories carries big implications—not only for federal spending and pharma policy, but for how millions of Americans access and pay for care.

This week’s recap is another small but necessary step toward the noise. If it’s getting louder, it’s because we’re getting closer to the source. We’re tracking the top policy shifts, regulatory updates, and industry signals, with particular attention to what they mean for kidney care and innovation.

Thank you for being here with us. If you find this recap valuable, consider forwarding it to a colleague or friend who’s working to make kidney health better for all.

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In this issue

• Trump’s latest Executive Order on drug pricing

• House GOP’s proposed Medicaid cuts spark pushback

• CMMI unveils its “Make America Healthy Again” strategy

• UnitedHealth CEO steps down; 2025 outlook suspended

• Vanderbilt adopts portable kidney perfusion tech

• FDA names first Chief AI Officer, rolls out AI-assisted reviews

• Pegcetacoplan receives Priority Review for rare kidney diseases

• Sonavex wins FDA clearance for EchoMap to aid dialysis access

• OpenAI launches HealthBench to evaluate medical LLMs

• Alport Syndrome Foundation hosts regulatory workshop

• Faith Lynch becomes ANNA’s new national president

• 15 new roles across Medtronic, Novartis, CVS, ADA, and more…

Signals

A wave of policy and regulatory shifts is reshaping the U.S. health landscape—from payment reform and drug pricing pressure to executive shakeups and CMS strategy resets. We’ll unpack many of these in upcoming briefs. For now, here are two major stories we’re watching that will impact the kidney space.

1. Trump’s new executive order revives drug pricing debate—and global pressure on pharma

President Trump has signed an executive order directing HHS to negotiate lower drug prices across public and private markets, with plans to enforce a “most favored nation” (MFN) pricing policy if talks stall. Under the order, HHS has 30 days to set international reference price targets and deliver them to drugmakers, with a proposed rulemaking plan to follow if “significant progress” isn’t made. The policy would cap U.S. prices based on those in peer nations and allow for direct-to-consumer pharmaceutical sales at those rates, while also tasking federal agencies with confronting foreign pricing practices and anti-competitive behavior. The announcement comes amid rising bipartisan momentum to rein in drug costs and follows new legislation from Sens. Josh Hawley and Peter Welch that would penalize companies for charging Americans more than patients in countries like Germany or Canada.1

The pharmaceutical industry is expected to push back, with prior PhRMA statements warning that international reference pricing would undermine investment and risk boosting reliance on foreign suppliers. But pressure is mounting: Americans pay significantly more for prescription drugs than those in other high-income countries—Revlimid, for example, costs nearly $1,000 per pill in the U.S. versus a fraction abroad (and costs 25 cents to make).2 A 2024 Congressional Budget Office report found international reference pricing would yield the greatest cost savings of seven major drug pricing proposals, though it also warned of potential impacts on innovation. Whether this order marks a shift in global drug pricing dynamics—or stalls like its predecessor—will depend on the next round of negotiations and how aggressively HHS moves to implement new rules.34

What do you think? What are you watching when it comes to this conversation and how do you see this impacting pricing and innovation in the kidney space?

2. House GOP proposes $880B in Medicaid cuts, triggering warnings from providers, patient groups, and kidney advocates

House Republicans have introduced a sweeping budget reconciliation package that would cut an estimated $880 billion in federal spending over the next decade—primarily by tightening eligibility, rolling back ACA provisions, and slashing Medicaid funding. The proposal includes work requirements of 80 hours per month for certain Medicaid enrollees, a shift to biannual eligibility redeterminations, and the elimination of pandemic-era funding boosts. The Congressional Budget Office estimates the changes would leave 13.7 million more Americans uninsured by 2034, with at least $715 billion of the total savings coming from health provisions.5

Industry and advocacy groups have responded with swift condemnation. The National Kidney Foundation warned that the proposals are a “direct threat to the health and survival” of patients, noting that nearly half of all dialysis patients rely on Medicaid. Hospital associations, Medicaid plans, and patient advocacy organizations—including Families USA and the American Hospital Association—echoed concerns that the bill would destabilize safety net programs, reduce access to life-saving care, and push vulnerable Americans into crisis. While Republican lawmakers frame the package as a “common sense” approach to restore fiscal balance, many analysts believe the cuts go too far to gain traction in the Senate. The House Energy & Commerce Committee is expected to hold hearings on the proposal this week as part of a broader push to pass the bill before Memorial Day.6

Visual of the Week

CKD receives $19 per person in research funding. This week’s visual comes from Pranav Garimella, who spotlighted the stark disparity in NIH research investment across major diseases. Despite affecting over 35 million Americans, chronic kidney disease receives only $19 per person—compared to $2,662 for HIV, $2,600 for cystic fibrosis, and $2,370 for sickle cell disease. It’s a timely reminder that research priorities often lag behind the true burden of disease. Personally, at a time when national policy is laser-focused on chronic illness, root causes, and cost containment, I’d hope to see far more—not less—resources directed toward a condition that accounts for 1 in every 5 Medicare dollars.

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News

• Omada Health files for IPO, signaling renewed momentum in digital health markets. Virtual chronic care provider Omada Health has filed to go public on the Nasdaq under the ticker “OMDA,” marking one of the first digital health IPOs of 2025. With over one million members served and a growing portfolio of condition-specific programs—including GLP-1 support—Omada is positioning itself as a scalable solution for employers and health plans navigating chronic disease management (Fierce, Second Opinion).

• FDA grants Priority Review to pegcetacoplan for C3G and IC-MPGN. The FDA has accepted a supplemental New Drug Application for pegcetacoplan (Empaveli) to treat C3 glomerulopathy and IC-MPGN, supported by phase 3 data showing a 68% reduction in proteinuria and stabilization of kidney function. If approved, it would mark the first targeted therapy for these rare, progressive kidney diseases, with a decision expected by July 28, 2025 (Neph Times).

• Sonavex secures FDA 510(k) clearance for EchoMap. EchoMap combines 3D ultrasound and AI algorithms to help dialysis technicians visualize fistulas or grafts before cannulation, aiming to reduce complications from missed access. As Dr. Randy Cooper, the study’s principal investigator, noted: “This device offers real promise to reduce cannulation complications and associated fear and stress for our patients.” A post-market study with a large dialysis organization, backed by NIH funding, will evaluate its clinical impact later this year (Press release).

• Vanderbilt surgeons first in Tennessee to use next-gen kidney preservation technology. Vanderbilt Health has become the first center in the state to adopt the FDA-approved KidneyVault from Paragonix, a portable hypothermic perfusion system that preserves donor kidneys more safely and consistently during transport. Unlike traditional ice storage, the device provides continuous perfusion and temperature control for up to 24 hours (AHA.org, h/t Paul Gordon).

• UnitedHealth CEO Andrew Witty resigns; company suspends 2025 outlook amid continued turmoil. Witty stepped down abruptly Tuesday, citing personal reasons after a turbulent four-year tenure marked by a cyberattack, executive tragedy, and mounting pressure on the Medicare Advantage business. The company also suspended its 2025 profit forecast—just weeks after a 12% downward revision—sending shares down more than 11% in morning trading (Reuters, STAT).

• Deerfield Management has raised over $600 million for its third Healthcare Innovations Fund, targeting breakthroughs in therapeutics, care delivery, and AI-enabled technologies. Backed by partnerships with top research institutions and housed at its NYC-based Cure innovation campus, the fund will operationalize innovation through Deerfield’s in-house discovery and development teams (Press Release, Endpoints).

• Robust pharma M&A and licensing activity continues despite market headwinds, with $60B in 2025 deal volume. Through early 2025, pharma companies have completed 38 deals totaling nearly $60 billion, with a strong tilt toward early-stage assets—especially in oncology and small molecules. Facing looming patent expirations and attractive biotech valuations, companies like Merck and BMS are doubling down on later-stage licensing and M&A to refill their pipelines (LinkedIn, h/t Andrew Pannu).

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Policy & Regulatory

• $880B in Medicaid cuts proposed. Republicans have unveiled a sweeping plan to slash Medicaid and ACA spending—introducing work requirements, biannual eligibility checks, and other restrictions—to help offset $4.5 trillion in Trump-era tax cuts set to expire this year. While GOP leaders tout it as a push to reduce fraud and rein in costs, Democrats warn the proposal could strip coverage from over 8 million people, reigniting ACA repeal tensions and raising uncertainty as Trump himself signals opposition to Medicaid cuts (AP News, NYT, The Hill).

• Trump administration unveils aggressive drug pricing plan tied to global benchmarks. President Trump announced a sweeping executive order adopting a “most-favored nation” policy that would tie U.S. drug prices to the lowest paid globally and authorize HHS to enforce price targets through federal rulemaking. The order also empowers federal agencies to negotiate directly with industry, challenge foreign pricing policies deemed discriminatory, and expand direct-to-consumer access. While framed as a win for U.S. patients, the administration expects the policy will raise drug prices abroad—bringing new revenue to pharma even as investor confidence wavered, sending stock prices down ahead of the announcement (Reuters, STAT, Axios, The Hill).

• CMS Innovation Center unveils “Make America Healthy Again” strategy focused on prevention and patient choice. CMS Administrator Dr. Mehmet Oz and Innovation Center Director Abe Sutton introduced a new strategic direction for CMMI that centers on evidence-based prevention, patient empowerment, and expanded competition across Medicare and Medicaid. The updated framework responds to the Trump administration’s call for transformation and includes plans to scale lifestyle-focused care models, promote digital tools, and build logical payment systems that reward healthier outcomes (CMS.gov, Webinar).

• FDA completes first AI-assisted scientific review and sets June 2025 deadline for agency-wide rollout. FDA Commissioner Dr. Marty Makary announced the success of the agency’s first generative AI pilot for scientific review, calling the technology a “game-changer” for reducing repetitive workload and accelerating drug evaluations. The FDA now plans to deploy AI tools across all centers by June 30, 2025, marking a major shift in how therapies are reviewed internally (FDA.gov).

• FDA appoints first Chief AI Officer and rolls out generative AI platform. Jeremy Walsh has been named the FDA’s Chief AI Officer as the agency begins deploying a generative AI system to streamline scientific reviews and reduce administrative burden. Walsh brings over a decade of healthcare AI experience from Booz Allen and will lead efforts to modernize FDA operations through cloud and machine learning technologies (MedTech Dive, h/t Ken Nelson).

• The Trump administration has appointed former Collective Medical CEO Chris Klomp to lead Medicare. He’s known for his cost-cutting ethos and tech-driven approach, and is expected to prioritize data sharing, efficiency, and digital modernization as he takes the helm of one of the nation’s largest and most expensive health programs. For context, Medicare controls payments and benefits for 68 million older adults and people with disabilities, at a cost of over $1 trillion a year (STAT).

• Vinay Prasad named head of FDA biologics center, drawing scrutiny and cautious optimism. Vinay Prasad, a UCSF professor and outspoken critic of the medical establishment, has been appointed to lead the FDA’s Center for Biologics Evaluation and Research (CBER), which regulates vaccines, gene therapies, and the blood supply. While markets reacted with unease—sending the S&P Biotech ETF down over 6%—Prasad’s first speech to FDA staff, described by multiple sources as unexpectedly measured and self-aware, suggested a return to nuance from a figure known as both a rigorous researcher and a polarizing public voice (STAT, MedPage Today, This Week at FDA).

• Proposed FDA reorganization could weaken regulatory expertise and disrupt oversight, experts warn. A new JAMA commentary by Drs. Scott Gottlieb and Mark McClellan argues that the DHHS plan to consolidate FDA product centers into a single regulatory office would erode domain-specific expertise and fracture coordination between review and compliance functions. The authors caution that such a sweeping overhaul risks bureaucratic inefficiency and undermining the FDA’s capacity to respond effectively to emerging public health threats (JAMA).

Research

• Guatemala-led resolution puts kidney health on the global NCD agenda for the first time. For the first time in history, the World Health Assembly is expected to vote on a resolution to formally recognize chronic kidney disease as a priority non-communicable disease, thanks to a proposal led by Guatemala and backed by 18 countries. The resolution calls for integrated, prevention-focused approaches—including early detection, primary care integration, and equitable access to therapies—to address a global burden that affects 850 million people and disproportionately harms those in low- and middle-income countries (The Lancet).

• Ten things I wish I knew as a new peritoneal dialysis nurse. A new guidance from the International Society for Peritoneal Dialysis offers practical advice for nurses entering home PD programs, emphasizing not just procedural skills but also patient education, individualized training, and long-term support. Using a modified Delphi method, experts identified essential insights to help nurses improve patient outcomes and extend time on PD beyond basic clinical competence (ISPD).

• New global survey aims to identify barriers in diagnosing and managing pregnancy-associated acute kidney injury (PrAKI). Led by King’s College London and supported by the Global PrAKI Consortium and ISN, this international effort seeks to better understand the challenges frontline providers face in recognizing and treating PrAKI—a leading and often preventable cause of maternal and fetal morbidity worldwide. The 10–15 minute survey is open to all healthcare professionals caring for pregnant or recently postpartum individuals (h/t Liz Lightstone).

• Deep learning model predicts lupus nephritis treatment response from multi-stain kidney biopsies. Researchers developed a deep learning model that integrates multiple renal histopathology stains to predict 12-month treatment response in lupus nephritis, achieving AUCs up to 0.90 in internal validation and outperforming conventional clinical markers. The model identified histologic features such as glomerulosclerosis and interstitial fibrosis as key predictors, offering a potential tool for risk stratification and personalized therapy decisions pending further validation (KI Reports, h/t Davide Garrisi).

• Medicare Advantage enrollment linked to lower odds of kidney transplant waitlisting, new study finds. A Regenstrief Institute study published in JASN found that older adults initiating dialysis under Medicare Advantage had an 18% lower likelihood of being waitlisted for transplant within one year compared to those with traditional Medicare—a disparity that persisted after adjusting for health and socioeconomic factors. As enrollment in Medicare Advantage grows, particularly among historically underserved groups, the findings raise concerns that network restrictions and benefit design may be contributing to inequities in transplant access (JASN).

• Face mask sensor detects kidney disease through breath with high accuracy, study shows. A new study in ACS Sensors found that a modified surgical mask equipped with a breath sensor could detect chronic kidney disease by identifying elevated ammonia and related gases—correctly diagnosing the condition 84% of the time. Researchers say the technology may help monitor disease progression and support earlier, noninvasive diagnosis in clinical and community settings. (ACS Sensors, see mockup below)

• Milken Institute report calls for action to expand connected care for aging at home. A new report from the Milken Institute outlines a roadmap for building a robust connected care ecosystem that supports healthy aging at home through telehealth, remote monitoring, and AgeTech. With 75% of adults over 50 preferring to age in place, the report highlights six core strategies to overcome adoption barriers, workforce gaps, and fragmented care tools—urging coordinated action across health systems, housing, tech, and finance (Milken Institute).

• ACOs in Medicare Shared Savings Program reduced costs by up to 2.4% over six years, study finds. A decade-long analysis of over 8 million patients found that ACOs participating in the MSSP lowered per-patient Medicare spending by $294 over six years, with physician-led and smaller ACOs achieving the greatest savings. These results translated to an estimated $4.1 to $8.1 billion in total Medicare savings between 2012 and 2019, underscoring the growing long-term impact of value-based care models (JAMA, see below).

• New NEJM AI paper outlines key challenges in applying machine learning to primary care. Unlike hospital data, which is deep and episodic, primary care data is longitudinal, low-signal, and fragmented—making it harder to train effective models. The authors argue that meaningful ML integration will require methods tailored to the realities of primary care delivery, including representative data, whole-person outcomes, and validation strategies for decentralized settings (NEJM, h/t Paulius Mui).

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Community

• Mark Lim reflected on the recent Alport Syndrome Research & Regulatory Workshop, hosted by the Alport Syndrome Foundation, which brought together families, clinicians, researchers, and FDA and NIH leaders to shape future treatment pathways for this rare genetic kidney disease.

• Faith Lynch was officially welcomed as the new National President of the American Nephrology Nurses Association (ANNA), representing over 60,000 nephrology nurses nationwide.

• The KARE Initiative, formerly the DECK study, secured local funding to continue its community-based kidney screening work in Richmond, VA (h/t Amber Paulus, PhD, RN).

• The American Kidney Fund hosted a Maryland town hall for APOL1-mediated kidney disease awareness, featuring patients, clinicians, and Congressman Glenn Ivey.

• Tufts Medicine opened a new Inpatient Abdominal Transplant Unit and hosted healthcare leaders for a tour of its Simulation and Clinical Skills lab (h/t Sharon Klarman).

• Carna Health co-founder Boris Berat shared his latest Forbes Technology Council piece on rebuilding healthcare infrastructure with technology that prioritizes real-world complexity over hype.

• Christina Farr spotlighted Jacob Reider’s argument for when health startups should buy or build their own EHRs—a nuanced take on product strategy in clinical tech.

• Lizzy Lawrence updated STAT’s FDA leadership tracker with recent high-level departures across oncology, drug marketing, and device divisions.

• Sachin Jain, MD, MBA reminded us that many of today’s “new” ideas—like value-based care and social services integration—are deeply rooted in earlier models, and still evolving.

• Raihan Faroqui, MD recapped the NAACOS Spring Conference, where stakeholders debated AI use cases, MSSP reforms, and operational challenges in managing mixed Medicare panels.

• Anna Kaltenboeck raised a timely question around a new ProPublica piece: what threshold of promise should justify investment in new drug development—and how do we define “enough” in today’s R&D environment?

• A new primary care training course from XPC is now freely available, offering 15 sessions on clinical workflows, payments, and operations (h/t Paulius Mui, MD and Kenneth Qiu, MD).

• Jonathan Slotkin highlighted the launch of HealthBench, OpenAI’s new benchmark to evaluate healthcare LLMs using 5,000 multilingual case conversations contributed by 262 physicians in 60 countries (see image).

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Events Calendar

• UCSD Reimagine Grand Rounds (May 14 in San Diego, CA)

• VASA 2025 (May 16-17 in St. Louis, MI)

• Kidney Innovation Conference (May 21-22 in Washington, DC)

• AMGA Value Roundtable (June 9-10 in Washington, DC)

• Benesch Nephrology & Dialysis Conf (June 26 in Chicago, IL)

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Jobs

• Sr Director Strategy and Transformation at Medtronic

• Principle Market Development Specialist - RDN at Medtronic

• Organ Health Specialist (Brooklyn) at Natera

• Global Program Clinical Head - Renal at Novartis

• Sr. Patient Relations Manager at Oak Street Health

• Principal – Evidence & Strategy at Avalere Health

• Global Head, Rare Disease Development at Recursion

• VP & CISO at Boston Children's Hospital

• Account Sales Representative IV at Mozarc Medical

• AVP, General Manager - Medicare (NY/NJ) at CVS Health

• APAC Pricing Analyst at Mozarc Medical

• Vice President, Information Technology at Akebia

• Head of Industry, Healthcare at Viant Technology

• Director of Impact and Innovation at Novartis Foundation

• Advocacy Coordinator at American Diabetes Association

• Senior Director, Policy and Strategy at American Diabetes Association

• Associate Professor/Clinical Investigator - Nephrology at Geisinger

• Browse 50+ more at jobs.signalsfs.com…

Find your next role

Moving You Forward

Thank you for reading Signals, the leading newsletter for kidney innovation, ideas, and investment. We recently launched Signals Advisory to help companies, investors, and organizations navigate the evolving kidney research, regulatory, and commercial landscapes. Share your next milestones here.

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As we head deeper into 2025, the landscape around kidney health, innovation, and policy is shifting quickly—and not just here in the United States. On May 19, the World Health Assembly will gather for its 78th meeting to decide how to allocate its (shrinking) resources toward the world’s most urgent health needs. A recent editorial in Nature argues that we have a golden opportunity to recognize and rein in the largely overlooked burden of chronic kidney disease—now one of the fastest-growing causes of premature death globally, projected to become the fifth leading cause of years of life lost by 2040.1

Here at home, we’re also navigating a thick fog of uncertainty that continues to spread far and wide. A huge thank you to Miriam Godwin from the National Kidney Foundation for lending her expertise to help us unpack the potential impact of the leaked FY2026 HHS budget proposal. It’s a powerful reminder of how much advocacy, research, and innovation remain essential as the ground moves beneath us.

Before we dive in: a fun surprise—Signals was named a Bestselling newsletter on Substack and landed at #60 on Substack’s Rising 100 Health & Wellness list. Thank you for helping put global kidney health "on the map." It’s encouraging to see topics like kidney disease, research, policy, innovation, and investment earn a seat at the table alongside broader conversations about health.

Thank you for being here with us. If you find this recap valuable, consider forwarding it to a colleague or friend who’s working to make kidney health better for all.

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In this issue

• What a proposed $40B cut to HHS could mean for kidney care

• FDA Commissioner appoints new leadership team

• First clinical trial using pig livers for liver failure approved

• MIT study highlights tradeoffs in kidney transplant allocation

• Kidney disease advocacy ramps up ahead of WHO vote

• Strive Health expands partnership with Aetna

• Paragonix hits 100th kidney transplant milestone

• New research on PD training, acute dialysis costs, and liver allocation

• Breakthroughs in kidney gene therapy and robotic transplant milestones

• TEDx, NEJM Catalyst, and podcast highlights from across the community

• New roles at Diality, CareDx, Novartis, NKF, Eurofins, and more

• See 50+ open kidney roles at jobs.signalsfs.com

This edition of Signals is brought to you by Natera. With over 130,000 patients tested with the Renasight™ test, Natera has the largest commercially available kidney disease database that can help accelerate research and drug development in the space. Discover how Natera’s Renasight™ database helped accelerate an Alport Syndrome clinical trial by 3x. Thanks team!

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What a Proposed $40B Cut to HHS Could Mean for Kidney Care

Summary: Last week, a leaked FY2026 budget proposal outlined plans to cut $40 billion—about one-third—of the Department of Health and Human Services’ discretionary funding. Major programs would be consolidated, eliminated, or reorganized, including the dissolution of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) into a broader National Institute on Body Systems, the elimination of the KidneyX innovation accelerator, and a shift away from chronic disease prevention at the CDC. These changes could have far-reaching implications for kidney health research, innovation pipelines, and access to federal funding streams that have supported progress over the last decade.

Thoughts: While budget proposals often face an uphill battle in Congress, the sheer scale and focus of this one sends an important signal about shifting federal priorities. Consolidations like those proposed for NIDDK could dilute disease-specific funding, while the elimination of KidneyX would dismantle a proven model for accelerating kidney innovation. Chronic disease efforts—already underfunded compared to infectious disease—would likely take another step backward. It's a moment that calls for close attention and collective advocacy from the kidney community.

A big thanks to Miriam Godwin, Vice President of Health Policy at the National Kidney Foundation, for sharing her perspective and helping us break this down. You can listen to Miriam’s quick take above and get more details in our full brief below.

What do you think? What are you watching most closely as this budget proposal unfolds? How should the kidney community prepare for these potential changes?

Get the full brief

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Visual of the Week

Behold: A “Simplified” U.S. Payer Landscape. This week’s visual comes from Emraan Khan, who captured the sprawling complexity of U.S. public payer pathways across Medicare, Medicaid, and PACE programs. Every box on the chart represents a real-world system someone has to navigate—often while sick, aging, or facing financial hardship. It’s a humbling reminder of how fragmented access to care remains, and how much work lies ahead to build systems that are truly navigable and equitable. The thoughtful comments on Emraan’s post highlight just how invisible and burdensome these barriers can be for patients—and how important collaboration and shared understanding will be to fix them.

For kidney patients, who may qualify for multiple programs but must navigate dialysis, transplant, or complex specialty care at the same time (if they’ve been referred), making these pathways simpler isn't just policy work—it’s a critical lifeline.2

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News

• Dr. Robert Montgomery was named to the TIME 100 Most Influential list for revolutionizing organ transplantation through innovations like laparoscopic kidney donation, domino paired donations, and advancing xenotransplantation. His work has expanded access to life-saving organs and shaped the future of transplant medicine (TIME).

• Paragonix Technologies announced a milestone 100th kidney transplant case using its FDA-cleared KidneyVault™ Portable Renal Perfusion System, reflecting the continued adoption of mobile, data-driven organ preservation. As of today, 12 OPOs stock the device, including Tennessee Donor Services, which serves 6 million people across Tennessee and Virginia (Business Wire).

• The FDA approved a first-of-its-kind clinical trial testing whether gene-edited pig livers can externally filter blood in patients with sudden liver failure. An estimated 35,000 Americans are hospitalized for acute liver failure each year, facing death rates as high as 50%, with few treatment options available (NBC News).

• Strive Health expanded its partnership with Aetna, adding Medicare Advantage members in Connecticut and Ohio (builds on existing coverage in Illinois, Indiana, and Michigan). The company also named Paul Marchetti as President and promoted Jen Browne to Chief Operating Officer as it scales operations to support growth (LinkedIn, Strive Health, h/t Will Stokes).

• Sonavex shared progress on its MAFASA clinical trial, partnering with Dr. Christopher Mitromaras and the team at Atrium Health and the Sanger Heart & Vascular Institute to study the the EchoMark®/EchoSure® System for AVF diagnostic ultrasound (LinkedIn, h/t John Rappe).

• University of Toledo scientists found that activating the melanocortin 5 receptor (MC5R) could reduce kidney damage, offering a more targeted approach to treating glomerular diseases and reducing proteinuria without relying on broad immunosuppressants. Their NIH-funded research was just published in Kidney International’s May issue (University of Toledo).

• Shraddha Kalgutkar’s transplant survival highlights organ preservation. Mayo Clinic used innovative warm perfusion technology ("liver in a box") and mobile ECMO support to perform a complex transplant that saved Shraddha Kalgutkar’s life, showcasing the power of combining advanced preservation methods with patient-centered critical care (Mayo Clinic).

Policy

• FDA Commissioner Marty Makary announced three new agency leaders this week, including Lowell Zeta as deputy commissioner for strategic initiatives and Craig Taylor as the acting chief information officer. Zeta served as a senior adviser to the commissioner during the first Trump administration, and helped lead the FDA’s 2020 initiative to evaluate its Covid-19 response (STAT News).

• FDA officials warned that staff reductions tied to the new Department of Government Efficiency (DOGE) restructuring have led to missing or delayed updates in drug safety and manufacturing databases. Experts say these databases are critical for clinicians, researchers, and supply chains, raising alarms about patient safety and transparency risks (Axios).

• STAT News launched a day-by-day interactive timeline documenting major policy changes impacting science, health agencies, and global health, including funding cuts, agency reorganizations, communication freezes, and executive orders reshaping public health infrastructure (STAT News).

• AdvaMed published an “AI Policy Roadmap” urging Congress and federal agencies to modernize regulations, payment models, and privacy protections to accelerate access to AI-enabled medical devices. Over 1,000 AI-authorized technologies have been cleared by the FDA to date, with future policies seen as critical to expanding patient access and innovation (AdvaMed, h/t Jed Dadson).

• How should we prioritize patients waiting for kidney transplants? MIT researchers found that current kidney transplant practices generate 9.29 additional life-years for recipients on average, but that figure could rise to 14.08 with optimized allocation favoring healthier patients — highlighting a policy tradeoff between prioritizing the sickest patients and maximizing overall survival gains (MIT Press).

Research

• A new chart collection from the Peterson Center on Healthcare-KFF Health System Tracker highlights that chronic kidney disease (CKD) prevalence in the U.S. has remained substantially higher than in peer nations over the past three decades, with a 24% higher prevalence rate than comparable countries as of 2021 (Peterson-KFF Health System Tracker).

• A new Nature editorial argues kidney disease must be recognized as a global health priority. Its authors call on the World Health Assembly to formally recognize chronic kidney disease as a major non-communicable disease (NCD), citing its global prevalence (674 million people), rapid growth, and links to premature mortality (Nature, h/t Helen Yeh).

• How do PD training methods and educational interventions impact on PD outcomes in adult patients? A narrative review highlights gaps in the evidence base for peritoneal dialysis (PD) training interventions but suggests that individualized training approaches, pre-training assessments, and consistent outcome measures may improve PD outcomes in adult patients (Journal of the International Society for Peritoneal Dialysis).

• An updated review of Membranous Nephropathy (MN) discusses recent advances in antigen mapping, genetic and environmental risk factors, and evolving therapeutic strategies, emphasizing its status as a leading cause of nephrotic syndrome in adults and the growing clinical role of PLA2R antibody testing (Indian Journal of Nephrology, h/t Edgar Lerma).

• A new case report published in AJT highlights the growing role of genetic testing in kidney transplant clinics and the need for collaboration among nephrologists, cardiologists, and genetic counselors when evaluating candidates with hereditary transthyretin (TTR) amyloidosis (AJT, h/t Yasar Caliskan).

• A new position paper from the International Xenotransplantation Association reviews the history, regulatory milestones, and technical innovations that have enabled recent clinical translation of heart and kidney xenografts, emphasizing emerging frameworks for ethical and safe application-specific standards (Transplantation, see milestones below).

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• If you are offered a choice to participate in a clinical trial - do you or your family know what questions to ask? A new survey led by the Kidney Health Initiative and National Kidney Foundation seeks patient and care partner input to help inform clinical trial decision-making for kidney xenotransplants, building on prior patient-focused research and a collaborative meeting with the FDA (KHI, h/t Mark Lim).

• A new study from Norman Regional Health System found that transitioning to an in-house dialysis care model at a regional acute care hospital in Oklahoma increased treatment volume by 400% and improved successful dialysis completion rates from 73.7% to 97.5% over nine months (Healio).

• A new study found that discontinuation of IV etelcalcetide following a US reimbursement policy change led to a rapid and sustained increase in parathyroid hormone (PTH) levels among hemodialysis patients, with particularly pronounced effects among Black patients, raising concerns about unintended clinical disparities (CJASN, h/t Neph Times).

• A new simulation study found that shifting to survival benefit-based liver transplant allocation would increase post-transplant survival by only 18 days on average, while potentially leading to 400 additional waitlist deaths annually, supporting the continued use of sickest-first allocation (Hepatology).

• A new perspective piece outlines how digital health technologies (DHTs) can expand decentralized clinical trials by enabling continuous remote data collection, improving participant access and engagement, and supporting the development of novel clinical trial endpoints (JAMA Health Forum).

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Community

• Vincent Ko recently highlighted Nephrogen, a new biotech developing next-generation gene therapies for kidney diseases, including a single-administration treatment for autosomal dominant polycystic kidney disease (ADPKD) using a novel capsid delivery platform 100x more efficient than standard AAVs (LinkedIn, h/t Vincent Ko).

• Dr. Tarek Alhamad, Medical Director of Transplant Nephrology at Washington University in St. Louis, celebrated a milestone of 45 kidney transplants performed in a single month, marking a new record pace for the program (LinkedIn, h/t Tarek Alhamad).

• Anna Kaltenboeck shared highlights from ATI Advisory’s 2024 Biopharma Year in Review, noting continued R&D momentum, a shift toward earlier-stage deals, the rise of China-based biotech licensing, and growing focus on the Medicare Part D redesign and its projected impact on biopharma revenues (LinkedIn, h/t Anna Kaltenboeck).

• Dr. Bijal Patel celebrated a major milestone for Balboa Nephrology and Sharp Memorial Hospital, where Dr. Marquis Hart performed San Diego’s first robotic-assisted kidney transplant — an exciting step forward in surgical innovation and patient care for the community (LinkedIn, h/t Bijal Patel).

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• NephCure recognized Dr. Martin Pollak and his team for their decades of groundbreaking work advancing research and hope for the rare kidney disease community (LinkedIn, h/t NephCure).

• Renee Aguiar-Lucander, former CEO of Calliditas Therapeutics, announced she has taken on the role of CEO at Hansa Biopharma to lead the development of its proprietary IgG-cleaving platform (LinkedIn, h/t Renee Aguiar-Lucander).

• Kate de Lisle highlighted new analysis from Rob Mechanic and the Institute for Accountable Care on TEAM, CMMI’s forthcoming mandatory episode-based payment model set to launch in 2026, which will require closer collaboration between hospitals, specialists, primary care, and ACOs (LinkedIn, h/t Kate de Lisle).

• The team at 34 Lives marked the one-year anniversary of their first rescued kidney transplant, reporting that their original study goal of 80 rescued kidneys has been surpassed with 125 completed transplants to date, in partnership with OPOs and transplant centers nationwide (LinkedIn, h/t 34 Lives).

• Nick Bartz, Co-Founder and CEO of Kairon Health, shared reflections on the persistent challenges in value-based care (VBC) contracting, highlighting how one-size-fits-all approaches often fail to account for real practice economics and operational realities. His post is a great reminder of the need for more tailored transition strategies as practices navigate the shift from fee-for-service to VBC models (LinkedIn, h/t Nick Bartz).

• Dr. Vimal Mishra, Chief Medical Officer at Dignity Health, shared results from a new NEJM Catalyst paper highlighting UC Davis Health’s Urgent Care at Home model, which served 815 high-risk patients over six months, achieved a >100% ROI, and reduced emergency department visits by delivering digitally enabled, clinically integrated care at home (LinkedIn, h/t Vimal Mishra).

Watch & Listen

• Dr. Joe Scalea, Vice Chair and Professor of Surgery at MUSC, delivered a powerful talk at TEDxCharleston last week titled ‘Four Reasons to Live.’ He reflects on lessons from transplant patients about what makes life meaningful, drawing on experiences from his work caring for patients facing organ failure and new chances at life (LinkedIn, h/t Joe Scalea).

• Dr. Erick Bricker joined Stacey Richter on the Relentless Health Value podcast to explain how hospital systems leveraged provider stop-loss reimbursement clauses and chargemaster manipulation to drive up costs for employer-sponsored plans—highlighting why recent insurer strategies to control these dynamics have started to fail (LinkedIn, h/t Erick Bricker).

Events Calendar

• ANNA National Symposium (May 1-4)

• KHI Kidney Innovation Conference (May 21-22)

• World Transplant Congress (August 2-6)

• ASN Kidney Week (November 5-9)

• VEITH Symposium (November 18-22)

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Jobs

• Senior Director, US Patient Advocacy at Lundbeck

• Transplant Laboratory Tech II at University of Utah

• Director, State Government Affairs at hims&hers

• Sr Director, Innovative Product Development at GSK

• Product Marketing Manager at Diality

• Solid Organ Transplant Clin Dir of Ops at Tufts MC

• Customer Implementation Manager at Healthie

• Senior Director, SEC Reporting & Accounting at CareDx, Inc.

• Organ Health Specialist at Natera

• Commercial Dev Manager, Digital Tech at Medtronic

• Associate Director, Health IT Strategy at Novartis

• Director of Professional & Sci Comms at NKF

• Market GM, Patient Care Solutions at GE Healthcare

• Implementations & Customer Success Specialist at Avo

• Director, Special Projects (ROPS) at DaVita

• Browse more at jobs.signalsfs.com…

Browse 40+ openings

Moving You Forward

Thank you for reading Signals Media, the leading newsletter for kidney innovation, ideas, and investment. We recently launched Signals Advisory to help companies, investors, and organizations navigate the growing, complex kidney health landscape. Learn more and share your next milestones here.

Learn more

It’s been a busy couple of weeks in kidney care and beyond. After back-to-back meetings at RPA and NKF, we’re still catching up with all of you and everything happening across the field. Thanks to everyone who stopped by to share what’s on your mind and what’s changing in your corner of kidney health.

In this issue, we’re digging into the two biggest headlines: sweeping HHS layoffs and CMS leadership changes, and the mass resignation of patient representatives from the OPTN Board. We also highlight dozens of headlines, research updates, and community voices that are shaping the kidneyverse right now.

We’re also excited to officially launch two major new efforts at Signals:

• Our Kidney Jobs site, where you’ll find some of the most compelling roles and key hires in the space. We connect bright minds with bold teams—try it out, and share any feedback or high-priority roles you’d like to see featured.

• Our Expert Advisory Network, which brings together subject matter experts across research, policy, industry, and care delivery to help organizations navigate the kidney landscape with confidence. Get matched for virtual 1:1s and roundtables on topics like discovery, pricing, market access, or value-based care.

Big welcome and thank you to our newest partners, Natera and Guaranteed, and the eight amazing teams who’ve signed on already this month. Your support makes this work possible.

As always, thanks for being here. Let’s keep exploring.

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In this issue

• HHS shakeup and CMS overhaul raise big questions for kidney care

• Patient reps resign from OPTN Board over lack of voice

• Avalere: CMMI models cost billions—but some show promise

• FDA approves new IgAN drug, expanding treatment options

• Pig kidney explant sets xenotransplantation milestone

• Interwell CEO: “You have to do everything. That’s what makes it hard.”

• Research on glomerular disease, home dialysis, ischemia & more

• Community updates from NKF, GloPAKH, Vitality, & more

• 20+ new open roles now live on jobs.signalsfs.com

This edition of Signals is brought to you by Natera. With over 130,000 patients tested with the Renasight™ test, Natera has the largest commercially available kidney disease database that can help accelerate research and drug development in the space. Discover how Natera’s Renasight™ database helped accelerate an Alport Syndrome clinical trial by 3x. Thanks team!

Learn more

Signals

What’s happening at HHS?

Layoffs, leadership shifts, and contradictory signals on chronic disease are reshaping federal health priorities—and raising big questions for kidneys.

Summary: The US Department of Health and Human Services is undergoing its most dramatic transformation in decades. Following a March executive order, HHS Secretary Robert F. Kennedy Jr. announced the elimination of 20,000 federal health jobs and a reorganization consolidating 28 offices into a new Administration for a Healthy America (AHA). Newly confirmed Dr. Mehmet Oz will lead CMS. While Kennedy says the goal is to “end the chronic disease epidemic,” the scale and pace of change have sparked concern among researchers, regulators, and providers.

Thoughts: Entire teams at FDA, CDC, and NIH have been cut, including units responsible for tobacco control, infection surveillance, and medical countermeasures. 3,500 FDA staff were part of the first wave of layoffs. Former FDA Commissioner Robert Califf warned that institutional knowledge is being lost “overnight.” Meanwhile, the Center for Medicare and Medicaid Innovation (CMMI), which oversees payment reform pilots like the now-terminated ETC Model, is facing renewed scrutiny. A new report from Avalere Health found that while CMMI lost $6.4 billion across 18 models, several—including disease-specific efforts—showed promise in reducing costs and improving care. Critics worry that ending models early may undermine longer-term kidney care innovation.

The kidney community is watching closely. In February, Dr. Jesse Roach of the National Kidney Foundation called the layoffs “haphazard and indiscriminate,” highlighting direct impacts on transplant oversight and dialysis safety. Kennedy had pledged to appear quarterly before the Senate HELP Committee but skipped a scheduled hearing last week. Meanwhile, the FDA’s top vaccine official, Dr. Peter Marks, resigned citing disagreements with Kennedy. HHS has acknowledged that 20% of the recent 10,000 job cuts may have been issued in error.

Those contradictions deepened after the sudden termination of the NIH’s Diabetes Prevention Program, a 25-year research effort involving 27 institutions. Though the program helped define how to prevent and manage one of the nation’s most expensive and deadly chronic conditions, it was defunded—seemingly not due to merit, but because its principal investigator had shifted affiliations to Columbia University, which recently lost $400 million in federal contracts. “This is a huge mistake,” said Dr. Ezekiel Emanuel, warning that dismantling high-impact, multi-institutional research in the name of politics could undermine the very priorities HHS claims to champion.

What do you think? Will this restructuring and renewed focus on chronic disease be the tailwind kidney care needs to move forward? Or will the disruption and uncertainty stall momentum across payment reform, reimbursement, and innovation?

Join the discussion

Patient Leaders Resign from OPTN Board Amid Growing Frustrations

Summary: Last week, nearly all patient and donor family representatives on the OPTN Board of Directors resigned in protest, citing a lack of voice in major decisions tied to the ongoing OPTN Modernization Initiative. In their joint resignation letter, the group said they could “no longer, in good conscience, participate in a Board where our voices go unheard.”

Thoughts: Their departure comes at a pivotal time, as HRSA works to implement recent legislation passed by Congress to reform the U.S. transplant system. In a February letter to HHS Secretary RFK Jr., Senators Bernie Sanders and Ron Wyden urged the administration to continue these efforts, noting that breaking up the OPTN contract—long held by UNOS—was “necessary” to achieve the goals of the 2023 Securing the U.S. OPTN Act.1

The resignations have prompted a wide range of responses. AOPO and ASTS both released statements acknowledging the concerns raised by the patient and donor family representatives, and expressing the need for careful reflection as HRSA moves forward (here and here). Amid strong feelings on all sides, voices in the community are calling for a more empathetic, inclusive dialogue. As Miriam Godwin shared, “There can be no higher stakes issue for policy and oversight than the allocation of donated organs… We will be better served by treating one another as human as we try to create a better system for patients.”2

What do you think? As the U.S. transplant system evolves, what does meaningful patient representation look like—and where do we go from here?

Join the discussion

Visual of the Week

A Closer Look at the ETC Model. New analysis by Avalere Health sheds light on the complex financial impact of CMMI's payment models. The ESRD Treatment Choices (ETC) Model—designed to boost home dialysis and transplant rates—ended up costing Medicare over $62 million, with limited quality improvements to show for it. But the report doesn’t just highlight failures—it offers a nuanced view of why many models fall short. Voluntary models may suffer from selection bias, while mandatory models like ETC risk unintended consequences without smaller-scale pilots. Still, one-third of all CMMI models did achieve meaningful savings, and the report says CMMI will likely continue to refine its model portfolio and development process.

Looking ahead, changes in agency leadership and policy priorities—especially under the newly formed Administration for a Healthy America—could reshape how models are designed, tested, and scaled. For kidney care, all eyes now turn to the future of Kidney Care Choices (KCC), IOTA, and the continued rise of Medicare Advantage, as CMS recalibrates its strategy on payment innovation.

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News

• Ms. Towana Looney, a 53-year-old Alabama woman, lived with a genetically modified pig kidney for a record 130 days before doctors at NYU Langone removed the organ due to signs of acute rejection. While she has returned to dialysis, her case marks the longest survival of a xenotransplant recipient to date. Dr. Robert Montgomery said the outcome is “not a setback” for the field, emphasizing the progress made in extending graft viability (NYT, STAT, NPR).

• A team at Massachusetts General Hospital successfully transplanted a kidney that had been frozen for 10 days, marking the first time a cryopreserved organ was transplanted into a large animal. Some say the advance could eventually extend kidney storage times beyond 36 hours, easing the organ shortage and enabling elective transplants (NYT).

• Novartis announced a $23 billion investment to build and expand 10 U.S. manufacturing and R&D sites, citing a U.S.-first strategy and pressure from looming pharmaceutical import tariffs. Two new plants for cancer therapies will be located in Florida and Texas, with more than 5,000 jobs expected across operations and construction (Reuters).

• The FDA granted accelerated approval to Vanrafia (atrasentan), a new treatment from Novartis for adults with IgA Nephropathy (IgAN) at risk of rapid disease progression. Based on interim data from the Phase 3 ALIGN trial, Vanrafia reduced proteinuria by 36.1% and showed a favorable safety profile. It's the third US approval for Novartis for its kidney disease portfolio in the last year, and the fourth FDA-approved therapy for IgAN, marking a significant expansion in treatment options for this rare kidney disease (NephCure).

• Interwell Health CEO Robert Sepucha says he’s unfazed by policy turmoil in D.C.—the real challenge came after merging three companies into one. In a recent interview, he emphasized that winning in kidney care requires more than home dialysis or analytics alone: “You have to do everything. That’s what makes it hard.” H/t Gabriel Perna, Modern Healthcare (paywalled)

• The Trump administration will increase Medicare Advantage payments by 5.06% in 2026—an additional $25 billion over last year’s rate. The move provides relief to insurers like Humana and CVS Health, which had struggled with rising medical costs, but experts caution it may not translate to richer benefits for enrollees. Healthcare costs remain high, and hospitals may still shift the financial burden to employers and retirees (Barron’s).

• As HHS Secretary RFK Jr. promotes a national push to prevent chronic disease, two major NIH-backed programs focused on diabetes, kidney disease, and dementia have been quietly discontinued. One of them—the Diabetes Prevention Program, a 25-year research initiative—was terminated after its grant was routed through Columbia University, which lost $400M in federal funding amid political controversy. Researchers warn the cuts threaten progress in areas Kennedy has publicly prioritized (NYT, STAT).

• The Clinical Accelerator is partnering with Proton Intelligence to launch a feasibility study on continuous potassium monitoring in dialysis patients. Led by Dr. Marat Fudim at Duke University, the study aims to explore novel tech-based approaches to preventing hyperkalemia and hypokalemia in people with CKD and CHF (Clinical Accelerator).

• The FDA approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with IgG4-related disease (IgG4-RD), a rare and chronic immune-mediated condition. Developed by Amgen, UPLIZNA reduces disease flares and dependence on long-term steroid use. The approval marks a major milestone for patients living with this complex, multi-organ inflammatory disease (Press release).

Research

• GlomCon Hawaii 2024, the inaugural international hybrid conference on glomerular diseases, brought together 619 participants and a faculty of 52 experts for four days of cutting-edge discussion on pathogenesis, clinical management, and trials. With over 26 million social impressions, the event reflected growing momentum in glomerular disease research and a renewed multidisciplinary focus on treatment innovation and collaboration (Glomerular Diseases).

• A new Health Affairs piece argues that regulatory failures—not just market dynamics—have crippled innovation and quality in dialysis care. The authors point to burdensome quality programs, certificate-of-need laws, and network adequacy requirements that entrench incumbents, inflate prices, and stifle new entrants. They call for CMS to simplify rules, eliminate loopholes, and expand flexibility models like Kidney Care Choices. H/t Eugene Lin, Ge Bai, and Erin Trish

• New data and clinician insights shared at the Annual Dialysis Conference suggest that solo home hemodialysis (HHD)—once seen as risky—is already happening more than many realize. A 2017 FDA clearance allowed unassisted use of the NxStage System One, but surveys show that patients were already going solo before formal approval. While some clinicians remain cautious, experts like Dr. Osama El Shamy argue that supporting safe solo HHD can expand access for motivated patients (Healio)

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• A study from Children’s Hospital of Philadelphia found that only 22% of families who preferred a language other than English received a living donor kidney for their child, compared to 73% of English-speaking families. Presented by Dr. Stephanie Kerkvliet at NKF’s Spring Clinical Meetings, the study identified unique linguistic, social, and logistical barriers to pediatric living donation—including transportation access, interpreter use, and insurance status (Healio).

• A new case series highlights the importance of genetic testing and multi-disciplinary evaluation for kidney transplant candidates with hereditary transthyretin (TTR) amyloidosis. Two Black women with end-stage kidney disease and the Val142Ile TTR variant were cleared for transplant after cardiac amyloidosis was ruled out. The study underscores the need for integrated nephrology, cardiology, and genetics collaboration in transplant evaluation. (AJT, h/t Yasar Caliskan).

• At NKF’s Spring Clinical Meetings, Dr. Niloufar Ebrahimi presented two case-based posters: one detailing the successful use of delayed-release budesonide in managing IgA nephropathy in a patient with chronic hepatitis B, and another exploring progressive lymphadenopathy that revealed IgG4-related disease as the underlying cause of kidney dysfunction. Both cases underscore the diagnostic complexity and treatment nuance in glomerular disease (LinkedIn)

• A new case report describes idiopathic nodular glomerulosclerosis (ING) in a non-smoking patient with long-term passive smoke exposure and newly diagnosed hypertension. The 60-year-old woman, who also had POEMS syndrome, was diagnosed after biopsy findings showed nodular mesangial expansion. The case underscores passive smoking as a potential risk factor for ING, even in the absence of direct tobacco use (JIMHICR, h/t Sayna Norouzi)

• A new study challenges long-held assumptions about ischemic time in heart transplantation, suggesting that cold storage is far from passive. Researchers mapped molecular changes during preservation and found that hearts stored up to 260 minutes showed no cases of severe graft dysfunction. The paper calls for a shift away from the “colder is better” mindset—arguing for cell-type-specific strategies, updated preservation solutions, and a deeper understanding of how molecular stress impacts organ viability. This isn’t the end of the ischemic time debate—but, as the authors put it, “the beginning of the beginning.” (JHLT)

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Community

• The Global Patient Alliance for Kidney Health’s Steering Committee wrapped up a two-day meeting in Boston last week, focusing on the global burden of chronic kidney disease (CKD) and strategies to elevate awareness through advocacy and collaboration. GloPAKH’s Medical Advisory Council continues to guide its efforts by identifying unmet clinical needs and shaping policy-focused solutions (LinkedIn).

• The NKF Innovation Fund is addressing a long-standing gap in funding for kidney and transplant startups. With 1 in 5 donated kidneys currently going unused due to damage or transportation delays, NKF is investing in technologies that improve preservation and delivery—including advanced cold storage, normothermic machine perfusion, and real-time GPS tracking (NKF).

• The ASN’s KidneyCure program saw a near-record 155 applications this year for its postdoctoral and independent investigator awards, aimed at fueling the next generation of kidney research. The Grants Review Committee, chaired by Leslie Gewin and Jeffrey Schelling, convened earlier this month to review submissions with support from Zach Cahill and Jennifer Kang. Since 2012, KidneyCure has funded early-career scientists across basic, clinical, and translational research—filling a critical gap in the research pipeline (LinkedIn, h/t Mark David Lim).

• ER doc Graham Walker sparked conversation with his comment that “The Pitt” star Noah Wyle is saying more about US healthcare than many leaders and policymakers—highlighting the power of narrative in healthcare reform (Variety)

• Mayo Clinic released a new podcast episode exploring pancreas transplantation, surgical innovation, and care coordination models (Mayo Clinic, h/t Andrea Thorp).

• Adam Wilson, founder of Vitality, called out the disconnect between national dialysis conferences and real change in clinics—arguing that most frontline nurses and techs are left out of the decision-making process. “If we can drive better outcomes with a small team, others can too,” he said, pointing to Vitality’s success with home dialysis, reduced hospitalizations, and improved patient quality of life (LinkedIn, h/t Adam & team).

• At NKF’s Spring Clinical Meetings in Boston, Karin Hehenberger raised a crucial question: Where are the patient voices? While the event brought together researchers, providers, and industry leaders, Dr. Hehenberger noted the noticeable absence of patient perspectives in clinical and scientific discussions. “Inclusion is key,” she wrote—emphasizing that only by inviting patients to the table can we build a more authentic, impactful approach to kidney advocacy and research (LinkedIn, h/t Karin Hehenberger)

• Yubin Park and Prince Baawuah archived the full database of CMS Office of Minority Health reports, including 100+ PDFs and Excel datasets following the recent layoffs. Their analysis using Claude.ai revealed decade-long trends in disease-specific research, population targeting, and accessibility strategies (see image below). The data is now preserved to ensure it’s not lost (LinkedIn, h/t Yubin Park)

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• Josh Dipzinski shared a behind-the-scenes look from Tennessee as Premier Home Dialysis Services prepares to certify its newest unit. Now in its fifth year, the company is expanding with three new units, nine SNF partnerships, and its first in-house hemodialysis den. “We’re redefining dialysis care by raising the standard for home and SNF patients nationwide” (LinkedIn, h/t Josh Dipzinski)

• The University of Pittsburgh Medical Center (UPMC) shared a comprehensive blueprint for population health management (PHM) in CKD. Their approach includes EHR-enabled risk tracking, palliative care strategies, and PHM models for dialysis and transplant transitions—leveraging their integrated payer-provider system and diverse clinical network (Managed Healthcare Executive).

• A new post by Rubicon Founders highlights risk stratification models as essential infrastructure for value-based care. In their latest Tech at the Crossing feature, they explored how AI-powered tools are shifting health systems from reactive to proactive, helping predict and manage patient risk before costly interventions are needed. (Rubicon Founders)

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• …Find 20+ more roles at jobs.signalsfs.com

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Welcome back! We just marked World Kidney Day, a moment to reflect on the latest news, research, and policy shaping kidney health today. First, a huge thank you—to everyone working to advance kidney care and to this community for being part of the conversation. Putting this issue together was a powerful reminder not just of how many lives kidney disease touches, but of how many people are committed to making a difference.

We start with the biggest development out of CMS last week: the shutdown of the ETC Model. As the dust settles, reactions feel like a slow exhale—it was expected, and it could have been worse. We’ll break down what this means, highlight key takeaways from MedPAC’s latest dialysis capacity report, and round up the biggest World Kidney Day updates from Canada to Cyprus and everywhere in between.

A warm welcome to the 202 new subscribers who joined us this month! If you missed it, we covered the ETC model closure, sat down with Roivios CEO John Erbey, and have more on the way, including an updated ESRD/AKI device landscape, three new KOL interviews, and a deep dive into Fresenius earnings.

If you find this newsletter valuable, consider sharing it with 1-2 colleagues or friends who care about the future of kidney health. Thanks for reading—let’s dive in.

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In this issue

• CMS Ends the ETC Model

• World Kidney Day Highlights

• MedPAC Report: Dialysis Capacity & Consolidation

• Novo Nordisk’s CagriSema REDEFINE 2 Results

• China Performs First Pig Kidney Transplant

• NYT Explores Ethics of Xenotransplantation

• Biogen Starts Phase 3 Study for Late AMR in KT

• UTMB Partners with NIPOKA on diagnostics

• Fresenius Releases 2024 Annual Report

• Strive Health Expands Partnership with Zing Health

• Cincinnati Children’s Licenses Renal Angina Index

• NephMadness 2025 Kicks Off with RFN Editors’ Picks

• Renal Fellows Course at MDIBL Celebrates 18 Years

• Kidney Foundation of Canada Awards Coronation Medal

• VHC Health One-Year Experience with Renal Denervation

• Open roles around the Kidneyverse

• & More…

Signals

CMS Shuts Down ETC—What's Next for Kidney Payments?

Summary: CMS has announced the early termination of the ESRD Treatment Choices (ETC) Model, a mandatory program aimed at increasing home dialysis and transplant rates. This decision is part of a broader federal shift away from alternative payment models (APMs), with CMS shutting down eight payment models by year-end, citing cost savings and strategic realignment. ETC, which covered about 31% of dialysis providers, had not yet demonstrated significant improvements in outcomes or cost savings, according to CMS evaluations. With Medicare Advantage (MA) enrollment among ESRD patients rising, the move raises questions about whether private payers will now take on a larger role in shaping kidney care payment reforms (CMS).

Thoughts: The early termination of the ESRD Treatment Choices (ETC) Model marks a significant shift in kidney payment reform, raising questions about the future of value-based care (VBC) models. The decision wasn’t unexpected—ASN’s Daniel Weiner points out that ETC struggled to show meaningful differences in home dialysis and transplant rates, with both the intervention and control groups seeing only small increases. External challenges, including COVID-19 disruptions and peritoneal dialysis supply shortages, further complicated its impact.

At the same time, CMS has made clear that Kidney Care Choices (KCC), a voluntary model, will continue, and the Increasing Organ Transplant Access (IOTA) Model remains on track for its July launch. But with ETC’s shutdown, KCC is now the only kidney-specific APM left standing. As Kate de Lisle of Leavitt Partners noted, last week’s announcement offers the first real signal from the new administration on CMMI’s direction. While some VBC proponents may be relieved that more models weren’t cut, the end of Making Care Primary (MCP) has raised a few questions around what comes next.12

From a frontline perspective, Dr. Graham Abra shared that many VBC models are simply too complex. With delayed data, high startup costs, and difficult-to-explain benchmarks, even experts struggle to engage with these programs effectively. He says that simpler incentives and clearer guardrails are needed to encourage participation while curtailing bad actors. The history of demonstration projects, MA C-SNPs, ESCOs, and now ETC suggests that, at scale, many VBC models fail to meet expectations.

So where does kidney payment reform go from here? Is the future of risk-based kidney care shifting to Medicare Advantage and private-sector innovation, or does CMS have another strategy in mind? We'll be tracking responses from industry leaders, advocacy groups, and policymakers as this unfolds.

What do you think? What should we keep when it comes to KCC and IOTA? Join the discussion on Slack, LinkedIn, or the comments.

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Visual of the Week

Dialysis facility growth slows as large providers consolidate. Last week’s MedPAC report highlights a decline in the number of dialysis facilities operated by the two largest providers (DaVita and Fresenius), which shrank by 3% between 2022 and 2023. Nonprofit facilities shrank by 7% over the same period. The trend reflects a shift in patient care, with lower in-center dialysis demand and increasing home dialysis adoption prompting facility closures and consolidations. While urban dialysis capacity slightly increased (0.4%), rural areas saw a 4% decline, raising concerns about access in less densely populated regions.

With 96% of dialysis delivered by freestanding centers and 90% by for-profit providers, I’m curious if home growth is making up for these closures. Is this a sign of greater efficiency, or do they pose risks to patient access—especially in rural areas?

Stay tuned, we'll be hearing industry perspectives on Signals KOLs this coming week—what’s your take? What questions do you have for the dialysis industry?

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News

• UTMB partners with NIPOKA to bring super-resolution kidney diagnostics to the U.S. The collaboration will introduce PEMP technology, enabling advanced biomarker analysis and high-resolution imaging for kidney disease detection (UTMB Health).

• CareDx expands AlloSure to pediatric heart and pancreas-kidney transplant patients. The new validations broaden the use of its noninvasive rejection monitoring, potentially improving post-transplant care (CareDx).

• China completes first pig kidney transplant in human patient. Surgeons at Xijing Hospital in Xi’an successfully transplanted a pig kidney into a 69-year-old woman, marking Asia’s first xenotransplantation (China Daily, h/t Raphael Meier).

• Fresenius reports 18% operating income growth in 2024 annual report. The company highlights financial gains and its ongoing commitment to reducing its environmental footprint (Press release).

• Pig kidney pioneers discuss next steps and first-ever clinical trials. Xenotransplantation leaders gathered in Orlando to assess progress and challenges as human trials advance (Healthcare Brew).

• NYT explores the ethical tensions of xenotransplantation. While supporters highlight the life-saving potential, critics question animal cloning ethics and advocate for increased human organ donation (The New York Times).

• Biogen has initiated the Phase 3 TRANSCEND study to evaluate felzartamab for treating late antibody-mediated rejection (AMR) in kidney transplant patients. AMR is a leading cause of transplant loss, affecting approximately 23,000 patients in the U.S. (Press release).

• Strive Health expands kidney care partnership with Zing Health. The collaboration now covers Medicare Advantage members in Ohio, Tennessee, and Mississippi, in addition to existing markets in Illinois, Indiana, and Michigan (Strive Health, h/t Will Stokes).

• Cincinnati Children’s licenses Renal Angina Index (RAI) to RAIDAR Health. The predictive tool for pediatric acute kidney injury (AKI) will help identify severe AKI within 72 hours of ICU admission, aiming to improve early intervention and reduce ICU stays (Cincinnati Children’s).

• Novo Nordisk’s CagriSema shows 15.7% weight loss in phase 3 REDEFINE 2 trial. The obesity and type 2 diabetes treatment significantly outperformed placebo, with regulatory filings planned for 2026 (Press release).

• Dr. Oz faces senators’ questions on healthcare cuts, calls CMS nomination a ‘monumental opportunity.’ Lawmakers grilled the former TV personality on Medicare policies and agency leadership (Healio Nephrology).

Research

• Advancing Equitable Kidney Care Through Population Health Approaches in Los Angeles County's Safety Net System (CJASN, h/t Kam Kalantar-Zadeh)

• The autoimmune architecture of childhood idiopathic nephrotic syndrome (Kidney International, h/t Davide Garrisi)

• We Can Finally Stop Worrying About SGLT2 Inhibitors and Acute Kidney Injury (AJKD, h/t Edgar Lerma)

• Long-Term Physical Exercise for Preventing CKD in Older Adults: A Randomized Clinical Trial (JASN, h/t Chang Alexander)

• Expression of ENL YEATS domain tumor mutations in nephrogenic or stromal lineage impairs kidney development (Nature)

• Prospective Cohort Study in Alport Syndrome Patients under Standard Therapy (Kidney International, h/t Julie Lin)

• The Genetics of IgA Nephropathy: Implications for Future Therapies (Semin Nephrol)

• Comparative assessment of the effects of dotinurad and febuxostat on the renal function in chronic kidney disease patients with hyperuricemia (scientific reports)

• A Combination Approach to Improving Prognostication in Autosomal Dominant Polycystic Kidney Disease. Two Better Than One? (CJASN, h/t Sayna Norouzi)

• IgA class-switched CD27−CD21+ B cells in IgA nephropathy (ndt)

• Webinar: A new trial presented at Grand Rounds by Dr. F. Perry Wilson examined the impact of a "Kidney Action Team" for hospitalized patients with acute kidney injury (AKI). The study found that more personalized AKI alerts could lead to better clinical outcomes, addressing a condition that affects 15% of hospitalized patients and is linked to an 8.5% higher inpatient mortality rate (RCT).

Community

Advocacy & Innovation

• Maze Tx launches Patient Advisory Committee. The PAC will amplify voices from the APOL1 kidney disease and CKD communities, featuring patient leaders Glenda Roberts, Curtis Warfield, Jamie Albright, Nichole Jefferson, Sharron Rouse, and Kevin Fowler (LinkedIn).

• NIPOKA’s kidney diagnostics tech moves forward. Dr. Nicole Endlich confirmed UTMB Galveston will implement its PEMP method, allowing precise podocyte imaging and personalized disease prediction (LinkedIn, UTMB).

• Radiofrequency renal denervation sees real-world validation. At CRT 2025, Dr. Jeremy Bock and VHC Health presented the largest U.S. patient cohort using this emerging hypertension treatment (LinkedIn).

• Transplant pioneers reflect on progress. Charles Bearden shares how surgical PAs helped address transplant surgeon shortages in the 1970s, paying tribute to Dr. Bob Richie’s contributions (LinkedIn).

• Alport Syndrome Foundation launches travel award. The new program aims to recruit and train more pediatric nephrologists, addressing a critical workforce shortage (ASPN Foundation).

• Canada backs kidney tech innovation. Northernmost’s organ preservation pump, supported by Alberta Innovates, improves transplant viability by replacing traditional icebox storage (LinkedIn).

Education & Workforce Development

• Dialysis & end-of-life care: Dr. Qasim Butt hosted a panel on DNR, palliative care, and "concurrent dialysis", a concept allowing patients to do both dialysis and hospice (Watch it here).

• Renal Fellows Course continues to shape nephrology careers. Since 2008, MDIBL’s fellowship program has trained nearly 300 fellows, fully supported by NIDDK. A new Renal Fellow Network series highlights alumni reflections (Renalfellow.org).

• NephMadness 2025 is live! The annual nephrology-themed tournament lets participants submit their brackets until March 31, with the champion revealed April 8 (Renal Fellow Network).

• Inspiring the next generation of nephrology nurses. Teresa Villaran led a hands-on high school nephrology session, giving students their first venipuncture experience on simulated arms (LinkedIn).

• The rising cost of middlemen in U.S. healthcare. The system spends $200B annually on billing, claims, and prior authorizations—as much as cancer treatment costs. Patients face growing financial barriers due to administrative complexity (Bloomberg).

World Kidney Day 🌍

• Kidney Health Australia airs first national "End Dialysis by 2050" campaign. A television ad featuring Rodrigo, a dialysis patient, aims to raise awareness and drive kidney care momentum. (LBB)

• Brazil sets records for World Kidney Day. With 1,200 activities nationwide and 10,000 point-of-care creatinine tests, this year’s campaign featured public walks, celebrity support, and illuminated landmarks (h/t Jose Moura-Neto).

• Canadian kidney health leaders honored with King Charles III Coronation Medal. Dr. Clara Bohm, Ms. Shirley McLaren, Dr. Peter Nickerson, and Dr. Navdeep Tangri were recognized for their contributions to kidney health (h/t Nav Tangri).

• Cross-border collaboration in transplantation. HLA & immunogenetics leaders from Cyprus, Greece, and Israel convened to expand patient access and improve outcomes, thanks to efforts by Chryso Pierides and Paul Costeas (Moshe Israeli).

Events Calendar

• Annual Dialysis Conference (Mar 13-16)

• LSI USA ‘25 (Mar 17-21)

• RPA Annual Meeting (Apr 3-6)

• NKF Spring Clinical Meetings (Apr 10-13)

• KHI Kidney Innovation Conference (May 21-22)

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Jobs

• SVP Value-Based Care at Guaranteed

• Transplant Manager (Remote) at Eurofins

• Sr. Dir., Clinical Product Strategy (Metabolic) at Ro

• VP, Healthcare at The Bliss Group

• Director, Data Modernization at NNPHI

• VP, Population Health at Interwell Health

• Senior MSL, Nephrology (Eastern US) at Biogen

• Manager, Life Science Partnerships at Flatiron Health

• Dir, US Patient Marketing, Hem/Neph at AstraZeneca

• Product Manager, Patient Engagement at Apellis Pharma

• Palliative APP (Birmingham, AL) at Monogram Health

• Head of Brand, Marketing, & Comms at Monogram Health

• Sr. Director, Compliance & Privacy at Monogram Health

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This issue is made possible by Guaranteed, the company optimizing end-of-life care experiences for CKD and ESRD patients at risk-bearing nephrology practices when conservative kidney management, dialysis and kidney transplants are no longer viable options. Email raihan@onguaranteed.com today to learn more. Thanks team!

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The Trump administration’s Medicare Innovation Center (CMMI) will shut down eight alternative payment models (APMs) by the end of the year, citing a strategic shift in federal payment policy. The first four terminations were announced just hours after Axios’ scoop, adding to the growing uncertainty around the future of federal value-based care models.

The first four models ending early include Maryland Total Cost of Care, Primary Care First, Making Care Primary, and the ESRD Treatment Choices (ETC) Model—a mandatory program designed to increase home dialysis and transplant rates. In addition, two upcoming drug pricing models have been canceled, including the $2 Medicare Drug List and a model aimed at incentivizing confirmatory trials for accelerated approval drugs.

CMS says these terminations will save $750 million and that participating providers will receive transition guidance. But some of these models, including ETC, have not yet demonstrated meaningful improvements in health outcomes or Medicare spending, according to their latest evaluations. CMMI currently operates 23 models and receives $10 billion in mandatory funding every decade to develop and test new payment models. While it’s common for a new administration to end or modify payment projects early in its term, the constant back-and-forth makes it difficult for providers to fully commit to these experimental models—a tension that has played out across the VBC landscape.1

Why It Matters

The elimination of the ETC Model is a major shift in kidney policy. It was one of only two mandatory models in all of CMMI, covering ~31% of dialysis facilities and clinicians treating ESRD patients. The model was designed to increase home dialysis and transplant rates—longstanding goals of federal kidney health initiatives—but now it joins a growing list of canceled experiments that never had time to fully mature.

CMS insists this is not a retreat from value-based care, but rather a shift to align with its statutory obligation and strategic goals. Yet, with no clear replacement, the move leaves providers, payers, and patients in limbo. Kidney care has been one of the most targeted areas for value-based reform, with bipartisan support over multiple administrations— even catalyzed by Trump and then-HHS Secretary Azar in 2019. If these efforts are being wound down, what does that mean for the future of kidney payment reform?

This decision also comes at a time when Medicare Advantage (MA) enrollment among ESRD patients is rising, particularly after the 21st Century Cures Act expanded eligibility in 2021. While MA’s role in kidney care continues to grow, it remains unclear whether these payment model shifts signal a broader handoff to private payers or simply a change in CMS’s strategy for federal APMs.2

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Background

Since its creation under the Affordable Care Act (ACA) in 2010, CMMI has aimed to move Medicare away from traditional FFS payments in favor of alternative payment models (APMs) that reward efficiency, quality, and patient outcomes. But a long-standing debate has surrounded whether participation in these models should be voluntary or mandatory—a crucial distinction in how much impact they can actually drive.

Of 50+ models tested, only two have ever been mandatory, due to strong resistance from providers and policymakers. The pandemic further slowed momentum for pushing providers into risk-based models, and now, with CMS canceling the ETC Model, kidney care providers lose the only mandatory APM currently in place. For what it’s worth, the mandatory transplant (IOTA) model is currently scheduled to begin on July 1, 2025 and will include 103 kidney transplant programs.

Kidney-Focused Models

CMMI’s kidney-focused models have evolved over time, with a focus on care coordination, home dialysis adoption, and transplants. The two most recent models—ESRD Treatment Choices (ETC) and Kidney Care Choices (KCC)—were designed as successors to earlier payment reform efforts, but they took different approaches.3

The ETC Model was mandatory, requiring participation from 30% of the market to drive higher home dialysis and transplant rates. The KCC Model took an ACO-style approach, expanding beyond dialysis to include late-stage CKD patients and transplant recipients, aiming to slow progression, optimize dialysis starts, reduce costs, and improve patient outcomes. KCC also introduced new risk-sharing tracks, allowing participants to take on full financial risk (100%), a significant evolution from prior models.

While KCC’s first evaluation report showed early promise, ETC was cut before it could generate conclusive results. CMS’s latest evaluation noted that the model hadn’t yet demonstrated improvements in health outcomes or cost savings. With ETC now set for early termination, it raises a critical question: Will CMS continue supporting kidney-specific ACO models like KCC, or is this part of a broader retreat from mandatory risk-based models? On the other side of the table, how will the private sector respond— given their parallel trajectory of increasing risk and opportunity.

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What’s Next

With the cancellation of the ETC Model, many in the kidney space are wondering what happens to KCC—and whether modifications are coming next. Both models were built as ACO-style frameworks for kidney payment reform, moving risk-based incentives upstream to improve early CKD management, dialysis starts, and transplant rates. While CMS has not yet announced changes to KCC, pulling the plug on ETC—the only other kidney-specific successor model—signals that federal payment policy is shifting.

This move is particularly striking given that Trump’s first term launched the Advancing American Kidney Health (AAKH) executive order in 2019, which set a bold 80% target for new ESRD patients to receive home dialysis or transplants by 2025. While aspirational, it spurred billions in investment around these kidney care models. The ETC Model was designed as a key lever to drive home dialysis and transplant growth, yet the U.S. has barely moved the needle—only 14% of patients are dialyzing at home today.

A recent JASN editorial response raised an uncomfortable question: Was the U.S. ever truly on track to hit these goals, or was denominator manipulation always the hidden lever? Given the choice between increasing available options (the numerator) or restricting access (the denominator), is a mandatory model a forcing function toward the path of least resistance?

Kate de Lisle of Leavitt Partners noted that CMS’s strategy is still taking shape, and further announcements may be delayed until after Dr. Oz’s confirmation as CMS Administrator. The administration says it wants to focus on “empowering people with information” and “driving choice and competition”, but it remains to be seen how that translates into policy.

As CMS reorganizes its APM portfolio, there are big unanswered questions for kidney care: What does this mean for value-based nephrology? What will KCC look like in its final two years? Is the future of risk-based kidney care simply shifting to Medicare Advantage and private payers? And, perhaps the biggest question of all: will chronic disease and cost cutting be major focus areas of the new administration— and if so, how will that eventually, inevitably reshape the kidney care landscape?

One day at a time. Keep exploring,

Thanks for being here and for all those who have reached out to share your thoughts and POVs. I know this is an evolving situation. Please share your thoughts below or join us in Slack to keep learning.

Discussion

1. How will nephrologists, dialysis providers, and transplant centers adapt if federal support for value-based kidney models diminishes?

2. Are Medicare Advantage plans ready to take on more risk for kidney patients, and what happens if CMS further scales back its role?

3. Should the kidney industry push for new payment models, or does the private sector offer a more stable alternative?

4. What does ETC’s termination mean for KCC? For IOTA? What would you like to see change (or stay the same) with these models?

5. How might this decision impact M&A activity in kidney care, particularly among value-based care providers?

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Resources

• In January 2024, the Lewin Group put together its Second Annual Evaluation Report of the ETC model. It’s a 158-page analysis of the ETC model and includes the summary graphic below on page 4.

Welcome back! We’re kicking off Kidney Month here in the United States, and what better way to raise awareness than by bringing you up to speed on the latest news, research, policy, and discussions shaping kidney health today.

This week, we lead off with the bombshell New York Times investigation that exposes an organ allocation system ‘in chaos’ as waiting lists are ignored. We’ll break down the findings, OPO responses, and what this means for patients and transplant policy. Meanwhile, mass layoffs at HHS, the VA, and key health agencies are raising alarms across the healthcare system. Thousands of federal workers—including those at the FDA, CMS, and NIH—have been fired, sparking legal battles and concerns over long-term oversight in areas like transplantation.

Extending a warm welcome to the 221 new subscribers who joined us last month to help shape the future of kidney health. We’ve been busy these last couple of weeks. In case you missed it, we published our value-based kidney care directory, KCC PY22 results overview, and DaVita Q4 earnings snapshot. Stay tuned for our Fresenius Q4 snapshot, updated device landscape, and more KOL interviews coming soon.

If you find this newsletter valuable, consider sharing it with 1-2 colleagues or friends who care about the future of kidney health. Thank you for being here with us.

Refer a friend

In this issue

• NYT: Organ transplant system ‘in chaos’—waiting lists ignored

• Mass layoffs at federal health agencies continue

• Third recipient of a pig kidney heads home

• Baxter Kidney Care rebrands as Vantive

• FDA grants priority review to new kidney cancer imaging drug

• Memorial Hermann hit with severe transplant sanctions

• NephCure’s journey from small idea to major movement

• JAMA paper challenges value-based payments in Medicare

• Indigenous Kidney Taskforce gathers to shape future care

• Congress investigates global kidney trade concerns

• AI predicts kidney injury risk in emergency patients

• OrganOx secures $142 million to grow metra platform

• The rising cost of liver transplantation in the U.S.

• New outpatient dialysis guidance for AKI patients

• A new approach to vascular access saves an ESRD patient

• Open roles around the Kidneyverse

• & More…

This issue is made possible by Guaranteed, the company optimizing end-of-life care experiences for CKD and ESRD patients at risk-bearing nephrology practices when conservative kidney management, dialysis and kidney transplants are no longer viable options. Email raihan@onguaranteed.com today to learn more. Thank you team!

Signals

NYT: Organ Transplant System ‘in Chaos’ as Waiting Lists Are Ignored

Summary: A New York Times investigation uncovered that nearly 1 in 5 organs from deceased donors in 2024 were allocated outside the standard waiting list process—a sixfold increase from previous years. The report highlights how hospitals and organ procurement organizations (OPOs) are bypassing the sickest and longest-waiting patients, often prioritizing recipients who are healthier, easier to transplant, or affiliated with certain transplant centers. While some argue these workarounds help reduce organ waste, the investigation raises serious concerns about equity, transparency, and accountability in the U.S. transplant system. Over the past five years, more than 1,200 patients died after being skipped despite being near the top of the list. The practice appears to disproportionately benefit white and Asian patients, men, and college graduates, exacerbating existing disparities in organ access. Since publication, several OPOs, including LifeGift’s CEO, have responded to the findings.

Thoughts: The transplant system relies on trust and transparency—without it, public confidence in organ donation will erode. While OPOs argue that out-of-sequence allocations prevent organ discards, the authors point out these shortcuts haven’t meaningfully reduced waste. The report highlights a lack of oversight, as regulators have largely failed to intervene despite clear deviations from policy. As Miriam puts it, the point of policy is to have policy and to almost always adhere to it. If the system now requires hospitals and OPOs to make real-time allocation decisions, it raises serious questions about governance and accountability. At the same time, as Jeanmarie noted, thousands of kidneys are still being discarded due to logistical issues despite commercially available solutions like perfusion, leaving patients in long-wait regions feeling hopeless. With xenotransplantation trials now underway, recent policy efforts like the End Kidney Deaths Act being debated, and mass layoffs in Washington, we are at a pivotal moment for the future of organ transplantation.

What do you think? Where do conversations go from here on topics like reform, transparency, and trust? What explains these outcomes?

Join the discussion

Mass Layoffs at HHS & VA Signal a Reshaped Federal Health Landscape

Summary: A wave of mass layoffs across HHS, the VA, and key health agencies is rapidly reshaping the federal workforce, with thousands of employees terminated under the new administration’s directive to "streamline government" and eliminate "corrupt bureaucracy." While framed as a cost-cutting measure—projected to save $781 million annually—the move has sparked legal battles, labor protests, and deep concerns about its long-term impact on public health infrastructure.

A federal judge ruled some of the firings illegal, citing overreach by the Office of Personnel Management (OPM), yet stopped short of reversing them. Meanwhile, agencies have been ordered to submit reorganization plans by April, including recommendations for further mass layoffs, real estate downsizing, and relocation of headquarters to "less-costly" areas. The administration's hiring freeze remains in effect, restricting agencies to hiring only one employee for every four fired.

Fallout: Veterans' disability claims backlog worsens as VA case analysts were cut; HHS scrambled to reverse firings of FDA and Indian Health Service employees; medical AI oversight at the FDA temporarily collapsed after half the device AI team was dismissed; public health experts, epidemiologists, and CMS officials were let go, raising concerns about government preparedness; DEI and health equity programs were slashed, with entire offices put on leave and references to health disparities quietly removed.1

Thoughts: These cuts go beyond bureaucracy—they threaten the backbone of federal healthcare oversight. While the administration frames this as efficiency, gutting agencies like the FDA, CMS, and VA weakens essential services, from veterans’ care to medical innovation and public health preparedness. With more layoffs expected and litigation mounting, the long-term stability of federal health policy is at stake. The Organ Procurement and Transplantation Network (OPTN) is among the entities navigating these changes, with its interim executive director addressing concerns about how the transition is impacting operations.

I welcome your feedback and would love to hear from those of you impacted by these latest changes. In fact, I'd like to open the mic for an 'exit interview' style Q&A with anyone willing to share their experiences. Your work, expertise, and thoughts on the road ahead deserve to be heard.2

What impacts have you seen or experienced from these changes—on your work, your community, or your outlook?

Leave a comment

Visual of the Week

Solutions to rising costs in liver transplantation. An impressive group of co-authors from top liver transplant programs have published a review paper on the rising costs of liver transplantation. They explore how expanded criteria, broader organ distribution, and costly new technologies are straining transplant programs. Despite these rising costs, reimbursement remains stagnant, threatening program sustainability and patient access. The paper examines policy changes, OPO practices, and emerging solutions to improve efficiency, resource allocation, and financial sustainability in LT.

What do you think—which of these proposed solutions do you see as most feasible in the coming years? Which have you seen firsthand?

Join discussion in Slack

News

• Third recipient of a pig kidney heads home from the hospital (STAT) – The latest milestone in xenotransplantation, as a patient successfully recovers post-surgery.

• Baxter Kidney Care rebrands as Vantive, a new standalone vital organ therapy company (Press release).

• OrganOx secures $142M equity financing for organ preservation technology platform metra (Mobihealthnews)

• Fresenius sells select lab assets to Quest Diagnostics (Press release, h/t Bryan Thompson).

• Paragonix successfully tests KidneyVault Renal Perfusion System in four transplants (DocWire).

• FDA grants priority review to TLX250-CDx (Zircaix®) for kidney cancer imaging (Press release).

• Northernmost partners with Mayo Clinic to develop NoMo Kidney Pump (Press release, h/t Ron Mills).

• Memorial Hermann hit with rare, severe sanction over organ transplant scandal—investigation cites a 'culture of intimidation' (Houston Chronicle, h/t Rebecca Baranoff).

• FDA removes semaglutide from its drug shortage list, confirmed in a press release by Novo Nordisk (Healio, Press release).

• YMCA of the USA expands partnership with DaVita to advance kidney health in seven communities (Morningstar, h/t Paul Gordon).

• Geographic gaps in kidney allocation policy leave Hawaii, Puerto Rico, and Alaska at a disadvantage (Hawaii News Now).

• 'Desperate' illegal kidney sales uncovered in Myanmar villages (BBC News).

• Queens teacher donates kidney to a colleague—despite barely knowing each other (NBC New York).

• Westmoreland County Navy veteran in search of kidney donor (ABC News)

Research

• ASN Kidney Health Guidance on the Outpatient Management of Patients with Dialysis-Requiring Acute Kidney Injury (JASN, h/t Anitha Vijayan)

• Prediction of contrast-associated acute kidney injury with machine-learning in patients undergoing contrast-enhanced computed tomography in emergency department (Nature)

• Sleep Patterns, Symptoms, and Mortality in Hemodialysis: A Prospective Cohort Study (Kidney Medicine)

• Factors affecting access to dialysis for patients with end-stage kidney disease in Sub-Saharan Africa: A scoping review (NursingOpen, h/t Bogdan M.)

• Haemodiafiltration versus high-flux haemodialysis - a Consensus Statement from the EuDial Working Group of the ERA (NDT)

• The rising cost of liver transplantation in the United States (Liver Transplantation, h/t Sharon Klarman)

• Venous thromboembolism prevention for nephrotic syndrome: The role of aspirin, vitamin K antagonists and direct oral anticoagulants (Kidney Intl, h/t Sayna Norouzi)

Community

• NYU Langone on OPTN modernization – In a new YouTube talk, Dr. Macey Levan breaks down the 2025 governance restructure of the Organ Procurement and Transplantation Network (OPTN), including the new independent board and what these changes mean for patients, providers, and the future of transplantation. (NYU Langone Health, h/t Charles Bearden)

• JAMA challenges value-based payment in Medicare – A new JAMA perspective argues that value-based payment (VBP) is failing to reduce costs and is instead creating more corporate intermediaries while impeding critical Medicare reforms. The authors propose a new Medicare agenda focused on fixing, not abandoning, fee-for-service (FFS) by addressing the true drivers of high costs: technology pricing and administrative waste. (JAMA, h/t Hayden Rooke-Ley)

• ABUNDANT sets world premiere in Hollywood on March 1 – The film, which explores living kidney donation, debuted yesterday. (Press Release, Website)

• NephCure: From a small idea to a movement – What started with four determined families has grown into a national force driving hope, collaboration, and change for rare kidney disease patients. (LinkedIn)

• Patrick O. Gee, Sr. on the power of community partnerships in research – He shared key takeaways on how leaders can collaborate with The PATIENTS Program to co-develop health initiatives. (LinkedIn)

• National Indigenous Kidney Transplantation Taskforce (NIKTT) 2025 Gathering – Last week, patient experts, caregivers, clinicians, and community leaders from across Australia met on Kaurna Yarta (Adelaide) to shape the future of Aboriginal and Torres Strait Islander kidney care. (LinkedIn, h/t Isabelle Haklar)

• Black History Month Spotlight: Dr. Silas Norman – The American Kidney Fund (AKF) celebrates their Board of Trustees Chair and transplant nephrologist in a recent Q&A. (Kidneyfund.org)

• AKHOMM’s series on Black patients with CKD continues – Part 2 featured kidney patient advocate Curtis Warfield, discussing ways to improve healthcare experiences for Black communities. (AKHOMM)

• AKF’s Rare Kidney Disease Action Network amplifies patient voices – Hear from Ariana, Jason, and Sherry as they share personal experiences with IgA Nephropathy. (Kidneyfund.org)

• Primary care has a funding crisis—this model could help (The Harvard Gazette).

• Access Save: A complex case in vascular access care – A 70-year-old ESRD patient with severe arm swelling post-surgery was told further interventions weren’t possible—until a new approach was explored. (LinkedIn, h/t Terry Litchfield)

Leave a comment

Jobs

• SVP Value-Based Care at Guaranteed

• Account Manager (Transplant) - SoCal at Eurofins

• Transplant Manager (Remote) at Eurofins

• Administrator on Duty (NY) at LiveOnNY

• VP, Digital Strategy/Solutions at Fresenius

• Regional Home Manager (NY) at DaVita

• Senior Director, Digital Health (SF) at Genentech

• Sr. Dir., Clinical Product Strategy (Metabolic) at Ro

• VP, Healthcare at The Bliss Group

• Director, Data Modernization at NNPHI

• VP, Population Health at Interwell Health

• Transplant Initiatives Manager (NY) at NKF

• Palliative APP (Birmingham, AL) at Monogram Health

• Head of Brand, Marketing, & Comms at Monogram Health

• Sr. Director, Compliance & Privacy at Monogram Health

Post a Job

Thank you for reading our latest biweekly recap on all things kidney health. If you found it valuable, please consider sharing this with 1-2 friends or peers around the Kidneyverse. Thank you!

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DaVita reported solid financial performance in Q4 2024, with $3.295 billion in revenue (+4.7% YoY) and adjusted EPS of $2.24 (+12.3% YoY). Operating income grew 45% YoY to $565 million, supported by a mix of revenue cycle improvements, reimbursement rate adjustments, and commercial payer mix trends. The company also provided 2025 guidance, projecting flat treatment volumes, 5% revenue per treatment growth, and 6-7% cost per treatment growth. As you can see in the charts below, shares have pulled back from recent highs following the earnings report but remain well above long-term levels, trading near 5-year and all-time highs.

Last 30 Days (-18.7%)

Last 5 Years (+83.8%)

Key Takeaways

• Treatment Volumes Expected to Remain Flat in 2025 – Guidance assumes no significant growth in treatment volumes, with impacts from fewer treatment days (leap year adjustment) and PD supply disruptions from Hurricane Helene that slowed admissions in late 2024. Main drivers of treatment volume expectations are treatment days, missed treatments, and elevated mortality rates in comparison to pre-pandemic levels.1

• Oral Drug Reimbursement Expands – DaVita expects 5% revenue per treatment growth, with 40% of that tied to the inclusion of oral phosphate binders in the dialysis bundle. Management noted that adherence rates and the mix between branded vs. generic drugs remain variables to monitor as we move past the initial 90-day prescription window. The remainder of the expected operating income (OI) growth is primarily driven by rate increases, collections, and mix improvement.

• Cost Pressures Continue – 2025 cost per treatment is expected to rise 6-7%, with labor and drug costs as the primary drivers. This will be a key area to watch for margin impact.

• IKC: Small, Growing, & Consistent – IKC remains a growing but unprofitable segment. DaVita’s Integrated Kidney Care (IKC) business reported a $35M adjusted operating loss in 2024, with revenue flat at $508M. While IKC patient volume has grown to around 82,000 as of 2024, it still represents a small portion of DaVita’s total business (~4% of revenue and ~29% of patient volume). The company continues to invest in scaling its VBC models and reaching patients earlier in the disease process.2

• Stock and Market Cap Trends – After a strong run-up ahead of earnings, DaVita’s stock has pulled back but remains near all-time highs. The company’s market cap nearly tested $15B prior to the earnings call, reflecting long-term investor confidence, even as near-term challenges like cost pressures and volume trends are being reassessed. As of this writing it sits closer to $11.5B.

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Background

DaVita operates 3,166 clinics serving 281,000 patients, making it one of the largest kidney care providers in the U.S. The company’s financials are closely tied to payer mix trends, with Medicare, Medicaid, and commercial plans representing key revenue sources. While commercial revenue has increased slightly this year, it accounts for about one-third of DaVita’s revenue.

The company continues investing in Integrated Kidney Care (IKC), a growing (though not-yet-profitable) segment focused on value-based care models.

What to Watch in 2025

• PD Recovery & Volume Trends – Can DaVita offset the Q4 PD admissions impact from supply constraints? They estimate a loss of 350 patients due to these impacts from Hurricane Helene.3 We’ve covered the promise and challenges of PD growth recently—see our deep dive on home dialysis trends from the latest USRDS annual data report here.

• Oral Drug Revenue Impact – How will adherence and payer response shape the financial impact of new oral drug reimbursement? The inclusion of oral phosphate binders in the dialysis bundle is significant, but adherence and cost control will determine its financial impact.4 We recently wrote about patient access and open questions about whether the increased bundle payment is “enough” to cover costs. Speaking of which…

• Managing Cost Growth – Labor and drug costs are expected to increase—how will DaVita respond? We have an exciting new multi-part series coming your way next month that digs a bit deeper into cross-industry employment models, so we’ll have more for you to unpack on that front soon.

• Market Sentiment & Stock Performance – With shares still trading near historical highs, how will investors weigh cost pressures against revenue growth and margin performance? How will payer mix, GLP-1s, home dialysis, and continued advances in organ transplantation impact the dialysis business? We track every one of these trends right here on Signals, so stay tuned.

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Downloads

Below you’ll find visuals, tables, and links to download our one-page summary with key metrics from the latest quarter, plus year-over-year comps for 2022-2025E.

Snapshot: One-Page Summary

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Welcome back. The kidneyverse has been buzzing with major developments these past two weeks, both in headlines and behind the scenes. That’s why we’re here—to bring you up to speed and open the floor for discussion.

Today, we’re diving into Humana’s expanded in-home kidney care program, the FDA’s approval of xenotransplant trials, the fourth pig kidney transplant milestone, and new insights on the rising transplant waitlist—plus marking National Donor Day and highlighting the latest in news, research, policy, and funding.

A warm welcome to the 200 new subscribers who joined us last month to help shape the future of kidney health. And a huge thank you—Signals is now a Substack bestseller! 110 posts and 18 months in, we’re building the only media-research platform dedicated to kidney innovation, and that’s because of you.

If you find this newsletter valuable, consider sharing it with 1-2 colleagues or friends who care about the future of kidney health. As always, thank you for being here, and keep exploring.

Refer a friend

In this issue

• Humana expands in-home kidney care amid MA headwinds

• FDA approves first xenotransplant trials for kidney patients

• New milestone: The fourth pig kidney transplant performed

• Researchers create 1,000-gene map tied to kidney disease

• Congress investigates one-sided kidney trade allegations

• MediBeacon’s GFR monitor gets FDA approval

• Trump 2.0: Health policies that could reshape kidney care

• Epic and Donate Life America partner on donor registration

• NephPearls: A new toolkit for RAASi therapy optimization

• NKF breaks down new administration policies for kidney care

• ISN partners with African nephrologists on kidney health

• Travere’s next planned FDA submission targets FSGS

• Visual: Kidney transplant waitlist trends over time

• Open roles around the Kidneyverse

• & more…

ICYMI

KCC in Numbers: What We Know, What We Don't, and What Comes Next. Our latest post revisits data from the first performance year (PY22) of the Kidney Care Choices model. We highlight key demographic, operational, and financial metrics across 10 affiliated care coordination organizations. We turned the post into a single-page PDF in case it’s helpful. Feel free to open and download it from the data room below.

Open KCC PDF Graphic

Signals

Humana Expands In-Home Kidney Care Amid MA Headwinds

Summary: Humana and Monogram Health are expanding their in-home kidney care program to Georgia, building on their existing partnership in Alabama, Louisiana, Mississippi, and Tennessee. This move aims to provide earlier interventions for eligible Medicare Advantage members with chronic kidney disease (CKD) and end-stage kidney disease (ESKD), particularly in underserved areas. The expansion aligns with Humana’s broader push into value-based care (VBC), as detailed in its 11th annual VBC report. The report underscores the role of Medicare Advantage in accelerating VBC adoption, highlighting improved outcomes, reduced hospitalizations, and financial incentives for providers. Humana continues to advocate for expanding VBC into Medicaid, emphasizing its potential to enhance chronic disease management and health equity. We covered Humana’s value-based kidney care report last year, which at the time had impacted over 77,000 patients nationwide, with notable improvements in unnecessary hospital admissions, MER, and rates of nephrology follow-up visits.1

Thoughts: Humana’s expansion with Monogram comes as the insurer navigates financial and operational headwinds, including a projected 10% decline in Medicare Advantage (MA) membership in 2025 (~550,000 members) and the impact of lower Star Ratings on future bonus payments. Despite these challenges, Humana continues to bet on value-based care (VBC) and in-home polychronic care as part of its long-term strategy. Its latest earnings call highlighted a focus on managing medical spending, improving patient and provider engagement, and driving profitable growth—all areas where home-based kidney care could play a role. Meanwhile, CMS’s first-year Kidney Care Choices (KCC) evaluation showed mixed-positive results, reinforcing the complexities of managing CKD and ESRD populations under risk-based models. As Humana and others double down on MA-driven VBC, the key question remains: Can these models scale effectively and deliver sustained improvements in cost and care outcomes?2

What do you think? What do people not know or misunderstand about Medicare Advantage, public or private ESRD costs that they should?3

Leave a comment

FDA Approves First Xenotransplant Trials for Kidney Patients

Summary: The FDA has approved clinical trials for two biotech companies, United Therapeutics and eGenesis, to transplant genetically modified pig kidneys into patients with kidney failure. United Therapeutics will begin with six patients, potentially expanding to 50, while eGenesis will start with three patients who are unlikely to receive a human kidney within five years. These trials mark a major step toward xenotransplantation, which could help address the severe organ shortage—nearly 100,000 Americans are currently on the kidney transplant waitlist. However, questions remain about long-term safety, immune response, biosecurity, and ethical concerns. Meanwhile, the fourth xenotransplant just took place, with Tim Andrews, a 66-year-old dialysis patient, receiving a pig kidney at Massachusetts General Hospital. His transplant team shared that Andrews had just a 9% chance of receiving a human kidney in the next five years and a nearly 50% chance of being removed from the waitlist due to declining health.

Thoughts: Xenotransplantation is moving from experimental surgeries to structured clinical trials, and the implications are massive. If these trials prove successful, we could be on the verge of a major shift in organ availability. But will it be enough? Many in the kidney community remain skeptical that “xeno” alone will meaningfully reduce the transplant waitlist in the near future. In my recent poll, nearly half of respondents predicted the waitlist would be longer in 10 years than it is today. Even with advancements in xenotransplantation, bioengineering, and donor incentives, rising rates of diabetes, hypertension, and kidney disease could outpace these innovations. The reality is that no single breakthrough will solve the organ shortage—it will take a combination of new therapies, better prevention, and systemic policy changes.

What is you biggest hope for transplant by the end of 2025?

Leave a comment

Visual of the Week

Kidney Transplant Waitlist Size, 2016 to Present. After years of decline, the kidney transplant waitlist has started growing again. This chart tracks the total number of people on the waitlist on each day over time, with key policy changes and the onset of COVID-19 marked by vertical lines. The newest kidney allocation policy (“KAS250”) broadened geographic distribution while increasing allocation system complexity.4 The long-term downward trend reversed in 2022, and the waitlist has been steadily climbing ever since.

Recent discussions in the kidney community reflect uncertainty about where this trend is headed. In my latest poll, nearly half of respondents predicted the waitlist will be longer in 10 years than it is today. While some see hope in xenotransplantation, organ bioengineering, and living donor incentives, others believe rising rates of kidney disease and systemic barriers to transplantation will outweigh these innovations.

What do you think—will the waitlist be longer or shorter in 2035? What factors will make the biggest impact?

Get transplant data

News

• eGenesis Announces A Fourth Person Has Received a Pig Kidney Transplant [TIME]

• Humana and Monogram Health Announce Expansion of Comprehensive Kidney Care Program in Alabama, Louisiana, Mississippi, Tennessee, and now Georgia [Press Release]

• Travere Therapeutics to Submit sNDA for FILSPARI® (sparsentan) in FSGS [Press Release]

• Congresswoman Jill Tokuda demands answers after news investigation exposes one-sided kidney trade [Hawaii News Now]

• Researchers create the most complete genetic map tied to kidney disease, with more than 1,000 genes that influence kidney function [Penn Today]

• Epic and Donate Life America (DLA) are collaborating to offer patients a seamless way to register as organ, eye and tissue donors directly through MyChart. [Press Release]

• MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function [Press Release]

• Junevity Raises $10M to Develop Cell Reset Therapeutics for Longevity, with an Initial Focus on Type 2 Diabetes, Obesity and Frailty [Press Release]

• Heather Knight has been appointed to the newly created role of Chief Operating Officer at Baxter International. [LinkedIn]

• Trump 2.0: Scott Alexander wrote an interesting piece about what new health policies might look like in a ~90th percentile best outcome scenario. He covers paying organ donors, better longevity biomarkers, Warp Speed for air quality, and improved FDA transparency to name a few. [Astral Codex Ten]

• Discussion about NIH research funding cuts requires 'data, time and careful evaluation' [Healio]

Research

• OPTN/SRTR 2023 Annual Data Report: Kidney [Amer J of Transpl] (H/t Krista Lentine for sharing and leading this effort)

• Researchers create genetic map tied to kidney disease

• Effects of Clazakizumab on Anemia and Iron Metabolism in Patients with Kidney Failure [JASN] (H/t Brendon Neuen for sharing, and great work!)

• Risk-directed management of chronic kidney disease [Nature Rev Neph]

• Combination therapy as a new standard of care in diabetic and non-diabetic chronic kidney disease [Nephrol Dial Transplant]

• Treatment of patients with IgA nephropathy: a call for a new paradigm [Kidney Int] (H/t Davide Garrisi for sharing)

• Remote management of anaemia in patients with end-stage kidney disease using a wearable, non-invasive sensor [Clin Kidney J]

• The rise of agentic AI teammates in medicine [The Lancet]

• NephPearls: Optimization of RAASi Therapy Toolkit [ISN] (H/t Edgar Lerma)

Community

• National Donor Day: Taking a moment to recognize the incredible impact of organ and tissue donation, celebrate donors and their families, and encourage more conversations around transplant awareness. [UPMC] [Miriam] [USA Today]

• Patient Voice: Dr. Patrick Gee, Sr. recently shared his perspective on the question: “Would You Consider Accepting a Pig Kidney Transplant?” [Kidney 360]

• Policy: New Administration, New Policies: What It Means for Kidney Patients [NKF]

• Equity: Black kidney patients find renewed hope after rules change for transplant list [ABC News]

• ISN25: ISN and the African Association of Nephrology signed an MOU to partner on kidney health initiatives across the African continent. [LinkedIn] (H/t for sharing Tushar Vachharajani)

• Events: 2025 Florida Kidney Day in Tallahassee on March 9-10, hosted by the Florida Renal Association [Get Tickets] (H/t for sharing Julie Spears)

• ISN25: The teams at Nova Biomed and hellokidney teamed up to run a CKD screening program for attendees using the NovaMaxPro and digital health platform. [LinkedIn] (H/t Bogdan Milojkovic for sharing)

• ISN25: Rolando Claure Del Granado recently shared a great post celebrating 40 years of the ISN Fellowship Program, and thanking Ravindra Mehta for his guidance.

• Global: Reducing the burden of noncommunicable diseases through promotion of kidney health and strengthening prevention and control of kidney disease [World Health Organization]

Jobs

• Palliative APP (Birmingham, AL) at Monogram Health

• Head of Brand, Marketing, & Comms at Monogram Health

• Sr. Director, Compliance & Privacy at Monogram Health

• SVP Value-Based Care at Guaranteed

• Hospital & Patient Services Mgr (Charlotte, NC) at Fresenius

• Thought Leader Liaison, Nephrology at Mallinckrodt

• Health and Home Strategy Lead at Google

• Organ Health Specialist (Boston, MA) at Natera

• Health Product Manager at Best Buy Health

• Senior Growth PM, US Digital Health at Samsung Health

• Director, Value Evidence Strategy, Nephrology at Otsuka

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Supported By

Signals is made possible with the generous support of our sponsors. We are grateful to partner with organizations committed to advancing global kidney care innovation. This post was made possible by Roivios, the team developing the world’s first renal assist device. Thanks team!

Learn more

We’re back in action with another Sunday batch of headlines, research, community updates and open roles across the Kidneyverse. Welcome to the 192 new subscribers who joined us last month to shape the future of global kidney health.

If you find this information valuable, please consider sharing this newsletter with 1-2 friends or colleagues. You’ll even earn free access to paid Signals content, including posts, KOL videos, data room, and Slack. Thank you for being here.

Refer a friend

In this issue

• FDA approves Ozempic to treat kidney disease

• Reddit EKDA debate on paying kidney donors

• A new milestone in xenotransplantation

• Trump’s latest executive orders on healthcare

• Health systems pushing for value-based care

• Beta Bionics opens the medtech IPO window

• NKF turns 75: celebrating top kidney milestones

• Should we be talking about cybersecurity more?

• Visual: KCC entity spending trends per beneficiary

• A new way to treat pain in dialysis patients?

• Links between climate and kidney health

• Open roles around the Kidneyverse

• & more…

Updates

ICYMI: We launched Signals Snapshots to help tell company’s stories. We aim to give you a bird’s-eye view of what companies do, who they serve, how they make money, and what their top priorities and milestones look like. These are designed as practical resources for anyone working in the kidney space—whether you’re building a business, growing a startup, conducting research, or diving into diligence. Have a company in mind you want us to tackle next? Let us know.

Company Snapshots

We’re also opening up the Slack #general channel so you can join the conversation and see the magic firsthand. I’m loving the back and forth questions, discussions, and candor you just can’t get on social media. People helping people. Paid subscribers get full access to all channels like #transplant, #dialysis, #VBC, #policy, #jobs, #questions and more.

Join Kidney Slack (It's Free)

Signals

F.D.A. Approves Ozempic to Treat Kidney Disease

Summary: The FDA has approved Ozempic to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in people with both Type 2 diabetes and chronic kidney disease (CKD). In a clinical trial, Ozempic lowered the likelihood of serious complications by 24% compared to a placebo. This decision expands the blockbuster drug’s use beyond diabetes and heart disease, offering new hope for a population with limited treatment options.

Thoughts: This is a major win for the millions managing diabetes and kidney disease worldwide. It reinforces the growing role of GLP-1 drugs beyond diabetes and weight loss, adding to the arsenal alongside SGLT2 inhibitors, which have already reshaped CKD treatment. But access remains a challenge. Demand for GLP-1 drugs already far outstrips supply, and insurance coverage will (continue to) be a key battleground. With Ozempic now selected for Medicare drug price negotiations and oral-only drugs newly included in the dialysis bundle as of January 1, affordability and availability are front and center in kidney care policy discussions.

How will Ozempic’s approval reshape CKD treatment over the next 5 to 10 years? What barriers stand in the way of access for patients? For providers? For payers?

Leave a comment

Beta Bionics goes public with upsized $204M IPO

Summary: Beta Bionics (Nasdaq: BBNX) has gone public with an upsized $204M IPO, significantly surpassing its original $114M target. The company, known for its iLet bionic pancreas, has rapidly expanded since its FDA clearance in 2023, with over 10,000 patients now using the system. Proceeds from the IPO will fund the development of a bihormonal iLet system, a new patch pump, and expanded sales and manufacturing. As Beta Bionics enters a competitive $17B insulin pump market, its ability to differentiate from industry giants like Medtronic, Insulet, and Tandem will be key.1

Thoughts: This IPO reinforces the growing investor confidence in medtech after a tough few years. Beta Bionics stands out with its fully automated insulin dosing—removing carb counting and manual corrections—but industry experts still question whether it’s a true "revolution" or an incremental improvement. Its real challenge? Scaling adoption while facing off against well-established competitors. The company’s future likely hinges on how quickly it can expand beyond insulin-only solutions to a bihormonal system, a potential game-changer if executed well.2

How might companies in this space (i.e. Beta, Medtronic, Dexcom) and other diabetes tech leaders bridge the gap between diabetes and kidney care? Is this what a possible future might look like with a wearable artificial kidney?

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EKDA: Bold Step or Slippery Slope?

Summary: A heated discussion on r/transplant highlights the End Kidney Deaths Act (EKDA), a proposed bill aiming to prevent up to 100,000 deaths and save $37 billion annually by expanding access to kidney transplants. Supporters argue that EKDA would overhaul outdated policies, prioritize transplants over dialysis, and provide financial incentives for living donors. However, the bill has (understandably) sparked strong emotions, particularly around its funding mechanisms, ethical concerns about incentivizing donation, and skepticism over whether it truly addresses systemic issues in organ allocation and healthcare access. Some worry that the focus on transplants could divert resources from improving dialysis care, while others see it as a long-overdue correction to a system that traps too many patients in expensive, lower-quality care.

Thoughts: As I’ve written before, EKDA is ambitious. The debate here reveals deep fault lines in how we approach kidney care. Supporters argue that prioritizing transplants over dialysis is both clinically and financially sound, but skeptics see a "slippery slope"—worrying that financial incentives could lead to unintended, unequal outcomes. Some contrast the cash incentives with the Michigan bill proposing tax credits and paid leave, questioning whether financial support should take the form of reimbursement rather than a lump sum. Equity is a major concern—who will benefit most, and will it leave lower-income dialysis patients behind? One point that stuck with me: Even if EKDA delivers 10,000 new transplants a year (a huge jump from today’s 300–400), it wouldn’t "end the waitlist” of more than 90,000 people. And what happens if people step forward for the $50K incentive but transplant centers, which are already cautious about living donors, say no? Big questions, high stakes, and a lot to unpack—I’d like to hear what you think.

What do you think about paying donors to donate their kidney to a stranger? What would need to be true for this system to work?

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Visual of the Week

Per Beneficiary CKD vs. ESRD Spending. In year one of the Kidney Care Choices (KCC) program, there was a general correlation between higher CKD spending and higher ESRD spending, though some entities managed to contain ESRD costs despite significant CKD expenditures. The scatter plot visualizes this relationship, with CKD spending on the x-axis and ESRD spending on the y-axis. Each bubble represents a participating entity, with larger bubbles indicating those managing more total beneficiaries (CKD + ESRD). The interactive chart shows the specific numbers for each entity.

While most organizations cluster within a moderate spending range, a few stand out as outliers—some spending heavily on CKD but still incurring high ESRD costs, others achieving cost efficiencies with lower-than-expected ESRD spending. Notably, certain affiliations (e.g., Interwell, DaVita, Strive) exhibit distinct spending patterns, suggesting different care management strategies. As KCC enters its fourth year, these early trends will be key to understanding how investments in CKD care translate to long-term ESRD cost containment. See the CMS findings at a glance here.

Interactive Chart

Data Room

News

• F.D.A. Approves Ozempic to Treat Kidney Disease [WSJ] [Novo PR]

• Trump’s initial orders reverse Biden on health care costs, protections from discrimination [STAT]

• NBA Hall of Famer Dwyane Wade reveals cancer diagnosis and partial kidney removal [NBC]

• Recipient of pig kidney transplant reaches a milestone [NPR] (H/t for sharing Sen. Bill Frist)

• How the NHS is reducing kidney failure risk nationally [NHE]

• Health systems ditch incrementalism in value-based care [Becker’s Review]

• Inside the lab that’s the beating heart of Medtronic’s product pipeline [Star Tribune]

• Lilly Cuts Mid-stage Relaxin Study in Chronic Kidney Disease for ‘Lack of Foreseeable Clinical Benefit’ [BioSpace]

• Proton’s device aims to help those with kidney disease and cut heart-failure risks [TechCrunch] (H/t Rory St Clair)

Research

• Effects of statins on kidney function in older adults [JAGS]

• Risk-directed management of chronic kidney disease [Nature]

• Safety of Kidney Transplantation from Donors with HIV [NEJM] [U Miami]

• Behavioral intervention decreases how much pain affects daily activities in people with dialysis-dependent kidney failure [NIH]

• Enhancing gene transfer to renal tubules and podocytes by context-dependent selection of AAV capsids [Nature]

• Urology on a changing planet: links between climate change and urological disease [Nature]

• Renal dysfunction contributes to deteriorated survival outcomes in patients with upper and lower gastrointestinal bleeding: insights from a cohort study of 1160 cases [Scientific Reports]

Community

• Anniversary: National Kidney Foundation’s 75th Anniversary: Top Milestones That Changed Kidney Care [NKF]

• Thread: Help save up to 100,000 lives & $37 billion in taxes with the End Kidney Deaths Act [Reddit]

• Podcast: Abe Sutton hosted Jennifer Erickson on the Rubicon Founders podcast in September to talk organ reform, OPO leadership, and transparency. [Spotify]

• Drug Duopolies: Everywhere you look in biopharma, you see drug duopolies. But why is this such a common structure? [Sleuth]

• Sonavex and Prisma Health just announced the first patient has enrolled in the MAFASA trial. [Sonavex] (H/t to John Rappe for sharing)

• Delta4 Secures European Patents for Two Compounds as Candidate Treatments for Focal Segmental Glomerulosclerosis (FSGS) [BioSpace] (H/t Kurt Herpel)

• Security: Why is healthcare so bad at cybersecurity? [Second Opinion]

• Many die awaiting kidney transplants in Wisconsin, so this man donated his [Wisconsin Watch]

• Report: 2024 year-end market overview: Davids and Goliaths [Rock Health]

• Report: Digital Health Trends 2024: Implications for Research & Patient Care [IQVIA]

Jobs

• Director, Provider Partnerships at Monogram Health

• Transplant - Hepatology at Piedmont Transplant Institute

• Global BD Lead, Healthcare & Life Sciences at NVIDIA

• Exec Dir, Product Strategy Lead at Novartis

• Assoc Dir, Patient Advocacy at American Kidney Fund

• Director, US Marketing - Nephrology at Alexion

• Assoc Dir, Innovation PM at AstraZeneca

• Director of Strategic Sales at Interwell Health

• Head of Clinical Outcomes at DeLorean AI

• Chief of Staff at Somatus

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Made Possible By

Signals is made possible with the generous support of our sponsors. We are grateful to partner with organizations committed to advancing kidney care and innovation. This post was made possible by Roivios and 3ive Labs. Thanks team!

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Welcome back, we’ve missed you. This is our first update of 2025, and it’s a fun one. A new year means new funding, new research, new jobs, and even a new look for us here at Signals HQ. There are two changes you can expect from our recaps going forward: they’ll be more consistent (Sundays, not anydays), and they’ll be more to the point (five or ten minutes, not fifty).

To support these changes, we’re tidying up our format. We’ll focus on the 2-3 stories you should know about and why they matter, followed by curated lists of headlines, research, community updates and open roles across the Kidneyverse.

As always, I’d love to hear from you. Leave a comment or join us in Signals Slack to let me know what you think of the new format, cadence, and branding. Let’s light this candle, shall we?

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In this issue

• Alex Azar and “pulling the band-aid” on VBC

• Carilion makes its case for kidney transplant

• Fraud allegations against TransMedics

• How CMS builds evidence-based care models

• Why dietitians should take charge of renal nutrition

• A petition for patients to know about organ offers

• SGLT2 prescription patterns by specialty (2015-20)

• Studying the gut-kidney-PKD axis in Cameroon

• Open roles around the Kidneyverse

• & more…

Updates

ICYMI: We just re-launched our data room with new resources and formats (PDF, PNG, XLSX), and made it a bit easier to navigate. Going forward, you’ll be able to find all our visuals, one-pagers, and databases there. We also added the direct link in our navigation bar on the Signals homepage so it’s easy to find when you need it.

Browse the Data Room

Good news: we’re also opening up the Slack #general channel so you can join the conversation and see the magic firsthand. I’m loving the back and forth questions, discussions, and candor you just can’t get on social media. People helping people. Paid subscribers get full access to all channels like #transplant, #dialysis, #VBC, #policy, #jobs, #questions and more.

Join kidney slack (it's free)

Signals

“Time to Rip the Band-Aid Off”: Alex Azar on Value-Based Care's Future

Summary: At the 2024 Fierce Health Payer Summit, former HHS Secretary Alex Azar urged the healthcare industry to fully commit to value-based care, citing progress in kidney care models as a foundation for broader reform. He highlighted data showing improved patient outcomes and cost savings from government and commercial kidney value-based programs, including increases in home dialysis, depression screening, and transplant waitlisting. Azar argued that kidney care's holistic approach makes it an ideal testing ground for pay-for-performance models and called for large-scale adoption across the healthcare system. Despite progress, Azar noted persistent challenges, including aligning incentives, improving clinician buy-in, and addressing gaps in data sharing and interoperability. He stressed the need for reliable government support and better data tools, such as predictive analytics for identifying high-risk patients. Looking ahead to 2025, Azar remains optimistic, emphasizing that the time has come for the healthcare system to stop experimenting and fully embrace value-based payment models to achieve transformative change.

Thoughts: Three calls to action here: align incentives, improve clinician buy-in, and enhance data sharing. The first two make sense to me: they take time and move at the speed of trust. The third I still struggle with as far as whether access to “good” data is a limitation of policy or technology. The latter seems unlikely. Either way, I think a bit more accountability and transparency in VBC performance (and stable goalposts) would be a great thing. And it’s “good” timing for a spark, given the recent blog from CMMI and kidney-friendly leadership changes headed to Washington this week. When I think about alternative payment models, particularly a second-gen model like Kidney Care Choices (KCC), I think about reach. My last (unofficial) count is in the ballpark of 1 million lives served across 11 providers, but I’ll be sharing that full breakdown here soon enough.

What do you think it will take to get to a full embrace of VBC? What would that even look like? For patients? For providers? For policy makers?

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Carilion makes its case for opening Roanoke Kidney Transplant Center

Summary: Carilion Clinic is advocating for the establishment of a kidney transplant center at Roanoke Memorial Hospital to serve Southwest Virginia's 40,000 chronic kidney disease patients. Currently, patients like Joey Shervey, diagnosed with stage 5 renal failure, face long trips to Charlottesville’s UVA Hospital for care. These burdens, both physical and emotional, highlight the need for localized care. Despite strong community support—including hundreds of letters and patient testimonies—the proposal faces opposition from UVA, concerned about its impact on their program. Carilion argues that a local transplant center would improve accessibility, reduce risks, and provide better outcomes for patients. The state health commissioner will review Carilion’s proposal and issue a decision in the spring.

Thoughts: This conversation ultimately comes down to balancing accessibility with quality care. Miriam Godwin reminded me of an important adage: once it's been granted, every healthcare entity will defend its market. Naturally, this complicates the entry of newer, smaller players. Ann Kempski pointed out that transplant centers of excellence are crucial, but the Certificate of Need (CON) process often fails to consider rural areas like East Tennessee and West Virginia, where Carilion could address unmet needs. Alice Wei and Cosme also emphasized that bigger isn’t always better—larger centers may have better outcomes, but consolidation can harm patients, especially when smaller hospitals could provide essential care with the right resources. Liise Kayler highlighted the importance of proximity in rural areas, where logistical and social challenges often outweigh the benefits of larger institutions. The debate is about ensuring specialized care is accessible to everyone, no matter their location.

What do you think—is there such thing as too much competition when it comes to kidney transplant?

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TransMedics Faces Allegations of Fraud, Organ Trafficking, and Ethical Violations

Summary: TransMedics is under scrutiny following allegations of fraud, organ trafficking, and unethical practices detailed in a report by Scorpion Capital. The claims, which include accusations of coercive business tactics, off-label use of its Organ Care System (OCS), and fraudulent billing, have triggered investigations by two shareholder rights law firms. In response, TransMedics has strongly denied the accusations, calling them baseless and aimed at market manipulation. Despite the controversy, the company remains focused on growth, including the launch of next-generation OCS programs in 2025, and highlights its role in enabling over 7,000 transplants with its technology. Shareholder investigations into potential securities law violations are ongoing.

Thoughts: The allegations against TransMedics raise serious concerns about ethics and oversight in organ transplantation. The 342-page Scorpion Capital report, based on six months of investigation and over 30 interviews, outlines key accusations against the company. While TransMedics firmly denies the claims, the ongoing shareholder investigations highlight the risks for patients and investors alike. As TransMedics looks to expand its Organ Care System (OCS) into heart and lung programs, this analysis offers a solid breakdown of the report’s main allegations, plus possible outcomes (not an issue, bad news, worst case).

What should we know about this space that we may not? Where do these types of technologies intersect with policy and broader calls for system reform?

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Visual of the Week

We often hear primary care and cardiology play a major role in managing kidney disease early. It's worth noting most prescriptions for both SGLT2is and GLP‐1s are provided by PCPs/internists. In 2020, this group accounted for the majority of national SGLT2i (57%) and GLP‐1 (52%) prescriptions, followed by advanced practice providers (24% and 26%), endocrinologists (15% and 19%), cardiologists (1.5% and 0.4%), and nephrologists (0.5% and 0.3%). That tiny sliver of red at the bottom of each chart is nephrology. The first approval for treating CKD arrived in April, 2021— what do you think the chart looks like now? See full comment thread here.

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News

• Novo’s Ozempic, Wegovy Targeted in Second Round of IRA Drug Price Negotiations [BioSpace]

• At JPM, biotech industry expresses excitement — and some anxiety — about therapies from China [STAT]

• With a major patent cliff coming, will JPM play host to some serious deal-making? [STAT]

• Maze Therapeutics looks for IPO lodestar to guide kidney disease assets through clinical trials [FierceBiotech][S-1]

• Metsera files IPO just 9 months after emerging [FierceBio][S-1]; also announces positive results in newest Phase IIa GLP-1RA [Clinical Trials Arena]

• Trump administration will likely kill the FTC’s controversial noncompete rule [Healio]

• Patient care technicians are key in dialysis but are often not fairly recognized [Healio] (H/t Paul Gordon)

Research

• Lived Experiences of Patients Hospitalized With Acute Decompensated Heart Failure and Kidney Dysfunction [JAMA]

• The survival of B cells is compromised in kidney disease [Nature]

• Vafseo trial update: more than 750 patients have now been enrolled in the VOICE study [U.S. Renal]

• Immunogenomic determinants of exceptional response to immune checkpoint inhibition in renal cell carcinoma [Nature Cancer]

• Gut microbiota and kidney function in autosomal dominant polycystic kidney disease participants in Cameroon: a cross-sectional study [BMC Nephrology]

• Belzutifan plus cabozantinib as first-line treatment for patients with advanced clear-cell renal cell carcinoma (LITESPARK-003): an open-label, single-arm, phase 2 study [Lancet]

Community

• Policy: Successor Models, Scaling Pathways, and the CMS Innovation Center [CMS Blog] (H/t Miriam Godwin)

• Petition: Patients Deserve To Know (about organ offers)! [NKF]

• Industry: #FutureFresenius Presentation at JPM [Fresenius]

• Industry: The 34 Lives team presented The First Dedicated Normothermic Rescue Center for Unused Renal Grafts [LinkedIn]

• Perspective: Dietitians should take the lead in weight management for patients with kidney disease [Healio]

• Public: New undergraduate organization provides free kidney disease screenings [Virginia Tech]

Jobs

• Transplant - Hepatology at Piedmont Transplant Institute

• Director, Product Strategy Lead - Renal at Novartis

• Director of Product and Strategy at Monogram Health

• VP, Business Development at Breakthrough T1D

• Account Executive, Healthcare at Stepful

• Senior Program Manager at Diality

Made Possible By

Signals is made possible with the generous support of our sponsors. We are grateful to partner with organizations committed to advancing kidney care and innovation. This post was made possible by Roivios and 3ive Labs. Thanks team!

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Become a sponsor

We’re also excited to announced our new Slack channels for subscribers, offering spaces to meet your peers, ask questions, and discuss topics like transplant, home dialysis, managing early CKD, vascular access, VBC, devices, and more. And speaking of ways to meet and connect with fellow explorers, don’t forget to check out the 2025 conference survey we sent out on Friday—share your plans and help highlight events others should consider as we prepare for the year ahead!

Thank you for being here this year, for supporting this labor of love, and for all you do for those in your orbit and this community. Keep exploring.

—Tim

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This week

• Poll: How are you feeling about kidney health?

• CMS finalizes IOTA model, starting July 1, 2025

• Hemodiafiltration’s U.S. launch: a new chapter

• Baxter restarts dialysis production lines post-Helene

• Akebia’s VOICE trial starts for CKD anemia

• BVP: AI drives health tech recovery into 2025

• Venrock predicts AI struggles, M&A in 2025

• Carilion kidney transplant opposition in VA

• BK virus study reveals new drug targets

• GLP-1 drugs linked to muscle loss risks

• Home care startups scaling with AI tools

• Medtech layoffs surpass 22,000 since 2022

• New strategies emerge for advanced kidney cancer

• Glucose monitoring predicts bradycardia in CKD patients

• & more…

This edition of Signals was made free for all readers thanks to Roivios, the team developing the world’s first renal assist device. Check out JuxtaFlow, a clinical-stage solution for renal insufficiency. Thanks team!

Weekly Poll

In this week's poll, we’d love to hear your thoughts on kidney care in 2025. How are you feeling about the challenges on your plate and the larger kidney care ecosystem over the next 12 months?

I was glad to see many of you are feeling optimistic about the year ahead. At the same time, some of you shared that you expect things to remain about the same. When it comes to real, demonstrable changes—especially in areas like early CKD detection, management, and the dialysis system—many of us remain (understandably) less optimistic.

Back in January, I wrote a piece about 16 key events I thought might shape kidney care in 2024. Some were spot on, while others were a surprise. I’m planning to update this list for 2025, so let me know which events are top of mind for you and what you expect to see in the year ahead.

Leave a comment

Signals

CMS issues final rule for mandatory organ transplant payment model

The Centers for Medicare & Medicaid Services (CMS) finalized the Increasing Organ Transplant Access Model, a mandatory six-year payment program aimed at improving kidney transplant access for end-stage renal disease patients while preserving care quality and reducing costs. Starting July 1, 2025, the model will involve 103 transplant hospitals and offer performance-based incentives of up to $15,000 per transplant case. Adjustments based on stakeholder feedback include revised transplant targets and removed transparency requirements on organ declines. This initiative highlights CMS's focus on equitable and cost-effective transplant care. Find FAQs about the model here.

The CMS Innovation Center will be hosting a welcome webinar to present an overview of the model on December 18, 2024, from 2 to 3 p.m. ET. Register to attend here.

Hemodiafiltration's US Launch: A New Chapter in Kidney Care Technology and Evidence Featured at Kidney Week

Hemodiafiltration (HDF) could be a transformative addition to dialysis care in the U.S., with Fresenius planning a broad rollout in 2025. Highlighted at ASN Kidney Week 2024, Peter Blankestijn, PhD, presented a meta-analysis published in The Lancet showing that HDF significantly reduces all-cause and cardiovascular mortality compared to standard hemodialysis (IHD). Fresenius’s new 5008X machine supports HDF delivery without major infrastructure changes, and global data from over 78,000 patients suggest benefits like fewer hospitalizations and improved outcomes. With its potential to enhance clinical results and reshape dialysis practices, HDF's U.S. adoption could mark the most significant shift in renal care delivery in decades.

Baxter resumes dialysis solution production at its hurricane-hit facility

Baxter International has resumed production of dialysis and IV solutions at its North Cove facility in North Carolina, which was temporarily shut down due to hurricane-related flooding in September. The plant, responsible for 60% of the U.S. supply of IV fluids and peritoneal dialysis solutions, has restarted manufacturing at reduced capacity, with IV solution production reaching 85% of pre-hurricane levels. While progress is underway, Baxter cautions that returning to full production will take time. This follows earlier guidance to limit new dialysis patients due to supply constraints, highlighting the critical importance of the facility in maintaining U.S. dialysis care.

US Renal Care & Akebia enroll first patient in Vafseo (vadadustat) trial

Akebia Therapeutics has launched the VOICE trial to evaluate the safety and efficacy of Vafseo® (vadadustat) for treating anemia in chronic kidney disease (CKD) patients on dialysis. The trial will involve approximately 2,200 participants and compare thrice-weekly Vafseo dosing to standard erythropoiesis-stimulating agents. With its anticipated U.S. market launch in January 2025, Vafseo aims to align with dialysis schedules and potentially reduce hospitalizations while maintaining non-inferiority in all-cause mortality. This study marks a significant step in addressing CKD-related anemia.

Report: Bessemer’s 2024 State of Health Tech

Bessemer Venture Partners’ State of Health Tech 2024 highlights the resilience of the health tech sector amid ongoing challenges, showcasing recovery in private market deal-making and a surge of innovation in AI-driven healthcare solutions. With nearly 40% of new healthcare venture investments targeting AI, startups are rapidly achieving scale in areas like payer workflows, drug pricing transparency, and clinical augmentation. Bessemer highlights that 2025 will likely see accelerated adoption of these technologies as players across healthcare—facing profitability headwinds and regulatory shifts—embrace innovation to meet survival imperatives. These trends mark the next phase in health tech’s transformation, blending AI, transparency, and value-based care into scalable, efficient systems.

Venrock's 2025 Healthcare Predictions: Key Takeaways

Bob Kocher and Bryan Roberts expect a year of significant shifts driven by policy battles, technological evolution, and market forces. With legislative gridlock expected to continue, much of the action will shift to the courts, where challenges to CMS and FDA rulemaking will dominate the agenda. In the private sector, a rebound in at-risk primary care is anticipated following a challenging 2024, as risk-bearing providers streamline costs and adapt to new reimbursement models. Health tech is also poised for resurgence, with a wave of M&A activity and renewed IPO interest, though valuations are expected to remain lower than peak levels.

Meanwhile, artificial intelligence in healthcare may face a reckoning. While larger, established companies will integrate AI to boost efficiency and profitability, many standalone health tech AI startups are likely to struggle, proving better suited as features within broader solutions rather than standalone businesses. Venrock also anticipates continued innovation in areas like glucose monitoring, with companies like Apple leading the way, and a revival in cell therapy, particularly in solid tumor applications. Overall, 2025 promises to be a transformative year, with opportunities and challenges across policy, innovation, and market dynamics.

Carilion wants to start a kidney transplant program in Roanoke. State health officials, and UVa, oppose it.

Carilion's proposal to establish a kidney transplant program in Roanoke faces opposition from state health officials and the University of Virginia (UVa). Citing long travel times for Southwest Virginia residents, Carilion aims to enhance access to transplant services, projecting 30 transplants annually after initial ramp-up. However, the Virginia Department of Health’s Division of Certificate of Public Need recommended denying the application, raising concerns over Carilion’s recent regulatory compliance issues, the experience of its proposed lead surgeon, and the program's potential impact on UVa's established transplant services. UVa argues that organ availability, not geographic proximity, is the primary barrier to transplant care and that the program would divert resources from its robust operations. While some support letters highlight the potential to improve patient outcomes, the state health commissioner will make the final decision following a January fact-finding hearing.

There are 6 kidney transplant programs in Virginia: at Inova Fairfax Hospital, Henrico Doctors Hospital, Children’s Hospital of the King’s Daughters, VCU, Sentara Norfolk General and UVa.

Study: New model for replication of BKPyV virus, a major cause of kidney transplant failure

Researchers at the University of Alabama at Birmingham (UAB) have uncovered new details about BK polyomavirus (BKPyV) replication, a major cause of kidney transplant failure, which could pave the way for new treatments. Their study, published in PLOS Pathogens, reveals that BKPyV relies on host kidney cells to complete a round of DNA replication before producing the viral large tumor antigen (TAg), contrary to prior beliefs. Blocking this early host DNA replication could prevent viral production, offering a potential drug target to protect transplanted kidneys. This breakthrough highlights new avenues for antiviral strategies, as targeting host cell processes reduces the likelihood of viral resistance.

Study: Muscle matters: the effects of medically induced weight loss on skeletal muscle

GLP-1 receptor agonists, widely used for weight loss, have drawn attention for their potential to cause significant skeletal muscle loss, accounting for 25% to 39% of total weight lost over 36–72 weeks. While this muscle loss is linked to the magnitude of weight loss rather than a direct pharmacological effect, it far exceeds age-related muscle decline. Comparatively, non-pharmacological weight loss typically results in smaller proportions of muscle loss (10–30%). The findings underscore the need for clinicians to address concerns about muscle preservation to ensure patient adherence and optimize treatment plans.

Top 30 home care startups by funding source

Thomas Hagemeijer of TLGG Group highlights the growing potential of tech-enabled home care, citing Signify Health's "staggering growth" and European startups like Heim gaining traction. With aging populations straining traditional care systems, innovative solutions are addressing workforce shortages by optimizing efficiency through AI, automation, and self-care tools. Models like Signify’s focused visits for chronic conditions demonstrate scalable, impactful care delivery. Hagemeijer also notes that private equity, when responsibly applied, can accelerate holistic home care solutions, ensuring better outcomes while meeting critical societal needs.

Layoffs in medtech: These companies recently reduced their workforce

The medtech industry is ending the year with more layoffs— now over 22,000 job cuts reported since mid-2022. While companies like Boston Scientific and Intuitive Surgical have maintained strong revenue growth, others are facing operational challenges, supply chain disruptions, inflation, and economic pressures, including the downturn in China. Upcoming tariffs and regulatory changes under the incoming administration may add further uncertainties.

Study: Renal Response Associated with Greater Likelihood of Long-Term Renal Survival in People with Lupus Nephritis

A new study in Lupus Science & Medicine highlights the link between kidney response and long-term renal survival in lupus nephritis (LN) patients. Achieving modified primary efficacy renal response (mPERR) or modified complete renal response (mCRR) at 24 months significantly increased the likelihood of long-term kidney survival, with 78.9% of mPERR responders and 80.4% of mCRR responders showing improved outcomes. These findings suggest integrating mPERR and mCRR into clinical practice could enable earlier interventions, helping prevent irreversible kidney damage and end-stage renal disease. Further research is needed to refine the timing of response assessments.

Q&A: Standard-of-Care Shift in Advanced Kidney Cancer Introduces Questions for Some Patients

The standard treatment for advanced renal cell carcinoma (RCC) has shifted to a combination of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors, significantly improving outcomes. However, special considerations are necessary for older patients and those with renal insufficiency. Dr. Xin Gao of the Mass General Cancer Center highlights that while these therapies are not dose-dependent on kidney function, careful monitoring of renal health and individual patient conditions is essential. TKI monotherapy remains an option for select cases, such as patients with favorable-risk RCC or contraindications to immunotherapy. Adverse events often depend on individual resilience rather than age alone, underscoring the importance of personalized treatment approaches for managing RCC in these populations.

Study: Monitoring individualized glucose levels predicts risk for bradycardia in type 2 diabetes patients with CKD

A pilot study exploring the link between glucose levels and bradycardia in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) revealed significant associations. Using interstitial glucose (IG) and ECG monitoring over 7 days, researchers identified a higher frequency of bradycardia episodes during low relative glucose periods, particularly in specific time windows. The study achieved a high predictive accuracy (AUC 0.94) for bradyarrhythmias using glucose and heart rate variability features, challenging the traditional definition of hypoglycemia by finding that only 4% of bradycardia episodes occurred at glucose levels below 70 mg/dL. These findings underscore the importance of personalized glucose monitoring in predicting cardiac risks for this high-risk population.

Study: Chocolate intake and risk of type 2 diabetes: prospective cohort studies 🍫

A recent study leveraging data from three large cohort studies suggests that higher dark chocolate consumption may lower the risk of type 2 diabetes (T2D). Participants consuming at least five servings of dark chocolate per week experienced a 21% lower risk of T2D, with a linear reduction of 3% per additional weekly serving. Interestingly, milk chocolate showed no significant T2D risk reduction and was linked to long-term weight gain.

Community Voices

A collection of insights, opinions, updates and upcoming events from your peers and fellow explorers across the Kidneyverse.

• No-cost heart & kidney screening Dec 7-9 in Tampa: Care Access is offering free heart and kidney health screenings in Tampa from December 7-9 at IMA Medical Clinic of North Dale Mabry. These screenings will include testing for diabetes, high cholesterol, and lipoprotein(a) (Lp(a)), a significant but lesser-known cardiovascular risk factor that impacts one in five people. Participants will also receive educational resources on heart and kidney health and opportunities to engage in clinical research aimed at advancing treatments for Lp(a) and related conditions. Walk-ins are welcome, but scheduling is recommended at MyFreeHeartTest.com.

• Tillamook Kidney Center opens soon: The reopening of the Tillamook Kidney Center brings life-saving dialysis care back to Tillamook, Oregon, ending the need for patients to travel long distances. Managed by Dialysis Clinics Incorporated (DCI), the center will operate three days a week, offer a home dialysis program, and benefit from strong community partnerships, including rent-free clinic space and shared staffing from Adventist Health. Despite a projected financial deficit, support from DCI’s foundations, profitable centers elsewhere, Adventist, Medicare, and local fundraising will help sustain operations. Dr. Claire Kassakian of Northwest Renal Clinic, the new medical director, described the reopening as a significant and emotional milestone, while patients expressed relief and gratitude for the return of local care.

“At the end of the day what we’re really trying to do is take care of our friends and family in our community,” Swanson said. “That’s the advantage of rural healthcare, you’re taking care of your friends and family.”

• John Erbey: Chronic kidney disease is a growing global challenge, but innovation is opening new doors. From advanced dialysis systems and bioengineered kidneys to breakthroughs in xenotransplantation, we’re witnessing a transformation in how we manage kidney health. I’m proud to share my insights, where I explore these exciting advancements and how they’re reshaping outcomes for patients worldwide. Together, we can create a future where kidney care is smarter, more efficient, and less invasive.

• Dr. Bill Frist: Last night we celebrated the incredible milestone of the 2000th heart transplant at the Vanderbilt Transplant Center. What was once a seed of an idea 30+ years ago is now the busiest heart transplant center in the world. Wonderful to see old friends, colleagues and patients.

• Davide Garrisi: “…In today's clinical development it is really exciting to see how the race to the next blockbuster is becoming more and more competitive, fostered by daily press releases - the last one just when I am writing about Zepbound vs Wegovy. And talking about news and press releases, we also appraised very recently the perceived market importance of the double-digit % weight reduction at 1/3 months as the main success indicator in this race.
  Along with the enthusiasm for the short-term wins of weight reduction, more and more publications in literature are shifting their attention towards the long-term effects of weight reduction and chronic weight management drugs on body mass composition...”

• Scott Nelson: “Over the past 18 months, Medtech has cut 14,000 people.

  In 2025, things will still be rough, however signs are pointing to increased investments/ acquisitions with falling interest rates and an expectation of increased IPO activity per Reuters. Recent large investments across digital health and data analytics covered by Fierce Healthcare. And Medline Industries just announced a planned public offering next year to raise up to $5B. Bottom line:

  Our MedTech markets— as exciting as they may be, are never really stable— we all need to look out for each other.”

• International Society of Glomerular Disease: Registration and abstract submissions open on Tuesday Dec 10 for the 2025 International Podocyte Conference happening June 10-13 in Hamburg.

• Neil G.: Awesome day at Heart House in Washington DC to talk about doing better for our patients! Many thanks to the American College of Cardiology for inviting US Heart and Vascular to the Value Based Care Forum. Fantastic opportunity to converse with leaders from government, health systems, private practices, and payors to discuss the challenges around VBC and how we think about the barriers. Fundamental problems have to be tackled: prioritizing patient access to outpatient care, avoiding unnecessary ER visits, and eliminating low-value care. The planning committee did a great job!

Made Possible By

Signals is made possible with the generous support of our sponsors. We are grateful to partner with organizations committed to advancing kidney care and innovation: Roivios, 3iveLabs, Dialysis Education Services, and IKONA.

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This edition of Signals was made free for all readers thanks to Roivios, the team developing the world’s first renal assist device. Check out JuxtaFlow, a clinical-stage solution for renal insufficiency. Thanks team!

In February 2021, after months of pandemic restrictions, Leila Mirhaydari was finally able to see her kidney doctor in person again—a huge relief after being unable to get the in-person care she needed for so long. But with that relief came anxiety. Transplanted organs require careful monitoring, and Leila had been looking after her transplanted kidney on her own for a year. So much was riding on those first lab results.

"Immediately, all my levels were just out of whack and I knew that I was in rejection," she says. "I've had to work through a lot of emotional pain, of feeling like I failed my donor. Like, why couldn't I hold on to this kidney?"

Her step-cousin’s donated kidney had allowed Leila to be free of dialysis, to travel the world, and live her life for eight "beautiful years." Now it seemed that time was coming to an end. Leila began preparing to go through the arduous journey of waiting for another transplant.

Leila’s experience highlights the reality for many kidney transplant recipients: while kidney transplants offer life-saving benefits, they are not a permanent cure. On average, a living donor kidney lasts 15 to 20 years, while a deceased donor kidney lasts 8 to 12 years. Some will last longer; others less. The uncertainty of kidney survival underscores the need for better tools to predict long-term outcomes after surgery— and it gets at the heart of what we’re talking about today.1

While Leila was facing kidney rejection, a global team of researchers over 7,000 miles away set out to better understand how we might predict the long-term success of kidneys after transplant— what’s known as graft survival. Their work has laid the foundation for a new metric that might help us cut through the fog in the distance once and for all.

The iBox Scoring System was developed to address a major gap in kidney transplantation: the lack of reliable early surrogate endpoints to support drug discovery, clinical trials, and long-term graft survival.2

Predicting long-term success with short-term data alone has proven difficult and unreliable. We are limited by our current toolset and time constraints. This is why tools like iBox hold so much potential—not only in reshaping transplant medicine, but also in helping us realize a long-held vision of giving every recipient “one kidney for life.”3

Today, let’s begin to answer three important questions:

• What are surrogate endpoints, and why do we need them?

• How would iBox improve decision-making in transplant care?

• Why would iBox unlock new drug development and innovation?

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What are surrogate endpoints, and why do we need them?

Surrogate endpoints are lab measures or physical signs used as substitutes for direct clinical outcomes. While they don’t measure the actual clinical benefit of a therapy, they are designed to predict it.

Why do we need them? Well, clinical outcomes may take years to observe, which could delay a therapy being available to patients who would benefit. As you can imagine, this becomes important in areas like kidney transplant, where much of our focus (and the system itself) is centered on short-term outcomes (i.e. 1-yr, 5-yr), while longer term outcomes can be little better than a coin flip in some cases. The 5 and 10 years graft survival rates are 77% and 49% for deceased donor and 86% and 64% for living donor transplants. This stark contrast makes it difficult to develop and test new drugs or therapies that could help us improve graft survival over longer time horizons— say 8, 10, or ever 20+ years beyond surgery.4

This complexity arises because late graft failure is often multifactorial—a result of several interconnected factors, such as immune response, rejection, and side effects of medications, making prediction difficult. In short: graft loss is complicated. A 2016 paper in Transplantation captures this well (see figure below), showing pathways to graft loss related to immunosuppression (blue) and those linked to graft immune response (red). We’ll cover some of these factors and how they play into decision-making in the next section. Simply put, short-term surrogate endpoints don’t capture the range of variables that influence long-term graft survival. This is why we need a more comprehensive model to predict long-term success.5

In clinical trials, surrogate endpoints can help catalyze the approval process. The FDA’s Accelerated Approval Program uses surrogate endpoints to approve drugs for serious conditions faster, allowing researchers to get treatments to patients sooner while still ensuring they’re safe and effective. For instance, reducing systolic blood pressure can predict stroke risk, allowing trials to be completed more quickly with smaller populations.67

However, surrogate endpoints must be carefully validated to truly predict the desired clinical outcome. In kidney transplantation, the lack of reliable long-term predictors has been a major challenge. Traditional endpoints fail to reliably predict long-term graft survival across organ types, leaving a gap for patients like Leila and Amy, who are at risk of graft failure.

“I’ve had the opportunity to sit in on a few closed-door meetings of professional transplant organizations where physicians speak about the problem openly, if briefly, in a safe space for voicing regret and frustration. They admit with shrugged shoulders that after the first five years post-transplant, they don’t know how much immunosuppressive medicine will keep a transplanted organ protected and a recipient’s body safe from harm.” — Amy Silverstein (April, 2023)

This is where the iBox Scoring System aims to fill a vast unknown. Developed by Dr. Alex Loupy and the team at PARCC— and with support from C-Path’s Transplant Therapeutics Consortium— the iBox score combines eGFR, proteinuria, histology, and HLA-DSA to predict long-term graft failure. This model offers a more comprehensive view of risk and outperforms traditional methods. By integrating multiple risk factors, the iBox model provides better insights into a kidney’s long-term survival, which is crucial for improving patient care, drug development, and clinical trial design.89

In 2022, iBox was endorsed and qualified by the European Medicines Agency (EMA), and just last month, it received FDA acceptance of its Biomarker Qualification Plan. This marks a significant milestone in the progression of the iBox system, as it continues to gain recognition on both sides of the Atlantic as a key tool in kidney transplant clinical trials. The Paris Transplant Group is the multidisciplinary team behind iBox. They bring together immunologists, researchers, nephrologists, cardiologists, pathologists, statisticians, and public health specialists to advance the field of transplantation. They also put together this helpful 2-minute video overview of the iBox algorithm for those interested.

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How can iBox improve decision-making in transplant care?

The Transplant Therapeutics Consortium (TTC) aims to quality iBox as a surrogate endpoint for long-term graft survival. In transplant medicine, decisions are often based on short-term outcomes, such as 1-year graft survival, which are important yet incomplete reflections of the full picture. As we’ve covered, the challenge with predicting long-term outcomes lies in the complexity of late graft failure, influenced by a host of factors from immune response and medication side effects to underlying health conditions. However, it’s important to note that individual measures—such as eGFR (estimated glomerular filtration rate) and proteinuria—are insufficient on their own to capture the full range of long-term risks, making it challenging to predict graft survival over time based on any single measure (see below table).1011

A second clear issue is the inconsistency in how different physicians interpret the same clinical data. A recent study comparing iBox to physician decision-making highlighted this problem. Physicians showed wide variability in their predictions, depending on which risk factors they prioritized (e.g., IFTA vs. ABMR), leading to inconsistent (and sometimes inaccurate) assessments. Dr. Alex Loupy, one of the study authors, points out that this variability is a clear indication of weak calibration and intra- and inter-observer variability. Unlike humans, who interpret data inconsistently, iBox provides a stable, data-driven prediction model that helps clinicians make more informed and consistent decisions. In the figure below, researchers asked 9 physicians to rank the 10 most important features driving their predictions across 400 patients. The features (y-axis) are presented from descending importance. The higher the value of mean decrease accuracy (x-axis), the higher the importance of the feature in the model. Take an extra second to ponder this one.

The iBox score stands out by combining several key factors known to affect long-term kidney function. It takes into account eGFR, proteinuria, histology (biopsy results), and donor-specific antibodies (DSAs). By combining these factors, iBox gives a more complete picture of a transplant recipient’s risk, which allows clinicians to make more informed decisions about care. This comprehensive model accounts for more variables than traditional methods, which often rely solely on eGFR or proteinuria to assess graft function. iBox’s ability to incorporate a combination of clinical, histological, and immunological data sets it apart, offering a more robust, reliable prediction of long-term graft survival.

Loupy and colleagues compared the predicted probabilities of kidney survival generated by physicians versus the iBox system. Their results (below) show a much more consistent prediction distribution from iBox, compared to the varied predictions from different physicians. Again, this demonstrates iBox’s potential to improve decision-making by offering a stable and reliable prediction model, reducing the variability inherent in human assessments.

iBox also improves upon the status quo by providing a tool that not only assesses non-inferiority, as is common in clinical trials, but also demonstrates the superiority of new immunosuppressive therapies (ISTs). By offering a more reliable prediction of long-term graft survival, iBox is now positioned to serve as a key secondary endpoint in clinical trials, particularly those evaluating therapies aimed at improving long-term kidney transplant outcomes. Its qualification enables its use in pivotal or exploratory drug studies, assessing treatment effects from 6 months to 2 years post-transplant—a critical period for understanding long-term impacts on graft survival. This longer time frame provides a more meaningful measure of success compared to traditional 1-year endpoints.12

This is especially important because, historically, there has been little incentive for drug developers to focus on long-term outcomes beyond 5 years. Current endpoints typically demonstrate non-inferiority rather than superiority, and the lack of reliable long-term surrogate endpoints has hindered the development of drugs that might improve kidney survival over the long term. By providing a more reliable method for predicting long-term success, iBox could fill this gap, helping clinicians and drug developers alike focus on the bigger picture of improving graft survival for years beyond the immediate post-transplant period.

Recent studies show iBox’s ability to bridge the gap between short-term and long-term outcomes (here, here, and here). By improving the accuracy of risk prediction, it helps reduce physician variability in making decisions and offers a more objective approach to patient care.

iBox’s regulatory momentum further backs its importance in transplant medicine. In 2022, the European Medicines Agency (EMA) qualified iBox for use in clinical trials, and now, the FDA has accepted iBox as a surrogate endpoint for kidney transplant clinical trials. This recognition is a major milestone and paves the way for its use in accelerating the development of new therapies. By offering more reliable predictions and minimizing human variability, iBox could change the way clinical trials are designed and help speed up the development of new treatments. Ultimately, this shift could lead to better, more personalized patient care, and more consistent transplant outcomes.

Kevin Fowler, a patient advocate and kidney transplant recipient, pointed out that while iBox has the potential to improve transplantation, it took the FDA 12 months to decide to review it. As the process continues, Fowler emphasizes that the kidney transplant community wants to be part of this review. For comparison, it took iBox one year from initial submission to receiving final QO from Europe’s regulatory body (EMA) in December, 2022 (see below).

What would this mean for drug discovery, clinical trials, and innovation?

The regulatory framework for kidney transplant therapies has long been focused on preventing organ rejection. However, no therapy has been approved for preventing long-term graft loss, which remains a critical gap in transplant medicine. Currently, all FDA-approved immunosuppressive therapies (ISTs) are indicated for the prophylaxis of organ rejection. This regulatory framework has centered around immediate post-transplant survival rather than the long-term health of the transplant, and, as a result, we have basically “maximized” 1-year graft survival as an endpoint for clinical trials (see below). Going a bit further, drug developers face few incentives to pursue treatments that aim to improve long-term graft survival.

This regulatory limitation has stifled the development of new therapies for kidney transplants. Over the past two decades, no new IST demonstrating improved efficacy has been developed, and no new IST has been approved for the prevention of organ rejection for more than a decade. There are also no new ISTs in Phase 3 clinical trials today. With iBox now qualified as a surrogate endpoint for clinical trials, particularly for the critical 6-month to 2-year period post-transplant, there is new hope for accelerating the development of therapies that target long-term transplant outcomes. iBox offers a tool to bridge the gap between short-term efficacy and long-term graft survival, enabling the development of new therapies that could help extend the life of kidney transplants and improve long-term outcomes for recipients.13

What if a new drug could be indicated for the prophylaxis of organ rejection and improvement in the iBox in kidney transplant?

This is not yet a reality, but it’s an example of what iBox’s prognostic ability—compared to markers like BPAR (biopsy-proven acute rejection)— could mean for potentially qualifying iBox as a reasonable likely surrogate endpoint (RLSE). This could provide sponsors with a pathway for accelerated approval through the FDA.

There’s precedent for this, including right here in the Kidneyverse. Surrogate endpoints have played a critical role in accelerating the availability of new treatments in areas like oncology, HIV, Alzheimer’s, sickle cell disease, and Fabry disease. IgA nephropathy serves as a prime example of what can happen when sponsors have the right endpoints in place. In 2020, there were no approved treatments for IgA nephropathy. As of writing, three IgAN treatments have been approved—Tarpeyo (2021), Filspari (2023), and Fabhalta (2024)— with at least 10 more in development. For a disease that affects 130,000 to 150,000 people in the US, up to 40% of whom will develop kidney failure within 10 to 20 years of diagnosis, this is the kind of progress that serves as a guiding light for the future.14

What’s Next

The qualification of iBox marks a critical milestone, bringing us closer to therapies that could significantly extend the lives of kidney transplant recipients and help us realize the ‘one kidney for life’ dream. As the first transplant endpoint to reach this stage, iBox is now positioned to be used as a co-primary endpoint in pivotal clinical trials and the Accelerated Approval Pathway at the FDA. This pathway fast-tracks approval for drugs addressing serious conditions and unmet medical needs, offering hope for quicker access to life-changing treatments.

The next step is the submission of the Full Qualification Package to the FDA, which will further establish iBox as a reliable tool for predicting long-term graft survival and improving transplant care. With ongoing research involving thousands of transplant recipients, the team behind iBox will continue to evolve, adapt, and solidify its role in clinical practice and drug development. The Transplant Therapeutics Consortium (TTC) and its partners have been instrumental in achieving this progress, and their collaboration will accelerate the development of new therapies.

Discussion

This win for iBox has significant implications for transplant medicine, drug development, patient outcomes, and regulatory pathways. How do you think about these questions?

• Surrogate Endpoints in Transplantation: How will surrogate endpoints like iBox transform the landscape of transplant medicine? Which other endpoints should we be aware of or paying attention to?

• Accelerating Drug Development: How will iBox’s FDA qualification open the door to faster approval for new immunosuppressive therapies? When do you think we will begin to see the benefits of iBox as a novel endpoint?

• Long-Term Patient Outcomes: What would iBox approval mean to you in terms of what it does in clinical practice or drug development? How could this change the way you approach patient care, trial design, or market assessment?

• Impact on Regulatory Processes: How might iBox change the way we evaluate kidney transplant therapies? Do you expect to see any changes in regulatory pathways as a result of iBox? What should we keep an eye on as the next Administration takes office in 2025?

As always, thank you for being here with us. If this conversation resonates, or if you have a story or point of view to share, we’d love to hear from you in the comments below. And if you want to join your peers in the brand new Signals slack community, we’d love to have you— please join the waitlist here.

— Tim

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Resources & Data

At the end of each brief I like to share a short list of sites, studies, reports, and other interesting gems I came across while researching the piece. Enjoy!

• Are Long-Term Outcomes after Kidney Transplantation Improving? The FDA hosted a public workshop in November, 2023 to discuss endpoints and trial designs to advance drug development in kidney transplant. Part of that workshop included presentations by Drs. Emilio Poggio, Ergun Velidedeoglu, Jeff Siegel, and Paul Conway to name a few. This single doc (yes, it is really 327 slides) has perspectives from FDA, academia, patient advocates, developers and other key stakeholders in the endpoints field. It contains enough data, charts, and insights to get you up to speed on subtopics while also giving you plenty of new threads to pull on. Enjoy!

• My Transplanted Heart and I Will Die Soon. This stirring, beautiful guest essay by Amy Silverstein was published in The New York Times last April. In it, she explains that “over the last almost four decades a toxic triad of immuno-suppressive medicines — calcineurin inhibitors, antimetabolites, steroids — has remained essentially the same with limited exceptions. These transplant drugs cause secondary diseases and dangerous conditions, including diabetes, uncontrollable high blood pressure, kidney damage and failure, serious infections and cancers. Transplantation is no different from lifelong illnesses that need newer, safer, more effective medicines. The key difference is that only in transplantation are patients expected to see their disease state as a “miracle…”

• Farewell, my kidney: Why the body may reject a lifesaving organ. Leila’s story at the top of this piece was captured and shared by the NPR Short Wave team in May of 2023. It’s fantastic, and well worth a read or listen.

• What goes into the iBOX algorithm anyways? Here are the component measures of the full and abbreviated iBOX.

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Yes, I’m still reeling from the frenetic, rhythmic pulse of Kidney Week. From Dr. Crews’ opening call to “redefine the standard” to the labyrinth of posters and bright-eyed fellows, I’m riding high with deep admiration and gratitude for those who make this week possible. To everyone I had the chance to meet in person—thank you for making those days feel like a true kidney-nerd's paradise. For those who reached out to share your stories, impressions, and optimism after the event, thanks for keeping Signals in your corner for kidney innovation updates.1

Later this week, we’ll start our full Kidney Week coverage, taking it one story at a time. If we missed you at the show and you have a story to share, please don’t hesitate to reach out and say hello.

Thanks, too, to everyone who voted on what you’d like us to cover. The top interests are innovation spotlights (50%) and scientific discovery (33%). So, we’ll stick with what we do best: covering the ideas, innovations, and investments shaping the future of kidney health. Stay tuned—there’s a lot more to come after this weekly recap.

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Brought to you by Roivios

This edition of Signals was made free for all readers thanks to Roivios, the team developing the world’s first renal assist device. Check out JuxtaFlow, a clinical-stage solution for renal insufficiency. Thanks team!

Last week, Roivios released new clinical data from the BIPASS-AKI Feasibility Study of the JuxtaFlow® Renal Assist Device (RAD) at the STS Perioperative Care meeting. Learn more below…

This week

• Poll: Top ethical considerations in transplantation

• CMS delays IOTA model; KTC responds with analysis

• Sonavex raises $15M to enhance dialysis ultrasound tech

• Roivios device shows kidney protection post-surgery

• Quanta gets FDA approval for home dialysis use

• KDIGO opens up anemia guidelines for public review

• Single APOL1 gene variant raises CKD risk in West Africans

• IgAN therapies take center stage at Kidney Week

• Renal denervation gains momentum in hypertension care

• Early eGFR changes in ADPKD may predict outcomes

• Report questions remote hypertension monitoring w/o med support

• Clinicians launch Scrub Capital VC for health innovation

• Year-end push highlights primary care in value-based models

• Study IDs top social determinants for women with lupus nephritis

• FDA panel votes against sotagliflozin for glucose control

• BioCom CEO Summit: resilience, Q1 2025 IPO hopes

• & More…

Transplant Ethics

In this week's poll, we want to know which of these ethical considerations you think is most important to "get right" as we shape the future of organ transplantation?

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More than half (58%) said equity in organ allocation is most important to you, followed by even splits between paying organ donors (18%) and using animal organs, or xenotransplantation (18%). A few of you also had other top of mind ethic questions, so let’s talk about a few of them.

Below are a few insightful comments, questions, and perspectives provided in the comments on this post. What do you think?

• Miriam Godwin: “It's not the sexiest answer but the failure to protect trust and transparency in organ allocation has been a spectacular failure of public policy. It is essential to have a robust and trustworthy regulatory framework that promotes innovation while defending against bad outcomes and bad behavior and on which novel, creative solutions to the problems that distress us can stand.”

• Vanessa Evans: “You know what I think- make it easier to get patients listed- use a common app (like they do for college applications )to register - pair potential donors and recipients with an advocate – someone that has gone through it before- compensate donors - think tax breaks or free healthcare we must think more creatively.”

• Stephen Ruby: “Extending the life of a kidney between the donor and recipient is perhaps one of the goals that may provide the greatest "bang for the buck." 34 Lives is doing that and has already made an impact for a number of patients who would otherwise not have received a donor kidney (at this time). Their impact will continue to grow into the future. Donated kidneys is perhaps one of the greatest resources we currently have for those with CRD and everything should be done to maximize the percentage of those kidneys that actually get into patients and change their life!”

• Qasim Butt: Not sure if this is an ethical issue, but one of the biggest hurdles to me is patient navigation of the kidney transplant process…. Early referral, Education, Which transplant center to go to, Can I go to different centers, Getting on waiting list / getting medical clearance, How to get a living donor, etc. One of the most interesting nephrologists in this space that is trying to do something about it is Eliot C. Heher MD - just got to meet him at ASN last week.”

• Jullie Hoggan: “Patients being referred for transplant evaluation when they qualify for listing rather than when they start or after they start dialysis. Patients should hear their options in time to make a choice and act. We'd never withhold information about the best treatment for heart disease or cancer, waiting until a more expensive less well tolerated treatment was necessary.”

• Lilian Okonkwo: “Miriam Godwin and Qasim Butt, MD have highlighted significant gaps in the U.S. transplant system. As we approach the end of 2024, many patients remain unaware of transplant waitlists and state-specific wait times until they are involved in the process. I have observed a troubling trend of patients seeking kidney transplants abroad at substantial personal cost and returning to the U.S. for follow-up care. This underscores the urgency many feel while navigating a complex healthcare system marked by limited transparency and prolonged wait times…”

• Matt Weeks: “I'd love to see better progress in advance donor election, moving way beyond checking the box on a drivers license, but yes, starting with the check-box and moving to live online curated (and private) networks, collecting the relevant profile data and doing a kind of shadow population matching. Instead of paying for donors, we might give those who have advance-registered as donors and given-up their medical profile stats, a kind of "priority" place in the long line for transplants should they end up needing a transplant. Just a thought experiment.”

• Andrew Placona: “These are all potentially game changing. That said I have always thought about when organs are not limiting factor but rather surgical capacity. I don't know if there has been a study on the max potential of the system. Given what I have seen in terms of the workforce challenges, it is something that should be explored.”

• Uptal Patel: “Great topic Tim! I'll call on my amazing KHI colleagues Mary & Kevin to share their views while pointing this group to a prior KHI project on xeno.” (see video below)

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Signals

Kidney group urges CMS to prioritize Increasing Organ Transplant Access payment model

A new analysis of kidney waitlist data released by the Kidney Transplant Collaborative (KTC) underscores a critical and growing challenge facing the U.S. healthcare system: a dramatic increase in the number of individuals waiting for a kidney transplant, especially in key presidential swing states. The Kidney Transplant Collaborative expressed disappointment at the delayed CMS launch of the Increasing Organ Transplant Access model. CMS is continuing to work on the final rule, but has indicated a later-than-expected start beyond the original implantation date of Jan. 1, 2025.

“The growing kidney transplant waitlist is a matter of life and death, and it is critical that we support policies that incentivize donation, reduce geographic disparities, and ensure every person in need of a kidney transplant has a chance to survive.”

Sonavex secures $15M Series A-2 financing

Sonavex, a Baltimore-based medtech company focused on ultrasound solutions, has raised $15 million in a Series A-2 round to advance its vascular and dialysis-focused technologies, EchoMark® and EchoSure®. These tools provide real-time, quantitative blood flow data and enable AV fistula assessment in dialysis clinics. This funding will support ongoing clinical trials, including the pivotal MAFASA study, and build further evidence for its technologies. The raise follows key milestones such as FDA approval for an IDE, a new CPT code, and additional funding for pipeline product clearances.

Roivios Releases Clinical Data on the JuxtaFlow RAD

At the Society of Thoracic Surgeons (STS) Perioperative Care Meeting, Roivios presented promising results from its BIPASS-AKI feasibility study on the JuxtaFlow® Renal Assist Device (RAD). This novel device, used post-cardiac surgery, showed potential to protect kidney function in high-risk patients. The trial results revealed a high success rate in catheter placement and no device-related adverse events, with only 2 out of 10 patients experiencing postoperative AKI—one due to protocol deviation. This breakthrough could significantly improve outcomes for cardiac surgery patients vulnerable to acute kidney injury. CEO John Erbey said:

"This study tested the initiation of the JuxtaFlow RAD nearly two hours after patients were weaned from cardiopulmonary bypass, likely after the insult to their kidneys already occurred. The results highlight the potential of JuxtaFlow RAD in enhancing postoperative recovery."

Quanta Dialysis Technologies Gains FDA Clearance for Home Use Dialysis System

Quanta Dialysis Technologies has received FDA 510(k) clearance for home use of its high-flow Quanta Dialysis System, making it the only high dialysate flow (500 mL/min) system approved for the full spectrum of care settings for end-stage renal disease (ESRD) patients. With fewer than 3% of U.S. dialysis patients receiving home hemodialysis (HHD), Quanta’s system offers an alternative by matching hospital-grade standards and simplifying home dialysis setup. Clinical trial results presented at ASN showed high patient satisfaction and a safe transition to home therapy, supporting Quanta’s goal of expanding accessible, effective home dialysis options.

KDIGO Opens Public Review for Updated Anemia in CKD Guidelines

KDIGO has released a draft update of its 2012 Clinical Practice Guideline for Anemia in Chronic Kidney Disease (CKD) and is inviting public feedback through November 22. The 2025 guideline draft offers comprehensive guidance on anemia management in CKD, addressing treatments like iron supplementation, erythropoiesis-stimulating agents, HIF-PH inhibitors, and RBC transfusions. Built on a GRADE-based analysis of the latest evidence, the update includes new recommendations and practice points for healthcare providers and patients managing CKD-related anemia. KDIGO encourages contributions from the community to refine the final publication, aiming to improve patient outcomes and inform future research directions.

Study: One APOL1 Variant Increases CKD Risk in West Africans

New research from the H3Africa Kidney Disease Research Network shows that even one APOL1 gene variant can raise the risk of chronic kidney disease (CKD) and focal segmental glomerulosclerosis (FSGS) in West Africans. Previously, only two variants were thought to significantly increase risk, but this study found that having one variant increases the chance of CKD by 18% and FSGS by 61%. With these variants common in some West African groups, the findings could guide future treatments to reduce CKD rates and severity in African populations.

ASN President Highlights Efforts to Address Inequities and Advance Kidney Care

During her opening remarks at ASN Kidney Week, Dr. Deidra Crews emphasized the need to address social disparities in kidney disease, noting that factors like income and structural inequities impact kidney health outcomes, especially among Black adults. The ASN is partnering with federal agencies and specialty groups to enhance funding, policy, and education. Crews also highlighted ASN’s initiatives, such as removing race from eGFR equations, advancing clinical trials on health disparities, and launching resources like the Kidney Health Guidance and Partnership for Responsible AI in Kidney Health. These efforts aim to redefine the standard of care and equip clinicians with timely tools to improve kidney health equity and outcomes.2

IgAN Was a Hot Topic at ASN Kidney Week

Jonathan Barratt, PhD, called IgAN "the world’s most important kidney disease" due to its widespread impact and evolving treatment landscape. At Kidney Week, a packed session highlighted IgAN's burden and the potential of APRIL—a molecule involved in the disease's pathogenesis—as a therapeutic target. Dr. Kenar Jhaveri emphasized that lowering proteinuria remains crucial in delaying IgAN progression, with new treatments offering promising options for patients, a stark contrast to the limited choices of just a few years ago. This focus on IgAN signals a shift toward more targeted and effective therapies in kidney disease.

Renal Denervation: Bizarre Coincidences, Opportunities, and Open Questions

Renal denervation (RDN), a minimally invasive procedure targeting kidney nerves to lower blood pressure, is gaining renewed attention following recent approvals for devices from Medtronic and Recor Medical. Clinical trials, including SPYRAL and RADIANCE, show promising, long-lasting reductions in blood pressure for patients undergoing RDN, with effects sustained up to three years. While the market is projected to grow to $128.7 million by 2028, lack of established reimbursement in the U.S. may limit uptake. If reimbursement improves, RDN could offer a valuable alternative to medication for people struggling to control their blood pressure, signaling a potential shift in hypertension care.3

Study: Early eGFR Changes with Tolvaptan Predict Long-Term Outcomes in ADPKD

A post hoc analysis of the TEMPO 3:4 study suggests that initial drops in estimated glomerular filtration rate (eGFR) within three weeks of starting tolvaptan can predict longer-term kidney health in patients with autosomal dominant polycystic kidney disease (ADPKD). Researchers found that a larger early drop in eGFR was linked to slower eGFR decline over time, indicating the potential for early eGFR measurements to help forecast tolvaptan's impact. This insight could guide clinicians in managing ADPKD, especially in the early stages of treatment. It’s worth noting tolvaptan is currently the only pharmaceutical treatment for ADPKD.

Report: Remote monitoring for hypertension has little value without medication management

The Peterson Health Technology Institute (PHTI) released a report on digital hypertension solutions, praising medication management-focused remote monitoring tools while questioning the impact of behavior change solutions. According to PHTI, companies like Cadence and Story Health, which integrate blood pressure monitoring with medication adjustments by dedicated care teams, deliver better outcomes and longer-term cost savings compared to traditional care. In contrast, behavior-driven solutions, like reminders for medication adherence or lifestyle changes, showed minimal impact on blood pressure outcomes and added financial strain to healthcare systems. This report echoes PHTI's prior findings on digital diabetes solutions, raising industry debate on the value of various digital health tools in managing chronic conditions.

How a group of clinicians launched a VC firm

Scrub Capital, a venture capital firm founded by a group of 650 clinicians, recently launched to invest in digital health and medical device startups. With a target of $10 million for its first fund, the firm uniquely engages clinicians in its due diligence process, allowing healthcare professionals to shape investments based on their on-the-ground expertise. Co-founder Christina Farr emphasized the firm’s mission to empower clinicians as investors, aiming to bring diverse, non-finance voices to the venture capital space and build lasting value in healthcare innovation.

Hello Patient launches out of stealth with $6M to roll out generative AI phone agents for medical practices

Startup Hello Patient, co-founded by former Carbon Health executive Alex Cohen, has introduced generative AI call agents to manage administrative tasks like appointment scheduling and prescription follow-ups in healthcare practices. By automating these routine communications, Hello Patient aims to reduce administrative costs and free staff for patient-facing roles, providing HIPAA-compliant support for both in-person and virtual care settings. With $6.3 million in seed funding, Hello Patient is poised to modernize healthcare communications by meeting patients' preferences for phone and text interactions, while enhancing practice efficiency and lowering costs.

Why is primary care more important in Q4?

Care gaps—the difference between clinical guidelines and actual care received—remain a major focus as health plans and providers shift to value-based care (VBC) models. Yet, due to fragmented contracts and conflicting quality metrics, providers struggle to prioritize and effectively close gaps. This leads to a chaotic "Q4 push," where healthcare organizations rush to meet quality measures before year-end deadlines, often frustrating patients. Experts suggest that flexible, rolling reporting periods and streamlined quality measures could reduce year-end pressure, allowing for smoother, more patient-centered care delivery.

Study: Transportation among top social determinants of health for adults with lupus nephritis

A lupus navigator pilot program identified transportation, copays, and treatment adherence as the top barriers to care for young African American women with lupus nephritis. Led by Dr. Abdallah Sassine Geara at the University of Pennsylvania, the program used community health workers to help patients navigate social determinants of health. Interventions included financial support, social services referrals, and assistance with medical supplies, underscoring the need for integrated support to improve lupus nephritis outcomes.

FDA panel votes against sotagliflozin for glucose control in type 1 diabetes, CKD

In an 11-3 vote, an FDA advisory panel recommended against approving sotagliflozin as an adjunct to insulin for type 1 diabetes patients with chronic kidney disease (CKD), citing concerns about diabetic ketoacidosis (DKA) risks. Despite evidence of improved glucose control, the committee found that the risk of DKA in this population outweighed the benefits. Prabir Roy-Chaudhury, who voted in favor for certain CKD subgroups, emphasized the importance of targeted risk mitigation. Although the FDA usually follows its advisory panels, the final decision on sotagliflozin is expected by December 20.

Study: Educational intervention improved dialysis decision-making in veterans with advanced CKD

A comprehensive pre-dialysis education program across five VA healthcare systems significantly improved veterans' decision-making about kidney replacement therapy (KRT). After the intervention, 94.5% of veterans were able to express a KRT preference, up from 38.5%, with home dialysis preference rising from 21% to 82%. The program highlighted that increasing CKD awareness and health literacy can empower patients to make informed choices, boosting confidence in treatment decisions among veterans with advanced kidney disease. Author’s note: music to my ears, where do I sign up and get involved? Great work, Dr. Wadhwa and team!

BioCom CEO Summit Highlights Investor and CEO Perspectives

In her latest edition of Vital Signs, Managing Director and co-lead of the Venture Talent Group Jackie Ross shared her takeaways from the recent BioCom CEO Summit. Investors noted strong interest in early-stage deals and anticipated more consolidations and shutdowns alongside fresh Series A investments. CEOs shared advice on resilience, the value of personal advisors, and finding balance between driving teams hard and offering positive reinforcement. Predictions included a challenging IPO landscape this quarter, with an expected rebound in Q1 2025.

Study: Kidney transplant patients with more pain report less involvement in social activities

Research presented at ASN Kidney Week reveals that kidney transplant recipients experiencing moderate to severe pain have lower social participation, highlighting the need for enhanced pain management. In a study of 282 transplant recipients, those with higher pain scores were five times more likely to report low social involvement. Dr. Istvan Mucsi suggests that dedicated symptom management or renal supportive care clinics, like those in Australia and some U.S. centers, could improve quality of life by addressing chronic pain in this population.

Community Voices

A collection of insights, opinions, updates and upcoming events from your peers and fellow explorers across the Kidneyverse.

Baxter International: "We are excited to announce that we’ve restarted our first IV fluids line at our North Cove facility. Initial batches will be manufactured concurrently with ongoing quality activities and would only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products. Thanks to the entire team across Baxter and our remediation partners for their hard work and dedication, and the ongoing support of federal, state and local government agencies..."4

Dr. Amber Paulus: "Thank you Sri Lekha Tummalapalli for sharing about policy implications for nephrology practice with our division for Renal Grand Rounds this week! Since that discussion and feedback from community nephrologists engaged in value-based care arrangements, I’ve reflected a lot on how I previously engaged nephrologists in automating modality referral. I was wrong. But I didn’t know it at the time. I was following information I had with limited understanding of the global picture including how everyone might understand the granular pieces of data utilized to make care decisions..."

American Society of Nephrology announced Prabir Roy-Chaudhury, MD, PhD, FASN, a prominent transplant nephrologist and kidney researcher, will assume the presidency of the American Society of Nephrology (ASN) on January 1, 2025. Known for his work in uremic vascular biology and dialysis access, Prabir has been a leader in kidney care innovation through roles like founding ASN co-chair of the Kidney Health Initiative and member of the KidneyX Innovation accelerator. He said:

“With ongoing progress in kidney-related care, including promising advances in transplantation in recent years, this is an exciting time to be leading ASN and the many clinicians and researchers who are dedicated to making a difference across the spectrum of kidney diseases.”

International Society of Glomerular Disease: "Congratulations to our colleagues in the H3Africa Consortium Kidney Disease Research Network on their groundbreaking research presented at Kidney Week and published in NEJM! This first APOL1 population-based study from Africa recruited over 8,000 people from academic medical centers in Ghana and Nigeria, including nearly 5,000 people with CKD stages 2-5 and biopsy-confirmed FSGS or other glomerular diseases, to investigate the role of having one or two copies of the APOL1 variants..."

Bear Valley Community Healthcare District (BVCHD): “Prashanth Kumar, MD, MPH met with one of our community advocates and two Dialysis patients at Bear Valley Community Healthcare District (BVCHD) today to discuss some exciting new technology in the field of Dialysis as well as show off the District's new Quanta Dialysis Technologies machines.”

Kerri Rathburn, J.D.: The results speak for themselves on the CMS/CMMI kidney program...DROP THE MIC for Interwell Health 1. Interwell is the largest participant in the CMS/CMMI kidney program. We operated 20 kidney contracting entities (KCEs) in 2022, but have since expanded to 23 KCEs. 2. Interwell achieved perfect quality in 3 KCEs, being the only organization to do so. 3. Interwell accounted for 16 of the 20 highest quality KCEs.4. Quality metric bonuses of $20M paid to 22 KCEs “high-performance pool” (Interwell received 80% of the total payment).

Healthmap Solutions: Last week, Healthmap Solutions’ Medical Leadership Team attended the American Society of Nephrology (ASN) Annual Meeting and presented a poster detailing a population health initiative conducted among chronic kidney disease patients in Healthmap’s program. Thank you to Dr. Howard Shaps (Chief Medical Officer), Dr. Stephanie Toth-Manikowski (National Medical Director and Nephrologist), and Dr. Lisandro Montalvo-Burke (Puerto Rico Medical Director and Nephrologist) for sharing the great work Healthmap is doing to improve outcomes for patients!

Yolinda van der Nest: "The kidney is underestimated for its size, but it affects every system in the body. Public awareness will remain low unless we as health care professionals start connecting the dots and inform patients about the interrelationship between the kidney and non communicable diseases (Hypertension, Diabetes, Cardiovascular Disease and Obesity as recognised by WHO)."

PKD Australia: "The International Society of Nephrology has launched a global petition to make kidney disease a policy priority.The goal is to secure 1 million signatures by 31st December 2024, and we need your support to get there! By signing the petition, the ISN can urge UN Member States to call on the WHO to recognise kidney disease as a top priority, potentially saving millions of lives 🙏🏼 Read more and sign the petition through the link here."

Spencer Dorn: At HLTH, Spencer reflected on past trends like telemedicine, remote patient monitoring, and digital therapeutics—all of which generated hype but struggled to reshape healthcare as expected. The challenges of patient adoption, operational complexity, and healthcare’s resistance to change have kept these tools in the background rather than the forefront. He wonders if AI will follow a similar path, persisting in the background while facing hurdles to mainstream adoption, or if it will eventually break through given its foundational potential.

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This week, we're focusing on the resilient spirit of innovation shaping the future of kidney care. Whether it's the biotech excitement from fundraises like Judo Bio and Purespring, or ties to space-age ‘moonshots’ from thought leaders like Dr. Leslie Wong, it’s clear that kidney care is on the brink— even if we don’t yet know what’s on the other side of that precipice. As we navigate these new frontiers, and recover from multiple weeks of historic destruction, patient safety and the continuity of care remain at the forefront of all we do and aspire to become.

I’d love to hear your thoughts, especially as we gear up for fall conferences. If you're planning to attend Kidney Week, let me know—I’d love to connect and learn about your work in person!

This is your weekly collection of news, research, funding and voices shaping the future of [kidney] care. All Signals posts and our full archive are now completely free to read, thanks to our sponsors.

This issue is presented by IKONA, the leading VR platform for kidney education & training, designed to support patient education and workforce training in dialysis clinics, practices, and beyond.

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This week

• Poll: How do we increase transplant listings?

• Fresenius, B Braun ramping production

• Baxter issues update on Helene recovery

• Judo Bio raises $100M for genetic medicines targeting CKD

• Purespring secures £80M for kidney gene therapy platform

• Leslie Wong discusses “moonshot” innovations in kidney care

• Study highlights the role of health equity in APOL-1 clinical studies

• Story: Living kidney donation lets two sisters live out their dreams

• Vivance completes trial for wearable dialysis device in Singapore

• Astellas lists DIGITIVA™ for heart failure management with the FDA

• Glooko raises $100M and appoints a new CEO

• Studies say AI can help learning... when it isn't a crutch.

• & More…

Increasing Transplant Access

CMS recently published the First Annual Evaluation Report for the first year following implementation of the Kidney Care Choices Model (KCC). Let’s take a closer look at their transplant access findings.

In this week’s Signals poll we asked for your take on these results. We asked you to fill in the blank:

“The MOST effective practice-level strategy to increase waitlisting and access to kidney transplant is _____________.

More than half (53%) said educating recipients and potential donors is the best strategy, followed by assisting patients with the evaluation process (21%) and increasing referrals for evaluation (18%).

Sharing a few insightful perspectives from you on LinkedIn:

• Todd Black: “Tim, its the timing of the referral and education that is most crucial. ~95% of patients on the waitlist were added after the start of dialysis. The KDIGO guidelines recommend education at CKD stage 4.”

• Vanessa Evans: “Tim, after filling out the common app with my applying college kids, it occurred to me why do we not have a common app format for transplant clinics. Each transplant clinic could gather the general information needed and there could be supplemental questions/labs that may be needed for certain patients/hospitals. This would streamline the process and enable many more patients, not only to get on the list, but also to be on multiple lists. Of course the patients would have to adhere to yearly evaluations and labs, but it could be done at one centralized location- close to their house and then they could use those labs for multiple hospitals. The system now is too complicated and convoluted.”

• Amy M.: “Finding ways to make anti-rejection medication affordable. My patients can not accept a new monthly $1100 out of pocket expense for the medication.”

• Glenna Frey: “Providing a support system to get living kidney donors (support for donors & recipients).”

• Odie Pauley: “Remove financial barriers.”

• Sharyn Kreitzer: “Nothing beats good old fashioned outreach and personalized navigation support. Follow Northwestern’s lead ( as well as other transplant programs with outreach liaisons) Outreach can also focus on primary care and nephrology practices. Target underserved communities. One size doesn’t fit all. This common sense approach will result in earlier referrals to transplant. Ideally, these outreach positions would be funded outside of a transplant centers program so the patient could be directed to center that best meets their medical needs ( versus the center that has a liaison).”

• Dan Field: “Pay for them.”

• Jeff Parke: “Tim, what about reducing systemic biases in the healthcare system. Addressing disparities in access to transplant lists for minority groups, low-income patients, and those with limited healthcare literacy is crucial. Implementing bias training for healthcare professionals, improving equity in care access, and offering support systems to guide vulnerable populations through the evaluation process would ensure more patients can be waitlisted regardless of socioeconomic or racial backgrounds— similar to Northwestern.”

Leave a comment

Signals

Fresenius Medical Care increasing IV, dialysis solutions production to alleviate shortages

Fresenius Medical Care is stepping up production of IV fluids and peritoneal dialysis (PD) products to help mitigate U.S. shortages caused by Hurricane Helene’s impact on the supply chain. To support the industrywide shortage, Fresenius is increasing capacity at international sites and collaborating with the Department of Health and Human Services to explore other solutions. Baxter, whose North Carolina facility was damaged, has implemented purchase limits to manage inventory, with plans to restore supply levels by the end of 2024. B. Braun is also increasing production, resuming operations at its Daytona Beach site after Hurricane Milton, and coordinating with federal agencies to ensure supply availability.

Baxter issues latest update on Hurricane Helene recovery

Baxter's North Cove manufacturing site in North Carolina was severely impacted by Hurricane Helene, resulting in significant flooding and disruptions to operations. In response, Baxter has implemented inventory allocation strategies, restricting customer orders to historical levels and medical necessity to manage product availability. Baxter is collaborating with the FDA to import products and scale production at other facilities while working toward restoring full operations at North Cove by the end of 2024.

Based on Baxter’s efforts to increase manufacturing capacity at its other sites and our current assessment of anticipated timing of inbound products and air shipments, we are increasing the current U.S. allocation levels of our highest demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%, effective Wednesday, Oct. 9.

🧰 AKF put together this list of state and local resources if you or someone you know was impacted.

Judo kickstarts with $100M to develop genetic medicines that strike out kidney disease

New biotech Judo Bio has emerged with $100 million in seed and series A funding to develop genetic medicines targeting the kidney. Led by CEO Rajiv Patni, M.D.—an industry veteran with past roles at Reata Pharmaceuticals, Global Blood Therapeutics, and Pfizer—Judo Bio aims to advance its lead ligand-siRNA conjugate into clinical trials. Backed by investors like Atlas Venture, The Column Group, and Droia Ventures, the company’s focus is on its STRIKE platform, which seeks to deliver genetic treatments to the kidney, a challenging target in genetic medicine.

Purespring bottles up $105M series B to bring kidney disease gene therapy to the clinic

London-based Purespring Therapeutics has raised £80 million in an oversubscribed series B round led by Sofinnova Partners. The funds will support Purespring’s gene therapy platform aimed at treating chronic kidney disease, which affects nearly 10% of the global population. Their lead candidate, PS-002, is being developed for IgA nephropathy, a condition that often leads to kidney failure in young adults. Using adeno-associated viral vectors, Purespring’s gene therapy targets podocytes—specialized kidney cells—offering hope for patients with kidney diseases such as nephrotic syndrome. See below animation from the company’s website.

Technology offers one ‘moonshot’ closer to optimal kidney care

Leslie Wong’s article in Healio reflects on the evolution of kidney care following the 2019 Advancing American Kidney Health executive order, which inspired a bold vision to transform the field. Since then, initiatives like the Kidney Care Choices model and KidneyX have sparked innovations in dialysis, kidney transplants, and patient-centered care. The term “moonshot” signifies the ambitious goals of improving outcomes and addressing the organ shortage crisis. The article covers technological advancements in wearable dialysis, artificial kidneys, and xenotransplantation, while noting challenges like labor shortages and reimbursement constraints. The piece highlights the importance of embracing both innovation and risk to achieve optimal kidney care, much like the Apollo program’s success despite setbacks.

Study: A Conceptual Model to Achieve Health Equity in APOL-1 Clinical Studies

Abstract: The socioecological model (SEM) conceptualizes health broadly and focuses on multiple factors that might affect health. This article takes a novel approach to leverage an SEM framework to identify challenges and sustainable opportunities to advance diversity for clinical study participation in apolipoprotein L1 (APOL-1)-mediated kidney disease. We describe four levels of an APOL-1 SEM—intrapersonal, interpersonal, community, and structures/systems—for improved diverse APOL-1 clinical study enrollment and engagement. This SEM can serve as a model for improving clinical study diversity and equity to help improve the generalizability of clinical study results in other disease conditions that disproportionally impact racial and ethnic minority populations.

Her little sister needed a kidney. The donation let them both live their dreams

Amaris Elston gave her younger sister Dominique more than just a kidney—she gave her a new lease on life and a path to follow her dreams. After Dominique was diagnosed with kidney failure at just 18, Amaris didn’t hesitate to get tested, ultimately becoming her sister’s living donor. The transplant not only restored Dominique’s health but inspired her to pursue a career in medicine. Amaris graduated from UAB’s Heersink School of Medicine in 2022, and just two years later, Dominique earned her bachelor's degree in nursing, following the life-changing experience of receiving a kidney. Their story highlights the life-saving impact of living kidney donation, which helped Dominique avoid years on a transplant waiting list and gave both sisters the opportunity to live out their dreams. Living kidney donations, like Amaris’s, are critical in addressing the organ shortage and provide hope for thousands waiting for transplants in the U.S.

Podcast: How do we prevent chronic kidney disease upstream?

Chronic kidney disease is a silent threat. It is one of the leading causes of death in the U.S., yet 90% of those affected are unaware they have it. The lack of widespread testing means many, particularly in the Black community, face rapid health deterioration, often landing in dialysis without warning. In this episode, Geoff Martin, CEO of Healthy.io, joins Fierce Healthcare’s Emma Beavins to explore how his company is tackling this hidden crisis and changing the future of chronic kidney disease care.

Vivance Completes Pre-Pivotal Trial of Wearable Dialysis Device

Vivance has announced the successful completion of a pre-pivotal trial for their wearable peritoneal dialysis device, Viva Kompact. Conducted at Singapore General Hospital, the trial focused on performance and safety as patients used the device independently at home. Results will be presented at ASN Kidney Week 2024, highlighting how 10 patients completed at least one week of dialysis with no serious device-related events. Vivance believes this innovation could transform kidney care by enabling dialysis "anytime, anywhere."

Astellas Announces FDA Listing of DIGITIVA™ for Heart Failure Management

Astellas Pharma has announced the FDA listing of DIGITIVA™, its first digital health solution for heart failure in the U.S. The non-invasive platform places patients at the center of their care by enabling at-home disease monitoring. DIGITIVA consists of the CORE 500™ Digital Stethoscope, a smartphone app designed for heart failure patients, and educational content from the American Heart Association. The platform aims to improve clinical outcomes by notifying physicians when patient data signals potential complications, helping prevent events like re-hospitalizations.

Glooko scores $100M and appoints new CEO

Glooko, a digital platform for managing diabetes and chronic diseases, has raised $100 million in a Series F funding round led by Georgian, with participation from Canaan and Health Catalyst Capital. The company also announced Mike Alvarez as the new CEO, who brings experience from leadership roles at Qardio, Medtronic, and Sanofi. Glooko plans to use the funds to scale its connected healthcare platform globally, supporting remote patient management and clinical trial research for chronic conditions.

Digital health’s great re-bundling in Europe?

TLGG’s Thomas Hagemeijer always puts out great visuals and content. They’ve inspired a few of ours here in the kidneyverse. His latest piece takes a closer look at M&A activity between Paris-based Doctolib and London-based Huma. Thomas shared a few observations on digital health activity in Europe:

1. Following a period of unbundling into point solutions, digital health is re-bundling into digital health platforms

2. More healthtech M&A is expected in the coming months

3. Huma is taking a big bet with its acquisition of eConsult

4. Doctolib is Europe’s largest healthtech play, and it’s finally ready for partnerships

Study: AI can help learning... when it isn't a crutch.

Wharton’s Ethan Mollick recently wrote “There are now multiple controlled experiments showing that students who use AI to get answers to problems hurts learning (even though they think they are learning), but that students who use AI as a tutor perform better on tests.” He cited three papers that show how and why this is the case, which may appeal to those of you using and exploring use cases for AI in kidney care education and training. (Here, here, and here)

Community Voices

A collection of insights, opinions, updates and upcoming events from your peers and fellow explorers across the Kidneyverse.

📬 Submit your updates here.

• Mahesh Krishnan: "Ultimately, this journey shaped my belief that to drive real change in care delivery, you need to work on the system level, influencing policy, clinical protocols, and innovation." and I sat down with Dr. Mahesh Krishnan to hear more about his career path and how he thinks about the state and future of kidney care. Learn more.

• Raven Hardy Richard: “I’m thrilled to share that my latest article, “A Conceptual Model to Achieve Health Equity in APOL-1 Clinical Studies” has been published in Health Equity. This work was coauthored with Christine Lee-Flemming, PhD, PharmD , Cesia Portillo, MPH, CHES, Becca Hayes, MD, MEHP, Richardae Araojo and Robert Flemming. This article explores strategies to ensure that health equity is a priority in APOL-1 research, with the goal of promoting more inclusive and impactful clinical studies. It's a topic I'm passionate about, and I hope it contributes to the ongoing conversation on making healthcare research more representative and just.” Learn more.

• Abhilash Koratala: “I’m honored to receive the Distinguished Educator Award from the American Society of Nephrology, which will be presented at Kidney Week 2024. I view this as recognition of the point-of-care ultrasound revolution in Nephrology. Thank you to everyone who has supported this movement to advance patient care and education.” Learn more.

• Shika Pappoe: “What a week! I just returned from trips to New York, DC, and Bermuda where I had the opportunity to represent Carna Health and champion the important work we’re doing to improve the care of individuals with chronic kidney disease (CKD)… We are excited to continue the important work of identifying and empowering individuals at risk for and with CKD.” Learn more.

• Suresha Venkataraya: “In our relentless pursuit of disruptive innovation in kidney care, we’ve hit another incredible milestone—the successful completion of the pre-pivotal trial for our one-of-its-kind Viva Kompact wearable PD device at Singapore General Hospital!” Learn more.

• Mandar Gori: “Another milestone for Vivance (f/k/a AWAK Technologies)! Happy to announce the conclusion of our pre-pivotal clinical trial of the first-of-its-kind wearable dialysis device, Viva Kompact! The journey until here was challenging but at the same time very rewarding. It would not have been possible without the relentless work of the entire Vivance Team, notably our Senior Clinical Manager Sheena Gow who led the clinical operations with the help of many technical leads from our Engineering, Chemistry, Manufacturing, Supply Chain, Pre-Clinical and QARA teams who were on the ground day-and-night.” Learn more.

• Jimmy Thomas: “Nursing training, compliance and survey readiness - check; Supply chain management, program marketing - check; 24/7 Nephrology team - check; Cutting edge hemodialysis technology - check; Dialysis access management support - check; Telemedicine robot with multilingual AI powered translator - check; Comprehensive renal care for rural America - check!!!” Learn more.

• Outset: “Imagine telling an ESRD patient that they no longer will have to travel to an outpatient facility multiple times a week to receive dialysis and can instead undergo treatment from the comfort of their own room or on-site dialysis site. We're partnering with service providers and facilities like Park Rose Care Center, Liberty Healthcare Corporation and Spectrum Dialysis to make this a reality.” Learn more.