One thing seems to be completely overlooked here. What is the quality of the kidney at the time of transplant?. The therapies to deal with long term detrimental effects are surely helpful so predicting that seems beneficial, But the major issue is surely the cellular decay of the donated organ which we see both in the number of discarded kidneys and the number of DGF's. The kidney needs to be better treated, not preserved but sustained, as to be in good condition when transplanted. That means delivering measurable oxygen to the cells. A product exists for that but, as Bill Fitzsimmons notes the FDA approval process is beyond Byzantine. I found it extraordinary that the EMA has already approved iBox while the FDA has yet to finalise
This really resonated, especially the point about how much of the post-transplant experience falls outside traditional endpoints.
I’ve navigated both BK virus and early rejection post-transplant, and those moments make it clear how quickly things can shift, even when everything appears stable on paper. These aren’t edge cases; they’re part of the lived reality many patients manage over time.
It’s encouraging to see more discussion around tools like iBox and how we can better account for long-term outcomes and variability. Aligning measurement with what patients actually experience is critical if we want innovation to move the field forward truly.
Hi Gary, thanks for sharing. Would be great to learn more, can you share any examples of labs or clinics doing this type of work? Where is it in development?
![Signals From [Space]](https://substackcdn.com/image/fetch/$s_!IXc-!,w_40,h_40,c_fill,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9f7142a0-6602-495d-ab65-0e4c98cc67d4_450x450.png)
![Signals From [Space]](https://substackcdn.com/image/fetch/$s_!IXc-!,w_120,h_120,c_fill,f_webp,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F9f7142a0-6602-495d-ab65-0e4c98cc67d4_450x450.png)
![Signals From [Space]](https://substackcdn.com/image/fetch/$s_!lBsj!,e_trim:10:white/e_trim:10:transparent/h_48,c_limit,f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2F0e0f61bc-e3f5-4f03-9c6e-5ca5da1fa095_1848x352.png)
One thing seems to be completely overlooked here. What is the quality of the kidney at the time of transplant?. The therapies to deal with long term detrimental effects are surely helpful so predicting that seems beneficial, But the major issue is surely the cellular decay of the donated organ which we see both in the number of discarded kidneys and the number of DGF's. The kidney needs to be better treated, not preserved but sustained, as to be in good condition when transplanted. That means delivering measurable oxygen to the cells. A product exists for that but, as Bill Fitzsimmons notes the FDA approval process is beyond Byzantine. I found it extraordinary that the EMA has already approved iBox while the FDA has yet to finalise
This really resonated, especially the point about how much of the post-transplant experience falls outside traditional endpoints.
I’ve navigated both BK virus and early rejection post-transplant, and those moments make it clear how quickly things can shift, even when everything appears stable on paper. These aren’t edge cases; they’re part of the lived reality many patients manage over time.
It’s encouraging to see more discussion around tools like iBox and how we can better account for long-term outcomes and variability. Aligning measurement with what patients actually experience is critical if we want innovation to move the field forward truly.
Antigen specific immunosuppression is the key to longer graft survival and reduced toxicity.
Hi Gary, thanks for sharing. Would be great to learn more, can you share any examples of labs or clinics doing this type of work? Where is it in development?
Great question for your experts!