Signals From [Space]

It's official! Signals is a bestselling newsletter on Substack. ???? Find out why hundreds of people and dozens of companies trust Signals to discover the ideas, innovations, and investments shaping the future of global kidney health. We're proud to be the first and only newsletter dedicated to kidney health on a platform with more than 35 million subscribers globally. New to the Kidneyverse? Let us show you why we're here... ?? trfitzpatrick.com/welcome

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Here's your biweekly scoop of ideas, innovations, and investments shaping global kidney health. In this edition, we take a closer look at the FDA's latest approval for Ozempic, Beta Bionics' $204M IPO for its bionic pancreas, and a heated Reddit thread on the End Kidney Deaths Act. ????????'?? ????????????: ? FDA approves Ozempic for CKD ? Dwayne Wade's kidney cancer story ? Reddit EKDA debate ? A new milestone in xeno ? Trump’s latest EOs on health ? Health systems pushing for VBC ? Beta Bionics lifts medtech IPOs ? NKF turns 75: top milestones ? Are we talking about cybersecurity? ? Visual: KCC entity spending trends ? A new way to treat pain in dialysis? ? Links b/n climate + kidney health Who's inside: Novo Nordisk FDA Reddit, Inc. Beta Bionics National Kidney Foundation DaVita Kidney Care Fresenius Medical Care Nasdaq Dexcom Medtronic Strive Health Interwell Health Evergreen Dialysis Clinic, Inc. Eli Lilly and Company Becker's Healthcare Bill Frist, M.D. Proton Intelligence TechCrunch Rory St Clair University of Miami Health System Abe Sutton Jennifer Erickson Andrew Pannu Rock Health IQVIA Centers for Medicare & Medicaid Services Christina Farr Second Opinion Media Signals From [Space] With Open Roles at: Monogram Health Piedmont NVIDIA Novartis American Kidney Fund Alexion Pharmaceuticals, Inc. AstraZeneca Somatus DeLorean Artificial Intelligence *** As a reminder, these LinkedIn posts are just previews and go out less often than the full newsletter and media platform. If you want to read this full post (for free) and get the most up-to-date insights and analysis on all things kidney, subscribe to Signals here: ?? trfitzpatrick.com/welcome ??

Currently, 71% ???? ?????????? ?????????????? are stored in static cold storage, a method that may lead to delayed graft function and wasted organs. The National Kidney Foundation (NKF) Innovation Fund has invested in Northernmost to support the development of its NoMo kidney pump, a portable, tech-enabled device designed to replace traditional ice coolers in kidney transplantation. NoMo aims to provide continuous perfusion in a compact, cost-effective form, improving organ preservation and transplant outcomes. NKF CEO Kevin Longino said "Northernmost's NoMo Kidney Pump offers a more advanced, portable, and efficient solution to improve transplant outcomes. By investing in this technology, the NKF Innovation Fund is helping to ensure that more kidneys reach patients in optimal condition, reducing waste and saving lives." According to CEO Ron Mills, the team plans to introduce NoMo in a few short months. Congratulations Ron, Daniel, and team - and good luck! -- Sources: [1] NKF PR: https://lnkd.in/e7intMAz [2] MHN: https://lnkd.in/ebqSxF7J [3] Northernmost: https://lnkd.in/eRBN48ng

Here's your biweekly scoop of ideas, innovations, and investments shaping global kidney health. In this edition, we take a closer look at the FDA's latest approval for Ozempic, Beta Bionics' $204M IPO for its bionic pancreas, and a heated Reddit thread on the End Kidney Deaths Act. ????????'?? ????????????: ? FDA approves Ozempic for CKD ? Dwayne Wade's kidney cancer story ? Reddit EKDA debate ? A new milestone in xeno ? Trump’s latest EOs on health ? Health systems pushing for VBC ? Beta Bionics lifts medtech IPOs ? NKF turns 75: top milestones ? Are we talking about cybersecurity? ? Visual: KCC entity spending trends ? A new way to treat pain in dialysis? ? Links b/n climate + kidney health Who's inside: Novo Nordisk FDA Reddit, Inc. Beta Bionics National Kidney Foundation DaVita Kidney Care Fresenius Medical Care Nasdaq Dexcom Medtronic Strive Health Interwell Health Evergreen Dialysis Clinic, Inc. Eli Lilly and Company Becker's Healthcare Bill Frist, M.D. Proton Intelligence TechCrunch Rory St Clair University of Miami Health System Abe Sutton Jennifer Erickson Andrew Pannu Rock Health IQVIA Centers for Medicare & Medicaid Services Christina Farr Second Opinion Media Signals From [Space] With Open Roles at: Monogram Health Piedmont NVIDIA Novartis American Kidney Fund Alexion Pharmaceuticals, Inc. AstraZeneca Somatus DeLorean Artificial Intelligence *** As a reminder, these LinkedIn posts are just previews and go out less often than the full newsletter and media platform. If you want to read this full post (for free) and get the most up-to-date insights and analysis on all things kidney, subscribe to Signals here: ?? trfitzpatrick.com/welcome ??

In the first year of the Kidney Care Choices program, higher CKD spending tended to mean higher ESRD spending—but not always. I put together a visual to help us get a sense of how much participating entities (and their affiliates) spent per beneficiary for both CKD and ESRD. The larger the bubble, the more monies owed by CMS. Here are a few thoughts and observations: 1?? Higher CKD spend usually means higher ESRD spend ? The trend line suggests a general positive correlation: healthcare entities that spend more per beneficiary on CKD tend to also have higher per-beneficiary spending on ESRD. ? Still, the relationship is not perfect—some entities spend more on CKD but still have high ESRD costs, indicating that early investment in CKD care does not always lead to lower ESRD costs. 2?? Some entities appear to spend more effectively than others ? A few organizations stand out by spending relatively less on CKD but still maintaining moderate ESRD costs, suggesting potential efficiencies in care management. ? Example: Integrated Patient Solutions IPA is an outlier with high ESRD spending (Top 3 - $91K) despite being "middle of the pack" among CKD spenders ($23K)—why is that? 3?? Outliers tell a story, but the pack is the VBC narrative ? Entities above the trend line spend more on ESRD than expected based on their CKD spending. Entities below the trend line spend less than expected on ESRD. What does this say (if anything) about care management, patient mix, and (un)expected cost drivers? ? The majority of organizations spend between $19,000 - $26,000 per CKD beneficiary, with a few outliers going above $30,000. Only one entity spent less than $18K (Alabama - $17.8K). ? Similarly, most ESRD spending falls between $60,000 - $75,000 per patient, but a few entities spend over $90,000 per patient. Only one spent less than $60K, and it was well below (Tennessee Valley - $53K). 4?? Does affiliation play a role in cost strategies? ? Several affiliations (Interwell, DaVita, Strive, etc.) cluster in certain areas, suggesting that affiliated groups may have different spending patterns and protocols in place. Others are a bit scattered. Use the interactive link below to play around with the chart and filter the data by affiliate. The trend line will update as well. *** Remember, this is only year one data. We are entering our third year beyond this visual. Many of you have shared that this first year was a lot of figuring out (naturally), so I'd expect the group to tighten a bit, with outliers reversing course (or leaving the model altogether in some cases). I'm happy to send over screenshots of this visual by affiliate, just leave a comment below or send me a DM. What other visuals would be helpful to see? ?? -- Sources: [1] Interactive: https://lnkd.in/eSTR4qiz [2] Signals: https://lnkd.in/evzPXkfR [3] KCC PY22 Eval: https://lnkd.in/etiZzjCY

In my latest piece for Signals we explore 4 observations of home dialysis trends from the latest USRDS annual report. We also include an audio summary of our piece about the IM-HOME study last year, which explored top patient- and provider-level barriers to home dialysis. ????????????????????????: 1. Home adoption continues, led by PD 2. Nephrologists place 4% of PD catheters 3. Not all certified home clinics have patients? 4. Payers matter for ESRD modalities & outcomes Each observation includes a graphic from the USRDS report, my simplified summary of what it means, and a few key points to help make sense of it all. Read the full piece below: ?? https://lnkd.in/exkhacBS *** I'd love to hear from you. Yesterday I shared one of these observations about facilities certified to offer home dialysis. Tara Irvine made a great point about patient-level barriers. She shared: "I don’t think home is always an easy choice for patients. They need room for supplies, a deeper understanding of the process to get themselves through it and the confidence to either start their own treatment or have access to a care partner to support home treatment for them. Would be interesting to see how many patients have been intro’d to home through full education compared to choosing it." Hopefully this post and discussion gets us a few steps closer to answering part of Tara's question. Thanks Tara!

???????????? ???????is an international initiative that aims to raise awareness of the substantial burden incurred by CKD across the globe. Researchers predicted an estimated 437 million cases across 31 countries / regions by 2027, with most cases (~80%) remaining undiagnosed. The image below shows the estimated clinical burden of CKD from 2022 to 2027 by region and country. The left side of the image includes bar graphs for different regions—Americas, Europe, and Asia-Pacific/Middle East—indicating the expected percentage change in CKD rates for various countries. The color-coded map on the right side shows where these changes are expected to occur, and by how much. Darker blue colors are bigger changes. For example, the United Arab Emirates (UAE) is projected to see the highest increase, while some countries in Europe like Denmark are expecting a decline. ?????????????????? ??Findings are consistent with existing epidemiological data (e.g. CaReMe CKD study). This substantiates the observation that CKD has reached global epidemic levels and predicts that cases are likely to remain high. ??The proportion of undiagnosed patients is a concern. Assuming current diagnostic protocols remain unchanged, most of the CKD population will not be eligible for treatment (unless therapeutic agents are prescribed for alternative reasons). ??The implications of clinical and political inertia may be substantial. Diagnosis rates vary in the literature between regions, with current estimates suggesting between 62% and 96% of those with CKD stage 3 are undiagnosed. ? Re: Kidney Replace Therapy (KRT), or dialysis, the literature suggests access to KRT varies regionally, and 47–73% of patients with kidney failure do not have receive these resource-intensive therapies. ?????? ?????? ?????????? ?????????? To get this specific, the research team designed and ran a simulation with a population of 20 million virtual individuals for each of the 31 countries / regions (620 million for the full data set). To ensure that the populations were reflective of a given population, they used local demographic data, online databases, published literature, and input from local clinical experts. These virtual individuals then progressed through a micro-simulation in 1-year increments from 2022 to 2027. Why only six years? Two reasons: (1) This short time frame allows for higher confidence than longer periods; and (2) this reflects a typical election cycle period that may impact healthcare policy. Note: The microsimulation did not account for the impact of the COVID-19 pandemic. The effects of climate change, and the possibility of future pandemics and broad-based geopolitical developments were also not considered. *** What do you hope to see change between now and 2027 that could make a positive difference in kidney care in your part of the world? -- Sources: [1] Lancet: https://lnkd.in/enuecMGc [2] Supp data: https://lnkd.in/erkxhw-A

Welcome back, we’ve missed you. This is our first update of 2025, and it was a fun one to bring together. 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: (1) they’ll be more?consistent?(Sundays, not anydays); and (2) 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. This is our first test run, so your feedback is important here. I’d love to hear from you. Leave a comment, send me a DM, 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???? What's inside this edition: Alex Azar, CMMI, CMS, Carilion Clinic, Interwell Health, Monogram Health, Roanoke Memorial Hospital, Miriam Godwin, Alice Wei, M.D., Ann Kempski, Liise Kayler, MD, MS, FACS, TransMedics, Inc., Novo Nordisk, Maze Therapeutics, Metsera, Abe Sutton, Paul D Gordon, National Kidney Foundation, Fresenius Group, 34 Lives. Rory Caswell Pace, MPH, RD, CSR, FAND, FNKF, Piedmont, Novartis, Diality *** As a reminder, these LinkedIn posts are just previews and go out less often than the full newsletter and media platform. If you want to read this full post (for free) and get the most up-to-date insights and analysis on all things kidney, subscribe to Signals here: ?? trfitzpatrick.com/welcome ??

We just reached a new single-year record of 27,759 kidney transplants in 2024! Here’s a closer look at how we got here over nearly 4 decades of donation— one year at a time. ?? Graph legend: ?? Colors = Donor Type ??? Height = # of Annual KTs (Y-Axis) ?? Size = Total # of KTs (X-Axis) As promised, we're spending a lot more time talking about transplant this year, thanks to a number of initiatives happening in parallel at the local, state, and federal levels. We have an exciting lineup of guests coming up on the Signals From [Space] show who will be sharing their wisdom and perspectives on progress, pitfalls, and potential in the months ahead. Here are a few pieces we wrote last year that provide a hint at our guest list and what we'll be talking about. 1?? iBox: Unlocking the next frontier in transplant medicine ?? https://lnkd.in/eZcQzTFi 2?? The Increasing Organ Transplant Access (IOTA) Model ?? https://lnkd.in/gZ6C5Xd7 3?? eGenesis, CRISPR, and the future of organ transplants ?? https://lnkd.in/e_AdeJya 4?? Would you donate a kidney to a stranger... for $50,000? ?? https://lnkd.in/eTzsn-mE 5?? How to save 28,000 organs and $40 billion ?? https://lnkd.in/eBihweQn 6?? Exploring Transplant Nephrology with Dr. Yasir Qazi (Full Episode) ?? https://lnkd.in/e5-cvpjN 7?? Introducing: Transplant Data ?? https://lnkd.in/eU6Nr_fm *** Who's at the American Society of Transplant Surgeons Winter Meeting in Phoenix this week? PS - yes, we did just update our branding. What do you think?? Leave a "??" comment or repost and we'll send over a free week of Signals data ????