Ozempic's Latest Approval, EKDA on Reddit, Lilly Stops Relaxin, Beta Bionics IPO, NKF Turns 75, & More...

Ozempic's Latest Approval, EKDA on Reddit, Lilly Stops Relaxin, Beta Bionics IPO, NKF Turns 75, & More...

We’re back in action with another batch of headlines, research, community updates and open roles across the Kidneyverse. This biweekly news recap goes out to 7,000+ subscribers who want to keep up with the latest advances and discussions happening across industry, R&D, academia, policy and advocacy. 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 our kidney Slack group.

Thank you for being here with us.


Please note: This is a preview. Access the full post (for free) and join conversations on kidney-focused topics with your peers on the Signals website.


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.

View / Download 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.


Signals

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

The New York Times

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

iLet Bionic Pancreas System – with Dexcom G7 and Abbott FreeStyle Libre 3 Plus sensor.

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...


...To continue reading about Beta Bionics upsized $204M IPO and the recent Reddit debate on the End Kidney Deaths Act, visit and subscribe to the Signals newsletter website here (it's free to get started).


Visual of the Week

Click to Open Interactive Chart

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). Open our interactive chart to see specific details 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.

??Find more charts like this in our data room.


News ??

Dwayne Wade shared the clip in Thursday's episode of his podcast The Why on YouTube. DwayneWade via YouTube

  • 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)
  • 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 ??


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!


How to support our work

  1. Sign up online - become a free or paid subscriber on our website to access more content, posts, data, video interviews, and ways to connect with your peers.
  2. Sponsor an upcoming issue - show the kidney world your company is passionate about advancing this space and supporting these conversations.
  3. Get work to pay for this - if your team reads this newsletter, chances are we can help you get your boss or L&D team to cover it. Get access to insights you won't find anywhere else.
  4. Spread the word - the best thing we can do is raise awareness for kidney health globally, and that means getting the word out to your network. Please share (and you'll earn rewards)!

jeff P.

Decades of clinical operations experience | Contract and Project Manager with global experience | Proven Success at delivering projects on time | Champion for Customer Satisfaction and DE&I | Educator

3 周

Tim Fitzpatrick I read the article about VBC. Was interesting. My thoughts This push for Value-Based Care (VBC) is a masterclass in deception—draping cost-cutting measures in the language of patient-centered care. The truth? VBC shifts financial risk from insurers to providers, forcing doctors to make decisions based on cost metrics rather than patient needs. Dr. Scheurer’s claim that this is “for the good of our patients” is laughable when VBC often leads to care delays, denial of necessary treatments, and physician burnout. Dr. Kelly’s obsession with “metric-based goals” makes it clear—VBC isn’t about better outcomes, it’s about forcing doctors into compliance with arbitrary cost-saving benchmarks. The AI and data analytics being hyped? Tools to ration care more efficiently, not improve it. Adams Health’s refusal to hire staff for this transition proves the point: VBC means more administrative burden on already stretched providers while executives and insurers reap the profits. Patients aren’t the winners here—corporate interests are.

Tim Fitzpatrick

Founder and writer building a platform for ideas, innovations, and investments to transform kidney health for 1 billion people

3 周

Read the full post and connect with your kidney innovation peers here: ?? https://trfitzpatrick.com/p/signals-recap-ozempics-latest-approval

要查看或添加评论,请登录

Tim Fitzpatrick的更多文章