Across the Kidneyverse: March 15, 2024
Baxter, Balboa, Strive, Stelo, World Kidney Day and much more!
Welcome to a special Kidney Month edition of our monthly Kidneyverse update! This month we’re bringing you (20) headlines, (3) closer looks, and (2) visuals worth exploring.
Because we have a few more headlines than usual, I’ve also included subcategories like policy & partnerships, market trends, research, and commentary.
As always, please do share any feedback on structure, organization, content ideas, and ways we might collaborate to make Signals even better.
Contents
Reminders
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Headlines
Here’s what caught my eye across the Kidneyverse this month:
Policy & Partnerships
Former HHS Secretary Alex Azar wrote an excellent piece on how to fix kidney care in the US. This powerful call to action shares his personal connection to kidney care, and his excitement to see how the work he and his team did with the kidney health initiative will help us realize the potential of value-based care. (The Hill — a closer look below).
This week the Colorado General Assembly amended and passed a bill drafted to remove disincentives to live donor kidney donation. The bill creates the "CARE for Living Organ Donors Act" and includes benefits and recognition for living organ donors. H/t to Gregory Whitman for testifying on Wednesday and bringing this to my attention. (HB24-1132)
Strive Health just announced a new multi-state agreement with Humana in five states, including Indiana, Illinois, Kentucky, Michigan and northwest North Carolina. This builds on an existing Humana-Strive relationship, which began in Indiana and Kentucky in 2020. They also added 10,000 additional members in Ohio with Medical Mutual. (Strive)
Evergreen Nephrology just announced two new additions to its executive leadership team. Philip Cooksey joins as CFO (previously at Humana, Goldman Sachs, and Lazard), and Dr. Tim Pflederer joins as Chief Medical Officer (CMO) (current president of Renal Care Association, past president of RPA). (Evergreen)
Delorean AI just announced a partnership with Constellation Kidney Group to deliver next-gen clinical care using AI. Integrating Renal AI into CKG's electronic medical records facilitates the creation of personalized care plans, predicts emergencies, and better supports care teams. (SF Examiner)
Balboa Nephrology announced its strategic partnership with IKONA to test and commercialize virtual reality (VR) education for people with kidney disease. Together they aim to bolster social support networks and raise awareness among patients with early stage CKD with comprehensive learning tools around ESKD treatment options. (Healio) Disclaimer: my day job is as CEO of IKONA — big things ahead for providers, patients and families! Okay, back to headlines…
Research & Innovation
KDIGO just released its 2024 CKD Clinical Practice Guidelines. Key highlights include guidance updates on measuring estimated glomerular filtration rate (eGFR) and albuminuria, utilization of CKD risk prediction equations, and personalized treatment recommendations for kidney and cardiovascular risk reductions tailored to individual patient needs and preferences. (KDIGO)
LifeLabs announced the inclusion of the Klinrisk Score as a validated equation in the latest KDIGO guidelines. The Klinrisk Score is designed to assess the risk of CKD progression early, including in individuals who are disease-free today. (GN)
New findings reveal the impact of health care algorithms on racial disparities and patient outcomes. A systematic review of 63 studies published between 2011 and 2023 identified 7 strategies to guide us toward more equitable algorithms. (AJMC)
CloudCath just released its latest clinical publication, which showed its CloudCath System was able to detect turbidity (cloudiness in PD fluid) consistent with peritonitis with a mean lead time of 3 days over the current standard of care. (ISN)
Market Trends & Insights
It sounds like Baxter is now considering selling its kidney care business instead of its previously announced plans to spinoff a new public company called Vantive. This news comes from the latest 8K filing— no final decision has been made but the timeline is now second half of 2024. (MedTech Dive — a closer look below).
The biotech market may finally — actually — be back. Biotech's benchmark index is up 56% from 2023 lows. Public biotechs have already raised over $13 billion on the secondary market, as good clinical data is being rewarded handsomely. IPOs are showing signs of life. Even crossover rounds are trickling back. Learn more in the latest from Andrew Dunn. (Endpoints News)
Eversana just published a great article on the Commercial Promise of Prescription Drug Use-Related Software (PDURS) - specifically FDA’s new framework that enables software that demonstrates a clinical benefit to a drug to be added to the drug’s label (“FDA-required labeling”). (Eversana — a closer look below).
FDA also just cleared the first over-the-counter (OTC) continuous glucose monitoring (CGM) device, Dexcom’s Stelo. The device is intended for anyone 18 years and older who does not use insulin— such as individuals with diabetes treating their condition with oral medications— or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. (FDA)
Are you a scientist-founder? If so, you’ll want to read A Scientific Approach to VC by NfX’s Omri Drory. As he puts it, “If you know how VCs think and how the game is played, it will totally change how you tell your story, generate excitement, and pick your investors.” (NfX)
Network & Commentary
Strive Health’s Will Stokes (Co-Founder, Chief Growth Officer) was on the latest episode of Vital Signs with Jacob Effron (Redpoint) and Nikhil Krishnan (Out of Pocket) to talk about what goes into a risk-based contract, how specialized VB models engage with primary care, and what makes kidney care attractive to value-based care. (Spotify)
Healio interviewed the new chair of Kidney Care Partners, Dr. Mahesh Krishnan, about what he brings to the table at KCP and his priorities for the upcoming year. This is an important read to understand current policy and payment barriers to innovation in kidney care, as well as what it will take to establish a clear market pathway for future products and technologies. (Healio)
A recent NPR piece explores how genetically modified pigs could end the shortage of organs for transplants. If you want to know where things stand today in this field of research, this is a great read-listen about the xenotransplant work being done at companies like Revivicor and eGenesis. (NPR)
Tired of all the buzz around LLMs in healthcare? 20 members of Forbes Tech Council recently shared real-world uses cases for LLMs — including a few they achieved themselves — and lessons we can learn from them. (Forbes)
A Closer Look
Here’s a closer look at a few headlines from above and why they matter:
1. US kidney care is broken. But we have the means to fix it.
A powerful call to action by former HHS Secretary Alex Azar appeared in The Hill last week. He shares his personal connection to kidney care, and excitement to see how the work he and his team did with the kidney health initiative will help:
reduce the number of patients "crashing";
increase the number of pre-emptive transplants; and
smooth transitions to home dialysis.
"All who are responsible for the health of Americans and the health of our care delivery system must ignore party lines and short-term profits to put individuals with kidney disease at the center of what we do. More insurance companies must push these value-based approaches forward to make them work at scale."
Why it matters: As many as 60 percent of people with late-stage kidney disease 'crash' into the emergency room with failed kidneys, needing emergency dialysis to survive. Each crash leads to poorer outcomes and $50,000 in added costs. The consequence of this dysfunction results in far too many patients spending years on in-center dialysis.
Dialysis in Value-Based Care
2. Baxter is considering selling its kidney care unit to private equity instead of spinning off a new public entity called Vantive.
Baxter first announced its plans spin out its renal care and acute therapies businesses into a separate, publicly traded company last year. The new kidney care company, called Vantive, would include dialysis and organ support therapies. Last year that unit made up nearly a third of Baxter’s total revenues (just shy of $4.5 billion).
Though Baxter previously said the spinoff would happen in the first half of this year, now it sounds like whether through a spinoff or sale, the kidney care business will be separated in the second half of 2024.
Why it matters: There’s precedent for this. Last year Baxter sold its biopharma solutions business to PE firms Warburg Pincus and Advent International for $4.25 billion. Take a look at the market growth drivers in the graphic below from their JPM presentation in January.
3. Harnessing the Commercial Promise of Prescription Drug Use-Related Software (PDURS).
The FDA’s draft guidance on Prescription Drug Use-Related Software (PDURS) offers pharmaceutical manufacturers a novel strategy to enhance a drug’s label by enabling an HCP to prescribe software alongside the drug at the HCP’s discretion. The new framework makes it easier than before to pair software with a medication to help patients manage complex dosing, monitor side effects, and access behavioral change support.
In the absence of the new PDURS framework, digital devices can be paired with drugs via two pathways: companion software and drug-device combination products (see below graphic). This framework is a “middle path” meant to foster innovation and give manufacturers added flexibility around new software.
Why it matters: For pharmaceutical companies, the benefits of developing a PDURS product include the potential for brand differentiation, improved patient adherence, and demand retention post loss of exclusivity (LOE). PDURS also unlocks a new go-to-market option for digital health software.
Ultimately, PDURS can be influential in supporting patient retention, which in turn can improve patient outcomes and brand performance.
Visuals of the Month
Pictures say a thousand words. This week we celebrated World Kidney Day. But what does this visual abstract tell us about global disparities in kidney disease— are we closing the gap?1
This second visual comes from Terry Litchfield, who many of you will know for her role shaping the kidney community’s approaches and thinking around patient advocacy and engagement. Yesterday, Terry shared a post on LinkedIn to honor the spirit and memory of her late husband, Bill Litchfield.
If you are not familiar with Bill’s story and life’s work, this is a wonderful tribute and reminder of why we are all here. Thank you for your leadership and for sharing with us, Terry!
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