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Place your bets: kidney care in 2024
16 key events from 2023 that shaped what happens next
I’m not big on predictions. Instead, let’s talk about what we learned in the past year that will inform our choices and actions over the next 50 weeks.
Normally I prefer tools like premortems and backcasting to help my team put together roadmaps for getting from A to Z. This time around, I thought we’d crowdsource our bets. I’ll kick things off with the 16 events below, then pass the mic to all of you— the kidney community.
This Signal is your map to the future state of the Kidneyverse in January, 2025. Choose a market segment below to get started:
Medical Devices
1. Baxter announced its plans to spin off its Kidney Care business into an independent, publicly traded company called Vantive.
The newco will be led by CEO Chris Toth and is expected to launch sometime in the first half of this year and will include peritoneal dialysis (PD) devices and solutions; connected technologies like its Sharesource remote patient management system; organ support therapies including continuous renal replacement therapy; and hemodialysis filters and systems. That business unit has a steep history, dating back 70 years to when they commercialized the first dialysis system based on Dr. Willem Kolff’s “artificial kidney” in 1954.
The business has a massive global reach with more than one million patients served across 70 countries. In FY22, the future Vantive business unit did ~$4.5 billion in revenue and had around 15,000 employees. The infographic below shows the side-by-side comparison of Baxter and Vantive.
2. Medtronic and DaVita launched Mozarc, a new $400 million joint venture to build new solutions for patients with kidney failure.
The JV aims to leverage Medtronic's global workforce (90,000+ strong across 150 countries), product portfolio and R&D pipeline, plus DaVita’s 200,000+ patients who mostly receive care in one of 2,700+ outpatient dialysis centers across the US.
The current Mozarc product portfolio includes dialysis AV access and maintenance solutions, acute therapies for critically ill patients in the ICU and NICU (i.e. Carpediem™), and chronic therapies (i.e. Clearum™) in certain geos.
Ven Manda is the CEO of Mozarc Medical and serves on its board of directors. Previously, he was the operating unit president of Medtronic Renal Care Solutions (RCS) and has been with the company since 1994, serving in roles across research, product development, and business leadership.
DaVita Group VP of R&D Dr. Mahesh Krishnan:
“The launch of Mozarc Medical holds tremendous promise to improve the lives of patients living with kidney disease as it seeks to revolutionize the approach to home dialysis by improving accessibility, ease of use, and clinical performance.”
3. The FDA approved the first two renal denervation (RDN) devices to treat hypertension after more than a decade in the making.
The devices from Recor Medical and Medtronic open a new market that Medtronic estimates to be over $1 billion. Even after other companies pulled out of the space, and a split decision by an FDA advisory panel in August, we now have two devices in the market gearing up to treat the nearly half of US adults who have high blood pressure— specifically, the 3 out of 4 who struggle to control it.
Here’s something I wrote in November after the first approval came through for Recor’s Paradise system if you want to learn more about how it works, why it matters, and what’s next according to supporters (and critics).
Value-Based Care
4. Monogram Health closed $375 million in growth capital to support continued expansion of its in-home kidney and polychronic care model.
This turned out to be one of the so called “megadeals” of 2023, which is all the more impressive considering we just wrapped up the second year of the startup funding slump. The milestone round included investments from leading strategic investors CVS Health, Cigna Ventures, Humana, Memorial Hermann Health System, and SCAN, as well as from both new and existing financial investors including TPG Capital, Frist Cressey Ventures, Heritage Group, Pura Vida Investments, and Norwest Venture Partners, among others.
This funding brings Monogram to a total of $557 million raised to date, following the $160 million Series B closed in June of 2022.
This week Monogram also announced its latest partnership with Millennium Physician Group, a leading value-based physician organization with over 800 providers across the Southeastern US.
5. Strive Health closed its $166 million Series C and inked a multi-year partnership with Oak Street Health in 21 states.
Oak Street Health is the primary care provider focused on Medicare that was acquired by CVS for $10.6 billion last year. The Strive-Oak partnership focuses on people with stage 4/5 kidney disease (CKD) and kidney failure (ESKD) across Oak Street’s network of 169 locations in 21 states.
Strive partners with health systems, medical groups, individual providers and payers to manage over 100,000 patients across 30 states.
Interestingly, Strive also added CVS to its list of strategic backers with the Series C funding. Other investors include NEA, CapitalG (Alphabet), Echo Health Ventures, Town Hall Ventures, Ascension Ventures and Redpoint.
6. Interwell Health marked its 1-year anniversary since the 3-way, $2 billion merger along with Fresenius Health Partners and Cricket Health.
In its first year, Interwell Health added almost 100 nephrologists to its network, growing to 1,700 physicians supporting kidney disease patients in small to large practices across the country. The company now covers 125,000 lives, an increase of 25 percent from its inception, and manages more than $7 billion in total medical costs.
Remember Oak Street Health from above? Last March, Interwell and Oak Street announced a joint venture called OakWell to offer primary care to ESKD patients directly in the dialysis center.
According to the original press release, OakWell aimed to begin offering care services in Chicago, Houston, and Dallas-Fort Worth dialysis centers in Q3 of 2023.
7. Value-based care continued to be the closest thing the Kidneyverse has to a rocketship — and it seems to have plenty of fuel.
12 of the top players manage around 700,000 patients and $20 billion in annual spend. By now it’s well known that within value-based care, nephrology makes for a compelling use case and investment for providers and capital partners alike. Even with talk of Medicare Advantage woes and eventual consolidation, there’s still room to run for the companies who can figure out the best ways to build, buy, and partner their way to reaching patients and partners in need.
Pharma & Life Sciences
8. Boehringer Ingelheim announced it’s preparing for an 11,000-person pivotal trial for BI 690817 after promising phase 2 data.
We learned more about the phase 2 data in The Lancet and at ASN Kidney Week in November. The experimental drug significantly reduced albuminuria — albumin in urine, a sign of kidney damage — for 50% of participants. When the experimental drug was paired with empagliflozin, a standard-care SGLT2 medication, 70% of participants reportedly experienced a significant reduction in albuminuria.
Some are calling this a major medical breakthrough that very well may have “broken the code” to fight kidney disease. Time will tell if this holds true — and if it does, whether we can ensure adequate access and uptake.
Oxford Population Health and Boehringer Ingelheim’s new, international Phase III EASi-KIDNEY trial will begin recruitment later this year.
9. GLP-1s continued to take kidney care, and the world, by storm.
The “miracle” class of diabetes drugs known as GLP-1 receptor agonists have quickly become the world’s most famous pills. They’re everywhere you look. In October, Novo Nordisk announced they would stop the kidney outcomes trial FLOW after interim results met pre-specified efficacy criteria.
Just imagine being able to delay progression of kidney disease and lower the risk of kidney and cardiovascular mortality. It’s potentially great news for patients.
But the dialysis industry was just one of many to feel the ripple effects of this news, which hit shares of food companies, dialysis providers, and medical device companies in bariatric surgery and glucose-monitoring. So much so that shares of the two large dialysis organizations dropped (17%) the day FLOW was halted — DaVita even issued a statement about future implications of GLP-1s on the need for dialysis.
If this topic strikes a chord, read this article from
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10. Calliditas received full approval for Tarpeyo, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function.
This news came two years after Calliditas received an accelerated approval for Tarpeyo. As Fierce pointed out, some graduations from accelerated to full approval are ceremonial, this one carries extra weight because it expands the label for Tarpeyo to allow access by all patients with IgAN. Previously, the FDA limited its use to those at risk for rapid disease progression.
There are as many as 150,000 people with IgAN in the United States. Two other key players are also actively developing and testing treatments in this space. Travere’s sparsentan has approval in Europe but recently came up short in a phase 3 trial. Novartis acquired Chinook for $3.2 billion last year, largely for its IgAN candidate, atrasentan.
11. SGLT2s continue to show promising benefits (and increased use) with kidney patients.
A recent chart review of over 1,000 CKD (non-dialysis) patient charts shows strong growth in the use of SGLT2 inhibitors, and expanding opportunities for MRAs and GLP-1s. The same review shows nephrologists indicated they would use more empagliflozin for patients with diabetic kidney disease (DKD) and non-diabetic CKD since the FDA expanded the label to include CKD.
That said, another team of researchers estimated that more than 80% of adults with type 2 diabetes in the US meet the criteria for GLP-1 receptor agonists or SGLT2 inhibitors, but only about one in 10 used either medication from 2017 to 2020 (image below).
Currently approved medicines in the SGLT2 inhibitor class include: Brenzavvy™ (bexaglifloxin), Invokana® (canagliflozin), Farxiga® (dapagliflozin), Jardiance® (empagliflozin), and Steglatro® (ertugliflozin).
Transplantation
12. New reforms to the organ procurement and transplantation network aim to improve performance, transparency, independence, and accountability.
The bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act is ushering in a fundamental sea change in how the OPTN operates.
Changes include an independent Board of Directors, multi-vendor competitive bidding and next gen contracting. These changes follow many years of criticism and advocacy on the parts of patients, lawmakers, and advocates seeking change at the highest levels of oversight. The sole contract to manage the OPTN has been handled by the United Network for Organ Sharing (UNOS) since 1986.
A key element of HRSA’s OPTN Modernization Initiative is the President’s Fiscal Year 2024 Budget proposal to more than double investment in organ procurement and transplantation over Fiscal Year 2023— to $67 million.
HRSA is expected to release solicitations for proposals for IT management, ops, data analytics, research, and communications later this month.
13. KDIGO supports creation of new race-free eGFR equation specific for transplantation.
Dr. Marc Raynaud serves as lead scientist at Paris Institute for Transplantation and Organ Regeneration. Last year, he and his team published the results of a study that compared performance of a newly developed race-free kidney recipient specific eGFR equation with the three current main equations.
Their equation was developed and validated using multiple, large, international cohorts of kidney transplant recipients. The equation showed high accuracy and outperformed the race-free CKD-EPI 2021 equation.
He pointed out that the previously created eGFR equation measures have had limited success because they were developed for use on native kidneys, created based on U.S.-only patient data, which may limit their generalizability, and have shown suboptimal performance in measuring GFR in transplanted kidneys.
14. Medeor cell therapy helps kidney transplant patients taper off immunosuppressant meds.
Patients who receive a new kidney need to stay on immunosuppressant drugs for the rest of their lives to prevent rejection. But these therapies are not only expensive — they also substantially increase the risk of cancer, diabetes, infection and other medical problems.
That’s where Medeor Therapeutics’ kidney transplant cell therapy comes in. MDR-101 is a single-dose cell therapy that combines a living donor’s cells with the recipient's through a process called chimerism. Results from their recent phase 3 pivotal trial showed more than half of study participants were able to stay off immunosuppressants for two years.
Besides the overall rejection data, Medeor also highlighted that patients reported improved quality of life two to three years after transplant.
Dialysis
15. Quanta gets expanded FDA clearance for two modes of CRRT and announced 510(k) submission for use of its dialysis machine in the home.
The Quanta Dialysis System was originally designed to serve the more than two million people with end-stage kidney disease (ESKD) worldwide who receive treatment with dialysis or a kidney transplant. The addition of its Trinal Kidney Therapy™ (TKT) software also adds a treatment solution for critically ill patients diagnosed with acute kidney injury (AKI) who require dialysis.
In their Home Run™ study, patients placed on home hemodialysis four times a week showed improved outcomes over in-center treatment using the Quanta Dialysis System. One researcher pointed out:
“Of the thirty-two evaluable participants successfully completing the Home Run study, 93% decided to take advantage of the IDE extension to prolong use of the Quanta Dialysis System in their homes.”
16. The Kidney Project hits a critical milestone, bringing us one step closer to in-vivo trials and bioartificial kidneys.
Last but certainly not least, we may finally be getting closer to answer the question of whether an artificial kidney can free patients from needing dialysis or immunosuppressant drugs, for good.
Last fall, the Kidney Project team proved that its bioreactor can keep kidney cells alive for at least one week. Their latest study showed that cells kept in an implantable device can survive inside the body of a pig and mimic several important kidney functions.
The team tracked the kidney cells and the recipient animals for seven days after transplantation and both did well. The next step will be month-long trials, as required by the FDA, first in animals and eventually in humans.
The nonprofit is jointly led by UCSF’s Shuvo Roy (technical director) and Vanderbilt’s William Fessell (medical director).
From Shuvo Roy:
“We are focused on safely replicating the key functions of a kidney.” We needed to prove that a functional bioreactor will not require immuno-suppressant drugs, and we did. We had no complications and can now iterate up, reaching for the whole panel of kidney functions at the human scale.”
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