Signals Weekly: Baxter restarts North Cove; CMS delays IOTA; IgAN at Kidney Week; Sonavex gets $15M; & more...

Yes, I’m still reeling from the frenetic, rhythmic pulse of Kidney Week. From Dr. Crews’ opening call to “redefine the standard” to the labyrinth of posters and bright-eyed fellows, I’m riding high with deep admiration and gratitude for those who make this week possible. To everyone I had the chance to meet in person—thank you for making those days feel like a true kidney-nerd's paradise. For those who reached out to share your stories, impressions, and optimism after the event, thanks for keeping Signals in your corner for kidney innovation updates.

Later this week, we’ll start our full Kidney Week coverage, taking it one story at a time. If we missed you at the show and you have a story to share, please don’t hesitate to reach out and say hello.

Thanks, too, to everyone who voted on what you’d like us to cover. The top interests are innovation spotlights (50%) and scientific discovery (33%). So, we’ll stick with what we do best: covering the ideas, innovations, and investments shaping the future of kidney health. Stay tuned—there’s a lot more to come after this weekly recap.

Brought to you by Roivios

This edition of Signals was made free for all readers thanks to Roivios, Ltd. , the team developing the world’s first renal assist device. Check out JuxtaFlow, a clinical-stage solution for renal insufficiency. Thanks team!

Last week, Roivios released new clinical data from the BIPASS-AKI Feasibility Study of the JuxtaFlow® Renal Assist Device (RAD) at the STS Perioperative Care meeting.

This week

• Poll: Top ethical considerations in transplantation
• CMS delays IOTA model; KTC responds with analysis
• Sonavex raises $15M to enhance dialysis ultrasound tech
• Roivios device shows kidney protection post-surgery
• Single APOL1 gene variant raises CKD risk in West Africans
• IgAN therapies take center stage at Kidney Week
• Renal denervation gains momentum in hypertension care
• Early eGFR changes in ADPKD may predict outcomes
• Report questions remote hypertension monitoring w/o med support
• Clinicians launch Scrub Capital VC for health innovation
• Year-end push highlights primary care in value-based models
• Study IDs top social determinants for women with lupus nephritis
• FDA panel votes against sotagliflozin for glucose control
• BioCom CEO Summit: resilience, Q1 2025 IPO hopes
• & More…read the full post here

Transplant Ethics

In this week's poll, we want to know which of these ethical considerations you think is most important to "get right" as we shape the future of organ transplantation?

More than half (58%) said equity in organ allocation is most important to you, followed by even splits between paying organ donors (18%) and using animal organs, or xeno-transplantation (18%). A few of you also had other top of mind ethic questions, so let’s talk about a few of them.

Below are a few insightful comments, questions, and perspectives provided in the comments on this post. What do you think?

• Miriam Godwin: “It's not the sexiest answer but the failure to protect trust and transparency in organ allocation has been a spectacular failure of public policy. It is essential to have a robust and trustworthy regulatory framework that promotes innovation while defending against bad outcomes and bad behavior and on which novel, creative solutions to the problems that distress us can stand.”
• Vanessa Evans: “You know what I think- make it easier to get patients listed- use a common app (like they do for college applications )to register - pair potential donors and recipients with an advocate – someone that has gone through it before- compensate donors - think tax breaks or free healthcare we must think more creatively.”
• Stephen Ruby: “Extending the life of a kidney between the donor and recipient is perhaps one of the goals that may provide the greatest "bang for the buck." 34 Lives is doing that and has already made an impact for a number of patients who would otherwise not have received a donor kidney (at this time). Their impact will continue to grow into the future. Donated kidneys is perhaps one of the greatest resources we currently have for those with CRD and everything should be done to maximize the percentage of those kidneys that actually get into patients and change their life!”
• Qasim Butt: Not sure if this is an ethical issue, but one of the biggest hurdles to me is patient navigation of the kidney transplant process…. Early referral, Education, Which transplant center to go to, Can I go to different centers, Getting on waiting list / getting medical clearance, How to get a living donor, etc. One of the most interesting nephrologists in this space that is trying to do something about it is Eliot C. Heher MD - just got to meet him at ASN last week.”

...keep reading the comments here.

Signals

1. Kidney group urges CMS to prioritize Increasing Organ Transplant Access payment model

A new analysis of kidney waitlist data released by the Kidney Transplant Collaborative (KTC) underscores a critical and growing challenge facing the U.S. healthcare system: a dramatic increase in the number of individuals waiting for a kidney transplant, especially in key presidential swing states. The Kidney Transplant Collaborative expressed disappointment at the delayed CMS launch of the Increasing Organ Transplant Access model. CMS is continuing to work on the final rule, but has indicated a later-than-expected start beyond the original implantation date of Jan. 1, 2025.

“The growing kidney transplant waitlist is a matter of life and death, and it is critical that we support policies that incentivize donation, reduce geographic disparities, and ensure every person in need of a kidney transplant has a chance to survive.”

2. Sonavex secures $15M Series A-2 financing

Sonavex, a Baltimore-based medtech company focused on ultrasound solutions, has raised $15 million in a Series A-2 round to advance its vascular and dialysis-focused technologies, EchoMark® and EchoSure®. These tools provide real-time, quantitative blood flow data and enable AV fistula assessment in dialysis clinics. This funding will support ongoing clinical trials, including the pivotal MAFASA study, and build further evidence for its technologies. The raise follows key milestones such as FDA approval for an IDE, a new CPT code, and additional funding for pipeline product clearances.

3. Roivios Releases Clinical Data on the JuxtaFlow RAD

At the Society of Thoracic Surgeons (STS) Perioperative Care Meeting, Roivios presented promising results from its BIPASS-AKI feasibility study on the JuxtaFlow® Renal Assist Device (RAD). This novel device, used post-cardiac surgery, showed potential to protect kidney function in high-risk patients. The trial results revealed a high success rate in catheter placement and no device-related adverse events, with only 2 out of 10 patients experiencing postoperative AKI—one due to protocol deviation. This breakthrough could significantly improve outcomes for cardiac surgery patients vulnerable to acute kidney injury. CEO John Erbey said:

"This study tested the initiation of the JuxtaFlow RAD nearly two hours after patients were weaned from cardiopulmonary bypass, likely after the insult to their kidneys already occurred. The results highlight the potential of JuxtaFlow RAD in enhancing postoperative recovery."

4. Quanta Dialysis Technologies Gains FDA Clearance for Home Use Dialysis System

Quanta Dialysis Technologies has received FDA 510(k) clearance for home use of its high-flow Quanta Dialysis System, making it the only high dialysate flow (500 mL/min) system approved for the full spectrum of care settings for end-stage renal disease (ESRD) patients. With fewer than 3% of U.S. dialysis patients receiving home hemodialysis (HHD), Quanta’s system offers an alternative by matching hospital-grade standards and simplifying home dialysis setup. Clinical trial results presented at ASN showed high patient satisfaction and a safe transition to home therapy, supporting Quanta’s goal of expanding accessible, effective home dialysis options.

5. Study: One APOL1 Variant Increases CKD Risk in West Africans

New research from the H3Africa Kidney Disease Research Network shows that even one APOL1 gene variant can raise the risk of chronic kidney disease (CKD) and focal segmental glomerulosclerosis (FSGS) in West Africans. Previously, only two variants were thought to significantly increase risk, but this study found that having one variant increases the chance of CKD by 18% and FSGS by 61%. With these variants common in some West African groups, the findings could guide future treatments to reduce CKD rates and severity in African populations.

6. IgAN Was a Hot Topic at ASN Kidney Week

Jonathan Barratt, PhD, called IgAN "the world’s most important kidney disease" due to its widespread impact and evolving treatment landscape. At Kidney Week, a packed session highlighted IgAN's burden and the potential of APRIL—a molecule involved in the disease's pathogenesis—as a therapeutic target. Dr. Kenar Jhaveri emphasized that lowering proteinuria remains crucial in delaying IgAN progression, with new treatments offering promising options for patients, a stark contrast to the limited choices of just a few years ago. This focus on IgAN signals a shift toward more targeted and effective therapies in kidney disease.

7. How a group of clinicians launched a VC firm

Scrub Capital, a venture capital firm founded by a group of 650 clinicians, recently launched to invest in digital health and medical device startups. With a target of $10 million for its first fund, the firm uniquely engages clinicians in its due diligence process, allowing healthcare professionals to shape investments based on their on-the-ground expertise. Co-founder Christina Farr emphasized the firm’s mission to empower clinicians as investors, aiming to bring diverse, non-finance voices to the venture capital space and build lasting value in healthcare innovation.

8. Why is primary care more important in Q4?

Care gaps—the difference between clinical guidelines and actual care received—remain a major focus as health plans and providers shift to value-based care (VBC) models. Yet, due to fragmented contracts and conflicting quality metrics, providers struggle to prioritize and effectively close gaps. This leads to a chaotic "Q4 push," where healthcare organizations rush to meet quality measures before year-end deadlines, often frustrating patients. Experts suggest that flexible, rolling reporting periods and streamlined quality measures could reduce year-end pressure, allowing for smoother, more patient-centered care delivery.

...continue reading more Signals here, including renal denervation updates, new KDIGO clinical practice guidelines for anemia in CKD are out for public review, a new tolvaptan study, a new report on digital hypertension solutions, new generative AI phone agents for medical practices, a new study on social determinants for women with lupus nephritis, FDA votes against sotagliflozin, and more.

Community Voices

A collection of insights, opinions, updates and upcoming events from your peers and fellow explorers across the Kidneyverse.

• Baxter International: "We are excited to announce that we’ve restarted our first IV fluids line at our North Cove facility. Initial batches will be manufactured concurrently with ongoing quality activities and would only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products. Thanks to the entire team across Baxter and our remediation partners for their hard work and dedication, and the ongoing support of federal, state and local government agencies..."
• Dr. Amber Paulus: "Thank you Sri Lekha Tummalapalli for sharing about policy implications for nephrology practice with our division for Renal Grand Rounds this week! Since that discussion and feedback from community nephrologists engaged in value-based care arrangements, I’ve reflected a lot on how I previously engaged nephrologists in automating modality referral. I was wrong. But I didn’t know it at the time. I was following information I had with limited understanding of the global picture including how everyone might understand the granular pieces of data utilized to make care decisions..."
• International Society of Glomerular Disease: "Congratulations to our colleagues in the H3Africa Consortium Kidney Disease Research Network on their groundbreaking research presented at Kidney Week and published in NEJM! This first APOL1 population-based study from Africa recruited over 8,000 people from academic medical centers in Ghana and Nigeria, including nearly 5,000 people with CKD stages 2-5 and biopsy-confirmed FSGS or other glomerular diseases, to investigate the role of having one or two copies of the APOL1 variants..."
• Kerri Rathburn, J.D.: The results speak for themselves on the CMS/CMMI kidney program...DROP THE MIC for Interwell Health 1. Interwell is the largest participant in the CMS/CMMI kidney program. We operated 20 kidney contracting entities (KCEs) in 2022, but have since expanded to 23 KCEs. 2. Interwell achieved perfect quality in 3 KCEs, being the only organization to do so. 3. Interwell accounted for 16 of the 20 highest quality KCEs.4. Quality metric bonuses of $20M paid to 22 KCEs “high-performance pool” (Interwell received 80% of the total payment).

• Healthmap Solutions: Last week, Healthmap Solutions’ Medical Leadership Team attended the American Society of Nephrology (ASN) Annual Meeting and presented a poster detailing a population health initiative conducted among chronic kidney disease patients in Healthmap’s program. Thank you to Dr. Howard Shaps (Chief Medical Officer), Dr. Stephanie Toth-Manikowski (National Medical Director and Nephrologist), and Dr. Lisandro Montalvo-Burke (Puerto Rico Medical Director and Nephrologist) for sharing the great work Healthmap is doing to improve outcomes for patients!

• Yolinda van der Nest: "The kidney is underestimated for its size, but it affects every system in the body. Public awareness will remain low unless we as health care professionals start connecting the dots and inform patients about the interrelationship between the kidney and non communicable diseases (Hypertension, Diabetes, Cardiovascular Disease and Obesity as recognised by WHO)."
• PKD Australia: "The International Society of Nephrology has launched a global petition to make kidney disease a policy priority.The goal is to secure 1 million signatures by 31st December 2024, and we need your support to get there! By signing the petition, the ISN can urge UN Member States to call on the WHO to recognise kidney disease as a top priority, potentially saving millions of lives 🙏🏼 Read more and sign the petition through the link here."
• Spencer Dorn: At HLTH, Spencer reflected on past trends like telemedicine, remote patient monitoring, and digital therapeutics—all of which generated hype but struggled to reshape healthcare as expected. The challenges of patient adoption, operational complexity, and healthcare’s resistance to change have kept these tools in the background rather than the forefront. He wonders if AI will follow a similar path, persisting in the background while facing hurdles to mainstream adoption, or if it will eventually break through given its foundational potential.

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