Signals Weekly: Diality wins FDA, Borealis emerges with $150M, Paragonix acquired for $477M, IKONA launches VR dialysis training study, & more...

Welcome to Signals, where we come together each week to discover and discuss the latest ideas, innovations, and investments shaping the future of kidney health. This week, we're trying a new summary-style layout to help you navigate news, writing, and events. To access all our full-length articles, news, and open source data, visit the Signals website . Please share your thoughts and questions for one another in the comments below.

As always, keep exploring and thank you for being here.

— Tim

This Week in Signals

1. Top Headlines
2. What We’re Writing
3. What We're Reading
4. Community Voices
5. Coming Soon
6. Get Involved

1. Top Headlines

Catch up on the latest news and insights shaping the future of kidney care.

• Diality Wins FDA Clearance for Moda-Flx: Diality has received FDA clearance for its portable hemodialysis machine, Moda-Flx. Designed for both home and clinic settings, this machine aims to revolutionize dialysis care by providing greater flexibility and ease of use for patients and healthcare providers alike.
• IKONA Partners with DES and Lifeliqe for VR Dialysis Training: IKONA, DES, and Lifeliqe have announced a partnership to study the impact of VR training for dialysis staff. This collaboration will focus on improving training efficiency and patient outcomes through immersive, tech-enabled education solutions.
• Novartis Partners with Versant Ventures to Launch New Biotech: Novartis has teamed up with VC firm Versant Ventures to launch a new biotech company, similar to Chinook Therapeutics, which Novartis acquired last year for $3.2 billion. Borealis Biosciences emerged from stealth with $150 million in Series A funding, led by Versant, and will focus on innovative treatments for kidney disease, leveraging key talent from Chinook’s Vancouver-based research team.
• Getinge to Acquire Paragonix Technologies for $477M: Medical technology company Getinge is set to acquire organ preservation tech company Paragonix Technologies, Inc. for $477 million. Paragonix is known for its innovative solutions in organ preservation and transportation, which includes offerings in liver, heart, pancreas and lung preservation.

2. What We're Writing

Explore our latest deep dives, analyses, and expert commentary on the biggest topics in kidney care.

• The Kidney Transplant System & Paying Donors—The End Kidney Deaths Act. A closer look at the new bipartisan bill introduced to incentivize living kidney donors. We explore how this legislation could reshape the kidney transplant system and address the organ shortage crisis in the U.S.
• Q&A on Patient-Centric Innovation . We sat down with 7 patients to explore what it really means to put them at the center of kidney care innovation. This Q&A captures their stories, challenges, and ideas for a more patient-focused future in healthcare.
• Protecting Patient Choice—The Ardelyx Lawsuit Against CMS . Our deep dive into Ardelyx's ongoing lawsuit against CMS and its potential impact on patient access to new kidney treatments. This piece unpacks the stakes for patient choice and innovation in the kidney care landscape.

3. What We're Reading

Articles, reports, and insights from around the web that are worth your time this week.

• The National Kidney Foundation (NKF) has released new comprehensive recommendations for the use of genetic testing in diagnosing genetic kidney diseases. The report sets new standards for integrating genetic testing into clinical practice to improve early detection and treatment.
• CMS Issues Final Notice on Program for Breakthrough Device Reimbursement While CMS has issued its final notice, many in the industry are looking to Congress for more inclusive solutions to ensure new and innovative devices can reach patients more effectively.
• How the Biotech Landscape Has Transformed Over the Past Three Years In a recent LinkedIn post , Erin Blank reflects on key milestones and companies driving change in the biotech market, particularly in Computational Science and Scientific AI. She highlights how breakthroughs in technology, shifts in global health needs, and innovative approaches to research have reshaped the industry since the pandemic.
• Building for Impact: Digital Health Innovation for Rural Americans A new Rock Health report explores how digital health companies can create meaningful impact in rural communities by addressing access gaps and developing solutions tailored to the needs of underserved populations.
• Is the End-Stage Renal Disease Treatment Choices Model Moving the Needle? Amit Kapoor, M.D., M.B.A., chief nephrology officer at Strive Health, discusses a recent JAMA Health Forum study showing that the ESRD Treatment Choices Model has had little impact on increasing home dialysis or transplant rates so far.

4. Community Voices

Each week, we ask the community a thought-provoking question about kidney care, innovation, or policy. Here's this week's poll .

Fill in the blank: A new bill would pay kidney donors $50,000 each, potentially saving taxpayers $_________ and helping ________ get kidneys over 10 years.

5. Coming Soon

We're always working on our next story, and we want to hear from you! Here’s an inside look at what’s in the Signals pipeline for the next few weeks:

• Biopharma Q&A: We're launching Part 1 of a series that brings biopharma to the forefront in kidney disease. This features a first-time collaborator—a scientist-turned-venture capitalist with an impressive background across the life sciences landscape. Warning: fun surprises ahead.
• A Hero's Journey Recap: I'll be teaming up with Kiku B. from Balboa Nephrology to share more about their recent staff education event, called A Hero's Journey. This case study highlights how provider organizations can promote a culture of innovation to improve overall patient care.
• Value-Based Kidney Care Discussion: Months in the making, we couldn't be more ready to share this with you. Tune in for the first in a series of discussions on complex, nuanced topics requiring deep clinical and operational expertise (and differing points of view). Spoiler alert: you might recognize some of our stellar co-hosts and guests.

Sign up for Signals (it's free) to make sure you get these when they go out to the world. Have other thoughts or topic ideas? Let us know what else should be on our radars!

6. Get Involved

Join the conversation, connect and collaborate with your peers across the Kidneyverse.

• Become a Signals Sponsor ?? : We're accepting applications from companies in the Kidneyverse looking to expand their footprint, achieve key milestones, and position themselves for growth. Join us and showcase your brand to a community of 12,000+ monthly readers across industry, investment, academia, advocacy and government.
• Kidneyverse Careers Job Board ?? : Explore top job opportunities across kidney care, from startups to established industry players. Whether you're hiring or looking for your next move, Kidneyverse Careers is the place to connect with top talent and cutting-edge companies.
• Submit News & Tips to the Signals Inbox ?? : Got a story, tip, or update that should be on our radar? Send it our way through the Signals Inbox. Your contributions help shape the conversation and keep the community informed on the latest developments.
• Join Signals Live Audio Events ??? : Participate in our next monthly Signals Live session on LinkedIn, where we discuss the latest trends, innovations, and news in kidney care. These drop-in audio events offer the chance to engage with industry leaders and share your insights in real time.

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