John Erbey on Targeting the Kidney’s Collecting System to Improve Fluid Removal & Sustain Function: Signals KOLs

In Part 1, John shares why the Roivios team came together, and the $650 billion elephant in the room when it comes to the true cost burden of kidney disease in the U.S.

Summary

In this episode, Roivios founder and CEO John Erbey delves into the science behind their unique approach to supporting kidney function. John explains how their team shifted focus away from forcing more blood into the kidney—which the body naturally resists through autoregulation—and instead explored the kidney’s collecting system, where fluid removal may help optimize filtration. He shares key insights from preclinical models and early feasibility studies, highlighting how Roivios' technology may improve kidney function, increase sodium excretion, and enhance diuresis (fluid removal) in patients with acute decompensated heart failure. John describes this shift as a "Copernican moment" for kidney science—a fundamental rethink of how we approach kidney function in critical care and post-surgical recovery.

Finally, he discusses early feasibility data and the next steps for clinical evaluation, including upcoming studies in the U.S. and Europe designed to assess whether their approach can help reduce the risk of kidney injury following cardiac surgery and ICU interventions.

Signals KOLs is the series that highlights key opinion leaders whose work is shaping the future of kidney health across industry, academia, policy, research, advocacy, and beyond.

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Guest Bio

John Erbey is the founder and CEO of Roivios. He has spent the past 25 years bringing innovative therapeutics and medical devices to the market. Prior to founding Roivios, John held roles of increasing responsibility across the pharmaceutical and medical device industries. He holds a PhD in epidemiology from the University of Pittsburgh’s Graduate School of Public Health. His dissertation on the cardiovascular risk associated with insulin resistance in adults with type 1 diabetes earned him induction into Delta Omega, the National Honor Society for Public Health. He has published 17 peer reviewed articles and delivered dozens of conference presentations and invited lectures.

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Keywords

kidney function, cardiac surgery, medtech, sepsis, health outcomes, autoregulation, medical innovation, clinical trials, VOID-HF, renal function, health economics

Chapters

• (00:20) – Targeting Solutions for Chronic Kidney Disease

• (02:36) – Innovative Approaches to Kidney Function Recovery

• (06:26) – The Journey of Convincing Stakeholders

• (06:57) – Clinical Studies and Their Impact

• (10:02) – Product Development and Implementation

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Takeaways

• Cardiac surgery is a major trigger for kidney injury: The heart-lung machine stresses the kidneys, increasing ICU stays and complications. Protecting kidney function could speed recovery and reduce costs.¹

• The kidney’s collecting system is the real unlock: Instead of forcing blood flow into the kidney (which it resists), targeting the collecting system allows for fluid removal that works with the kidney’s natural processes.²

• Animal studies confirmed the kidney’s response: Experiments in pigs demonstrated that increasing central venous pressure (CVP) shuts down kidney function, while Roivios' therapy restored filtration in a dose dependent manner—proving the concept.³

• Early human trials showed improvements: The VOID-HF study showed a 9x increase in fluid removal and a 2.5x increase in sodium excretion, even in CKD patients, defying expectations in its first three patients.⁴

• Pivotal trials are underway: The next U.S. and European studies will test Roivios' technology in cardiac surgery patients to see if it can prevent post-op kidney injury and improve ICU outcomes.⁵

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Milestones

• Jan-2025: Roivios and Caresyntax Partner to Revolutionize Renal Care Through Data-Driven Insights (Press release)

• Dec-2024: FDA Grants IDE Approval for the Pivotal Trial of the JuxtaFlow® Renal Assist Device (RAD) (BioSpace)

• Nov-2024: Roivios Shares Promising Data on JuxtaFlow Renal Assist Device From BIPASS-AKI Feasibility Study (Press release, Study research poster)

• Oct-2024: Company Presentation at LSI Europe '24 (YouTube)

• Apr-2024: Roivios Secures FDA Breakthrough Device Designation for JuxtaFlow® RAD, Showcases Pioneering Data at Society of Cardiovascular Anesthesiologists Annual Meeting (Press release)

Data presented at STS 2024 in Philadelphia, PA

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Discussion

• Why has kidney function traditionally been addressed by increasing blood flow rather than focusing on the collecting system?

• What lessons from past innovations in nephrology (e.g., new dialysis devices, SGLT2 inhibitors) could help accelerate adoption of new approaches like this?

• If we rethink kidney support in ICU and post-surgical settings, could this shift have implications for earlier CKD management as well?

• What questions do you have for John and the Roivios team?

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Made Possible By

This issue is made possible by Guaranteed, the company optimizing end-of-life care experiences for CKD and ESRD patients at risk-bearing nephrology practices when conservative kidney management, dialysis and kidney transplants are no longer viable options. Email raihan@onguaranteed.com today to learn more.

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1. Renal Insufficiency Meets Stress: Patients with renal insufficiency undergoing cardiac surgery are at significant risk for exacerbation of renal dysfunction postoperatively. (Roivios.com/condition).

2. Emerging Individualized Approaches in the Management of Acute Cardiorenal Syndrome With Renal Assist Devices (JACC: Heart Failure, 2023)

3. Stafford-Smith, et al. A porcine study of mock cardiac surgery using a parallel group design. Eight animals underwent baseline, surgery and recovery comparing the JuxtaFlow RAD to no treatment. (Roivios.com/studies)

4. VOID-HF: Negative Pressure Diuresis, Preliminary Results of a First in Human Treatment of Cardiorenal Syndrome (Research poster)

5. FDA Grants IDE Approval for the Pivotal Trial of the JuxtaFlow® Renal Assist Device (RAD) (Press release)