Roivios is a clinical-stage medical device company at the forefront of kidney health management. The company has developed the JuxtaFlow Renal Assist Device (RAD), a groundbreaking advancement in kidney care. Pulse 2.0 interviewed Roivios CEO and Founder John Erbey to explore the company’s innovative solutions aimed at enhancing kidney function and patient outcomes.
John Erbey’s Background
JOHN ERBEY, PhD Chief Executive Officer Roivios
What is John Erbey’s background? Erbey said:
“I trained as an epidemiologist, focusing on the causes and determinants of diabetes complications, including kidney failure. I knew I didn’t have the personality for academia, so I did a postdoc in industry. I’ve spent nearly 25 years in the industry and held various roles, from R&D through to marketing. I found a niche in translating science into business. That generalist approach has been invaluable to building Roivios.”
Formation of Roivios
How did the idea for Roivios come together? Erbey shared:
“The inception of Roivios is a story of serendipity and innovation that transformed an unexpected discovery into a groundbreaking venture. Throughout my career, dialysis hovered as the outcome everyone sought to avoid, always on the periphery. Then, by sheer chance, I stumbled upon an idea that would eventually become Roivios. Initially, I was skeptical; it took months to convince myself that this seemingly simple concept hadn’t been attempted—or failed—before. It felt almost too straightforward to have been overlooked.”
“The breakthrough came from daring to challenge conventional wisdom. By viewing the problem from a novel perspective, I unraveled the complexities of kidney failure and discovered a clearer path to correction. This fresh outlook illuminated why the kidneys were failing and revealed an innovative method to address it. What started as an accidental insight soon evolved into Roivios, driven by a commitment to redefine kidney health care with originality and courage. This journey from a chance idea to a pioneering company is a testament to the power of curiosity and the courage to think differently.”
Favorite Memory
What has been your favorite memory working for the company so far? Erbey reflected: “Working at Roivios has been a journey filled with both challenges and triumphs, like any startup. Among the many milestones, receiving FDA Breakthrough Device Designation is a pivotal achievement, but my most cherished memories center around the profound impact on physicians and patients.”
“One unforgettable moment was when I first presented our idea to a nephrologist. Initially met with skepticism, I watched as their demeanor shifted—from doubt to curiosity and eventually to excitement. Witnessing that transformation was incredibly powerful, affirming our concept.”
“Equally memorable was the experience with one of our earliest patients—a severely ill acute heart failure patient, whose body was so volume overloaded that his hand resembled the swollen appearance of the Michelin Man, unable to form a fist. Remarkably, within hours of beginning treatment, he was able to clench his fist. This rapid improvement was not just a testament to our technology but also a deeply moving validation of our mission to change lives. These moments of personal connection and real-world impact make the journey truly rewarding and remind me why we do what we do.”
Core Products
What are the company’s core products and features? Erbey explained:
“At Roivios, our flagship product is the JuxtaFlow RAD, a revolutionary device designed to optimize kidney function. The kidneys are vital for maintaining the body’s internal equilibrium, managing everything from waste removal and electrolyte balance to bone metabolism and red blood cell production. Central to these processes is the kidney’s ability to filter blood effectively.”
“The JuxtaFlow RAD enhances this critical function by precisely regulating the pressure on the outlet side of the kidney. By lowering the pressure below the filter, the device restores and improves the kidney’s filtering capability, enabling it to perform its essential roles more efficiently. This innovation not only supports the natural functions of the kidneys but also ensures the well-being of the body’s internal systems. The JuxtaFlow RAD represents a significant advancement in kidney health, providing a sophisticated solution to enhance life-sustaining processes.”
Challenges Faced
What challenges have Erbey and the team faced in building the company? Erbey acknowledged:
“Facing challenges is an inevitable fact of the healthcare sector, and Roivios has navigated its fair share in recent years. The onset of COVID-19 significantly disrupted hospital operations, particularly their capacity to conduct non-vaccine research. Just as these activities resumed, the funding landscape became increasingly volatile. Despite these formidable obstacles, Roivios has been fortunate to have a resilient, dedicated team and the unwavering support of our investors who believe in our mission and potential.”
“Although we are a pre-revenue startup, our commitment to pursuing innovative solutions for patient care remains steadfast. Our team’s optimism and resilience are fueled by the shared vision of the transformative impact our work can have on kidney health. By focusing on our goals and leveraging the support around us, Roivios continues to advance its mission, determined to overcome challenges and seize opportunities to make a meaningful difference in patients’ lives.”
Evolution of Roivios’ Technology
How has the company’s technology evolved since launching? Erbey noted:
“Since its inception, Roivios has been dedicated to the advancement of its core technology, the JuxtaFlow RAD, particularly within acute care environments. While the fundamental technology has remained consistent, our comprehension of its vast potential has expanded significantly. Initially, our focus was on acute heart failure, specifically evaluating whether our device could help kidneys manage excessive salt and fluid in patients unresponsive to traditional diuretics.”
“Our journey has since progressed to testing the JuxtaFlow RAD in cardiac surgery settings, particularly during bypass procedures. This exploration seeks to determine if we can protect the kidneys under the acute stress induced by heart-lung machines, which is a critical advancement in safeguarding vital organ function during these challenging situations.”
“Looking forward, we are excited about broadening the horizons of the JuxtaFlow RAD. Its design is well-suited for intensive care and hospital environments, but our ambitions extend far beyond. We are innovating towards developing solutions that facilitate long-term, home-based treatments. This evolution will enable us to explore new questions, such as the potential to slow chronic kidney disease progression, ultimately strengthening our commitment to revolutionizing kidney health care and improving patient outcomes.”
Significant Milestones
What have been some of the company’s most significant milestones? Erbey cited:
“Roivios has celebrated numerous milestones that have marked its journey toward innovation and impact in the medical field. A significant personal and professional milestone was hiring our first employee, Jacob Upperco, in October 2015. Bringing Jake on board was a stroke of luck that set the foundation for the exciting and impactful milestones that followed.”
“One of our earliest project milestones was the successful testing of our initial prototype in an animal model. Although it was a creatively assembled system reminiscent of a MacGyver project, it proved our concept could work in practice.”
“Securing our first issued patent was a major achievement, paving the way for a robust intellectual property portfolio that has grown to over 100 patents across 29 countries. This accomplishment underscores our commitment to innovation and leadership in our field.”
“Our clinical milestones have been equally significant. We’ve successfully treated a heart failure patient in the U.S. and a cardiac surgery patient in the EU, demonstrating the real-world applicability of our technology. Further validation came when we demonstrated our system’s ability to reduce kidney hypoxia in an animal model.”
“Achieving FDA Breakthrough Device Designation was a pivotal moment, signifying the potential of our technology to address unmet medical needs. Our journey continues as we’ve recently submitted the pivotal trial protocol to the FDA, marking another step toward bringing our innovative solutions to patients in need.”
“These milestones not only reflect our growth and achievements but also our unwavering commitment to transforming kidney health care and improving patient outcomes.”
Customer Success Stories
When asking Erbey about customer success stories, he highlighted:
“While Roivios is still on the journey to receiving FDA clearance and formally acquiring customers, our engagement with patients during the voice of the customer discovery process has provided invaluable insights into the potential life-changing impact of our technology. Patients who have faced the harrowing experience of a “crash into dialysis” often recount overwhelming emotions of stress and fear, highlighting a critical area where our innovations could bring relief and hope.”
“These interactions have reinforced our commitment to advancing solutions that can significantly alter the trajectory of kidney health care. The stories shared by patients underscore the immense opportunity we have to make a positive impact on the lives of tens to hundreds of thousands of individuals each year. Our focus remains on developing technologies that not only address medical needs, but also enhance the quality of life, promising a future where such distressing experiences can be mitigated.”
Funding
When asking Erbey about the company’s funding details, he revealed:
“We are actively pursuing a $20 million investment to initiate a pivotal trial, marking a significant step in transforming kidney health care. Our focus aligns with the recent surge in investment within this sector, as illustrated by leaders like Monument, Somatus, and Strive Health, who have collectively raised over a billion dollars to reduce hospitalizations for kidney disease patients. Our strategic initiative not only complements these efforts but specifically targets the protection of 14 million admissions among patients with kidney disease.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Erbey assessed:
“We are targeting a substantial $105 billion addressable market (TAM), focusing on the 14 million annual hospitalizations of chronic kidney disease (CKD) patients. This dual approach underscores our commitment to advancing kidney health care by safeguarding vulnerable patient populations and tapping into significant market potential.”
Differentiation From The Competition
What differentiates the company from its competition? Erbey affirmed:
“Roivios sets itself apart from the competition with a groundbreaking approach to kidney filtration, redefining how kidney health challenges are addressed. Unlike conventional methods that rely on adjusting blood pressure, Roivios employs a novel technique by applying mild controlled negative pressure where urine exits the kidney. This innovative process enhances filtration efficiency by optimally distributing the force throughout the kidney’s nephrons, directly boosting its ability to perform vital functions.”
“This fresh perspective on kidney function leverages the kidney’s natural autoregulation mechanisms, providing a more effective solution to maintaining kidney health. Roivios’ strategic first-mover advantage has allowed it to secure patents that protect these unique solutions, cementing its leadership in the industry.”
Future Company Goals
What are some of the company’s future goals? Erbey pointed out:
“Our future goals include launching the JuxtaFlow RAD for cardiac surgery and expanding across the surgical and medical ICU. Our big goals include developing other devices to enable therapy outside the hospital, such as a ‘pacemaker for the kidney.’”
Additional Thoughts
Are there any other topics you would like to discuss? Erbey concluded:
“I invite support through advocacy, investment, and social media engagement from all those passionate about healthcare innovation. Your support can help us advance our mission to improve patient outcomes and reduce healthcare costs.”
