Nuwellis is a medical technology company developing solutions for patients with cardiorenal conditions, particularly those experiencing fluid overload associated with heart failure, kidney disease, and critical illness. Its flagship Aquadex SmartFlow system provides controlled fluid removal for patients whose conditions have not responded adequately to conventional medical management, including diuretics. The company is also expanding into pediatric renal support, kidney function monitoring, and technologies designed to improve clinical decision-making. Led by President and CEO Mike McCormick, Nuwellis has an established presence in approximately 135 U.S. hospitals, including 47 children’s hospitals. Pulse 2.0 interviewed Nuwellis President and CEO Mike McCormick to learn more about the company’s precision ultrafiltration technology, expanding pediatric applications, clinical adoption, and strategy for developing an integrated cardiorenal care platform.
Mike McCormick’s Background
When asked about his background, McCormick shared:
I am the President and CEO of Nuwellis, a medical technology company committed to delivering solutions for patients with cardiorenal conditions. I have more than 35 years of experience in the medical technology industry, spanning product development, commercialization, corporate strategy, and business development.
Throughout my career, I have had the opportunity to lead both public and private medical technology companies, with a focus on bringing innovative solutions to market, scaling operations, and driving long-term growth.
Before joining Nuwellis, I held several executive leadership positions, including President and CEO of Osprey Medical and Anulex Technologies, as well as President of the Spine-Tech Division of Centerpulse, where I led the global spinal business through its acquisition by Zimmer. Earlier in my career, I spent 10 years with SciMed and Boston Scientific, which provided a strong foundation in medical technology commercialization.
Having worked across multiple areas of medical technology, I have seen firsthand the importance of developing solutions that address meaningful clinical needs while also delivering value to healthcare providers. I’ve also learned that successful innovation requires strong commercial execution.
That experience is particularly relevant to my role at Nuwellis, where we are focused on expanding the adoption of our precision fluid management technologies and building a broader platform of integrated solutions for patients with cardiorenal conditions.
How The Idea For Nuwellis Came Together
When asked about the clinical needs that shaped Nuwellis and its technology, McCormick explained:
Nuwellis was built around addressing a significant and often underrecognized challenge in healthcare: fluid overload. This condition occurs when excess fluid accumulates in the body and the heart, kidneys, or conventional treatments cannot adequately remove it. It is particularly prevalent among patients with heart failure, kidney disease, and those recovering from complex surgical procedures.
Diuretics have traditionally been the standard of care for managing fluid overload, but they are not effective for every patient. This creates a significant treatment gap, particularly for patients who need more precise volume management but may not require dialysis-based therapy.
Our Aquadex SmartFlow® system was designed to address that gap by providing clinicians with a controlled, predictable method of removing excess fluid when conventional medical management is insufficient.
Over time, our vision has expanded beyond a single therapy. We recognize that effectively managing cardiorenal conditions requires a more comprehensive approach that combines monitoring, treatment, and data-informed clinical decision-making.
Today, Nuwellis is building an integrated platform designed to help clinicians identify fluid imbalances earlier, intervene more effectively, and manage patients throughout their care journey. We are also leveraging our established relationships with hospitals and clinicians to expand access to innovative therapies.
Core Products And Features
When asked about Nuwellis’ core products and features, McCormick explained:
Our flagship technology is the Aquadex system, which delivers controlled, predictable isotonic fluid removal for adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.
Unlike traditional dialysis systems, which are designed primarily for renal replacement therapy, Aquadex is specifically designed for precision ultrafiltration. It allows clinicians to carefully control the rate and volume of fluid removed, making it particularly valuable for patients who require precise fluid management.
Aquadex is increasingly being utilized across three primary areas: heart failure, critical care, and pediatrics.
Beyond Aquadex, we are expanding our portfolio through internal innovation and strategic partnerships. This includes our Vivian™ system, a next-generation pediatric renal support platform currently in development and designed to support patients as small as 2.5 kilograms.
Supported by a $3 million National Institutes of Health grant, Vivian is being developed to integrate multiple renal support therapies into a single platform.
Together, these technologies reflect our strategy to continue to grow beyond fluid removal into a broader, integrated cardiorenal solutions platform, leveraging our established hospital relationships and clinical expertise to introduce complementary technologies.
Challenges In Advancing Precision Fluid Management
When asked about the challenges facing Nuwellis and the broader medical technology sector, McCormick explained:
One of the most significant challenges in our industry is driving broader awareness and adoption of innovative treatment approaches, particularly in areas where conventional therapies have been the standard of care for decades.
For example, diuretics remain the primary treatment for fluid overload. However, there is growing recognition that prolonged fluid overload and delayed intervention can contribute to poor outcomes, extended hospitalizations, and increased healthcare costs.
Changing established treatment pathways requires clinical education, strong supporting evidence, and collaboration across medical specialties. We work closely with cardiologists, nephrologists, intensivists, and pediatric specialists to demonstrate how precision ultrafiltration can complement existing treatment strategies and help clinicians identify patients who may benefit from earlier intervention.
Another challenge is the complexity of introducing new technologies into hospital environments. Hospitals must balance clinical benefits with operational efficiency and financial considerations.
Our approach is to provide not only differentiated technology but also the clinical training and implementation support necessary to integrate our solutions into existing workflows.
We view these challenges as opportunities to advance the conversation around fluid management and demonstrate the value of more proactive, precise, and coordinated care.
How Nuwellis’ Technology Has Evolved
When asked how the company’s technology has evolved since launching, McCormick explained:
Our core technology has evolved in terms of its clinical applications and as a company, we have also expanded on the capabilities we are developing.
Aquadex established our foundation in precision ultrafiltration, initially serving patients with heart failure and fluid overload. Over time, we have expanded its applications into critical care, cardiac surgery, and pediatric medicine, where precise fluid management is especially important.
One of the most meaningful developments has been our growing focus on pediatric patients. Children have significantly smaller circulating blood volumes than adults, meaning even minor changes in fluid balance can have serious consequences.
Our experience in this population has helped inform the development of more specialized technologies and our efforts to expand the current Aquadex indication to patients weighing as little as 5 kilograms, subject to FDA clearance after our anticipated submission in the fourth quarter of 2026.
This represents an important opportunity to serve a broader population of critically ill pediatric patients. We are also advancing our Vivian pediatric renal support platform.
Additionally, we are investing in innovations designed to make Aquadex more intelligent, versatile, and easier to integrate into clinical environments.
These include SmartView, which is being developed to provide enhanced real-time therapy visibility and integration with hospital information systems, and Pressure IQ™, which is intended to improve system performance by adapting to changing inlet pressures and reducing unnecessary therapy interruptions.
Our acquisition of Rendiatech in March 2026 represented another important step, adding automated kidney function monitoring technology to our portfolio.
Ultimately, we are evolving from a company centered on a single fluid-removal device into a platform that combines precision therapy, monitoring, and clinical insights to address more patient needs across the cardiorenal continuum.
This evolution builds on our established clinical relationships and commercial infrastructure to support our continued growth and expansion.
Significant Company Milestones And Clinical Adoption
When asked about Nuwellis’ most significant milestones, McCormick highlighted the company’s hospital adoption, pediatric growth, and regulatory progress:
One of our most significant achievements has been the growing adoption of Aquadex across leading U.S. hospitals, particularly within pediatric critical care.
Today, our technology has an established presence in approximately 135 U.S. hospitals, including 47 children’s hospitals and six of the top 10 children’s hospitals as ranked by U.S. News & World Report.
Pediatrics has become our largest and fastest-growing category, accounting for approximately 50% of our U.S. revenue. This adoption reflects the significant unmet need for precise fluid management among critically ill children.
Another important milestone was completing our FDA pre-submission meeting regarding the proposed expansion of the Aquadex indication from patients weighing 20 kilograms or more to those weighing 5 kilograms or more.
We are targeting a 510(k) submission in the fourth quarter of 2026, which, if cleared, could significantly expand the pediatric population we are able to serve.
Additionally, our acquisition of Rendiatech and strategic relationship with Atrility Medical have strengthened our ability to expand beyond our core ultrafiltration business into complementary critical care technologies.
What Differentiates Nuwellis From Its Competition
When asked what distinguishes Nuwellis from other medical technology companies, McCormick explained:
I believe we are differentiated in three key ways: the precision of our technology, our established clinical presence, and our strategy to deliver integrated solutions across the cardiorenal continuum.
Aquadex is designed to deliver controlled ultrafiltration for patients whose fluid overload has not responded adequately to medical management, giving clinicians another option when conventional approaches are insufficient.
Unlike traditional dialysis systems, Aquadex is purpose-built for precise fluid removal and with a low Extracorporeal Circuit Volume (ECV) of only 35 ml, offering a simpler, more focused approach to managing fluid overload.
We also differentiate ourselves through our experienced clinical support team, which works directly with hospitals to facilitate implementation, education, and ongoing utilization.
Our established presence in leading hospitals, particularly in pediatric and critical care, provides an important competitive advantage as we expand our portfolio.
We believe the combination of innovative technology, clinical expertise, and an expanding platform positions Nuwellis to play an increasingly important role in the future of cardiorenal care.
Future Company Goals
When asked about Nuwellis’ future goals, McCormick outlined plans to expand the company’s technology portfolio, strengthen its commercial presence, and improve treatment options for adult and pediatric patients:
Our overarching goal is to establish Nuwellis as a leader in integrated cardiorenal solutions by expanding our commercial footprint, advancing our technology pipeline, and addressing unmet needs across adult and pediatric patient populations.
In the near term, a major priority is expanding our pediatric capabilities. We are working toward submitting our 510(k) application to the FDA for the proposed Aquadex indication expansion to patients weighing 5 kilograms or more.
We also continue to advance Vivian, our next-generation pediatric renal support platform designed specifically for smaller patients.
Looking further ahead, our vision is to help transform fluid management from a reactive intervention into a more proactive, integrated component of patient care.
By combining precise therapies with enhanced monitoring and actionable clinical insights, we aim to provide healthcare professionals with the tools they need to make more informed treatment decisions and ultimately improve the care of patients with complex cardiorenal conditions.
