MINNEAPOLIS, June 24, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, reviews the year-to-date and outlines strategic priorities in a Letter to Shareholders from newly appointed CEO, Mike McCormick.
Dear Valued Shareholders,
Recently we announced an important leadership transition for Nuwellis. Effective June 30, 2026, I will assume the role of Chief Executive Officer, while John Erb will transition from his executive responsibilities and continue as Chairman of the Board.
We embark on this leadership transition with growing commercial momentum, improving margins, and a strengthened capital position. During the first quarter of 2026, Nuwellis delivered 26% year-over-year revenue growth while improving gross margin to 70.1%, representing a 14% point improvement compared to the prior-year period. These results reflect the continued adoption of our technology, the dedication of our employees, and our focus on disciplined execution.
At the same time, we have taken meaningful steps to improve operating efficiency and reduce capital requirements. By concentrating resources on our highest-priority opportunities and aligning spending with near-term growth initiatives, we believe we are building a stronger foundation for sustainable value creation.
Looking forward, our strategy remains focused on the areas where we see the greatest opportunity to expand our impact and strengthen our business.
Today, approximately 75% of our revenue is generated from the pediatric and critical care categories, and these customers continue to demonstrate strong momentum. We believe precision fluid management addresses important unmet medical needs in both adult and pediatric intensive care settings, and we remain committed to supporting clinicians who care for some of the most critically ill patients.
In pediatrics, we continue advancing our efforts to expand the Aquadex indication from the current 20-kilogram patient population to children weighing as few as 5 kilograms and above. As part of this initiative, we recently engaged with the FDA regarding a proposed submission strategy that includes the use of existing clinical experience and real-world clinical evidence generated through pediatric use of Aquadex. We believe this effort has the potential to expand access to the therapy for a broader group of pediatric patients while further strengthening our position in this important market.
We are also advancing our cardiorenal platform beyond fluid removal. Earlier this year, Nuwellis acquired Rendiatech, Inc., adding automated kidney function monitoring technology to our portfolio. This acquisition expands our presence in the ICU by complementing the Aquadex platform with diagnostic monitoring capabilities, creating additional opportunities for growth within our existing customer base and the broader critical care market.
We recently strengthened our capital position, providing resources to execute on our key commercial and development initiatives. Maintaining our Nasdaq listing remains an important component of our strategy as we continue to broaden awareness of Nuwellis among institutional and long-term investors. Our focus continues to be on disciplined deployment of capital toward opportunities that can accelerate growth, expand margins, and create long-term shareholder value.
Furthermore, improving operational efficiency and reducing cash burn remains a key priority as we move through 2026. Through disciplined expense management and a continued focus on our highest-impact growth initiatives, we are working toward a meaningful reduction in burn from the first quarter through year-end while continuing to invest in opportunities that drive long-term value creation.
As we enter the next phase of growth, our objectives are clear:
- Deliver consistent double-digit revenue growth through focused commercial execution
- Continue expanding gross margins through product mix, operational efficiency, and increased utilization
- Advance strategic pipeline programs that complement our existing critical care and pediatric franchise
- Maintain disciplined capital allocation while pursuing opportunities that create long-term shareholder value
We are grateful to our employees, customers, clinicians, investors, and Board members for their continued support and confidence. We believe Nuwellis is well positioned to build upon its recent momentum and execute on the significant opportunities ahead in critical care, pediatrics, and cardiorenal medicine.
Thank you for your continued support.
Sincerely,
Mike McCormick
Incoming Chief Executive Officer
John Erb
Chairman of the Board
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
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