Nuwellis appoints Mike McCormick as CEO, effective June 30

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Key Highlights

Nuwellis, Inc. has appointed Mike McCormick as Chief Executive Officer, effective June 30, 2026, succeeding John Erb who will remain Chairman of the Board.

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Nuwellis, Inc. (Nasdaq: NUWE) has appointed Mike McCormick as its new Chief Executive Officer, effective June 30, 2026. John Erb, who currently serves as President, CEO, and Chairman of the Board, will transition from his executive leadership role and continue serving as Chairman of the Board. This leadership change is intended to drive the company's next phase of growth in the cardiorenal care market.

McCormick is a seasoned medical technology executive with more than three decades of leadership experience spanning product development, commercialization, corporate strategy, and value creation. He served as a Board Member and Independent Director of Nuwellis from June 2023 through January 2026. Throughout his career, McCormick has founded, scaled, and led both public and private medical technology companies.

"Mike brings an exceptional combination of operational leadership, commercial expertise, and strategic vision," said Erb. "His deep understanding of the medical device industry and proven track record of building and scaling innovative healthcare companies make him uniquely qualified to lead Nuwellis into its next phase of growth."

McCormick stated that Nuwellis has an important opportunity to expand the role of precision fluid management in cardiorenal care. He aims to build on the company's momentum, strengthen commercial execution, advance the pipeline, and create value for patients, healthcare providers, and shareholders.

Leadership Transition Details

The following table outlines the changes in Nuwellis' executive leadership structure:

Executive Previous Role New Role Effective Date
Mike McCormick Board Member and Independent Director Chief Executive Officer June 30, 2026
John Erb President, CEO, and Chairman of the Board Chairman of the Board June 30, 2026

About Nuwellis

Nuwellis, Inc. is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis' portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions.

What specific strategic shifts can investors expect under McCormick's leadership regarding Nuwellis' commercial execution?

How will the transition of executive responsibilities impact Nuwellis' product pipeline development timeline over the next 18 months?

What are the primary growth targets for the precision fluid management market that Nuwellis aims to capture by 2028?

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Nuwellis expands Aquadex SmartFlow integration in South Carolina

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Key Highlights

Nuwellis has expanded its collaboration with a South Carolina healthcare system to integrate its Aquadex SmartFlow devices into a children's hospital and upgraded existing technology at two other locations. The Aquadex system provides ultrafiltration therapy for patients weighing 20 kg and above. Nuwellis plans to submit a proposal to the FDA by the end of 2026 to expand the device's label to patients weighing 5 kg and above.

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Nuwellis has expanded its collaboration with a South Carolina healthcare system to integrate its Aquadex SmartFlow devices into a children's hospital. The provider also upgraded to the latest Aquadex devices at its two locations that already use the technology. This expansion aims to help clinicians provide controlled, predictable fluid removal for pediatric patients.

The Aquadex system is designed to provide precise ultrafiltration therapy for adult and pediatric patients weighing 20 kg and above who are suffering from fluid overload. The therapy supports improved patient management and may help reduce rehospitalizations associated with heart failure and related conditions.

"Expanding this important collaboration will bring our Aquadex therapy to more pediatric patients in need," said Nuwellis' CEO John Erb. "This further validates Nuwellis' ultrafiltration system as a clinically important and increasingly adopted solution for managing fluid overload, while reinforcing our growing leadership and continued momentum in the pediatric category."

Nuwellis recently completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) to propose expansion of the Aquadex SmartFlow System's label to support pediatric patients weighing 5 kg and above. The Company anticipates submitting to the FDA by the end of 2026.

What impact will the FDA label expansion to 5 kg have on Nuwellis' total addressable market in the pediatric segment?

How might this expanded collaboration influence adoption rates among other major healthcare systems?

What are the potential revenue implications from the device upgrades at the two existing locations?

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