Valcare Medical, Inc. Announces Corporate Restructuring and Appointment of New CEO
TAMPA, Fla., April 24, 2024 /PRNewswire/ -- Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced a comprehensive corporate restructure by a group of investors led by Techwald Next, aimed at accelerating the company's plans to initiate the AMEND mitral annuloplasty clinical studies in Europe and the United States.
As part of the restructuring, TechWald has appointed Steve Sandweg to serve as Chief Executive Officer. Sandweg brings a successful 25-year history in the medical device space having worked for both Fortune 500 and startup companies in the cardiovascular and structural heart space. Sandweg most recently served as Chief Commercial Officer for EBR Systems, Inc, developer of the world's only wireless cardiac pacing system for heart failure. Prior to that, Sandweg worked for Keystone Heart where he served as General Manager, and Direct Flow Medical serving as Director, US Clinical Field Operations.
Sandweg began his cardiovascular and structural heart career with Medtronic Corp. in 2006 where he held positions of increasing responsibility with Medtronic's peripheral vascular, coronary, and structural heart business units. While with Medtronic, Sandweg played a key role in helping execute several strategic product launches including Endeavor and Resolute, the company's first drug eluting stents and Corevalve/EVOLUT, the company's first transcatheter aortic valve devices.
"I'm excited and honored to be joining such a remarkably talented team," Sandweg said. "The corporate restructure offers a unique opportunity for us to increase focus and accelerate performance. Following the success of our first in human experience in which 33 patients were treated with AMEND and showed promising results (17 treated under clinical protocol and followed out to 6 months), we are eager to now begin enrolling patients in the AMEND Plus European pilot study and continuing our work with the FDA on a future IDE submission."
In addition to the appointment of Sandweg, the company also appointed a new Board of Directors led by Executive Board Chair, Chris Richardson. Richardson has over 30 years of experience in the medical device industry, and an extensive record of successfully leading medtech startups from clinical study phase through regulatory approval, commercial launch, and acquisition.
Prior to joining the Valcare Medical Board, Richardson served as President and CEO of Keystone Heart which was acquired by Venus Medtech in 2018. He also served as International President and Chief Commercial Officer of Direct Flow Medical, a transcatheter aortic valve company, and General Manager of Evalve (MitraClip), which was acquired by Abbott Vascular in 2009.
"We're fortunate to have Steve come on board at this important stage in Valcare's development," said Chris Richardson. "Steve has the experience and operational track record the company needs at this time to execute on its ambitious plan to transform the standard of care for patients suffering from severe mitral regurgitation."
Valcare's AMEND mitral valve repair device is an innovative, clinically proven, D-shaped, semi-rigid closed ring with proprietary anchoring capabilities. AMEND is designed to provide clinical standard-of-care surgical treatment via a transcatheter-based procedure. The AMEND platform also serves as the foundation for Valcare's future mitral replacement and tricuspid repair solutions.
The AMEND device is limited to investigational use and is not commercially available.
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Valcare Medical is dedicated to providing innovative minimally invasive technologies for the treatment of mitral regurgitation.
SOURCE Valcare Medical
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