Valcare Medical, a transcatheter mitral valve solutions provider, has announced a significant corporate restructuring, as part of which it appointed Steve Sandweg as CEO.
This strategic move, led by investor group Techwald Next, is set to expedite the company's plans to commence the AMEND mitral annuloplasty clinical trials in the US and Europe.
The restructuring also includes the appointment of a new board of directors led by executive board chair Chris Richardson.
Sandweg has 25 years of experience in the medical device sector, spanning from Fortune 500 companies to startups in the structural heart and cardiovascular arena.
In his most recent role, Sandweg served as chief commercial officer for EBR Systems, which develops the only wireless cardiac pacing system for heart failure.
Richardson brings more than 30 years of medical device industry experience. His previous roles include president and CEO of Keystone Heart, acquired by Venus Medtech in 2018, as well as held leadership positions at Direct Flow Medical and Evalve, which was acquired by Abbott Vascular in 2009.
Richardson said: “We're fortunate to have Steve come on board at this important stage in Valcare's development.
“Steve has the experience and operational track record the company needs at this time to execute its ambitious plan to transform the standard of care for patients suffering from severe mitral regurgitation.”
Valcare's AMEND mitral valve repair device is at the forefront of the company's innovative portfolio.
With proprietary anchoring capabilities, the D-shaped, semi-rigid closed ring is designed to deliver surgical standard-of-care treatment through a transcatheter-based procedure.
The AMEND platform is also the foundation for Valcare's future mitral replacement and tricuspid repair solutions.
Sandweg said: “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 six 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.”
