Valcare Medical

About

Valcare Medical is an Israel-based medical device company focused on developing minimally-invasive technologies for treating mitral regurgitation, a heart condition affecting the mitral valve. The company was acquired by TechWald Holding S.p.A. in April 2024. Valcare's main product is the AMEND™ (Amend Trans-Septal System), a transcatheter mitral valve repair device. This innovative technology features a D-shaped, semi-rigid closed ring that effectively repairs the mitral annulus and serves as a docking station for future prosthetic devices. The AMEND platform is designed to address various valve conditions and is the basis for Valcare's future products, including mitral replacement and tricuspid repair solutions. Currently, the device is for investigational use only. The company has completed a first-in-human study with positive results and has received FDA approval to start an Early Feasibility Study in the U.S. Valcare is also conducting the AMEND TS EU Pilot Study in Europe, which has expanded to include Italy. The leadership team, led by CEO Steve Sandweg, includes experts in interventional cardiology and regulatory affairs.