Boston Scientific has led a $175 million funding round for the mitral valve developer 4C Medical, which is currently working on an international pivotal study.
The series D proceeds represent a big jump over the company’s previous $35 million raise in early 2022. The latest round was also joined by unnamed new and returning investors.
“The enthusiasm for participation in our ATLAS pivotal trial is palpable, and with this strong capital raise and the backing of Boston Scientific, we look forward to clinically demonstrating the safety and effectiveness of the AltaValve System in treating patients with [mitral regurgitation],” 4C Medical CEO Saravana Kumar said in a statement.
4C Medical’s approach differs from others in the structural heart space, as its globe-shaped AltaValve is designed to fit entirely within the left atrium, instead of being placed at the site of the mitral valve between the chamber and the lower left ventricle.
4C Medical AltaValve
The AltaValve. (4C Medical)
The company says this position may allow it to avoid the potential complications that can come with other transcatheter mitral valves—such as obstructions of the left ventricular outflow tract, where blood moves into the aorta, or damage to the supportive tendinous cords that connect to the valve. The repositionable AltaValve is also designed to be used in patients that have already undergone a valve repair procedure.
4C Medical began enrolling 450 participants in its ATLAS trial across the U.S. and Europe last October, including people with mitral valve calcification ranging from none to severe—an aspect that may limit some treatment options.
Last year the company also obtained two breakthrough designations from the FDA, for separate indications in the treatment of moderate to severe mitral regurgitation and the addition of moderate and severe mitral annular calcification.