Start-up developing "first ever" open-stent heart valve closes €2.5m round

Open Stent Solution (OSS), a medtech start-up company developing open-stent heart valves, has closed a €2.5 million seed financing round. The funding will support the development of its ribbon-shaped stented mitral valve for transcatheter replacement. 

OSS says its breakthrough device is the first ever open-stent heart valve and the only device bearing the promise to implant large size mitral valves through small delivery systems, comparable in size to TAVI (transcatheter aortic valve implantation). The OSS valve components are attached to a ribbon-shaped open stent, which reduces the overall device’s size when loaded onto a delivery system, compared to conventional, radially expanding devices.

Once implanted, the OSS heart valve gets locked, forming a circular shape, with stable radial anchoring force exactly like balloon expandable devices.

Doctor Doron Carmi, senior cardiac surgeon, founder and CEO of Open Stent Solution, said: “We are grateful to our investors for their trust and for their support to our venture. The financing enables us to proceed to concept freeze for our unique minimally invasive solution. In few years from now, we aim to offer an effective transfemoral solution to millions of patients with failed mitral valves who cannot access treatment today.”

There are currently no devices approved for transfemoral or transeptal transcatheter mitral valve replacement (TMVR). Today, most patients with severe mitral regurgitation are unsuitable for open heart surgery and cannot have their valves replaced.

The OSS funding round was led by Angels Santé, a French health business angel network, BeAngels, a Belgian business angel network, Bpifrance, the French government agency, and private investors, of which several cardiologists and cardiac surgeons.

Eduoard Caram of Angels Santé said: “We have been impressed by OSS's technology paradigm shift, which overrides radial expansion, whilst several start-up companies are currently trying to address TMVR challenges through more standard approaches. As mitral regurgitation is continuing to grow as a result of an ageing global population, TMVR is expected to become one of the most prominent cardiovascular solutions of the next decade.”

Mitral regurgitation (MR) is the most common valvular heart disease. Mitral valve regurgitation is often the result of heart failure, myocardial infarction, or other cardiomyopathies (secondary) and it is generally associated with poor clinical outcomes.

Thomas Modine, cardiac surgeon Hôpital Pont L'eveque - Bordeaux, France, said: “The lack of a TMVR treatment is a serious concern when we look at patients with secondary mitral valve regurgitation, as it is unfortunately associated with higher morbidity and mortality rates. A transcatheter solution is very much needed and OSS’s unique approach seems to potentially address the specific anatomical challenges of the mitral space, such as sizing, due to a dilated ventricle, and the need of a flexible device.”