Healthcare Industry News:  Open Stent Solution 

Devices Interventional Cardiology Venture Capital

 News Release - September 28, 2021

Open Stent Solution closes €2.5M Seed financing round for its breakthrough open-stent TMVR device

AMIENS, France, Sept. 28, 2021 -- (Healthcare Sales & Marketing Network) -- Open Stent Solution (OSS), a medtech start-up company developing the first open-stent heart valves, today announced the closing of a €2.5 million Seed financing round. The funding will support the development of its ribbon-shaped stented mitral valve for transcatheter replacement.

OSS' 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 best-in-class TAVI (transcatheter aortic valve implantation). The OSS valve components are attached to a ribbon-shaped open stent, which drastically 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 perfect circular shape, with stable radial anchoring force exactly like balloon expandable devices. OSS' ribbon-shaped open stents have an unprecedented approach compared to existing stented heart valves, which are all cylinder-shaped and radially expanding.

"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," said Doctor Doron Carmi, senior cardiac surgeon, founder and CEO of Open Stent 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.

"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," stated Edouard Caram of Angels Santé. "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 solution of the next decade."

TMVR challenge and need

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.[1]

"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," stated Thomas Modine, cardiac surgeon Hôpital Pont L'eveque - Bordeaux, France. "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."

About Mitral Valve Disease and Replacement

Mitral valve regurgitation affects around two percent of the population and about nine percent of over 75s in industrialised countries.[2] It can be treated with open heart surgery but most patients with severe mitral regurgitation are unsuitable for it, so their failed valves cannot be replaced. Mitral regurgitation is prevalent in high-risk patients because it is often the result of heart failure, myocardial infarction or other cardiomyopathies (secondary) and it is generally associated with poor clinical outcomes.[3] Transcatheter Mitral Valve Replacement may enable their treatment and improve and extend their lives.

About Open Stent Solution

Open Stent Solution (OSS) is a French MedTech start-up company developing the first open-stent heart valve, a paradigm shift in transcatheter mitral valve replacement. The company was founded by senior cardiac surgeon doctor Doron Carmi, who envisioned a novel approach to overcome the limitations of conventional cylindrical stents to treat patients suffering from severe mitral valve regurgitation. The company's unique heart valve supported by a ribbon-shaped stent structure represents a paradigm shift in transcatheter valve replacement. The company has built a team of world-renowned executives, skilled medtech engineers, and leading scientific and medical experts. OSS recently closed a €2.5 million Seed financing round to support its TMVR device development.

1. Paul Sorajja, MD Transcatheter Therapy for Mitral Regurgitation Clinical Challenges and Potential Solutions Circulation. 2017;136:404–417

2. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez- Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005–1011. doi: 10.1016/S0140-6736(06)69208-8.

3. Mirabel M, Iung B, Baron G, et al. What are thecharacteristics of patients with severe, symptomatic,mitral regurgitation who are denied surgery? Eur Heart J 2007;28:1358–65.

Source: Open Stent Solution

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