Founded in 2018, Open Stent Solution is developing Cornelis™, a transcatheter valve replacement system designed to treat mitral and tricuspid regurgitation, two of the most common and serious valve diseases in elderly patients.
Cornelis™ is a next-generation solution: a valve designed to be implanted via catheter, without open-heart surgery, and with a repositionable system that allows accurate and safe placement. Its unique structure is compatible with both the mitral and tricuspid valves, simplifying the development path and broadening its clinical applications.
A growing but underserved patient population
Mitral and tricuspid regurgitation affect more than 10% of people over 75, yet over 80% of diagnosed patients are left untreated. Surgery remains too risky for many, and most transcatheter alternative solutions fall short — they struggle to fit large valves or to adapt to complex anatomies.
Cornelis™ was designed precisely to overcome these limitations. It offers the adjustable positioning during the procedure, ensuring precise fit and optimal outcomes. Its unique design adapts to different heart anatomies and works in harmony with the heart’s motion, offering secure anchoring without harming tissue — an ideal solution for complex and high-risk cases.
An enormous and fast-growing market
As life expectancy increases, demand for minimally invasive cardiac therapies continues to rise. Analysts estimate that the global market for transcatheter mitral and tricuspid valve replacement (TMVR/TTVR) will exceed $41 billion by 2030. However, only 20% of patients qualify for current available solutions.
Cornelis™ is ideally positioned to address this gap, offering a versatile platform that targets two major indications with a single system.
A highly experienced team
Open Stent Solution is led by a seasoned and complementary team with deep expertise in interventional cardiology, medical technology, and entrepreneurship. The company was founded by Doron Carmi, a cardiac surgeon with more than 20 years of clinical experience in heart valve diseases and the development of innovative cardiology devices, who also holds a master’s degree in bioengineering. He is joined by Hikmat Hojeibane, Chief Technology Officer, a MedTech innovator with over 30 years of experience developing cutting-edge medical devices, with a strong focus on cardiovascular technologies. The team also includes a cardiac surgeon with more than 20 years of clinical experience in heart valve diseases and the development of innovative cardiology devices, who also holds a master’s degree in bioengineering. Yoshinori Oikawa has joined as Executive Chairman. He is a successful entrepreneur with a proven track record in the financial and technology sectors and co-founder of Given Imaging, the company behind capsule endoscopy, which was acquired by Covidien for close to one billion dollar. This unique combination of clinical insight, technical expertise, and business acumen positions Open Stent Solution to successfully bring Cornelis™ to market.
Major progress since the last round
Since its previous financing round with Capital Cell in 2024, Open Stent Solution has made significant advances. The Cornelis™ valve system has reached design freeze, with a fully functional dual-valve implant that can be applied to both the mitral and tricuspid positions. The team has completed successful ex vivo implantation and chronic animal implantations. We are actively preparing for the verification and validation phase, paving the way for a first-in-human clinical study planned for late 2026.
The current €1.5M round is designed to fund manufacturing transfer, pre-device verification testing, and pre-clinical implantation. Of this amount, €220,000 is allocated to chronic animal testing — a critical inflection point that will unlock the Series A.
This round will enable the scale-up and verification of the manufacturing process. With the tricuspid application already technically advanced, we are positioned for faster clinical entry and a more direct path to commercial partnerships. In parallel, we continue refining the delivery system to address the unique challenges of mitral valve interventions.
These milestones will strategically position the company for a Series A round, which will support regulatory submissions and the initiation of first-in-human clinical trials.
Why invest now
This round comes at a key strategic inflection point: just before the verification and clinical phase. This is one of the most value-driving stages in MedTech development, where clinical data unlocks interest from major players and paves the way for future partnerships.
Despite the substantial progress made since the last round, the company is raising at the same valuation. This offers investors a rare opportunity to enter at an attractive price, just ahead of a major value step-up.
Join us in advancing a promising new treatment for one of the most common — and still largely untreated — heart diseases.
