TruLeaf Achieves First-in-Human Implantation of Revolutionary Catheter-Based Heart Valve System
Key Insights
TruLeaf Medical (search) successfully completed the first phase of a first-in-human clinical trial for its RoseDoc docking system (search), performing the first-ever transcatheter tricuspid valve (search) replacement on September 5th, 2025 in India.
The innovative two-stage system enables heart valve replacement via catheter without open-heart surgery, targeting millions of patients with valvular heart disease (search) who are too high-risk for traditional surgical approaches.
Two patients with severe refractory congestive heart failure (search) due to leaking tricuspid valves received the docking system implantation, with the second phase of valve implantation planned for the coming months.
TruLeaf Medical (search), a subsidiary of AllMeD Solutions (search) (TASE: ALMD), has achieved a significant milestone in cardiovascular medicine by successfully completing the first phase of a first-in-human clinical trial for its revolutionary RoseDoc docking system (search). On September 5th, 2025, the company performed the world's first transcatheter tricuspid valve (search) replacement using its innovative catheter-based approach in India.
Breakthrough Two-Stage Technology
The procedure was performed on two patients suffering from severe refractory congestive heart failure (search) due to leaking tricuspid valves who had no alternative therapeutic options. The treatment was administered through a compassionate care pathway, highlighting the urgent medical need for these patients.
TruLeaf's innovative technology operates through a unique two-stage implantation process. First, a specialized docking station is implanted via catheter, followed by the subsequent implantation of the heart valve itself within the docking device. This method was specifically designed to provide solutions for patients without requiring open-heart surgery.
The second phase of the trial, involving percutaneous implantation of the valve itself using only needle stick access, is expected to be performed in the coming months according to the established trial protocol.
Addressing Critical Unmet Medical Need
Prof. Oz Shapira, CEO of AllMeD Solutions (search) Group, emphasized the significance of this achievement: "This trial is not only an important step for TruLeaf-Medical, but also a huge step for the entire medical community and a ray of hope for millions of patients. As a heart surgeon, I deeply understand the absolute necessity of transitioning from an high-risk invasive and complex open-heart surgery to a simple, smart, safe and effective catheter-based solution."
The RoseDoc platform has the potential to offer effective treatment to millions of patients with valvular heart disease (search) who are deemed too high-risk for surgery and are unsuitable for currently available catheter-based techniques.
Company Background and Future Plans
TruLeaf Medical (search) was founded in 2017 by three Israeli entrepreneurs: Benjamin Spenser, Nathanael Benichu, and the late Dr. Rosenstein. The founding team brings significant experience from their previous success at PVT, where they developed the Sapien3 valve (search) – the first-ever transcatheter valve replacement device for patients with severe aortic stenosis (search), which was subsequently sold to Edwards Lifesciences (search).
Building on this foundation, the team has now tackled the more technically challenging problem of atrioventricular valves, specifically targeting mitral and tricuspid valve (search) replacement.
The company continues patient recruitment for the first-in-human trial across India and Uzbekistan, with plans to expand to additional participating sites in other countries. This first human implantation represents a critical milestone that is expected to accelerate the regulatory approval process, bringing this innovative solution closer to widespread availability for patients worldwide.
The successful completion of stage 1 represents a major proof of concept for TruLeaf's innovative technology aimed at transcatheter replacement of both mitral and tricuspid valves, potentially changing the treatment landscape for millions of patients with defective heart valves who previously lacked effective medical solutions.