AllMeD Solutions, which holds the Israeli biomedical company TruLeaf-Medical, announced the successful completion of stage 1 of the first human implantation of the innovative RoseDoc docking system for transcatheter replacement of the tricuspidvalve. This is a breakthrough system that replaces diseased heart valves and is inserted via catheter, without the need for open-heart surgery.
The procedure was successfully performed for the first time on September 5th, 2025, in India, using a compassionate care pathway, on two patients suffering from severe refractory congestive heart failure due to a leaking tricuspid valve who had no alternative therapeutic options. The second phase of percutaneously (using needle stick only) implanting the implantation of valve itself, developed by the company withing the docking device, is expected to be performed in the coming months according to the trial protocol. The current step represents a major proof of concept in humans for TruLeaf innovative technology aimed at transcatheter replacement of the mitral and tricuspid valves.
TruLeaf's innovative technology enables the implantation to be performed in two stages. First, a unique docking station is implanted, and subsequently, the heart valve is implanted. The method, which was specifically designed to provide solutions for patients without open-heart surgery, is expected to change the future of treatment for millions of patients worldwide suffering from defective valves, who until now have not had effective medical solutions available.
"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," says Prof. Oz Shapira, CEO of Allmed Solutions Group. "As a heart surgeon, I deeply understand the absolute necessity of transitioning from a high-risk invasive and complex open-heart surgery to a simple, smart, safe and effective catheter-based solution. TruLeaf Medical RoseDoc platform has the potential to offer an effective treatment to millions of patients with valvular heart disease who have been deemed to be too high risk for surgery and are unsuitable for currently available catheter-based techniques."
