TruLeaf’s RoseDoc Docking System for Transcatheter Heart Valve Replacement Studied in First Phase of FIH Trial

September 22, 2025—AllMeD Solutions, which holds the Israel-based biomedical company TruLeaf Medical, announced the successful completion of stage 1 of the first-in-human (FIH) implantations of the TruLeaf’s RoseDoc docking system for transcatheter replacement of the tricuspid valve. The company’s technology enables the valve implantation to be performed in two stages.

According to AllMeD Solutions, the RoseDoc procedures were performed September 5, 2025, in India using a compassionate care pathway. The procedures treated two patients with severe refractory congestive heart failure caused by leaking tricuspid valves and who had no alternative therapeutic options.

The current step represents a major proof of concept in humans for the TruLeaf technology aimed for transcatheter replacement of the mitral and tricuspid valves, noted the company.

AllMeD Solutions further advised that the second phase of the treatment is percutaneously implanting the valve itself within the docking device. This phase is expected to be performed in the coming months per the trial protocol.

TruLeaf Medical continues with patient recruitment for the FIH trial in India and Uzbekistan, and plans to expand to participating sites in additional countries, stated the press release.