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The company emphasized the significance of this milestone for patients worldwide who are unable to undergo either open-heart surgery or existing transcatheter therapies.
By Shula Rosen
TruLeaf Medical, an Israeli biomedical company owned by Allmed Solutions, has completed the first stage of a first-in-human trial involving a new approach to heart valve replacement.
The company reported that on September 5, doctors in India implanted its RoseDoc docking device in two patients with advanced heart failure, both of whom had no remaining treatment options.
The procedure marked the first time the RoseDoc system has been used in humans.
Designed for patients with tricuspid and mitral valve failure, the technology avoids the need for open-heart surgery by using a two-stage catheter-based approach.
In this initial step, the RoseDoc docking platform was implanted via catheter. The second stage, which will involve placement of the replacement valve itself, is expected to proceed in the coming months under clinical trial protocols.
According to Allmed, both patients were treated under a compassionate-use pathway due to the severity of their condition.
The company emphasized the significance of this milestone for patients worldwide who are unable to undergo either open-heart surgery or existing transcatheter therapies.
“This is not only a major step for our company but a breakthrough for the medical field as a whole,” Prof. Oz Shapira, CEO of Allmed Solutions, told Ynet. “As a heart surgeon, I know how critical it is to move away from high-risk procedures and toward safer, more accessible treatments. The RoseDoc platform offers that possibility.”
Founded in 2017 by Israeli entrepreneurs Benjamin Spenser, Nathanael Benichu, and the late Dr. Uri Rosenstein, TruLeaf’s team previously contributed to the development of the Sapien 3 valve, now a widely used transcatheter solution.
With the success of the initial procedures, TruLeaf is enrolling additional patients in India and Uzbekistan and preparing for expansion to more countries.
Allmed says this early achievement may help accelerate regulatory approvals and bring the RoseDoc technology to patients globally.
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