TruLeaf Medical’s RoseDoc TMVR Platform to Be Evaluated in First-in-Human Trial

February 1, 2023—AllMeD Solutions announced that the company’s subsidiary, TruLeaf Medical, has received the Helsinki Ethics Committee’s approval to conduct a first-in-human clinical trial of the TruLeaf RoseDoc transcatheter mitral valve replacement (TMVR) platform.

According to the company, the RoseDoc implantation is performed in two stages. In the first stage, a docking station is implanted in the left atrium; a few weeks later, an artificial biologic mitral valve prosthesis is implanted.

The approval to perform the implantation of the TMVR platform in humans comes a few months after the completion of research and development of all the components of the platform, as well as a series of successful short- and long-term animal experiments, noted the company.

The final design of the device was tested by Professor Horst Sievert, MD, from the CardioVascular Center in Frankfurt, Germany. Prof. Sievert recently joined TruLeaf’s Scientific Advisory Board and will lead the human trial.

“I congratulate TruLeaf Medical’s professional team," commented Prof. Sievert in the press release. "I am honored to be part of the future success. The concept of the product is ingeniously simple and very promising. I look forward to leading the first human trial of this innovative technology.”

TruLeaf Medical was founded in 2017 by chief executive officer Benjamin Spencer, chief technology officer Nathanel Benichou, and the late Dr. Uri Rosenstein.

Mr. Spencer stated in the press release, “The main challenge with existing TMVR technologies is achieving optimal anchoring of the valve prosthesis to the heart, given the complex native mitral valve anatomy and physiology. The RoseDoc TMVR platform is technically simple, safe, and has been proven to be effective in rigorous long-term animal testing.”

AllMeD Solutions CEO, Professor Oz Shapira, MD, added, “As a heart surgeon who has performed hundreds of open heart surgeries to treat leaky heart valves, the possibility of replacing the mitral valve in a simple and quick operation, through a needle puncture only, is a real revolution that may bring a cure to millions of people who currently have no other option.”

Dr. Shapira continued, “The first-in-human trial is both exciting and mission-critical to the success of TruLeaf. Given the outstanding results of the preclinical experiments, I am confident that TruLeaf's innovative RoseDoc TMVR platform will perform stellar in humans, and eventually will save countless lives of patients who currently have no alternatives.”