#Israel #Clinical Trials #Tashkent #TruLeaf Medical #RoseDoc

TruLeaf Medical Innovates Heart Valve Surgery with RoseDoc Platform

In a significant advancement in the field of interventional cardiology, TruLeaf Medical Ltd., a subsidiary of AllMeD Solutions, has completed successful initial procedures utilizing its revolutionary RoseDoc™ system in Uzbekistan. This innovative technology enables the transcatheter replacement of diseased valves without the need for open-heart surgery, a groundbreaking step in medical technology.

The RoseDoc™ Platform: A Game Changer

The RoseDoc platform is designed for the replacement of malfunctioning atrioventricular valves, specifically targeting the tricuspid and mitral valves. The procedures employ a fully percutaneous technique, allowing patients to undergo treatment with minimal invasiveness—often described as a 'needle stick only' approach. As a result, patients can avoid the pain and recovery time associated with traditional surgical interventions, which can be substantial.

During the initial stage of their clinical trials, TruLeaf Medical successfully operated on two patients in Tashkent suffering from severe congestive heart failure caused by massive tricuspid regurgitation. These patients had exhausted typical treatment options and faced dire health consequences. The RoseDoc docking mechanism was implanted in both cases without any acute complications, marking a remarkable achievement for both the medical team and the patients involved.

International Collaboration

The procedures were executed by a highly skilled international team of interventional cardiologists, including:

• - Prof. Horst Sievert from the CardioVascular Center in Frankfurt, Germany.
• - Prof. Amir Halkin from the Tel Aviv Sourasky Medical Center in Israel.
• - Dr. Alisher Yuldashov, Head of Interventional Cardiology at the Republican Specialized Scientific and Practical Medical Center of Cardiology in Tashkent.

This collaboration harnesses expertise from around the world, showcasing the global effort to push the boundaries of what is possible in cardiovascular treatment.

Continued Success and Future Trials

TruLeaf Medical's recent operations build upon the initial success of its first-in-human study conducted in India, where initial results showed a remarkable 100% procedural success rate, demonstrating the efficacy and safety of the RoseDoc system. At the 10-to-13 month follow-up mark from those initial trials, patients showed significant clinical improvement, with only one patient experiencing non-device related complications.

Prof. Oz M. Shapira, CEO of AllMeD Solutions and Chairman of TruLeaf Medical, emphasized the importance of these findings, stating, “The procedural success achieved across centers in India and Uzbekistan serves as powerful validation of TruLeaf’s elegant engineering. Our goal is to alleviate the burden of surgical complications and provide viable treatment alternatives for high-risk patients currently without options.”

TruLeaf Medical is now gearing up for the next phase of its clinical programs in Uzbekistan, while concurrently preparing for trials in South Africa and potential studies in Israel and Europe. The company is on a mission to change the landscape of heart valve surgery, addressing critical unmet needs in treating severe tricuspid and mitral valve diseases.

About TruLeaf Medical Ltd.

Founded in 2016, TruLeaf Medical is a leader in the development of next-generation cardiovascular solutions. Its founding team includes medical device pioneers who have made substantial contributions to the field. The company aims to push forward technological advancements in heart valve replacement, ensuring patients receive the best possible care without extensive recovery times often associated with traditional surgeries.

As TruLeaf Medical continues to expand its clinical trial programs, the medical community remains hopeful that innovations like the RoseDoc platform will redefine the future of heart valve replacement, providing life-saving solutions to patients worldwide.