TruLeaf Medical Expands First-in-Human Clinical Program: Successfully Implants Breakthrough RoseDoc™ Platform via Pure Percutaneous Access

AllMeD Solutions subsidiary demonstrates procedural success in Uzbekistan, building on positive 1-year follow-up data from its initial first-in-human cohort.

OR AKIVA, Israel, Oct. 22, 2026 /PRNewswire/ -- AllMeD Solutions, Inc. (TASE: ALMD), a biomedical technology company, today announced that its subsidiary, TruLeaf Medical Ltd., has successfully completed the first stage of clinical implants in Uzbekistan evaluating its proprietary RoseDoc™ platform for transcatheter tricuspid valve replacement (TTVR).

The RoseDoc system is designed to enable transcatheter replacement of diseased atrioventricular (tricuspid and mitral) valves through a fully percutaneous approach ("needle stick only"), eliminating the need for open-heart surgery or surgical cutdowns.

The procedures were performed on two patients suffering from severe, refractory congestive heart failure secondary to massive tricuspid regurgitation who had exhausted all standard therapeutic options. In both cases, the RoseDoc docking system was implanted successfully with no acute complications. In accordance with the clinical protocol, the second stage—percutaneous deployment of the dedicated prosthetic valve within the dock—is scheduled to take place in the coming months.

The procedures were conducted in Tashkent, Uzbekistan, by an international team of interventional cardiologists:

• Prof. Horst Sievert, Director of the CardioVascular Center (CVC), Frankfurt, Germany
• Prof. Amir Halkin, Director of Interventional Cardiology, Tel Aviv Sourasky Medical Center, Israel
• Dr. Alisher Yuldashov, Head of Interventional Cardiology, Republican Specialized Scientific and Practical Medical Center of Cardiology, Tashkent, Uzbekistan

This milestone builds upon TruLeaf Medical's initial First-in-Human (FIH) study conducted in India, where both docking device and prosthetic valve implantations achieved a 100% procedural success rate. At 10-to-13 months of clinical follow-up, no device-related adverse events have been reported. Three of the four treated patients remain alive, demonstrating marked clinical and functional improvement on minimal medical therapy; one patient succumbed four months post-procedure to non-device-related end-stage renal disease complications.

"The procedural success achieved across centers in India and Uzbekistan by an international team of operators serves as powerful validation of TruLeaf's elegant engineering," said Prof. Oz M. Shapira, CEO of AllMeD Solutions and Chairman of TruLeaf Medical. "By streamlining complex transcatheter atrioventricular valve replacement into a predictable, staged percutaneous intervention, we aim to deliver a truly viable solution to millions of underserved, high-risk patients who currently have no surgical or transcatheter alternatives."

TruLeaf Medical continues active patient enrolment in its clinical programs in Uzbekistan (TTVR) and South Africa for transcatheter mitral valve replacement (TMVR), while preparing regulatory submissions to initiate multi-center trials in Israel and Europe.

About TruLeaf Medical Ltd.

TruLeaf Medical was founded in 2016 by medical device pioneers Benjamin Spenser, Netanel Benichou, and the late Dr. Uri Rosenschein. The founding team previously developed the revolutionary SAPIEN™ transcatheter heart valve at Percutaneous Valve Technologies (PVT), which was subsequently acquired by Edwards Lifesciences. TruLeaf Medical is developing next-generation, transfemoral docking and bioprosthetic valve platforms to address the high unmet clinical need in severe tricuspid and mitral valve disease.

About AllMeD Solutions, Inc.

AllMeD Solutions, Inc. (TASE: ALMD) is an Israeli publicly traded holding and investment company focused on identifying, funding, and advancing breakthrough technologies in the life sciences and medical device sectors. For more information, visit [www.allmed-solutions.com].

SOURCE AllMeD Solutions