AllMeD Solutions announced subsidiary TruLeaf Medical's receipt of the Helsinki Ethics Committee's approval in Uzbekistan to conduct clinical trial in human subjects. As part of the trial, a prosthetic mitral valve will be implanted via two needle sticks in the groins in a two-stage catheterization procedure without the need for open-heart surgery (transcatheter mitral valve replacement, TMVR). The implantation of the innovative platform (the RoseDoc) developed by TruLeaf, which replaces the patient's leaky heart valve, will be carried out in two stages.

In the first stage, a docking station will be implanted in the left atrium, followed a few weeks later by implantation of an artificial 'biological' mitral valve prosthesis. Today, there are tens of millions of patients with severe, life-threatening mitral valve regurgitation (leaky valve) across the world. This leak causes heart failure, heart arrhythmia, brain strokes leading to high mortality.

About 10% of the world's population over the age of 75 suffer from a leaky mitral heart valve. In the U.S. alone there are about 4 million patients. These patients experience a substantial decrease in their functional capacity manifesting, such as fatigue, shortness of breath on exertion with lower and lower exertion and arrhythmias, progressively impairing their daily routine.

Today, the most effective treatment for these patients is complex open-heart surgery to repair or replace the leaky heart valve. However, it is only offered to about 2% of patients due to the high surgical risk. The unique RoseDoc platform developed by TruLeaf is the first-of-its-kind technology allowing implantation of a biological bioprosthesis to replace the diseased valve through catheterization only.

This ground-breaking procedure is minimally invasive, performed on a beating heart via two needle punctures without surgery or the use of a heart-lung machine. As such, it is associated with substantially lower risk compared to the traditional open-heart mitral valve surgery. As a result, millions of patients around the world, who until now were deemed inoperable, will be able to get receive a new valve and experience a significant improvement in their functional capacity, quality of life and life expectancy, allowing them to resume normal life.

As part of the preparations for human implantations in clinical trials in Uzbekistan, TruLeaf conducted additional implantations in large animals with the participation of Dr. Horst Sievert, one of the world's leading interventional cardiologists, who is expected to lead TruLeaf's clinical trials.