AllMeD Solutions said that its subsidiary TruLeaf Medical has received the Helsinki Ethics Committee’s approval in Uzbekistan to undertake a clinical trial of the RoseDoc platform for transcatheter mitral valve replacement (TMVR) procedure in human subjects.
RoseDoc is a prosthetic mitral valve designed to replace the patient’s leaky heart valve.
During the trial, the prosthetic valve will be implanted using two groin needle sticks in a two-stage catheterisation procedure, which eliminates the need for open-heart surgery.
The procedure involves implanting a docking station in the left atrium, which is followed weeks later by the insertion of an artificial biological mitral valve prosthesis.
AllMeD Solutions said that the RoseDoc platform introduces a new technology for catheter-based implantation of biological bioprostheses to replace diseased valves.
The minimally invasive procedure is performed on a beating heart via two needle punctures without surgery or the use of a heart-lung machine.
According to AllMeD Solutions, the technology reduces risks compared to traditional open-heart mitral valve surgery.
Additionally, it can help patients who were previously considered inoperable, allowing them to receive a new valve and experience enhanced functional capacity, quality of life, and life expectancy.
In preparation for human trials in Uzbekistan, TruLeaf Medical conducted animal implantations, which saw participation from Horst Sievert, an interventional cardiologist who is expected to lead the upcoming studies of the firm.
TruLeaf Medical CEO Benjamin Spencer said: “The RoseDoc TMVR platform is technically simple, safe, and has proven effective in long-term animal testing.
“Completely eliminating the leak prevents the progressive dilation of the heart, which otherwise worsens the leak in a vicious cycle, leading to further weakening of the heart muscle and intractable heart failure.
“Currently, patients with severe mitral valve leaks that are unresponsive to maximal medical treatment have no effective options.
“The vast majority of these patients are declined surgery due to prohibitive risk. The unique RoseDoc TMVR platform provides a potential lifeline for these patients.”
Spencer and Nathaniel Benisho, his co-founder of TruLeaf Medical, had played a key role in developing the first transcatheter aortic bioprosthesis, known as the Sapien valve. The valve technology was later acquired by the medical technology firm Edwards Lifesciences.
