AllMeD Solutions (TASE:ALMD) subsidiary TruLeaf Medical
receives Helsinki Ethics Committee's approval in Uzbekistan to conduct clinical trial in human
subjects, paving the way for minimally invasive heart valve
treatments
CAESAREA, Israel, July 11,
2024 /PRNewswire/ -- 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.
TruLeaf Medical, Ltd was founded in 2017 by three Israeli
entrepreneurs - Benjamin Spencer,
Nathaniel Benisho and the late Dr. Uri
Rosenstein. Benjamin and Nathaniel's played a seminal role
in the development of the first ever transcatheter aortic
bioprosthesis, the Sapien valve, initially within the Israeli
company PVT, that was later acquired by the medical technology
giant Edwards Lifesciences. Today, the aortic valve that Benjamin
and Nathaniel developed saves thousands of lives of patients with
aortic stenosis every year all over the world.
Benjamin Spencer, TruLeaf
Medical CEO, explains, "The main challenge with existing
transcatheter TMVR technologies is achieving optimal anchoring of
the valve prosthesis to the heart, given the complex anatomy and
physiology of the native mitral valve. 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."
Professor Oz Shapira, AllMeD Solutions CEO, adds, "As a
heart surgeon who has performed hundreds of open-heart surgeries to
treat leaky heart valves, the possibility of replacing the mitral
valve through a simple and quick needle puncture operation is a
true revolution that may offer a solution to millions who currently
have no other option."
"The first-in-human trial is both exciting and mission-critical
for TruLeaf's success. Given the outstanding results of the
preclinical experiments, I am confident that TruLeaf's innovative
RoseDoc TMVR platform will perform exceptionally well in
humans and eventually save countless lives of patients who
currently have no alternatives. AllMeD Solutions will continue to
demonstrate its ability to identify early-stage startups and
leverage its vast knowledge, experience, and expertise in the
med-tech space to lead these companies to engineering, clinical,
and business success."
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SOURCE AllMeD Solutions