MIDLAND PARK, NJ – February 14,2019 – Medality Medical LLC, a U.S.-based medical technology company, announced that it has received U.S. Food & Drug Administration (FDA) Investigational Device Exemption (IDE”) approval to undertake a clinical trial of its patented proprietary medical device and surgical procedure designed to reverse type 2 diabetes and associated obesity. According to the American Diabetes Association (ADA), one of 11 Americans have type 2 diabetes.
The patented device
developed by Mark Andrew, MD, Medality Medical’s founder, is designed to gently
and selectively extract excess mesenteric
visceral fat, which has been associated with insulin resistance, a
precursor to type 2 diabetes. Enrollment in the clinical trial is
expected to commence by mid-year, with initial results shortly thereafter.
FDA approval was based in part upon a
landmark, National Institutes of Health (NIH) funded, pre-clinical non-human primate study.
Reversal of insulin resistance, associated with type 2 diabetes, was achieved in
all experimental baboons. Each had rapid recovery and no ill effects
from the surgery, and experienced steady overall weight reduction over a
6-week period, with no dietary restrictions. The majority maintained this reduced weight to the end of the study
period (over a year for
some). Low-Density Lipoprotein (LDL)
cholesterol levels were also reduced. In
early 2018, study results were published in the peer-reviewed journal, Surgery
for Obesity and Related Diseases,
in an article entitled: Mesenteric visceral
lipectomy using tissue liquefaction technology reverses insulin resistance and
causes weight loss in baboons. Based
upon the non-human primate study results, it is anticipated there will not be any
dietary restrictions or nutritional supplementation that is typical for other
gastric surgery alternatives.
The clinical trial
will be conducted at The University of Texas Health Science Center at San
Antonio (“UT Health San Antonio”),
upon receipt of Institutional Review Board (IRB) approval. The Principal Investigator will be Ralph DeFronzo, MD, Professor of Medicine and Chief, Diabetes
at UT Health San Antonio and Deputy Director, Texas Diabetes Institute. Dr. DeFronzo is a leading endocrinologist who has been globally recognized for his numerous
research and clinical advances in type 2 diabetes. His research was instrumental
of insulin resistance in the development and progression of type 2 diabetes. The
Sub-Investigator will be
Richard Peterson, MD, MPH, FACS,
FASMBS Professor and Chief, UT Health
San Antonio Bariatric and Metabolic Surgery and Director, University of Texas Medicine Center for Bariatric
and Metabolic Surgery. Dr.
Peterson performed all of the surgeries in the primate study.
Dr. DeFronzo commented: “After the selective extraction of excess
mesenteric visceral fat, insulin resistance, which leads to type 2 diabetes,
was reversed. This was a very encouraging outcome in the baboon pre-clinical
study. Previously, there had not been a
method to safely remove this metabolically active tissue. If we can replicate these positive
pre-clinical results in humans, the beneficial impact on type 2 diabetes could
Edward Gillen, Medality Medical’s Chief Executive
Officer, who has decades of experience in the diabetes arena, stated: “Unlike
the vast majority of therapies available today, Medality Medical’s approach has
the potential to reverse, instead of just treat, type 2 diabetes. This FDA
Investigational Device Exemption is a critically important step toward
achieving that goal.”