Medality Medical™ LLC Receives FDA Investigational Device Exemption Approval for Reversal of Type 2 Diabetes Clinical Trial
MIDLAND PARK, N.J.--(BUSINESS WIRE)--Feb 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 in defining the role 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 be extraordinary.”
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.”
About Medality Medical LLC
Medality Medical LLC, a privately funded (including an NIH grant) medical technology company, is focused on reversing type 2 diabetes and associated obesity. Its patented proprietary technology enables the gentle and selective extraction of excess mesenteric visceral fat, which has been associated with insulin resistance, a precursor to type 2 diabetes. In a published pre-clinical primate trial, reversal of insulin resistance was achieved and was the basis for having received FDA Investigational Device Exemption (IDE) clearance to research the benefits of this approach in humans. Medality Medical’s extraction technology is FDA-cleared for the removal of subcutaneous fat and has been safely and effectively used on humans since 2013. Medality Medical is currently raising additional capital to fund the clinical trial and expand its IP portfolio. For more information: www.medalitymedical.com.
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KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY
INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS MEDICAL DEVICES PHILANTHROPY PROFESSIONAL SERVICES ACCOUNTING COMMUNICATIONS PUBLIC RELATIONS/INVESTOR RELATIONS DIABETES FDA FOUNDATION GENERAL HEALTH
SOURCE: Medality Medical LLC
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PUB: 02/14/2019 02:55 PM/DISC: 02/14/2019 02:54 PM