Medality Medical LLC, a privately funded (including an NIH grant) innovative medical technology company, is pursuing a surgical solution to improve glycemic control and associated complications in people suffering from type 2 diabetes. Its patented technology enables the gentle extraction of excess mesenteric visceral fat found inside the abdomen. On February 5, 2019, the FDA approved Medality’s Investigational Device Exemption (“IDE”) application to undertake a human clinical trial for the extraction of excess mesenteric visceral fat to reverse T2D using its already FDA-cleared Targeted Cell Separation and Extraction device/system.
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. In early 2018, these 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.
The clinical trial will be conducted at The University of Texas Health Science Center at San Antonio upon receipt of Institutional Review Board (IRB) approval.
A renown endocrinologist (Ralph DeFronzo, M.D.) and bariatric surgeon (Richard Peterson, M.D.) have been engaged in the development effort. Edward Gillen, formerly Senior Director, Diabetes Care Division of Becton Dickinson & Co., has joined as CEO. He has over 30 years of medical device industry experience, with 15 years business experience in diabetes care and surgical devices.
Fundraising to support the above activities is underway.
Please contact Brian V. Murray - BVM@BVMurray.com if you would like more information.
Visit Medality Medical YouTube Channel by clicking on the link below:
https://www.youtube.com/channel/UCWhZOCo3Q3JMWwY3w1kwuag
