MIDLAND PARK, N.J.--(BUSINESS WIRE)--Medality Medical LLC (“Medality” or the “Company”), a U.S.-based medical technology company, announced that it has received Institutional Review Board (IRB) approval from the University of Texas Health Science Center at San Antonio to commence human trials. Patient recruitment is currently underway for the first in-human clinical trial for Medality Medical’s proprietary medical device, HydraSolve T2D™ Visceral Fat Extraction System (“HydraSolve T2D™ System”) and the associated surgical procedure designed to reverse type 2 diabetes and associated obesity.
The trial will investigate the safety and efficacy of the HydraSolve T2D™ System for improving blood glucose control and insulin resistance. The target group consists of overweight/obese individuals with type 2 diabetes who have not achieved targeted levels of blood glucose control using oral diabetes medications. The Company anticipates the first patient procedure will take place in October 2019.
The HydraSolve T2D™ System operates using a unique, proprietary and patented Targeted Cell Separation and Extraction Technology (TC-SET), invented and developed by Medality Medical's Founder and Chief Scientific Officer Mark S. Andrew, M.D. During the procedure, a hand-held surgical device streams warmed, low-pressurized and pulsed saline solution into the patient’s mesentery and works to selectively separate and extract the mesenteric visceral fat cells while leaving non-fat cells unharmed (video – click here).
The Company’s Principal Investigator of the trial is Dr. Ralph DeFronzo, a leading endocrinologist and recognized expert in type 2 diabetes. In addition, Dr. Richard Peterson, a prominent bariatric surgeon who performed the surgeries in the company’s earlier primate study will lead the surgical team. Dr. DeFronzo commented on the upcoming clinical trial, “We are very excited to be involved in such an important study. While many treatments exist for the treatment of type 2 diabetes, this unique approach targets one of the root causes of insulin resistance - visceral fat.”
Edward Gillen, CEO of Medality, remarked, “The IRB approval is a very important milestone for Medality Medical. We look forward to demonstrating the safety and effectiveness of the HydraSolve T2D system in removing visceral fat from the patient’s mesentery to reverse type 2 diabetes.”
For more information about the trial, please visit www.ClinicalTrials.gov, key word search “Medality”.
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 Tissue Cell Separation and Extraction Technology (TC-SET™) 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.