Medality Medical LLC, a U.S.-based medical technology company, announced that it has received approval to commence human trials of its proprietary medical device, HydraSolve T2D™ Visceral Fat Extraction System and an associated surgical procedure designed to reverse Type 2 diabetes and 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.
During the procedure, a hand-held surgical device streams warmed, low-pressure 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.
The technology was invented and developed by Medality Medical’s Founder and Chief Scientific Officer Dr. Mark S. Andrew.
“We are very excited to be involved in such an important study,” commented the company’s principal investigator of the trial is Dr. Ralph DeFronzo. “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,” he said.
For more information about the trial, please visit www.ClinicalTrials.gov, and keyword search: “Medality.”
Medality Medical LLC. (2019, Sept 16). Medality Medical Commences Clinical Trial for Type 2 Diabetes. Business Wire. Retrieved September 23, 2019, from https://www.businesswire.com/news/home/20190916005106/en