Hydrasolve T2D Technology

Medality Medical’s HydraSolve T2D Visceral Fat Extraction System utilizes the 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 handheld surgical device streams a 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. to separate the mesenteric visceral fat cells; while leaving non-fat cells unharmed. The mesenteric visceral fat cells are instantaneously exposed to the energized saline stream inside the opening of the handheld surgical device and are subdivided into small clusters that are immediately extracted out of the abdomen and into a collection canister. The handheld surgical instrument is blunt and rounded to avoid cutting any tissue and the warm (not hot) saline stream is not capable of burning tissue. It applies “just enough energy” to separate the mesenteric visceral fat cells and enable rapid extraction.

Visceral fat deposits are found mainly in the mesentery. It has been suggested that the mesentery deserves to be recognized as a new human organ, see video. Fat deposit in the mesentery also called mesenteric fat has been shown to play an important role in diseases such as type 2 diabetes, metabolic syndrome and cardiovascular disease.

Research Update

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. On August 21, 2019 the University of Texas Health Sciences Center at San Antonio (“UT Health San Antonio”) Institutional Review Board (“IRB”) approved the commencement of patient screening for the clinical trial.

The clinical trial is conducted at The UT Health San Antonio.

The Principal Investigator is 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 is 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 was the lead Bariatric surgeon on all of the surgeries performed in the primate study.

This study will evaluate the safety and efficacy of the investigational use of the HydraSolve T2D™ System (previously FDA-cleared for liposuction and fat transfer) to perform a novel, minimally invasive laparoscopic and mini-laparotomy procedure to selectively remove intra-abdominal fat from the mesentery and to assess the resulting changes in blood glucose control, insulin sensitivity and body weight in 12 overweight/obese patients with type 2 diabetes. Excess intra-abdominal mesenteric fat has been directly linked to insulin resistance, an important precursor of type 2 diabetes. During the 12-month period post-procedure, the patients will be periodically monitored for improvements in blood glucose control, body weight, changes in fat deposits and overall metabolic health. Safety assessments and monitoring for adverse events will be performed, throughout.

For more information about the trial, please visit
https://www.clinicaltrials.gov/ct2/show/NCT03953963?term=medality&rank=1

For more information about participating in the trial, please visit https://uthscsa.trialstoday.org/trial/NCT03953963