About Medality Medical

Medality Medical LLC. (formerly Andrew Technologies LLC) is a privately funded (including an NIH grant) innovative medical technology company focused on reversing type 2 diabetes and associated obesity. The company’s patented and proprietary Targeted Cell Separation and Extraction technology (TC-SET™) was developed by the founder, Mark S. Andrew, MD. This technology is FDA-cleared for the removal of subcutaneous fat and has been safely and effectively used on humans since 2013 under the brand name HydraSolve® with outstanding clinical outcomes. In June 2017, Medality Medical made the strategic decision to exclusively focus on excess mesenteric visceral fat extraction due to the tremendous unmet needs associated with type 2 diabetes.

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 and related obesity.

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.

Enrollment in the clinical trial is expected to commence by mid-2019, with initial results shortly thereafter.

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Medality Medical Financial Conflict of Interest Policy
Medality Medical strives to create a research climate that promotes objectivity in research by establishing standards such that the design, conduct and reporting of Public Health Service (PHS, which includes NIH) funded research is free from bias resulting from financial conflict of interest (FCOI). This policy is applicable to each employee who is planning to or is participating in research activity that is either partially or wholly supported by PHS funds. Each such employee must:
  • disclose his or her significant financial interests (SFI) in non-Medality Medical entities that would appear to be related to the employee’s professional responsibilities on behalf of Medality Medical;
  • comply with an FCOI management plan, if an FCOI is identified; and
  • undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for Medality Medical to determine if an FCOI exists, and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation.