Anastassia Amaro, MD, a University of Pennsylvania endocrinologist and the Company’s advisor, states, “The interim analysis of the MVL pilot trial shows safety of the procedure and suggests preliminary efficacy in treatment of type 2 diabetes.”
Our Focus
Medality Medical is pursuing a surgical solution to improve the lives of patients with type 2 diabetes (“T2D”). The patented HydraSolve T2D™ System safely removes the mesenteric visceral fat (fat around the intestines) in order to improve glycemic control of type 2 diabetes. If T2D is not controlled, long-term complications such as heart attacks, strokes, blindness, kidney failures, and amputations are serious unavoidable consequences of this disease.
Diabetes:
A worldwide epidemic
According to the Journal of Clinical Diabetes and Endocrinology, diabetes is likely the largest epidemic in human history. It is a global epidemic[1] with 537 million people currently with this disease (10% of the adult population), 541 million adults have Impaired Glucose Tolerance (IGT) which places them at high risk of type 2 diabetes. In the US alone, the Center for Disease Control and Prevention (CDC) estimated that 28.6 million<[2] people had been diagnosed with diabetes in 2019. In a recent study among a large group of US type 2 diabetes patients, where access to therapy is at the highest level, 44% had discontinued their diabetes medications, altogether, at 6 months[3] the drug therapy necessary to reduce the potential for long-term complications and death. A straightforward surgical alternative may provide a valuable option to address this global epidemic.
[1] International Diabetes Federation. IDF Diabetes Atlas, 8th edition, 2017, Brussels, Belgium: http://www.diabetesatlas.org
[2] https://www.cdc.gov/diabetes/data/statistics-report/index.html
[3] Evaluation of Treatment Persistence in Individuals with Type 2 Diabetes in a Real-World Setting; WILLIAM T. CEFALU et. al. Diabetes 2018 Jul; 67(Supplement 1): -. https://doi.org/10.2337/db18-135-OR
Our Results
A landmark, National Institutes of Health (“NIH”) funded, pre-clinical non-human primate study with the unique HydraSolve T2D Visceral Fat Extraction System and associated surgical procedure demonstrated a reversal of insulin resistance, associated with type 2 diabetes, in all experimental baboons.
- Each had rapid recovery and no ill effects from the surgery.
- Experienced steady overall weight reduction >10% over a 6-week period, with no dietary restrictions. The majority maintained this reduced weight to the end of the study period (over a year for some).
- Low-Density Lipoprotein (LDL) cholesterol levels were also reduced.
In early 2018, study 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. Based upon the non-human primate study results, it is anticipated there will not be any dietary restrictions or nutritional supplementation that is typical for other gastric surgery alternatives. (Volume 14, ISSUE 6, P833-841, June 2018) – click here
In this Company’s published pre‐clinical non‐human primate trial funded by the National Institutes of Health (“NIH”) and led by Mark Andrew, MD, the Company’s Founder and Chief Scientific Officer, reversal of insulin resistance, a precursor of T2D, was achieved and was the basis for having received the necessary approvals to commence the Pilot Trial.
Patient recruitment of the Pilot trial conducted at the University of Texas Health Science Center at San Antonio (“UTHSCSA”) is underway. For more information please visit the HydraSolve T2D page.