Voted 2019’s Company
"Most Likely to Succeed”
by the NJ Tech Council

Our Focus

Medality Medical is developing a surgical device (HydraSolve T2D™) and technique to extract fat located inside the abdomen (visceral fat) to reverse type 2 diabetes (which can lead to heart attack, stroke, blindness, kidney failure, amputation – and death).

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 425M people currently with this disease (9% of adult population), 352M have pre-diabetes (another 7% of adult population). In the US alone, the Center for Disease Control and Prevention (CDC) estimated that 23.1 million[2] people had diagnosed diabetes in 2015. 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.

https://www.soard.org/article/S1550-7289(18)30127-8/abstract

In this Company’s published pre‐clinical non‐human primate trial funded by the National Institutes of Health (“NIH”) and lead 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 is underway. For more information please visit the HydraSolve T2D page.