Metavention Initiates Trial for Novel Treatment of Type 2 Diabetes

Metavention announced the initiation of an U.S. Food and Drug Administration (FDA) approved clinical investigation, DeLIVER, for the Company's intravascular iRF Denervation System to determine safety in patients with type 2 diabetes (T2D).

Physicians at HSHS St. John's Hospital in Springfield, IL treated the first patient in the U.S. DeLIVER study, "we are excited to be participating in this ground-breaking, minimally invasive treatment for patients with type 2 diabetes," said Krishna Rocha-Singh, M.D., Chief Scientific Officer of the Prairie Heart Institute. "There remains a substantial unmet clinical need for improved treatment options in the management of type 2 diabetes. The prospect of adding an endovascular therapy as an adjunct to the care of this challenging patient population is compelling and exciting."

People with T2D have abnormal levels of sugar, also known as glucose, in their blood. A key contributor to this unwanted glucose is often the patient's own liver. The liver plays a central role in the proper regulation of glucose levels, but excessive release of glucose into the bloodstream by the liver, triggered by overactive sympathetic nerve signaling, can be a major limitation in the control of T2D. Metavention's patented iRF Denervation System is designed to be a one-time transcatheter procedure utilizing radio frequency energy to inhibit overactive sympathetic nerve signaling to the liver, thereby improving overall glucose control.

"T2D continues to be a global epidemic. Patients are expected to accept lifelong daily use of complex and expensive drug regimens with high probability of disease progression, resulting in insulin dependence and serious health complications," said Todd Berg, CEO of Metavention. "Metavention's iRF Denervation System has the potential to provide patients with a fundamentally new treatment option for the management of their T2D by targeting an underlying cause of their disease."

T2D is a chronic, progressive disease that affects more than 400 million people worldwide. Despite significant treatment efforts with lifestyle changes and medications, about 50% of patients fail to achieve adequate blood sugar control, putting them at a higher risk of complications. Potential complications of T2D include increased risk of heart disease, stroke, high blood pressure and narrowing of blood vessels (atherosclerosis), nerve damage, kidney failure, glaucoma, and blindness.