St. Paul, MN — EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the U.S. Food and Drug Administration (FDA) Advisory Gastroenterology and Urology Devices Panel (GUDP) voted 8 to 1 “in favor” that the device is safe when used as designed, and voted 4 to 5 “against” on the issue of a reasonable assurance of efficacy. The final vote, on whether the relative benefits outweighed the relative risk, was 6 to 2 “in favor,” with 1 abstention.
The FDA is not bound by the GUDP’s recommendation, but will take it into consideration when reviewing the Maestro System Premarket Approval (PMA). As previously announced, the Company expects a decision on approval of the PMA later this year. If approved, the Maestro Rechargeable System will be the first new medical device approved for obesity by the FDA in over ten years.
“Obesity is the most under-treated disease in this country, despite its increasingly well-understood role in co-morbid conditions ranging from hypertension and diabetes to cancer,” said Greg Lea, Senior Vice President, Chief Operating Officer and Chief Financial Officer of EnteroMedics, “Where existing options are clearly failing to address the growing epidemic of obesity, we believe VBLOC Therapy may offer a unique approach to treating obesity, a choice that fills this void by offering a safe, reversible option that does not alter the anatomy, allowing patients to take a positive path towards improving their overall health. We thank the Committee members for their insights and look forward to a continued, productive dialogue with the FDA.”
In the most recent clinical trial, the ReCharge Study, VBLOC Therapy treated patients demonstrated a clinically meaningful and statistically significant excess weight loss (EWL) at 12 months of 24.4%, sustained out to 18 months. The majority (52.5%) lost 20% or more of their excess weight and nearly one-third of VBLOC Therapy treated patients lost 30% or more. The 24.4% average EWL far exceeds the 10% to 15% thresholds at which patients experience substantial positive health effects. Statistically significant improvements were observed in the VBLOC Therapy treatment group in total cholesterol, LDL, triglycerides, systolic and diastolic blood pressure, heart rate and waist circumference.