Publication of 24 months results of ReCharge Clinical Study of vBloc Neurometabolic Therapy in 239 patients with obesity.-EnteroMedics Inc.

EnteroMedics Inc.,announced the publication of 24 month results from the Company's ReCharge Clinical Study. The article, titled "Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial," was published in Obesity Surgery (DOI: 10.1007/s11695-016-2325-7).

The ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial of vBloc Neurometabolic Therapy in 239 patients with obesity. At 24 months, 76% percent of the randomized vBloc participants (n=123) remained in the trial. The mean excess weight loss (EWL) among vBloc participants who presented for their 24-month visit was 21%, with a mean percent total weight loss (TWL) of 8%. Of the 24 Sham control patients who had not yet crossed over to vBloc at 24 months, the EWL and TWL was 4% and 1%, respectively. The authors noted that comparative randomized controlled trials for conventional bariatric procedures demonstrated only 6% TWL for laparoscopic adjustable gastric banding (LAGB) at the same time point.

Patients' quality of life improvements, as measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, were shown to be durable with a sustained increase of 20 units from their preoperative level, and the Three-Factor Eating Questionnaire (TFEQ) showed that patients continued to have a 50% reduction in hunger.

Comment: vBloc Neurometabolic Therapy received a CE Mark in 2009 and was FDA approved in January 2015.