- Penny stock EnteroMedics (ETRM) is up 12% premarket on increased volume in response to its announcement that 24-month data from its Phase 3 ReCharge clinical trial has been published in the journal Obesity Surgery. The study assessed the efficacy of its Maestro Rechargeable System in reducing weight in obese patients. The FDA approved it in January 2015 for weight loss treatment in adult patients who have been unable to lose weight with a weight loss program and who have a body mass index (BMI) of 35 to 45 with at least one other obesity-related co-morbidity (hypertension, type 2 diabetes, high cholesterol).
- In 123 subjects who presented in their 24-month visit, the mean excess weight loss was 21% and the mean percent total weight loss (TWL) was 8%. In patients treated with sham control who had not yet crossed over to Maestro, the values were 4% and 1%, respectively. For comparison purposes, published studies on bariatric procedures (i.e., gastric banding) showed 6% TWL at the same time point. Maestro patients also reported improvements in quality-of-life measures and reductions in hunger.
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Maestro, a pacemaker-like device, delivers VBLOC vagal nerve blocking therapy via electrodes that are surgically implanted subcutaneously in the abdomen. The electrodes are placed in contact with the trunks of the vagus nerves just above the junction between the esophagus and the stomach. The device intermittently blocks vagal nerve signals throughout the patient's waking hours.
- Previously: FDA clears new obesity device (Jan. 14, 2015)