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$ETRM 1.52
EnteroMedics Announces 18 Month ReCharge Study Results
VBLOC Therapy Continues to Demonstrate Durable and Safe Weight Loss
ST. PAUL, MN--(Marketwired - Dec 3, 2013) - EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced 18 month efficacy and safety results from its 5 year ReCharge Pivotal Trial of VBLOC® vagal blocking therapy for the treatment of obesity.

Patients in the VBLOC group (n=117), achieved excess weight loss (EWL) of 25%, or 10% total body weight loss (TBL), compared to 12% EWL, or 4% TBL for sham control group patients (n=42). The 13% difference in EWL demonstrated statistical superiority over sham control (p < 0.001). In total, 54% of patients in the VBLOC group achieved at least 20% EWL and 41% achieved at least 25% EWL, compared to 26% and 17%, respectively, for the sham control group at the 18-month interval. Significantly, approximately 78% of the patients who reported for their 18-month visit remained under the clinical trial's randomized blind.

The rate of device-related serious adverse events at 18 months was 4.3% for the VBLOC group, meaningfully lower than the 12 month threshold of 15% (p < 0.0001). The safety results continued to confirm VBLOC Therapy had no adverse cardiovascular effects. Overall, a reduction in blood pressure and heart rate was observed.

"Durable weight loss over time is a critical, if challenging, goal in bariatric medicine, one that plays a significant role in achieving long-term health benefits," said Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer. "These study results, along with multi-year data from our earlier clinical trials, demonstrate durability of effect and a superior record of safety, underscoring the attractive benefit risk profile of VBLOC Therapy. If approved, VBLOC may help to address the lifelong challenges associated with obesity by offering a treatment option that supports safe, long-term weight loss and a healthy lifestyle."

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