For Immediate Release
EnteroMedics Announces Eighteen-Month Excess Weight Loss Results from its VBLOC-RF2 Feasibility Study
January 12, 2009
ST. PAUL, MN -- EnteroMedics Inc., (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, its associated co-morbidities, and other gastrointestinal disorders, today announced interim clinical results from the VBLOC-RF2 feasibility study of the Company's VBLOC™ vagal blocking therapy device, the Maestro™ System.
The study includes 38 implanted subjects and is designed to evaluate the system’s safety and efficacy. Follow-up data show excess weight loss, or EWL, of 37.6% in 9 patients at 18 months of VBLOC Therapy, 28.1% in 17 patients at 12 months of therapy and 17.9% in 35 patients at six months of therapy. To date, no deaths or unanticipated adverse device events have been reported.
In addition, further subgroup analysis of the effect of VBLOC Therapy on two of the major co-morbidities frequently associated with obesity, type 2 diabetes and hypertension, showed the following: ten patients with diabetes, showed a statistically significant reduction of 1.1 percentage points (p=.002) from 8.2% at baseline to 7.1% at four weeks and fifteen patients with both systolic and diastolic hypertension, which was either untreated or controlled with drugs, showed statistically significant reductions of 13.9 mm Hg in systolic pressure and 10.7 mm Hg in diastolic pressure at four weeks. The improvements in blood pressure are maintained through six months.
"VBLOC Therapy is designed to produce weight loss, in part, by controlling the feelings that lead patients to fail at losing weight, including hunger and a lack of feeling full," commented President and CEO Mark B. Knudson, Ph.D. "These results are an encouraging sign that significant weight loss, occurring over a extended period of time, can take place without the serious side effects and adverse lifestyle impact seen in other obesity procedures. We continue to look forward to releasing the results of our randomized pivotal trial in the second half this year."
In addition to the VBLOC-RF2 study, the Maestro System is being used in the Company's pivotal EMPOWER clinical trial, a randomized, prospective, double-blind, placebo-controlled study being conducted in the United States and Australia under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration. The trial was fully enrolled at 15 Centers of Excellence with 294 patients in September 2008. The study blind, which remains in place for 12 months after activation of therapy in the experiment arm, is expected to lift in the second half of this year.
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