ST. PAUL, Minn., July 16, 2015 /PRNewswire/ -- EnteroMedics Inc. (NASDAQ : ETRM ), the developer of medical devices using neuroblocking therapy to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that 18 month results from the Company's ReCharge Clinical Study were published in the Journal of Obesity, Volume 2015. The article, titled "Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial," which highlights sustained weight loss in patients receiving vBloc® Neurometabolic Therapy, is available online here.
"Because of the cyclical nature of obesity, sustainable weight loss is a critical measure of success in the treatment of this disease," said Scott A. Shikora, MD, FACS, Chief Medical Officer of EnteroMedics and lead author of the article. "Results at 18 months from the ReCharge Study demonstrate both the sustainability of weight loss using vBloc Therapy, a distinct contrast to the weight regain experienced by the sham control group, and the unique safety profile of the device over time. Publication of these results underscores vBloc Therapy's important new position within the obesity treatment spectrum, where, historically, options such as anatomy altering or restricting surgery have required substantial tradeoffs in lifestyle, nutrition and safety."
The ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial of vBloc® Neurometabolic Therapy in 239 patients with obesity. As described in the published data, at 12 months, patients in the vBloc Therapy group (n=162) demonstrated excess weight loss (EWL) of 25.8%, compared to 16.9% EWL in the Sham control group (N=77). At 18 months, the gap between the vBloc Therapy Group and the Sham group widened, with the vBloc Therapy group sustaining their weight loss at 23.5% EWL, compared to a significant excess weight regain in the Sham control group which had dropped to 10.2% EWL at the same time point. Sensitivity analyses showed that the unblinding of the trial did not significantly influence the larger treatment effect with vBloc over time, as most of the patients in the Sham group were still blinded at 16 months (P=0.34 for the unblinding by treatment interaction). Similarly, when the analysis was restricted to patients who remained blinded throughout 18 months, the estimated mean percent EWLs were similar to that of the overall sample. The safety profile of vBloc Therapy remained favorable at 18 months.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics' Maestro Rechargeable System has received U.S. Food and Drug Administration approval, CE Mark and is listed on the Australian Register of Therapeutic Goods.
Information about the Maestro® Rechargeable System and vBloc® Therapy
You should not have an implanted Maestro Rechargeable System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the Maestro System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.
Talk with your doctor about the full risks and benefits of vBloc® Neurometabolic Therapy and the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com
If you are interested in learning more about vBloc Neurometabolic Therapy, please visit http://www.enteromedics.com/vbloc or call 1-800-MY-VBLOC.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial sales experience with our Maestro® Rechargable System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and vBloc® Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission, particularly those factors identified as "risk factors" in the annual report on Form 10-K filed March 13, 2015. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
SOURCE EnteroMedics Inc.