— Data from the ReCharge Study Published in Obesity Surgery —
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the publication of results from the Company’s ReCharge Study on the effect of vBloc® Neurometabolic Therapy in patients with moderate obesity with an obesity-related comorbid condition. In this population, patients saw 74% greater weight loss with vBloc therapy compared to a rigorous sham control, resulting in an average loss of 33% of excess weight at 12 months. Further, three quarters of patients lost at least 20% of their excess weight and a quarter lost at least 50%. The publication, entitled “Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: The ReCharge Study,” was published in the journal Obesity Surgery and is available online here.
vBloc therapy is approved for use in helping with weight loss in people aged 18 years through age 65 who are obese, with a Body Mass Index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels.
“Results observed in the moderately obese population provide strong support for vBloc Therapy’s application within this subgroup of patients, many of whom are not willing to undergo, or not appropriate for, more aggressive surgical interventions,” said Scott Shikora, M.D., F.A.C.S., EnteroMedics Executive Vice President and Chief Medical Officer. “We look forward to further understanding how vBloc performs in this population, as we continue to review long-term data derived from ReCharge and other vBloc studies.”
“vBloc Therapy represents a safe and well-tolerated, neuroscience-based approach for the treatment of patients with moderate obesity and related comorbid conditions,” said John Morton, M.D., Chief of Bariatric and Minimally Invasive Surgery at Stanford University School of Medicine. “Its ability to foster clinically meaningful weight loss safely, without changes in anatomy, establishes vBloc as a much needed anatomy sparing alternative to existing treatment options.”
“The moderately obese data from ReCharge, and their publication in Obesity Surgery, highlights an important and meaningful segment of the obesity population for which vBloc Therapy fills a significant unmet need, delivering a safe, effective, durable treatment for obesity and its comorbidities,” said Dan Gladney, EnteroMedics President and Chief Executive Officer. “This population is an important area of focus for our commercial efforts, and one where we believe we can deliver differentiated value to the patient, their physician and payers.”
The ReCharge Pivotal Trial is a prospective, randomized, double-blind, sham-controlled, multicenter clinical trial of vBloc Neurometabolic Therapy in 239 patients with obesity. Of the 162 randomized vBloc participants and 77 sham patients, 53 vBloc and 31 sham patients were defined as moderately obese (body mass index [BMI] of 35-40 kg/m2), with comorbidities at baseline. Percent excess weight loss (EWL), percent total weight loss (TWL) and safety in subjects who attended their 12-month study visit were reviewed. The 12-month visit completion rates were 87 percent in both the vBloc and sham groups.
No serious adverse events occurred in the moderately obese vBloc participants through 12 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® Neurometabolic 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 Rechargeable 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 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 www.vbloc.com 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® Rechargeable 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® Neurometabolic 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 28, 2016. 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.
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SOURCE EnteroMedics Inc.
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