Sustained Weight Loss, Ongoing Reduction of Cardiovascular Risk Factors and Continued Glycemic Control at Two Years: Data from EnteroMedics' vBloc DM2 Study Published in the Journal of Obesity Surgery
ST. PAUL, Minn., Oct. 27, 2015 /PRNewswire/ -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the online publication of two year results from the Company's vBloc DM2 ENABLE Study in the Journal of Obesity Surgery. The article, titled, "Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the vBloc DM2 Study," is available online here.
"Publication of results from the DM2 study underscores the positive outcomes of both the weight loss and metabolic effects of vBloc® vagal blocking therapy in patients with obesity and Type II Diabetes Mellitus," said Scott Shikora, M.D., F.A.C.S, Chief Medical Officer of EnteroMedics. "Achieving durable weight loss and control of obesity-related co-morbidities are critical goals for the effective, long-term health of people with obesity. vBloc® has demonstrated the ability to safely achieve clinically meaningful long-term weight loss and co-morbidity reduction. As such, vBloc represents a unique and attractive alternative for patients with obesity. These results were integral in obtaining an expanded indication for our CE Mark to include the management of Type 2 diabetes mellitus through improved glycemic control."
The DM2 Study is an international, open-label, prospective, multi-center study designed to evaluate the safety and efficacy of vBloc® vagal blocking therapy delivered via the Maestro® RC System in 28 diabetic subjects with obesity by measuring average percentage excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose (FPG, blood sugar) and blood pressure, following device activation. To date, no deaths or unanticipated adverse device effects have been reported during the vBloc-DM2 Study and the safety profile is similar to that seen in other vBloc clinical trials.
As reported in this publication, at 24 months, HbA1c levels dropped 0.6 percentage points (p=0.003) on average from a baseline of 7.8% and 63% of subjects had a HbA1c level of 7% or lower, which, according to the American Diabetes Association, is the reasonable target for adults with diabetes and has been shown to reduce microvascular complications of diabetes. In combination with the HbA1c results, two year fasting plasma glucose (dropped 15 mg/dL (p=0.056) from 151.0 mg/dl at) and excess weight loss of 22% (p < 0.0001) continue to demonstrate the long-term stability of vBloc Therapy as both a weight loss and a promising metabolic disease intervention. Of note, the improvement in blood pressure at 24 months in hypertensive patients was also maintained. Systolic pressure was reduced by 10 mmHg (p=0.02); Diastolic pressure was reduced by 6 mmHg (p=0.042); and mean arterial pressure declined by 7 mmHg (p=0.014). These metabolic effects in diabetes, hypertension and weight loss are consistent with previous findings from this study and are considered medically meaningful improvements.
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 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 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.
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