ST. PAUL, Minn., June 29, 2016 /PRNewswire/ -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced a recent successful outcome following implantation of vBloc® Neurometabolic Therapy. The surgery was performed by Charles Procter, MD, Bariatric and General Surgeon at the Beltline Bariatric and Surgical Group in Atlanta, Georgia, where five vBloc procedures have been performed to date.
After three months of treatment with vBloc Therapy and participation in vBloc® Achieve, the Company's comprehensive weight loss support program, the patient has lost approximately 25 pounds, and has had his Body Mass Index (BMI) reduced from 37.5 kg/m2 to 34 kg/m2. The patient has also experienced a significant improvement in his hypertension and quality of life since undergoing the procedure.*
"For patients struggling with obesity and its comorbidities, few effective solutions exist that do not require pharmaceutical, or drastic, anatomy-altering surgical interventions," said Dr. Procter. "It has been a privilege to be able to witness first-hand successes attributable to vBloc Therapy and vBloc Achieve, and I look forward to being able to share this groundbreaking, minimally invasive alternative with more patients in the very near future."
vBloc Achieve is a comprehensive, personalized weight loss support program to help vBloc patients reach and maintain health goals. While vBloc Therapy addresses hunger signals and cravings, vBloc Achieve provides emotional support and helps patients make positive lifestyle changes, including healthy, balanced eating and regular exercise that are essential to long-term weight-loss success.
"As we continue forward with our mission to expand the availability of vBloc Therapy, success stories reinforce the value that vBloc holds for patients that have exhausted existing options," said Dan Gladney, EnteroMedics President and Chief Executive Officer. "The Beltline Bariatric and Surgical Group team is the eighth of our twelve vBloc Institute programs to have integrated vBloc Therapy and vBloc Achieve into their practice to fight obesity. Key to expanding vBloc Therapy's reach will be obtaining reimbursement for the procedure, which continues to be a high priority for EnteroMedics."
"Over the last 20 years, I have been in a constant battle with managing my weight," said Steven Loyd, a patient of Dr. Procter's who received a vBloc Therapy implant approximately three months ago. "Since receiving vBloc and participating in the vBloc Achieve support program, I have lost and kept off close to 25 pounds. These results have far exceeded my expectations, and for the first time in my life, I feel in control of my health."
vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea.
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.
* Individual results will vary
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SOURCE EnteroMedics Inc.