Healthcare Industry News: neuromodulation
News Release - September 13, 2016
vBloc Institute Demonstrates Positive Clinical Success in Patients Struggling with Weight Loss as Compared to Pivotal FDA Trial with EnteroMedics vBloc(R) Therapy in Combination with vBloc(R) Achieve ProgramST. PAUL, Minn., Sept. 13, 2016 -- (Healthcare Sales & Marketing Network) -- EnteroMedics Inc. (ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced clinical success at the Bariatric Center at Sky Ridge Medical Center in Colorado, a vBloc Institute partner, where several vBloc procedures have been performed to date by Frank H. Chae, MD, FACS, Chief Surgeon and Head of the Bariatric Center at Sky Ridge Medical Center. vBloc Institute partners are facilities that have integrated vBloc Therapy and vBloc Achieve into their practices.
"The weight loss observed in my vBloc patients is trending greater than reported in the vBloc ReCharge Study," said Dr. Chae. "Our patients have experienced more than 30 percent improvement in the percent total weight loss (TWL) in the first three months when compared to the ReCharge Study patients. While our observations are not a clinical trial, the positive results of these practical applications should be recognized, particularly as vBloc moves towards obtaining broad reimbursement coverage."
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.
"vBloc Therapy is a revolutionary treatment option for morbidly obese patients who do not wish to undergo anatomy-altering weight-loss procedures," continued Dr. Chae. "I would expect vBloc to be the preferred choice of eligible patients when there is insurance coverage and they do not have to carry the full financial burden themselves."
vBloc Therapy works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally-invasive procedure that does not alter or remove any patient anatomy. This device can be adjusted to optimize patients' therapy needs. Patients feel the sensation of fullness, empowering them to eat less, control their appetite, make healthier choices and lose weight without the major lifestyle implications of traditional weight loss surgeries. 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 the coaching and emotional support necessary to help patients make positive lifestyle changes, including healthy, balanced eating and regular exercise that are essential to long-term weight loss success. vBloc can be adjusted postoperatively for a patient's lifestyle or eating patterns in order to optimize therapy when patients need it the most.
"We were pleased to see the impressive results from Dr. Chae and his team," said Dan Gladney, EnteroMedics President and Chief Executive Officer. "We are diligently working with our other vBloc Institute partners to document weight loss across all sites with vBloc Therapy and vBloc Achieve. The support of Dr. Chae and Sky Ridge represents key validation for the promise that vBloc holds as an effective, safe and lifelong therapy for morbidly obese patients. We are dedicated to securing reimbursement for vBloc Therapy, and continuing ahead with our highly targeted marketing strategies."
Studies have shown that after receiving vBloc Therapy, patients have experienced improvements in low-density lipoprotein (LDL) cholesterol levels, triglyceride levels, blood pressure and heart rate, as well as a reduction in waist circumference. Patients also reported an improvement in quality of life. Additionally, in one study, 85 percent of patients who received vBloc Therapy were able to maintain, decrease or discontinue their diabetes medications while achieving improved glycemic control after 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 limited 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 regain and then maintain compliance 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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