Healthcare Industry News: obstructive sleep apnea
News Release - July 25, 2017
EnteroMedics Announces First Veterans Choice Program vBloc(R) Implant for Obesity at Methodist Dallas Medical CenterST. PAUL, Minn., July 25, 2017 -- (Healthcare Sales & Marketing Network) -- EnteroMedics Inc. (NASDAQ: ETRM), a developer of minimally invasive medical devices to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Methodist Dallas Medical Center successfully completed its first implant of the Company's vBloc® Neurometabolic Therapy through the Veterans Choice Program. The surgery was performed on July 24, 2017 by Sachin Kukreja, M.D., a bariatric surgeon in Dallas, Texas.
The federal Veterans Choice Program allows veterans to have the vBloc procedure within a facility in their local community instead of at a Department of Veteran's Affairs (VA) hospital, significantly increasing the accessibility to vBloc for veterans. According to the VA, in the first quarter of FY2017, they observed a more than 30 percent increase in authorizations through the program as compared to the same period in FY2016. The company's previously announced agreement with Academy Medical covers the cost of vBloc for qualified veterans in accordance with their VA health benefits.
"There are over one million veterans battling obesity today, and it is a privilege for EnteroMedics to be able to facilitate their access to our life-changing solutions," said Dan Gladney, EnteroMedics' President, Chief Executive Officer, and Chairman of the Board. "This first VA Choice implant represents another successful step for EnteroMedics towards our goal of establishing vBloc Therapy as a standard of care for patients seeking anatomy-friendly options for weight loss."
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. The vBloc System gives the patient a sensation of fullness, empowering them to eat less, control their appetite, and lose weight. Studies have shown that vBloc Therapy produces meaningful weight loss while also reducing comorbidity factors related to obesity.
"It is an honor to help our veterans and their families who have served this country," said Dr. Kukreja. "With a minimally-invasive, non-anatomy-altering solution to help fight obesity, vBloc Therapy offers patients a healthier alternative to other surgical weight loss solutions."
vBloc Therapy is approved for use 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 who have had a poor response to trying to lose weight under supervision in the last 5 years.
Information about the vBloc® System and vBloc® Neurometabolic Therapy
You should not have an implanted vBloc 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 vBloc 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 vBloc 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.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by an FDA-approved pacemaker-like device called the vBloc® System, is designed to help patients feel full and eat less by intermittently blocking hunger signals on the vagus nerve. EnteroMedics recently acquired the Gastric Vest System™ through its acquisition of BarioSurg, Inc. The Gastric Vest is an investigational, minimally invasive, laparoscopically implanted medical device being studied for weight loss in morbidly obese patients. The device wraps around the stomach, emulating the effect of conventional weight-loss surgery, and enables gastric volume reduction without permanently changing patient anatomy.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this release include our goal of establishing vBloc Therapy as a standard of care for patients seeking anatomy-friendly options for weight loss. These forward-looking statements are based on the current expectations of our management and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience with our vBloc® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; the competitive industry in which we operate; our ability to maintain compliance with the Nasdaq continued listing requirements; our ability to commercialize our vBloc® System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our vBloc® System; physician adoption of our vBloc® 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; the cost and management time of operating a public company; 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 8, 2017 and quarterly report on Form 10-Q filed May 15, 2017. 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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