ST. PAUL, Minn., June 28, 2017 /PRNewswire/ -- EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices to treat obesity, metabolic diseases, and other obesity-related comorbidities, announced today the launch of the vBloc Now program. The program provides qualified patients access to vBloc® Therapy at a reduced cost in partnership with select bariatric and weight loss centers across the United States. vBloc Therapy is designed to help patients feel full, eat less food, and lose weight, thereby improving their overall health.
"We've repeatedly stated that our goal remains broad coverage and reimbursement for vBloc Therapy," said Dan Gladney, EnteroMedics President, Chief Executive Officer, and Chairman of the Board. "Since receiving FDA approval in 2015, the largest barrier to adoption for patients who want vBloc Therapy has been cost. Discussions with interested payers indicate our final hurdle to insurance coverage is gathering additional patient data in a commercial setting. The vBloc Now program is designed to generate commercial vBloc patient outcomes and support positive coverage decisions."
The vBloc Now program provides qualified patients battling obesity the opportunity to receive vBloc Therapy including the device, procedure, and vBloc Achieve follow up program at an affordable price in exchange for sharing detailed health data with EnteroMedics. The program is available for a limited time, will reduce patient total out-of-pocket costs, and compete with leading covered bariatric surgery procedures as well as other low-cost weight loss devices.
Hundreds of clinical trial patients with vBloc Therapy have shown durable excess weight loss at two years, as well as meaningful improvements in related health conditions such as Type 2 diabetes. The vBloc Now program kicked off at two vBloc Institutes in the beginning of June. Over thirty patients who applied for the program are expected to complete the minimally invasive procedure and start vBloc Therapy before the end of the June. To learn more about the program call 1-800-MY-VBLOC.
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 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 to obtain broad coverage and reimbursement for vBloc Therapy, including our ability to gather additional patient data in a commercial setting in order to obtain insurance coverage; the ability of vBloc Now to compete with leading covered bariatric surgery procedures and other low-cost weight loss devices; and our expectation that patients will complete the procedure and start vBloc Therapy before the end of June. 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® 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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SOURCE EnteroMedics Inc.