Healthcare Industry News: vBloc
News Release - January 7, 2008
EnteroMedics(TM) Announces Pivotal Clinical Study of its VBLOC(TM) Therapy for Obesity
EMPOWER Study Will Test Safety and Effectiveness of Vagal Blocking Therapy at 15 Sites in U.S. and AustraliaST. PAUL, Minn.--(HSMN NewsFeed)--EnteroMedics, Inc. (NASDAQ:ETRM ), a developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced its EMPOWER pivotal clinical study. The FDA has recently granted approval for the pivotal clinical study of the company’s investigational vBloc Therapy using the Maestro™ System, its initial product for the treatment of obesity. The EMPOWER Study will evaluate the safety and effectiveness of the Company’s proprietary vBloc™ vagal blocking therapy for the treatment of obesity at 15 clinical sites in the U.S. and Australia.
The EMPOWER study is a randomized, double-blind, placebo-controlled study and will include up to 220 patients across 15 clinical sites. The vBloc Therapy system is the only neuroblocking device currently under investigation for the potential treatment of obesity.
Obesity has become a significant public health threat in the United States and worldwide. Between 1980 and 2004, obesity rates doubled among U.S. adults. According to the Centers for Disease Control, more than 30 percent of the adult population, or 65 million American adults, are obese. According to World Health Organization estimates, as many as 400 million people suffer from obesity worldwide. Obese individuals are at a higher risk of being diagnosed with heart disease, high blood pressure, joint problems, and diabetes, among other health problems. Upon completion of the first year of the trial, EnteroMedics plans to use data from this study to support a premarket approval, or PMA, application to the FDA for the treatment of obesity in the United States. The Maestro System has not been approved for commercial sale in the United States.
“Bariatric surgeons and the millions of Americans with obesity are seeking lower risk alternatives to the current surgical treatments for obesity with their many known side effects and complications. vBloc Therapy has the potential to address these unmet medical needs with an implantable system designed to empower weight loss by promoting earlier feelings of fullness and reduced hunger while essentially preserving the individual's normal anatomy” said Mark B. Knudson, Ph.D., President and CEO of EnteroMedics. The EMPOWER trial, whose objective is to evaluate a new and potentially effective, lower risk option for the treatment of obesity, is being conducted in partnership with several nationally and internationally recognized obesity experts and institutions.
About vBloc Therapy
EnteroMedics developed vBloc™ vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. vBloc Therapy is delivered via the Maestro System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low energy electrical impulses. vBloc Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.
About the EMPOWER Study
The EMPOWER Study is a randomized, double-blind, placebo-controlled study being conducted to evaluate the safety and effectiveness of the Company’s investigational vBloc Therapy after 12 months of use in obese patients. The study will be conducted at up to 15 sites in the U.S. and Australia and will include up to 220 patients with obesity. The company expects to complete enrollment during the first half of 2008. In order to qualify for the study, patients must be 18 years of age or older, with a body mass index (BMI) between 35 and 45. To learn more about the EMPOWER Study, visit www.EMPOWERstudy.com or call 866 97 vBloc (866-978-2562).
About EnteroMedics Inc.
EnteroMedics is a development stage medical device company focused on the design and development of devices that use neuroblocking technology to treat obesity and other gastrointestinal disorders. EnteroMedics' proprietary neuroblocking technology, vBloc™ vagal blocking therapy, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. The FDA recently granted EnteroMedics approval for a pivotal clinical study of the Company’s investigational vBloc Therapy as delivered by the Maestro™ System, its initial product for the treatment of obesity.
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 regulatory approval for our Maestro System for the treatment of obesity; our inability to complete our EMPOWER pivotal trial and other clinical trials, or significant delays in the completion of our clinical trials; our ability to timely 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 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; 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; 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 Company's Prospectus dated November 14, 2007. 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.
Caution-Investigational device. Limited by Federal law to investigational use.
Source: EnteroMedics
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