MINEOLA, N.Y. and ST. PAUL, Minn., April 21, 2016 /PRNewswire/ -- Weight Loss Surgery Foundation of America and EnteroMedics Inc. (NASDAQ: ETRM) announced today that Weight Loss Surgery Foundation of America will include EnteroMedics vBloc® Therapy in their grant referral program starting June 1, 2016.
"We are eager to include vBloc therapy as we now have a new way to help people with this medical device and we are thrilled to see advances and new tools to help people overcome obesity," said Antonia Namnath, CEO and Founder of the WLSFA.ORG. "The WLSFA is honored to include FDA approved therapies in our grant program. Until insurance companies are required to cover medical treatments for obesity in all policies, we will fund grants for those who have no access to the medical care they need to overcome obesity. EnteroMedics vBloc Therapy adds a new resource for our community and we look forward to awarding our first grant to cover this procedure."
vBloc Therapy is approved for use in helping with weight loss in people aged 18 years through age 65 who are obese, with a Body Mass Index (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 or high cholesterol levels.
"vBloc Therapy represents a safe and well-tolerated, neuroscience-based approach for the treatment of patients with moderate obesity and related comorbid conditions," said Scott Shikora, M.D., F.A.C.S., EnteroMedics Executive Vice President and Chief Medical Officer. "Its ability to foster clinically meaningful weight loss safely, without changes in anatomy, establishes vBloc as a much needed anatomy sparing alternative to existing treatment options."
"We welcome the support of the Weight Loss Surgery Foundation of America," said Dan Gladney, EnteroMedics President and Chief Executive Officer. "Until payors routinely cover treatment for those struggling with the chronic disease of obesity, it's critical that organizations like the WLSFA and companies like EnteroMedics join forces to help patients without other options."
About Weight Loss Surgery Foundation of America – WLSFA.ORG
The Weight Loss Surgery Foundation of America is a 501(c)3 Non-Profit Charitable Organization. Powered by the weight loss surgery patient community, medical professionals and industry partners together we fund grants for bariatric surgery, obesity medical treatments and reconstructive plastic surgery after the medical treatment of obesity. The WLSFA is 100% volunteer organization. For more information about the WLSFA go to http://www.wlsfa.org or call 415-234-9074.
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.
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"We are eager to include vBloc therapy as we now have a new way to help people with this medical device and we are thrilled to see advances and new tools to help people overcome obesity," said Antonia Namnath, CEO and Founder of the WLSFA.ORG. "The WLSFA is honored to include FDA approved therapies in our grant program. Until insurance companies are required to cover medical treatments for obesity in all policies, we will fund grants for those who have no access to the medical care they need to overcome obesity. EnteroMedics vBloc Therapy adds a new resource for our community and we look forward to awarding our first grant to cover this procedure."
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vBloc Therapy is approved for use in helping with weight loss in people aged 18 years through age 65 who are obese, with a Body Mass Index (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 or high cholesterol levels.
"vBloc Therapy represents a safe and well-tolerated, neuroscience-based approach for the treatment of patients with moderate obesity and related comorbid conditions," said Scott Shikora, M.D., F.A.C.S., EnteroMedics Executive Vice President and Chief Medical Officer. "Its ability to foster clinically meaningful weight loss safely, without changes in anatomy, establishes vBloc as a much needed anatomy sparing alternative to existing treatment options."
"We welcome the support of the Weight Loss Surgery Foundation of America," said Dan Gladney, EnteroMedics President and Chief Executive Officer. "Until payors routinely cover treatment for those struggling with the chronic disease of obesity, it's critical that organizations like the WLSFA and companies like EnteroMedics join forces to help patients without other options."
About Weight Loss Surgery Foundation of America – WLSFA.ORG
The Weight Loss Surgery Foundation of America is a 501(c)3 Non-Profit Charitable Organization. Powered by the weight loss surgery patient community, medical professionals and industry partners together we fund grants for bariatric surgery, obesity medical treatments and reconstructive plastic surgery after the medical treatment of obesity. The WLSFA is 100% volunteer organization. For more information about the WLSFA go to http://www.wlsfa.org or call 415-234-9074.
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.
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SOURCE EnteroMedics Inc.
