Lap-Band® is the Only FDA Approved Device Indicated for Weight Reduction in Patients With a Body Mass Index (BMI) of at Least 40 kg/m2 or a BMI of at least 30 kg/m2 With One or More Obesity-Related Comorbidities
Updated Guidelines Recommend Metabolic and Bariatric Surgery for Individuals with a BMI Greater Than 35 kg/m2 and Considered for Those With Metabolic Disease and a BMI Over 30 kg/m2
SAN CLEMENTE, Calif., Oct. 31, 2022 (GLOBE NEWSWIRE) -- ReShape Lifesciences™ (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that the American Society for Metabolic and Bariatric Surgery (ASMBS) and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) have issued updated guidelines for Metabolic and Bariatric Surgery, including the Lap-Band®, replacing the 30 year old guidelines issued by the National Institutes of Health (NIH) in 1991.
The ASMBS/IFSO Guidelines now recommend metabolic and bariatric surgery for individuals with a BMI of 35 or more, regardless of the presence, absence or severity of obesity-related conditions, and that it be considered for adults with a BMI 30-34.9 and metabolic disease, and in appropriately selected children and adolescents. The guidelines further state that, even without metabolic disease, weight loss surgery should be considered an option for people whose BMI is greater than 30 and who have not achieved substantial or durable weight loss or improvement in obesity-related diseases using nonsurgical methods. It is also recommended that obesity definitions using standard BMI thresholds be adjusted by population and that Asian individuals consider weight loss surgery beginning at BMI 27.5. The full text of the guidelines can be accessed via the following link https://www.soard.org/article/S1550-7289(22)00641-4/fulltext.
“These updates to the 1991 NIH Consensus Statement on Bariatric Surgery, which, at the time, set the standard most insurers and doctors still rely upon to make decisions about who should get weight loss surgery, what kind they should get, and when they should get it, are long overdue and are supported by hundreds of high-quality studies, including several randomized clinical trials,” stated Shanu N. Kothari, M.D., FACS, FASMBS, immediate past president of ASMBS. “The ASMBS currently endorses six different surgical procedures. Metabolic and bariatric surgery, is currently the most effective evidence-based treatment for obesity across all BMI classes.”
“The compelling evidence-based standards issued by the ASMBS and IFSO, if supported by payers, can dramatically increase the number of patients eligible for bariatric surgery and it is our strong belief that among the approved procedures, the personalized Lap-Band® will prevail as the least invasive surgical treatment option to help address the global obesity epidemic,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “We applaud the leadership of these two industry-leading societies, working together to update these guidelines for bariatric surgery. These new guidelines align well the Lap-Band®, which is approved by the U.S Food and Drug Administration (FDA) for adult patients with a BMI over 30, with at least one obesity-related comorbidity as well as any patient with a BMI over 40. Importantly, the Lap-Band®, backed by 25 years of clinical evidence, is the only FDA approved laparoscopic weight loss device on the market. We are optimistic that these new guidelines will improve access to care for people who seek a safe and effective treatment for durable weight loss, improvement in obesity related comorbidities and quality of life.”
About ReShape Lifesciences™
ReShape Lifesciences™ is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® Program provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. Reshapecare™ is a virtual weight-management program that supports lifestyle changes for all weight loss patients led by board-certified health coaches to help them keep the weight off over time. The recently launched ReShape Marketplace™ is an online collection of quality wellness products curated for all consumers to help them achieve their health goals. The investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of Type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. The ReShape Vest™ System is an investigational minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating the gastric volume reduction effect of conventional weight loss surgery. It helps enable rapid weight loss in persons with obesity without permanently changing patient anatomy. For more information, please visit www.reshapelifesciences.com.
Forward-Looking Safe Harbor Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. 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 press release include statements about our expectation that the marketing campaign should continue to promote increased demand for Lap-Band® procedures and, thus, potentially a significant increase in revenues for ReShape. These and additional risks and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, including those factors identified as "risk factors" in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. 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, except as required by law.
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