ReShape Lifesciences Inc. (RSLS) : 1.7500+0.0600 (+3.55%)
After-Hours Volume 2,901,613
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ReShape Lifesciences® Submits FDA PMA Supplement Application for the Next-Generation Lap-Band® 2.0
ReShape Lifesciences Inc
Mon, June 26, 2023 at 10:05 PM GMT+2
Enhanced Band Reservoir Technology Designed to Improve the Patient Experience
IRVINE, Calif., June 26, 2023 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced the submission of a Premarket Approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for the company’s next generation, enhanced Lap-Band® 2.0, utilizing a band reservoir technology.
“The PMA supplement submission is a significant milestone and is consistent with our second growth pillar to develop and, ultimately, commercialize new products and therapies,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. “This next generation, enhanced Lap-Band® 2.0 was developed with physician feedback to improve the patient experience. Similar to our current Lap-Band, the Lap-Band 2.0 is adjustable postoperatively to increase or decrease the opening of the band in order to optimize an individual’s comfort, thereby improving therapy effectiveness. However, unique to the Lap-Band 2.0 is an enhanced band reservoir technology that serves as a relief valve, designed to alleviate discomfort from swallowing large pieces of food, that may require in-office band adjustments. We expect feedback from the FDA by year end. If approved, we believe that based on discussions with physicians, that there will be broad adoption by existing Lap-Band® surgeons and surgeons that newly adopt the Lap-Band® 2.0.”
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® System 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. 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. For more information, please visit www.reshapelifesciences.com.
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