NEW YORK, NY, December 13, 2023 – ReShape Lifesciences (Nasdaq: RSLS) has been granted FDA approval of a PMA supplement for the company’s next generation, enhanced Lap-Band® 2.0 FLEX. The company’s share price surged 100% in trading on Wednesday morning.
Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences, said, “PMA supplement approval for our next generation Lap-Band® 2.0 FLEX is a historic event for ReShape that is expected to be a key growth catalyst for the company’s Lap-Band® franchise,” stated “The enhanced Lap-Band® 2.0 FLEX development effort was physician-led with the goal of improving the patient experience. The Lap-Band® system is the safest and most durable weight loss option for obese patients and is ideal for those who are averse to medically managed weight loss and who opt for the only available anatomy preserving surgery.”
ReShape is now preparing for its U.S. product launch of the Lap-Band 2.0 FLEX.
Lap-Band® 2.0 has a new feature called FLEX Technology, which acts as a relief valve, allowing larger pieces of food to more easily pass through the narrowed passage (or stoma), created by the band.
Christine Ren-Fielding, M.D., Professor of Surgery at NYU Grossman School of Medicine, Director of the NYU Langone Weight Management Program and Chief of the Division of Bariatric Surgery, said, “Based on my 20-year use of the Lap-Band®, over time, some patients have needed adjustments, particularly when related to urgent loosening to relieve food obstruction. Lap-Band 2.0® FLEX will potentially remedy this issue because of the ability for self-correction, utilizing an internal reservoir system.”
A Pre-Market Approval (PMA) supplement is the submission required for a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA.
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. 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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Source: PRISM MarketView
FDA Grants PMA Supplement Approval for @ReShape Lifesciences (Nasdaq: $RSLS) Lap Band; Shares Surge 100%https://t.co/vzPzdkJtXp@ReShapeLifesci #stockstowatch #StocksInFocus #investors#PrismMarketView #PrismMediaWire #PrismDigitalMedia— PrismMarketView (@PrismMarketView) December 13, 2023