ReShape Lifesciences® Submits FDA PMA Supplement Application for the Next-Generation Lap-Band® 2.0

Rhea-AI Summary

ReShape Lifesciences submits PMA supplement application for enhanced Lap-Band 2.0 with band reservoir technology to FDA.

Positive

• ReShape Lifesciences announces submission of PMA supplement application for enhanced Lap-Band 2.0 with band reservoir technology to FDA.
• Enhanced Lap-Band 2.0 developed to improve patient experience.
• Lap-Band 2.0 adjustable postoperatively to optimize comfort and therapy effectiveness.
• Enhanced band reservoir technology designed to alleviate discomfort from swallowing large food pieces.
• Broad adoption expected if approved by FDA.

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• None.

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.

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 the statements that we expect feedback on the PMA submission from the FDA by year end, and, if approved, that we believe based on physician feedback that there will be broad adoption of the Lap-Band^® 2.0 by existing Lap-Band^® surgeons and surgeons that newly adopt the Lap-Band^® 2.0. 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.

CONTACTS
ReShape Lifesciences Investor Contact:
Thomas Stankovich
Chief Financial Officer
949-276-6042
ir@ReShapeLifesci.com

Investor Relations Contact:
Rx Communications Group
Michael Miller
(917)-633-6086
mmiller@rxir.com

FAQ

What is ReShape Lifesciences announcing?

ReShape Lifesciences is announcing the submission of a PMA supplement application for their enhanced Lap-Band 2.0 with band reservoir technology to the FDA.

What is the purpose of the Lap-Band 2.0?

The Lap-Band 2.0 is developed to improve the patient experience by being adjustable postoperatively to optimize comfort and therapy effectiveness.

What is unique about the Lap-Band 2.0?

The Lap-Band 2.0 features an enhanced band reservoir technology that serves as a relief valve, designed to alleviate discomfort from swallowing large pieces of food.

What happens next?

ReShape Lifesciences expects feedback from the FDA by year end. If approved, they believe there will be broad adoption by existing Lap-Band surgeons and surgeons that newly adopt the Lap-Band 2.0.