Press Release

ReShape Lifesciences™ Receives FDA 510(k) Clearance for the GIBI HD™ Calibration Tubes for use in Gastric and Bariatric Procedures

August 10, 2022 at 12:05 PM EDT

New Calibration Tubes, in Three Sizes, Will Simplify Gastric and Bariatric Procedures Including Laparoscopic Sleeve Gastrectomy, Gastric Bypass and Gastric Banding

Company to Introduce Product at IFSO 2022 World Congress in August; Sales to Commence in September

SAN CLEMENTE, Calif., Aug. 10, 2022 (GLOBE NEWSWIRE) -- ReShape Lifesciences™ (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the disposable, Gastro Intestinal Balloon Indicator (GIBI HD™) calibration tube for use in gastric and bariatric surgical procedures. The company expects U.S. commercial sales to begin in September 2022.

The GIBI HD™ includes three new sizes – 32, 36, and 40 Fr – all designed to simplify bariatric procedures such as laparoscopic sleeve gastrectomy, gastric bypass and adjustable gastric banding. The large diameter and blunt tip design of the new calibration tube allows for confident placement and rapid decompression to ensure greater visibility and provide guidance to allow for straighter staple lines. Additionally, compared to reusable bougies and disposable gastric tubes, ReShape Lifesciences’ GIBI HD™ is a multifunctional device. The GIBI HD™ is also less traumatic to the patient, as it is intended to fit to the lesser curvature of the stomach more easily and quickly reach the pylorus.

“FDA clearance of our GIBI HD™ calibration tube, which supports bariatric procedures across the spectrum, marks an important addition to our suite of physician led weight loss solutions and we look forward to formally introducing this important new product at the International Federation for the Surgery of Obesity and Metabolic Disorders – IFSO 2022 World Congress in Miami, later this month,” stated Michael Bordainick, Senior Vice President, Commercial Operations at ReShape Lifesciences. “The GIBI HD™ is a valuable tool for physicians, with a balloon feature that helps bariatric surgeons better visualize the anatomy, making it easier to identify potential defects. As we have communicated to the market, we continue to innovate our pipeline of physician prescribed, insurance reimbursed weight loss solutions including the Lap-Band® Program, supportive reshapecare™ Virtual Health Coaching Platform and the ReShape Optimize™ line of supplements by ProCare Health, available on ReShape Marketplace™. It is truly an exciting time for ReShape as we solidify our position as the premier physician-led weight loss and metabolic health-solutions company.”

About ReShape Lifesciences™
ReShape Lifesciences™ is the premier global weight loss and metabolic health-solutions company, offering an integrated portfolio of physician-led, 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. The ReShape Vest™ System is an investigational (outside the U.S.) 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 obese and morbidly obese patients without permanently changing patient anatomy. 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. 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 that the company expects U.S. commercial sales of the GIBI HD™ to begin in September 2022. 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


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Source: ReShape Lifesciences Inc