ReShape Lifesciences Continues Expansion in Middle East with Approval of ReShape Balloon in Saudi Arabia

SAN CLEMENTE, Calif., April 3, 2018 /PRNewswire/ -- ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, today announced approval of the Company's ReShape Balloonby the Kingdom of Saudi Arabia Saudi Food and Drug Authority. Congruent with this approval, the Company received an initial stocking order from Dar Al Zahrawi Medical Co LLC, KSA.

"We are pleased to announce the approval and recent order of the ReShape Balloon in Saudi Arabia, both of which support the continued acceptance and affirmation of our product as a solution for obesity," said Dan Gladney, President and Chief Executive Officer of ReShape Lifesciences. "Dar Al Zahrawi is one of the largest surgical distributors in the Middle East and we are honored to be able to partner with them in helping to reduce the growing obesity crisis in Saudi Arabia."

Saudi Arabia has one of the highest obesity and overweight prevalence rates in the world, as reported in an October 2016 article published by the Journal of Obesity and Eating Disorders. While close to 30% of the global population is estimated to be obese, current obesity in 2017 in Saudi Arabia was estimated at 53% in 2017 and is projected to grow to 60% by 2022 according to World Atlas.

About ReShape Lifesciences Inc.

ReShape Lifesciences™ is a medical device company focused on technologies to treat obesity and metabolic diseases. The FDA-approved ReShape Balloon™ System involves a non-surgical weight loss procedure that uses advanced balloon technology designed to take up room in the stomach to help people with a 30-40 kg/m2 Body Mass Index (BMI) and at least one co-morbidity lose weight. ReShape vBloc™ Therapy, delivered by an FDA-approved pacemaker-like device called the ReShape vBloc System, is designed to help patients with a 40-45 kg/m2, or a 35-39.9 kg/m2 BMI and at least one co-morbidity feel full and eat less by intermittently blocking hunger signals on the vagus nerve. 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, and is intended to enable rapid weight loss in obese and morbidly obese patients without permanently changing patient anatomy.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements about the continued acceptance and affirmation of the ReShape Balloon as a solution for obesity. 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. These forward-looking statements are based on the current expectations of our management and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: risks and uncertainties related to our acquisitions of ReShape Medical, Inc. and BarioSurg, Inc.; risks related to the U.S. Food and Drug Administration's announcement to alert health care providers of unanticipated deaths involving the ReShape Balloon; our proposed ReShape Vest product may not be successfully developed and commercialized; our ability to continue as a going concern if we are unsuccessful in our pursuit of various funding options; our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience; the competitive industry in which we operate; our ability to maintain compliance with the Nasdaq continued listing requirements; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for our ReShape Vest and any modifications to our vBloc system or ReShape Balloon; physician adoption of our products; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; the cost and management time of operating a public company; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission, particularly those factors identified as "risk factors" in our Annual Report on Form 10-K filed April 2, 2018. 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.

 

 

CONTACT: Investor, Scott Youngstrom, Chief Financial Officer, ReShape Lifesciences Inc., 949-429-6680 x106, syoungstrom@reshapelifesci.com; or Gilmartin Group, Debbie Kaster, 415-937-5403, Investor Relations, debbie@gilmartinir.com

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SOURCE ReShape Lifesciences Inc.

 

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