SAN CLEMENTE, CA / ACCESSWIRE / October 4, 2018 / ReShape Lifesciences Inc. (NASDAQ: RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, announced today that new data supporting increased weight loss related to use of the ReShape BalloonTM interactiave web portal was presented by Dr. Scott Shikora, MD, FACS; Professor of Surgery Harvard Medical School; Director, Center for Metabolic and Bariatric Surgery, Brigham and Women's Hospital, Boston, MA. Dr. Shikora shared the data last week during a poster presentation at the 23rd World Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), in Dubai, United Arab Emirates.
The presentation discussed the use of a proprietary ReShape Lifesciences interactive patient portal that was created to engage patients after implantation of a ReShape BalloonTM . This exclusive patient portal is desgined to help patients track weight loss progress, activity and food intake. The ReShape intragastric balloons are removed 6 months after insertion, however the portal is intended to be used during the first 6 months of implantation as well as after balloon explant. Typically, without the balloon in place, many patients will regain lost weight; however Dr. Shikora analyzed whether use of the ReShape patient portal program would improve weight loss results.
All patients who received the ReShape Balloon were offered the voluntary and confidential ReShape web portal, which patients could then access as frequently as desired. The study followed 549 patients (82% female) with an average initial BMI of 37 kg/m2 who were registered on the portal between November 11, 2015 and May 2, 2017.
The study concluded that at 3, 6, and 12 months, there were statistically significant correlations between portal engagements and total body weight loss. Additionally, weight loss was maintained, and for higher portal-use patients, continued to improve at least 6 months after balloon removal. Specifically, the top 25% of patient portal users experienced 11%, 16% and 24% total weight loss at 3, 6 and 12 months, respectively.
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. 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, including updates thereto, 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 and remain listed on Nasdaq; 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 and quarterly report on Form 10-Q filed August 20, 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, except as required by law.
Investor Contact:Scott Youngstrom
Chief Financial Officer
ReShape Lifesciences, Inc.
Debbie Kaster, 415-937-5403
SOURCE: ReShape Lifesciences
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