SAN CLEMENTE, Calif., March 5, 2018 /PRNewswire/ -- ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, announced today that results from a study examining real-world safety and efficacy of the ReShape BalloonTM were published in the February issue of The Journal of Clinical Gastroenterology and Hepatology.
The publication, titled "Real-world Safety and Efficacy of Fluid-Filled Dual Intra-Gastric Balloon for Weight Loss" discusses a retrospective, physician-sponsored study of data collected on 202 adults at two academic centers and five private practices in which all patients paid for the ReShape Balloon procedure and follow-up visits out of pocket. All patients had the ReShape Balloon inserted for weight loss therapy and the Balloon was removed from each patient after six months. Patients also received counselling on lifestyle modifications focused on diet and exercise.
Primary outcomes were percent total body weight loss (%TBWL) and percent excess weight loss (%EWL) at one, three, six, nine and twelve months after the procedure. Mean %TBWL was 11.4% and 14.7% at six and twelve months, respectively. 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL.
"I am incredibly excited to participate in the real-world use of the ReShape Balloon across several sites," stated Sameer Islam, MD, MBA, Clinical Assistant Professor of Medicine TTUHSC - Department of Internal Medicine. "The results of the study verify the weight loss benefits of the ReShape Balloon, with most patients achieving greater than 10% TBWL at 6 months. I am excited to continue to integrate this technology into my practice."
Study investigators concluded that the ReShape Balloon is a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at six months.
"We are thrilled to have real-world confirmation of the safety and efficacy of our ReShape Balloon," stated Dan Gladney, President and Chief Executive Officer of ReShape Lifesciences. "With the recent focus amongst industry practitioners and leaders on real-life outcomes, the desire for investigators to perform the study and the outcomes they found are a powerful validation of this technology as a real option for patients who are battling obesity."
About ReShape Lifesciences Inc.
ReShape Lifesciences is a medical device company focused on technology to treat obesity and metabolic diseases. The FDA-approved ReShape BalloonTM involves a non-surgical weight loss procedure that uses advanced interconnected balloon technology designed to take up room in the stomach to help people with a 30-40 BMI, and at least one co-morbidity, lose weight. ReShape vBlocTM Neurometabolic Therapy, delivered by an FDA-approved pacemaker-like device called the vBloc System, is designed to help patients with a Body Mass Index (BMI) of 40-45, or 35-39.9 with a minimum of one related comorbid condition, feel full, eat less and lose weight 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 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 Exhibit 99.3 of our current report on Form 8-K filed January 31, 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.
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SOURCE ReShape Lifesciences Inc.
