SAN CLEMENTE, Calif., Nov. 3, 2017 /PRNewswire/ -- ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, today announced new data that was presented this week at the ObesityWeek 2017 conference in Washington D.C.
"Obesity has become a global epidemic that involves significant health issues, comorbidities, and high associated costs to the healthcare system," said Dan Gladney, President, Chief Executive Officer and Chairman of the Board of ReShape Lifesciences. "New, minimally invasive treatment options that are anatomy friendly and help patients manage their disease are required, as existing options are not adequately addressing the concerns of patients and physicians. We believe the data presented at ObesityWeek 2017 continues to demonstrate the compelling and differentiated benefits of all three of our technologies and validates the use of our devices as effective treatments for obesity."
ReShape Integrated Dual Balloon Podium Presentation
The presentation discussed 342 patients that were implanted with the ReShape® Integrated Dual Balloon at a multicenter bariatric practice (mean age of 45, average weight of 231 lbs., average Body Mass Index (BMI) of 38, 76% female). The mean treatment duration for retrieved balloons was 166 days, with 276 balloons retrieved and 66 still implanted.
- Mean weight loss for 240 patients with 120 days or more of treatment was 24.3 lbs., 10.5% of initial body weight and 36.2% of excess weight loss (EWL)
- 81% of patients lost ? 5% initial body weight and 49% lost more than 10% of initial body weight
- No complications were reported during balloon implantations
The study concluded that the ReShape Integrated Dual Balloon is safe and effective for weight loss in appropriate patients and that gastric ulceration, deflations, pancreatitis and early retrievals for intolerance of the ReShape balloon occur infrequently and have no long-term sequelae if treated promptly.
Gastric Vest Podium Presentation
The presentation of the prospective study included the laparoscopic Gastric Vest SystemTM (GVS) implanted for 12 months in 15 obese patients (mean age of 34 years, initial BMI of 40, 93% female). All patients completed 12-month follow-up.
- Mean operative time was 90 minutes, mean hospital stay was 24 hours and no intraoperative complications occurred
- At 1 month, all patients had EWL ? 20.1%; at 12 months the mean EWL was 85.5%
- There has been no record of weight regain in any patient to date
The study concluded that the GVS is a feasible, safe, and effective bariatric procedure and that the average EWL achieved is comparable to more invasive surgical procedures, with the advantage that the GVS preserves the stomach while preventing gastric dilation. The GVS is currently considered an investigational device and is not commercially available.
vBloc Poster Presentation
In addition to podium presentations, ReShape Lifesciences' vBloc® technology was the subject of a poster presentation at ObesityWeek 2017. The presentation showcased early results of 35 vBloc Therapy patients in a real-world setting (mean age of 55, average BMI of 41, 60% female). vBloc Therapy settings (levels and times of active therapy) were personalized to each patient's needs. Twenty eight of these patients reached their nine-month follow-up visit and achieved the following results:
- Average BMI dropped from 41 to 36
- 71% of patients lost ? 5% initial body weight, with a mean initial body weight loss of 12% within this group
- No serious complications were reported.
The presentation concluded that the short-term use of vBloc Therapy can achieve significant, meaningful weight loss with minimal complications in severely obese patients in a "real-world" setting.
About ReShape Lifesciences Inc.
ReShape Lifesciences is a medical device company focused on technology to treat obesity and metabolic diseases. vBloc® 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 FDA-approved ReShape® Integrated Dual Balloon System 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. The Gastric 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. Forward-looking statements in this release include our belief that the data presented demonstrates the compelling and differentiated benefits of our technologies and validates the use of our devices as effective treatments for obesity. 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 acquisition of ReShape Medical, Inc., including unexpected costs or liabilities, the ability to recognize the benefits of the acquisition and that the acquisition may involve unexpected costs or liabilities; our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience with our vBloc® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; the competitive industry in which we operate; our ability to maintain compliance with the Nasdaq continued listing requirements; our ability to commercialize our vBloc System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our vBloc System; physician adoption of our vBloc System and vBloc Neurometabolic Therapy; 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 July 26, 2017. 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.