ReShape Lifesciences™ Announces Positive Preclinical Results for Its Investigational Diabetes Bloc-Stim Neuromodulation Device

SAN CLEMENTE, Calif., Sept. 10, 2020 /PRNewswire/ -- ReShape Lifesciences Inc., (OTCQB: RSLS) a global weight-loss solutions leader, today announced preclinical research demonstrating the Company's investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) proprietary device for the treatment of type 2 diabetes mellitus (T2DM) was well-tolerated and met the study endpoints. The study was conducted as a part of the National Institutes of Health (NIH) Small Business Innovation Research Phase I grant that was previously awarded August 1, 2019.

The preclinical investigation consisted of simultaneous electrical blockade and stimulation of individual vagal nerve branches and was conducted in a type 2 diabetic porcine animal model. Results showed a significant reduction of blood glucose.  Histopathology of organ systems effected by the neuromodulation demonstrated healthy tissue. These findings broaden the proof-of-concept and mechanism of action, results of which were initially presented at ObesityWeek 2018.  Further demonstrating that dual vagus nerve neuromodulation – a novel and proprietary approach - improves glycemic control in animal models of T2DM.  

"Bioelectronic medicine represents a growing and exciting field as it supports the potential for less dependence on drug therapy and addresses the challenges associated with daily compliance for those suffering from diabetes," said Bart Bandy, President & CEO of ReShape Lifesciences Inc. "Our exploration of neuromodulation for diabetes aligns with the ReShape Lifesciences™ corporate strategy to build our portfolio and pipeline with technologies and services that improve the treatment of obesity and metabolic diseases. Based on these positive outcomes, the preclinical study represents a successful completion of the NIH Phase I grant and we look forward to advancing this unique diabetes focused innovation."

"The ReShape Lifesciences Diabetes Bloc-Stim Neuromodulation technology has accomplished key goals through the NIH Phase I Small Business Innovation Research grant study. The preliminary data strongly calls for pursuit of further evaluating this treatment for type 2 diabetes mellitus," said Charles Billington, M.D., Chief of Endocrinology at the VA Medical Center in Minneapolis, MN and Professor of Medicine at the University of Minnesota, and the lead advisor in the ReShape Lifesciences preclinical diabetes research program.  

Research reported in this press release was supported by National Institute of Diabetes and Digestive and Kidney Diseases of the NIH under award number 1R43DK122846-01. The NIH award for this research was $299,048. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About ReShape Lifesciences Inc.

ReShape Lifesciences is America's premier weight-loss solutions company, offering an integrated portfolio of 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. The recently launched ReShapeCare™ Virtual health coaching program is a virtual tele-health weight management program that supports lifestyle changes for all weight-loss patients, to help them keep the weight off over time.

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. 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 related to the effects of the COVID-19 outbreak on our results of operations, financial condition or liquidity; risks and uncertainties related to our acquisition of the Lap-Band system; our ability to continue as a going concern if we are unable to improve our operating results or obtain additional financing; risks related to ownership of our securities as a result of our delisting from the NASDAQ Capital Market; our proposed ReShape Vest product may not be successfully developed and commercialized; our limited history of operations; our losses since inception and for the foreseeable future; the competitive industry in which we operate; 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 Lap-Band system; 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 30, 2020. 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.

SOURCE ReShape Lifesciences Inc.

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