PR-Inside.com: 2018-11-08 14:04:54
SAN CLEMENTE, CA / ACCESSWIRE / November 8, 2018 / ReShape Lifesciences Inc. (NASDAQ: RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, announced today that the ReShape Balloon™ System is now available at U.S. Department of Veterans Affairs (VA) medical facilities through the previously-announced ReShape Lifesciences™ partnership with Academy Medical, LLC.Academy Medical isa certified Service-Disabled Veteran-Owned Small Business specializing in the distribution of medical products to VA and Department of Defense (DoD) facilities.As of October 9, 2018, the ReShape Balloon has been added to Academy Medical's five-year sole source agreement with the U.S. Department of Veterans Affairs, which allows any VA surgeon in the U.S. to purchase the ReShape Balloon System from Academy Medical under a national contract.
"We are very pleased that surgeons at VA medical facilities now have the ability to treat veterans fighting obesity with the ReShape Balloon," said Dan Gladney, ReShape Lifesciences President and Chief Executive Officer. " There are over one million eligible veterans who are struggling with obesity and they, as well as all patients, deserve access to every option that may help them fight this disease.We look forward to working closely with the VA and Academy Medical to increase awareness and training so that the ReShape Balloon can be offered as soon as possible."
"Academy Medical is pleased to be able to work with both the U.S. Department of Veterans Affairs and ReShape Lifesciences to provide veterans with easy access to this revolutionary and cutting edge weight loss option," said Dan Shaw, Founder and President of Academy Medical, LLC. "This agreement is another example of how we are able to deliver on our shared mission to provide innovative medical devices like the ReShape Balloon to VA hospitals."
The Veterans Health Administration operates one of the largest health care systems in the world. This opens up the opportunity for the ReShape Balloon to be in 150 VA Hospitals that serve nearly 6 million patients annually.
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. 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; 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.
Chief Financial Officer
ReShape Lifesciences Inc.
SOURCE: ReShape Lifesciences Inc.