AUSTIN, Texas--(BUSINESS WIRE)--Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today it has entered into a Registry Funding Agreement with the American Gastroenterological Association (AGA) Center for GI Innovation and Technology to develop and administer a registry to evaluate flexible endoscopic procedures enabled by the OverStitch™ Endoscopic Suturing System.
Flexible endoscopic suturing is an important tool for both endoscopic surgeons and gastroenterologists. The Endoscopic Suturing Registry will be managed by the AGA and the two Principal Investigators for the registry will be Jennifer Maranki, MD, the Director of Endoscopy at Penn State Milton S. Hershey School of Medicine, and Brian Dunkin, MD, Head of Endoscopic Surgery and Medical Director of the Houston Methodist Institute for Technology, Innovation and Education.
The Endoscopic Suturing Registry will provide real-world evidence related to the safety and efficacy of a number of flexible endoscopic suturing enabled procedures, including the revisions of patients after a failed bariatric surgery and the fixation of esophageal stents to prevent migration, while collecting data usage on other procedures currently in practice. These procedures are performed using the OverStitch™ device trans-orally, eliminating risks associated with incisions into the abdomen, thus also having the potential to lower complication rates and reduce total healthcare costs.
“Flexible endoscopic suturing is an important tool for the treatment of a number of gastroenterology disorders,” said Michael Kochman, MD, AGAF, director of the Center for Endoscopic Innovation, Research, and Training, University of Pennsylvania, and past chair, AGA Center for GI Innovation and Technology. “As these procedures become more routine in gastrointestinal and surgery practices across the country, the real-world data AGA will collect through the Endoscopic Suturing Registry will guide all stakeholders in making informed decisions around the continued adoption of these procedures in clinical practice.”
The AGA Center for GI Innovation and Technology works with device, diagnostic and other life science companies in the gastrointestinal space to identify and gather the data needed by key stakeholders in the healthcare system. These stakeholders include providers, payors, purchasers, accountable care organizations and regulatory agencies. It is the goal of the AGA and its technology center to identify and help assess the value of new technologies on patient care and support approval, coverage and adoption of technologies that demonstrate promise and merit.
“As healthcare plans evaluate the benefits of flexible endoscopic suturing relative to traditional therapies, the Endoscopic Suturing Registry will be an important repository of highly credible clinical data,” said Todd Newton, CEO of Apollo Endosurgery. “Independent real-world data is an important consideration as health plans and payors determine coverage policies for procedures that depend on flexible endoscopic suturing.”
The OverStitch™ endoscopic suturing system enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures from a flexible endoscope. This new technology enables a secure approximation of tissue endoscopically and a wide range of less invasive solutions for physicians who treat defects in both the upper and lower GI tract of their patients. Additionally, physicians are leveraging endoscopic suturing to perform a variety of advanced bariatric procedures. For more information regarding OverStitch™ go to: apolloendo.com.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal disorders. Apollo Endosurgery’s device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo Endosurgery’s products are offered in over 80 countries today.
Apollo Endosurgery’s common stock is traded on NASDAQ Global Market under the symbol "APEN." For more information regarding Apollo Endosurgery, go to: apolloendo.com.
About the American Gastroenterological Association Institute
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to more than 16,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. gastro.org.
The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. gastro.org/CGIT
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: product liability claims relating to our Endo-bariatric products; physician adoption and recommendations of procedures utilizing our products; misuse or off-label use of our products resulting in injuries or death; continued extensive FDA regulatory oversight; potential product recalls; health care provider education and on-going training to ensure patient safety and treatment; and other factors detailed from time to time in the reports Apollo Endosurgery files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2016 and its Form 10-Q for the three months ended June 30, 2017. Copies of reports filed with the SEC are posted on Apollo Endosurgery’s website and are available from Apollo Endosurgery without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Apollo Endosurgery disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
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