Registry to track and evaluate patient outcomes after procedures done with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System.
Bethesda, MD (Oct. 24, 2017) — The American Gastroenterological Association (AGA) Center for GI Innovation and Technology announced today that it will partner with Apollo Endosurgery, Inc. to establish a clinical research registry to track and evaluate patient outcomes after trans-oral endoscopic suturing procedures. These procedures allow physicians to place stitches in the upper or lower gastrointestinal tract using a flexible endoscope.
The Prospective Registry for Trans-Oral Suturing Applications (“Endoscopic Suturing Registry”) will collect real-world data related to the safety and effectiveness of procedures done with Apollo Endosurgery’s OverStitch™ Endoscopic Suturing System.
“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.”
Through its registry initiative, AGA serves as a neutral, objective broker to establish and run registries that assess the safety and effectiveness of new technologies and therapies on patients. These data support the approval, coverage and adoption of devices and treatments that demonstrate promise and merit. This process allows innovations that will improve patient care to make it into physicians’ practices much faster than traditionally possible.
The data collected in the Endoscopic Suturing Registry will support informed decision making among physicians, purchasers and payors related to the approval, coverage and adoption of flexible endoscopic suturing devices. Most importantly, data on patient outcomes will lay the groundwork for shared decision making between patients and physicians about treatment options.
“As health care 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”.
Jennifer Maranki, MD, director of endoscopy, Penn State Milton S. Hershey School of Medicine, and Brian Dunkin, MD, head of endoscopic surgery and medical director, Houston Methodist Institute for Technology, Innovation and Education, will serve as principal investigators for the Endoscopic Suturing Registry. The Registry will begin collecting patient data in early 2018.
About the AGA 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.www.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. www.gastro.org/CGIT.
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.
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.
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: price levels for established and innovative medical devices compared to the costs of procedures utilizing our products; developments in medical technology; regulatory approvals; reimbursement decisions by private or government payors or other government actions; physician adoption and recommendations of procedures utilizing our products; 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.
American Gastroenterological Association Contact:
Apollo Endosurgery, Inc. Contacts:
Media: Jen Cook
Investors: Stefanie Cavanaugh, Chief Financial Officer
Lee Roth or Zack Kubow, The Ruth Group