Apollo Endosurgery Receives 510(k) Clearance for Polypropylene Suture-Anchor Assembly
AUSTIN, Texas — (BUSINESS WIRE) — Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Polypropylene Suture-Anchor Assembly for use specifically with the OverStitch™ Endoscopic Suturing Systems. This proprietary suture-anchor implant is used as part of Apollo’s OverStitch™ and OverStitch Sx™ Endoscopic Suturing Systems to pass and anchor suture in the gastrointestinal tract.
Apollo is currently distributing a suture anchor that is manufactured by a third party according to Apollo design specifications. “Obtaining 510(k) clearance for our own proprietary suture-anchor component is expected to improve our gross margins, and allow us greater control over the supply of our suture by reducing our dependency on third party suppliers. This will be key as we seek to expand into new OverStitch markets outside the United States,” stated Todd Newton, Apollo’s Chief Executive Officer.
About OverStitch and OverStitch Sx
The OverStitch and OverStitch Sx endoscopic suturing systems enable 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: www.apolloendo.com.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies to treat various gastrointestinal conditions, ranging from gastrointestinal defect repairs to the interventional treatment of obesity. Apollo’s device-based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 70 countries today and include the OverStitch™ Endoscopic Suturing System, the OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.
Apollo’s common stock is traded on NASDAQ Global Market under the symbol “APEN”. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.
Cautionary Note on Forward-Looking Statements
Certain statements in this press release are forward-looking statements under the federal securities laws, 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: reports of adverse events related to our products, outcomes of clinical studies, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2018 and its Form 10-Q for the three months ended June 30, 2019. Copies of reports filed with the SEC are posted on Apollo’s website and are available from Apollo 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 disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.