Apollo Endosurgery Receives Special 510(k) Clearance for OverStitch™ Sx Endoscopic Suturing System
AUSTIN, Texas — (BUSINESS WIRE) — Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that it has received Special 510(k) clearance from the U.S. Food and Drug Administration for OverStitch™ Sx Endoscopic Suturing System.
The OverStitch Sx System, a new, full-thickness flexible endoscopic suturing system, received initial 510(k) clearance in November 2017. The Special 510(k) addressed an accessory to the system that is intended to ease the attachment of the device to compatible endoscopes (single-channel endoscopes with diameters ranging from 8.8mm to 9.8mm). The Special 510(k) clearance is the last regulatory requirement needed prior to the system’s introduction into the US market.
Flexible endoscopic suturing using Apollo’s current version of OverStitch™ is an important tool for both surgeons and gastroenterologists, but it is currently only compatible with a limited number of dual-channel endoscopes and physicians without access to this specific capital equipment cannot leverage the benefits of endoscopic suturing.
OverStitch Sx removes this access limitation, and once available, the combination of the current version of OverStitch and OverStitch Sx will provide most physicians with access to the benefits of full-thickness flexible endoscopic suturing regardless of their hospital’s selection of endoscopic capital equipment or endoscope manufacturer.
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 device company focused on less invasive therapies for the treatment of obesity, a condition facing over 650 million people globally, as well as other gastrointestinal conditions. 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 ORBERA® Intragastric Balloon, and the LAP-BAND® Adjustable Gastric Banding System.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol “APEN.” For more information regarding Apollo, go to: www.apolloendo.com.
© 2018 Apollo Endosurgery, Inc. All rights reserved. Any third-party trademarks used herein are the property of their respective owners.
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: reports of adverse events related to our products, 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, 2017, its Form 10-Q for the three months ended March 31, 2018, and its Form 424B5 Prospectus filed June 21, 2018. 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.