Apollo Endosurgery Announces 510k Submission for the X-Tack(TM) Endoscopic HeliX Tacking System for the Treatment of Gastrointestinal Defect Closures
AUSTIN, TX / ACCESSWIRE / July 7, 2020 / Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced today the 510k submission of the X-Tack™ Endoscopic HeliX Tacking System to the U.S. Food and Drug Administration seeking clearance for the new, through-the-scope, suture-based device designed specifically for closing defects in the lower gastrointestinal tract with additional applications in the upper gastrointestinal tract.
“Endoscopists have long expressed a desire and need for improved and more robust closure devices, especially for tissue defects created during resection or dissection procedures in the colon. X-Tack was designed to meet this need and provide endoscopists with an advanced suture-based tool to address potential complications and risks following an endolumenal procedure such as the risk of delayed bleeding,” stated Todd Newton, Apollo’s Chief Executive Officer. “X-Tack will expand our endolumenal portfolio with a solution for the lower GI tract. Additionally, we expect X-Tack will have application during certain upper gastrointestinal procedures as well.”
Designed for compatibility with market leading gastroscopes and colonoscopes, X-Tack can be implanted using any working channel. Therefore, physicians will have on-demand access to the benefits of through-the-scope, suture-based fixation during their upper or lower gastrointestinal therapeutic procedures.
The X-Tack device enables physicians to place a series of individual HeliX Tacks into healthy tissue adjacent to a defect. Each HeliX Tack is tethered with a single polypropylene suture. Pulling tension on the suture approximates the HeliX Tacks and in turn closes the tissue defect. A suture cinch is then used as the final step to secure the suture in place. Because it offers multiple points of fixation, the X-Tack is expected to enhance a physician’s ability to address the closure challenges of commonly encountered large or irregularly shaped defects.
“Depending on a lesion’s size, shape and location in the gastrointestinal tract, closing a resection site can often be challenging for an endoscopist,” says Andrew Storm, MD, Assistant Professor of Medicine and Advanced Endoscopist at Mayo Clinic in Rochester, Minnesota. “The X-Tack System successfully addresses a number of these challenges and makes difficult or previously impossible closures both feasible and more efficient for physicians – it combines the convenience of a clip with the flexibility of suturing through a standard gastroscope or colonoscope.”
Approximately 20 million endoscopic procedures are performed in the United States every year in the lower gastrointestinal tract. With the increasing rate of colonoscopy screenings, improved technology for early cancer detection, and growth in therapeutic treatments, endoscopic removal of benign colorectal lesions provides a minimally invasive, cost effective alternative to surgery.
The submission of the 510k is followed by a regulatory review of the 510k which could result in questions or requests for additional information, changes to the intended use, or additional testing. The timing for concluding the 510k review and clearance process is therefore uncertain and will depend on the nature of the FDA’s comments. While management believes the 510k submission incorporates FDA’s guidance there are no assurances as to whether, when or under what conditions that FDA will clear the 510k. When the FDA is satisfied that the X-Tack has met the standard for ‘substantial equivalence,’ the company will receive a letter from FDA granting clearance to market and sell the product in the United States at which time a 510k summary will be posted on the FDA website.
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 75 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: delays or denials of regulatory approvals, extensive regulatory oversight by the FDA or other regulatory bodies, reports of adverse events related to our products, outcomes of clinical studies, developments in medical technology, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of our products or 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, 2019 and its Form 10-Q for the three months ended March 31, 2020. 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.
Apollo Endosurgery, Inc.
Stefanie Cavanaugh, 512-279-5100
Darrow Associates Investor Relations
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SOURCE: Apollo Endosurgery, Inc.