Apollo Endosurgery Receives FDA Clearance for the X-Tack(TM) Endoscopic HeliX Tacking System

Rhea-AI Summary

Apollo Endosurgery (NASDAQ:APEN) announced FDA 510(k) clearance of its X-Tack™ Endoscopic HeliX Tacking System on December 15, 2020. This innovative suture-based device addresses challenges in closing defects in the gastrointestinal tract, particularly large or irregular ones. A limited launch is set for January 2021, followed by a full launch in late Q1 2021. The device aims to enhance healing and reduce complications post-polypectomy, catering to the growing demand for minimally invasive procedures as around 20 million endoscopic procedures occur annually in the U.S.

Positive

• FDA clearance for the X-Tack™ device enhances Apollo's product offerings.
• Device addresses a significant need in closing gastrointestinal defects.
• Limited launch is expected in January 2021, potentially increasing market presence.

Negative

• None.

AUSTIN, TX / ACCESSWIRE / December 15, 2020 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced today U.S. Food and Drug Administration 510k clearance of the X-Tack™ Endoscopic HeliX Tacking System. X-Tack is a new, through-the-scope, suture-based device designed specifically for closing and healing defects in the lower gastrointestinal tract with additional applications in the upper gastrointestinal tract.

The X-Tack device enables physicians to easily address the challenges commonly encountered when closing large or irregularly shaped defects. The procedure involves suture-tethered HeliX Tacks, independently positioned into healthy tissue adjacent to a defect, then cinched to close the construct. X-Tack fulfills a long-expressed need for advanced closure devices to improve healing and address potential adverse events that can occur following colonic polypectomy and mucosal resections, such as delayed bleeding or perforation.

Apollo plans to initiate a limited launch with select gastroenterologists beginning January 2021, to be followed by a full launch planned for late in the 1^st quarter of 2021.

"The X-Tack System fills a substantial gap in the ability of endoscopists to close full thickness defects, particularly large or irregular colonic and small bowel resection sites. It has the potential for making a significant impact in other procedures as well," says, Stavros Stavropoulos, MD, Director of Endoscopy, NYU-Winthrop Hospital. "X-Tack is a highly versatile technology that has the potential to revolutionize our tissue approximation capabilities during endoscopic surgery. I am looking forward to exploring the diverse applications of this technology and the possible benefits to our patients."

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. As the complexity of polyp removal sites expand, endoscopy societies are recommending preventative closure of removal sites to decrease the patient risk of delayed bleeding, especially in the large number of colonoscopy patients who are taking blood thinning medications.

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 X-Tack™ Endoscopic HeliX Tacking System, 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: physician adoption and recommendations of our products or procedures utilizing our products, 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, delays or denials of regulatory approvals, extensive regulatory oversight by the FDA or other regulatory bodies, 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 September 30, 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.

Contact:

Apollo Endosurgery, Inc.
Stefanie Cavanaugh, 512-279-5100
investor-relations@apolloendo.com

Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
mkreps@darrowir.com

SOURCE: Apollo Endosurgery, Inc.

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FAQ

What is the X-Tack™ Endoscopic HeliX Tacking System?

The X-Tack™ is a suture-based device designed for closing and healing defects in the lower gastrointestinal tract.

When will the X-Tack™ be launched?

A limited launch is planned for January 2021, followed by a full launch in late Q1 2021.

What company is behind the X-Tack™ device?

The X-Tack™ device is developed by Apollo Endosurgery, Inc.

How does the X-Tack™ improve gastrointestinal procedures?

It helps close full thickness defects, reducing the risk of complications like delayed bleeding and perforation.

What potential impact does the FDA clearance have for Apollo Endosurgery?

The FDA clearance could enhance Apollo's market presence and revenue potential through increased physician adoption.