Apollo Endosurgery Announces Publication of Pre-Clinical Results for X-Tack(TM) Endoscopic HeliX Tacking System

Authors conclude, "Compared to TTS clip, X-Tack is superior for effecting large mucosal defect closure, including durable sealing of full-thickness perforation."

AUSTIN, TX / ACCESSWIRE / April 21, 2021 / Apollo Endosurgery, Inc. ("Apollo") (Nasdaq:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced the publication of supporting pre-clinical results for 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 upper and lower gastrointestinal (GI) tract.

The X-Tack device enables physicians to reliably overcome the challenges commonly encountered when closing large or irregularly shaped defects.

This innovative closure system fulfills a long-expressed need for advanced closure devices to improve healing and address potential adverse events, such as delayed bleeding and perforation, that can occur following colonic polypectomy and mucosal resections.

X-Tack underwent a rigorous animal study performed at the Mayo Clinic Developmental Endoscopy Research Unit led by Andrew Storm, MD, Assistant Professor of Medicine and Advanced Endoscopist at Mayo Clinic in Rochester, Minnesota. In the study, the X-Tack device was compared to through-the-scope clips (TTS clips), the standard of care, for their ability to close defects ranging in size from 2-5 cm in both the upper and lower GI tract. Technical closure success was achieved in 100% of defects (24/24) treated with X-Tack compared to 81.3% (13/16) with TTS clips. Both groups demonstrated equivalent healing at one month. However, defects that could not be closed with TTS clips, due to the size or geometry of the defect, were successfully closed with X-Tack. The X-Tack results, for both lower and upper gastrointestinal sites, were consistent with complete healing, and the authors concluded, "Compared to TTS clip, X-Tack is superior for effecting large mucosal defect closure, including durable sealing of full-thickness perforation." Study results are available through Endoscopy International Open (Thieme).[1]

"Building off our pre-clinical experience, we began integrating X-Tack into our clinical practice early this year and are very encouraged by clinical use of the device to date. Not only has X-Tack performed as intended for closure of standard mucosal defects after polypectomy, but also in very large resection site closure, for closure of perforations of the GI tract, and across a range of other interventions and indications," said Andrew Storm, MD. "Most importantly, we are using the device to the benefit of patients who would not have been candidates for other closure techniques due to complex anatomy, size of the defect, or other reasons. Our preclinical study, as well as a step-by-step instructional video and case report using X-Tack were recently published to share our experience with other endoscopists who are planning to integrate X-Tack into their clinical practice."[2]

"X-Tack offers physicians a powerful and easy to use tool to help improve clinical outcomes for their patients," said Chas McKhann, CEO and President at Apollo Endosurgery. "We are continually listening to what physicians need, and we are proud to now offer a suite of groundbreaking tools, including X-Tack and our OverStitch™ platform, to improve closure and approximation of soft tissue throughout the upper and lower GI tract."

Following successful completion of a limited launch with select gastroenterologists in Q1, X-Tack is now available for sale in the US.

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, less invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications and the 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 that are subject to risks and uncertainties that could cause results to be materially different than expectations. In addition, there is uncertainty about the continued spread of the COVID-19 virus and the impact it may have on the Company's operations, the demand for the Company's products, the Company's liquidity position, global supply chains and economic activity in general. 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, coverage and reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products as well as other factors detailed in Apollo's periodic reports filed with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 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.

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

[1] *Hernandez, Storm, et al "Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model". Endosc Int Open 2021; 09: E572-E577
[2] **Hernandez, Storm, et al "Step-by-step instruction: using an endoscopic tack and suture device for gastrointestinal defect closure". Video GIE, April 5, 2021

SOURCE: Apollo Endosurgery, Inc.

 


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