OverStitch has new indications for use statement under CE-Mark, including indications for defect closure, stent fixation, endoscopic sleeve gastroplasty and transoral outlet reduction
AUSTIN, TX / ACCESSWIRE / November 21, 2022 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today that it has successfully transitioned its legacy products to CE Mark under the European Medical Device Regulation (MDR). The new certificates were issued by British Standards Institute and were received by the company on November 17, 2022. The certificates are valid for five years.
Importantly, as part of the transition to EU MDR, the OverStitch system has a new, more specific, intended use statement in the Instructions For Use (IFU) in CE-Mark countries, reading as follows:
"The OverStitch™ Endoscopic Suture System is indicated for the endoscopic placement of anchor sutures. Anchor-sutures can be placed for defect closure (e.g., perforation, ESD/EMR, and fistula/leak), stent fixation to reduce migration rates in the upper GI tract, endoscopic sleeve gastroplasty, and transoral outlet reduction."
David Hooper, PhD, Apollo's Vice President of Quality and Regulatory, remarked, "It has been a rigorous process to meet the new MDR requirements and complete the reviews. We are very pleased that the intended use statement for our OverStitch products has been revised to specifically identify defect closure, stent fixation, endoscopic sleeve gastroplasty and transoral outlet reduction."
"This is a significant milestone for Apollo. David and his team have done a remarkable job navigating the complexities of these requirements over the past year," commented Chas McKhann, President and CEO of Apollo. "The successful transition to EU MDR mitigates the risk of significant business interruptions that this process poses for any medical device company with operations in Europe. In addition, the new European intended use statement for OverStitch is a positive development as it accurately reflects the range of procedures for which these devices are routinely used."
The new certificates will soon be posted at www.apolloendo.com.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, minimally invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions, including closure of gastrointestinal defects, managing gastrointestinal complications, and weight loss as a 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 SxTM Endoscopic Suturing System, the Orbera® Intragastric Balloon System, the X-Tack® Endoscopic HeliX Tacking System, as well as the Apollo ESGTM, Apollo ESG SxTM, Apollo REVISETM and Apollo REVISE SxTM Systems.
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.
Legal Notice Regarding 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 spread of the COVID-19 virus and the impact it may have on the Company's operations, the Company's financial outlook for future periods, 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: adverse events related to the Company's products, outcomes of clinical studies related to the Company's products, development of competitive medical products by competitors, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory authorities, unfavorable media coverage related to the Company's products or related procedures, coverage and reimbursement decisions by private or government payors, the Company's ability to support the adoption of its products and broaden its product portfolio 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, 2021 and its Form 10-Q for the period ended September 30, 2022. 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.
Jeff Black, Chief Financial Officer, 512-279-5126
investor-relations@apolloendo.com
Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
mkreps@darrowir.com
SOURCE: Apollo Endosurgery, Inc.
View source version on accesswire.com:
https://www.accesswire.com/727271/Apollo-Endosurgery-Completes-Transition-to-European-MDR-Requirements-for-the-OverStitch-Systems-BIB-and-Orbera-365-intragastric-balloons-and-OverTube
