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AUSTIN, TX / ACCESSWIRE / June 14, 2021 / Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ: APEN), a worldwide chief in minimally invasive medical gadgets for gastrointestinal and bariatric procedures, introduced that investigators of the Multi-Heart ESG Randomized Interventional (MERIT) examine have reported based mostly on a preliminary evaluation the profitable achievement of the examine’s major endpoints.
In a presentation on the 2021 Surgical Disruptive Applied sciences Summit assembly in Houston, Texas, Dr. Barham Abu Dayyeh, Professor of Medication and Director of Superior Endoscopy on the Mayo Clinic, commented, “I’m very happy to report that, in a preliminary evaluation, the MERIT examine evaluating the Endoscopic Sleeve Gastroplasty (ESG) process to medically supervised average depth life-style modification has achieved its major endpoints for each efficacy and security. We hope to current the detailed examine outcomes at a global medical convention later this 12 months.”
The MERIT examine (NCT03406975) is a multi-center, potential randomized medical trial evaluating the protection and effectiveness of the ESG process, a minimally invasive, endoscopic weight reduction process carried out with Apollo Endosurgery’s OverStitch” Endoscopic Suturing System in comparison with a medically monitored routine of food plan and wholesome life-style. The Co-Major Investigators are Dr. Erik Wilson, College of Texas at Houston (Houston, TX), and Dr. Barham Abu Dayyeh, Mayo Clinic, (Rochester, MN) beneath a collaborative analysis settlement sponsored by Apollo Endosurgery. The examine’s major efficacy endpoint is % extra physique weight reduction (%EBWL) vs. management, and the first security endpoint is a critical opposed occasion charge of lower than 5%. Moreover, sufferers present process ESG are being evaluated for enchancment in hypertension and kind 2 diabetes at 24 months.
The MERIT examine investigators have submitted an summary to the Worldwide Federation for the Surgical procedure of Weight problems and Metabolic Problems (IFSO), and if accepted, the total outcomes shall be offered on the IFSO annual assembly in Miami in October.
“We’re delighted that the Mayo Clinic’s preliminary evaluation confirmed the profitable achievement of the MERIT examine’s major endpoints for weight reduction and security, and we sit up for the publication of the total MERIT outcomes offering an necessary addition to the substantial physique of proof for the ESG process,” stated Chas McKhann, President and CEO of Apollo Endosurgery. “We plan to make the most of the MERIT examine outcomes, together with actual world proof, in a submission to the FDA to probably add a brand new indication for ESG.”
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical expertise firm centered on improvement of next-generation, much less invasive gadgets to advance therapeutic endoscopy designed to deal with quite a lot of gastrointestinal situations together with closure of gastrointestinal defects, managing gastrointestinal problems and the remedy of weight problems. Apollo’s device-based therapies are a substitute for invasive surgical procedures, thus decreasing complication charges and decreasing whole healthcare prices. Apollo’s merchandise are provided in over 75 nations at present and embrace 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 widespread inventory is traded on NASDAQ World Market beneath the image “APEN”. For extra info relating to Apollo Endosurgery, go to: www.apolloendo.com.
Cautionary Word on Ahead-Trying Statements
Sure statements on this press launch are forward-looking statements which are topic to dangers and uncertainties that would trigger outcomes to be materially completely different than expectations, together with Apollo’s expectations relating to the ultimate evaluation of the MERIT examine information supporting the conclusions of the preliminary evaluation and Apollo’s plan to make the most of the MERIT examine ends in a submission to the FDA to probably add a brand new indication for ESG. Necessary elements that would trigger precise outcomes to vary materially embrace: additional evaluation of the MERIT examine information could end in a unique conclusion relating to the achievement of the first endpoints for weight reduction and security; the affect of the continued COVID-19 pandemic and the impact it could have on Apollo’s operations, the demand for the Apollo’s merchandise, Apollo’s liquidity place, world provide chains and financial exercise basically; studies of opposed occasions associated to our merchandise, outcomes of medical research associated to our merchandise; improvement of aggressive merchandise or procedures; regulatory approvals and intensive regulatory oversight by the FDA or different regulatory authorities; unfavorable media protection associated to our merchandise or associated procedures; protection and reimbursement selections by personal or authorities payors; Apollo’s skill to help the adoption of its merchandise and broaden its product portfolio; the potential measurement of Apollo’s addressable markets; the execution of our gross margin enchancment initiatives; the supply of money for Apollo’s future operations in addition to different elements detailed in Apollo’s periodic studies filed with the Securities and Trade Fee, or SEC, together with its Form 10-K for the year ended December 31, 2020 and its Type 10-Q for the interval ending March 31, 2021. Copies of studies filed with the SEC are posted on Apollo’s web site and can be found from Apollo with out cost. These forward-looking statements are usually not ensures of future efficiency and converse solely as of the date hereof, and, besides as required by regulation, Apollo disclaims any obligation to replace these forward-looking statements to replicate future occasions or circumstances.
Apollo Endosurgery, Inc.
Stefanie Cavanaugh, 512-279-5100
Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
SOURCE: Apollo Endosurgery, Inc.
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