AUSTIN, TX / ACCESSWIRE / May 18, 2022 / Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today that Apollo products and procedures that utilize Apollo products will be featured in more than 40 academic posters and videos and over 60 podium presentations and lectures at the upcoming Digestive Disease Week 2022 to be held in San Diego, May 21-24.
Highlights include:
- Full presentation of the MERIT study of the Endoscopic Sleeve Gastroplasty (ESG) procedure’s impact on obesity (Presentation 995)
- 5-year follow-up data for Endoscopic Sleeve Gastroplasty (Presentation 687)
- Endoscopic Sleeve Gastroplasty in Class III Obesity (Presentation 996)
- A systemic review and meta-analysis comparison of ESG and laparoscopic sleeve gastrectomy (Presentation 51)
- Revisional Endoscopic Sleeve Gastroplasty and GLP-1 agonist medications (Presentation 295)
- A multicenter study of the efficacy, feasibility and safety of the X-Tack® Endoscopic HeliX Tacking System (Presentation 388)
- Closure of colonic EMR defects using the X-Tack® Endoscopic HeliX Tacking System (Su1434)
“Apollo Endosurgery’s products and our customers have played a critical role in driving the field of therapeutic endoscopy forward, to the betterment of patient care,” commented Chas McKhann, President and CEO of Apollo. “We are excited to have so many posters and presentations reporting on the expanding and increasingly diverse use of Apollo’s products. We anticipate several key milestones in the coming months will further expand use and adoption of our entire portfolio of endoscopic technologies.”
Included with these presented works will be the full data from the landmark Multi-center ESG Randomized Interventional Trial (MERIT). ESG is a minimally invasive procedure that uses the OverStitch® Endoscopic Suturing System to reduce the volume of a person’s stomach. The preliminary MERIT results reported in October at the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) revealed that patients who underwent ESG demonstrated an excess body weight loss (EWL) of 49.2% (+32%) at 12 months, which was a 45% difference in %EWL compared to patients undergoing moderate intensity lifestyle modification.
Presentation of the full MERIT dataset will provide additional information on patient responses to ESG and add to a larger body of evidence of more than 250 publications and abstracts reporting positive outcomes after ESG in over 6,500 patients(1).
Apollo has submitted a De Novo classification request to the U.S. Food and Drug Administration seeking 510(k) classification and clearance for the Apollo ESGTM and Apollo REVISETM devices.
Key Abstracts of Interest at DDW 2022 (partial list)
All programs are listed in Pacific Time and will take place at the San Diego Convention Center. For more information, visit Apollo at booth #4251. Research represents a mix of independent and sponsored work.
GI Defect Closure
Prospective study of utility of OverStitch Sx Endoscopic Suturing System to close large defects after endoscopic submucosal dissection: Dr. Mohamed O. Othman will present on Saturday, May 21, 2022, 12:30-1:30pm in the Poster Hall (#1692).
Efficacy, feasibility and safety of the X-Tack Endoscopic HeliX Tacking System: a multicenter experience: Dr. Reem Sharaiha will present on Sunday, May 22, 2022 at 10:00am in Room 33.
A novel through-the-scope helix tack and suture device for mucosal defect closure following colorectal endoscopic submucosal dissection (ESD): a multicenter study: Dr. Jad Farha will present on Sunday May 22, 2022, 12:30-1:30pm in the Poster Hall (#1449).
Novel through-the-scope suture closure of colonic EMR defects: Dr. Danse Bi will present on Sunday, May 22, 2022, 12:30-1:30pm in the Poster Hall (#1434).
“Holey moly”: comprehensive management of an eroded aortic prosthetic graft: Dr. Antoinette Hu will present on Tuesday, May 24, 2022 at 9:44am in Room 6DE during the ASGE Video Plenary Session II.
Through-the-scope suture closure of non-ampullary duodenal EMR defects: Dr. Jose Antonio Almario will present on Tuesday, May 24, 2022 at 4:50pm in Room 26.
Endobariatrics
Direct comparative efficacy and safety of endoscopic sleeve gastroplasty vs. laparoscopic sleeve gastrectomy: a systematic review and meta-analysis: Dr. Azizullah Beran will present on Saturday, May 21 at 9:00am in Room 9.
GLP-1 analogues in combination with revisional endoscopic sleeve gastroplasty: 24-month follow-up: Dr. Anna Carolina Hoff will present on Saturday, May 21, 2022 at 4:10pm in Room 5.
Medium term efficacy of the endoscopic transoral outlet reduction for weight regain and dumping syndrome after gastric bypass: Dr. Valerio Pontecorvi will present on Saturday, May 21, 2022 at 4:35pm in Room 5.
Combination therapy yields improved safety and similar efficacy compared to surgical revision for the management of weight regain following Roux-en-Y gastric bypass: Dr. Pichamol Jirapinyo will present on Saturday, May 21, 2022 at 4:55 in Room 5.
Intragastric balloon outcomes on diabetes, hypertension and dyslipidemia at 6 months: a systematic review and meta-analysis: Dr. Rahil Shah will present on Sunday, May 22, 12:30-1:30pm in the Poster Hall (#1613).
Endoscopic sleeve gastroplasty significantly reduces the comorbidities of the metabolic syndrome at 5 year follow-up: Dr. Donevan Westerveld will present on Monday, May 23 at 2:54pm in Room 28ABC.
Endoscopic sleeve gastroplasty impact on obesity and comorbidities: results from a US prospective, multicenter, randomized clinical trial with 104 weeks follow-up: Dr. Barham K. Abu Dayyeh will present on Tuesday, May 24 at 10:00am in Room 2.
Endoscopic sleeve gastroplasty in class III obesity: weight loss and metabolic outcomes in 339 consecutive patients: Dr. Christopher McGowan will present on Tuesday, May 24 at 10:10am in Room 2.
About the MERIT Study
The MERIT study is a multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of the ESG procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo’s OverStitch® Endoscopic Suturing System compared to a medically monitored regimen of diet and healthy lifestyle. The co-principal investigators are Dr. Erik Wilson, University of Texas at Houston (Houston, TX), and Dr. Barham Abu Dayyeh, Mayo Clinic, (Rochester, MN) under a collaborative research agreement sponsored by Apollo. More information can be found at clinicaltrials.gov (NCT03406975).
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 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 SxTM Endoscopic Suturing System, and the Orbera® Intragastric Balloon System.
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 March 31, 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
(1)Apollo Endosurgery internal meta-analysis of published ESG studies
CONTACT:
Apollo Endosurgery, Inc.
Jeff Black, 512-279-5126
[email protected]
Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
[email protected]
SOURCE: Apollo Endosurgery, Inc.
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