MERIT Study Investigators Announce Successful Achievement of the Study's Primary Efficacy & Safety Endpoints

AUSTIN, TX / ACCESSWIRE / June 14, 2021 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced that investigators of the Multi-Center ESG Randomized Interventional (MERIT) study have reported based on a preliminary analysis the successful achievement of the study's primary endpoints.

In a presentation at the 2021 Surgical Disruptive Technologies Summit meeting in Houston, Texas, Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, commented, "I am very pleased to report that, in a preliminary analysis, the MERIT study comparing the Endoscopic Sleeve Gastroplasty (ESG) procedure to medically supervised moderate intensity lifestyle modification has achieved its primary endpoints for both efficacy and safety. We hope to present the detailed study results at an international medical conference later this year."

The MERIT study (NCT03406975) 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 Endosurgery's OverStitch™ Endoscopic Suturing System compared to a medically monitored regimen of diet and healthy lifestyle. The Co-Primary 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 Endosurgery. The study's primary efficacy endpoint is percent excess body weight loss (%EBWL) vs. control, and the primary safety endpoint is a serious adverse event rate of less than 5%. Additionally, patients undergoing ESG are being evaluated for improvement in hypertension and type 2 diabetes at 24 months.

The MERIT study investigators have submitted an abstract to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), and if accepted, the full results will be presented at the IFSO annual meeting in Miami in October.

"We are delighted that the Mayo Clinic's preliminary analysis showed the successful achievement of the MERIT study's primary endpoints for weight loss and safety, and we look forward to the publication of the full MERIT results providing an important addition to the substantial body of evidence for the ESG procedure," said Chas McKhann, President and CEO of Apollo Endosurgery. "We plan to utilize the MERIT study results, along with real world evidence, in a submission to the FDA to potentially add a new indication for ESG."