Publication of MERIT Study Follows FDA Market Authorization of Apollo ESG™

AUSTIN, TX / ACCESSWIRE / July 29, 2022 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today the electronic publication of the landmark Multi-center ESG Randomized Interventional Trial (MERIT) Study in The Lancet.(1) The MERIT study is a multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of the Endoscopic Sleeve Gastroplasty (ESG) procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo's Endosurgery's OverStitch® Endoscopic Suturing System. In the study, patients with Body Mass Index (BMI) ≥30 and ≤40 kg/m² were randomized to treatment with ESG and lifestyle modification or to a control group which involved lifestyle modification alone. At the conclusion of the primary end point (52 weeks), qualifying patients in the control group were allowed to cross-over to ESG if they met certain conditions. Nine US centers participated in the study, representing both gastroenterology and bariatric surgery practices from academic and community settings. One hundred and fifty-seven subjects completed the study through 52 weeks of follow-up (68 treatment and 89 control subjects). Seventy-two control patients crossed over to treatment at 52 weeks, and both groups were followed an additional 52 weeks. Key results for patients undergoing ESG include:

• 49.2% excess body weight loss at 12 months in the treatment group (vs 3.2% EWL in control)
• 16.3% average total body weight loss in the responder group
• 68.3% of responders maintained at least 25% EWL at 104 weeks
• Improvements in quality of life, eating behaviors, and depression
• Three ESG patients (2.0%) experienced a device or procedure related serious adverse event, all of which resolved and did not require intensive care or surgical intervention.(2)

"In addition to weight loss, the MERIT study demonstrated clinically meaningful improvements in obesity related comorbidities," stated Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at Mayo Clinic and one of the co-principal investigators. "This procedure is a global advancement in the fields of bariatrics and endoscopy." " After decades of research in the field of bariatric endoscopy, we finally have an endoscopic procedure that has proven to be safe, effective, and durable out to at least two years in a randomized controlled trial," stated Dr. Erik Wilson, Professor and Vice Chair of Surgery at The University of Texas Health Science Center at Houston and the other co-principal investigator. "The ESG procedure will be an important tool for both surgeons and gastroenterologists to help address the global obesity epidemic." The full publication of MERIT adds to more than 250 publications and abstracts reporting outcomes in over 10,000 individual patients undergoing ESG procedures.(3) The Lancet publication follows closely on the heels of 120 lectures, presentations, and posters featuring Apollo products at Digestive Disease Week earlier this year. "The publication of this randomized trial in such a high impact and influential journal as The Lancet speaks to the significance of its findings and implications for patients who suffer from obesity," commented Chas McKhann, President and CEO of Apollo. "The results of the study are a strong testament to the opportunity that we have at Apollo to expand the therapeutic spectrum of obesity and metabolic care to affect real change in the obesity epidemic." To read the full publication, visit https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01280-6/fulltext. More information on the MERIT study can be found at clinicaltrials.gov (NCT03406975). On July 12, 2022, following a De Novo Classification review, the U.S. Food and Drug Administration (FDA) authorized the marketing of the Apollo ESG™ and Apollo REVISETM Systems, the first and only FDA-authorized systems for ESG and endoscopic bariatric revision.