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.
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.
About Apollo ESG™ and Apollo REVISE™
The Apollo ESGTM and Apollo REVISETM Systems are intended to facilitate weight loss in patients with obesity (BMI 30-50 kg/m2) and are the first and only devices to be authorized by the FDA for performance of ESG and TORe, respectively. ESG and TORe are performed endoscopically without incisions or scars, allowing patients typically to go home the same day. More than 25,000 ESGs and more than 10,000 endoscopic revision procedures have been performed worldwide by gastroenterologists and surgeons. To review the full indications for use, visit www.apolloendo.com/dfus.
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) Abu Dayyeh BK, Bazerbachi F, Vargas EJ, et al. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. Vol 400. July 28, 2022. Epub ahead of print.
(2) The investigators cited three serious adverse events (2%): a peri-gastric abscess, bleeding, and malnutrition. All were treated successfully by endoscopy without need for intensive care or formal surgery. In addition, while most patients received the ESG as an outpatient procedure, six patients (4%) were briefly hospitalized for non-serious adverse events to manage their difficulties with accommodation of reduced gastric volume.
(3) Apollo Endosurgery internal meta-analysis of published ESG studies
Apollo Endosurgery, Inc.
Jeff Black, Chief Financial Officer, 512-279-5126
Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
SOURCE: Apollo Endosurgery, Inc.
View source version on accesswire.com: