Apollo Endosurgery Announces Completion of Patient Enrollment for the Multi-Center ESG Randomized Interventional Trial (MERIT)
AUSTIN, Texas — (BUSINESS WIRE) — Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a leader in less invasive medical devices for gastrointestinal and bariatric procedures, today announced that the final patient has been enrolled in the Multi-Center ESG Randomized Interventional Trial (MERIT). The US based, prospective randomized multi-center-controlled trial is evaluating the effectiveness of the endoscopic sleeve gastroplasty (“ESG”) procedure.
ESG is an endoscopic minimally invasive weight loss procedure based on full-thickness endoscopic suturing using Apollo’s OverStitch™ device. In the ESG procedure, a series of sutures are placed through the gastric wall reducing the stomach volume by up to 80% creating a restrictive endoscopic sleeve. The result allows a patient to consume less food and remain satiated longer.
The purpose of the study is to demonstrate weight loss and quality of life at 12 months following the ESG procedure when compared to lifestyle modifications alone. Additionally, improvement in hypertension and type 2 diabetes at 24 months versus control will be measured. The MERIT-Trial is being conducted at nine sites in the United States. The trial’s safety and effectiveness endpoints are based on endpoints set forth in a consensus statement of the American Society of Gastrointestinal Endoscopy (ASGE) and the American Society of Metabolic Bariatric Surgery (ASMBS) and its impact on obesity related co-morbidities in patients with obesity and body mass index (BMI) between 30 – 45 kg/m².
The trial enrolled two hundred patients (80 treatment / 120 control), stratified into three groups (Obesity, Obesity with hypertension, Obesity with diabetes). ESG participants who do not achieve the endpoints will receive a repeat upper endoscopy at 52 weeks +/- 4 weeks to evaluate stitch placement and thereafter remain in follow-up for twelve additional months. Control participants will follow a low-calorie, healthy lifestyle intervention for twelve months and then may be eligible for crossover to receive the ESG procedure.
The OverStitch endoscopic suturing system enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures from a flexible endoscope. This new technology enables a secure approximation of tissue endoscopically and a wide range of less invasive solutions for physicians who treat defects in both the upper and lower GI tract of their patients. Additionally, physicians are leveraging endoscopic suturing to perform a variety of advanced bariatric procedures. For more information regarding OverStitch go to: www.apolloendo.com.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies to treat various gastrointestinal conditions, ranging from gastrointestinal defect repairs to the interventional 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 70 countries today and include the OverStitch™ Endoscopic Suturing System, the OverStitch Sx™ Endoscopic Suturing System, and the ORBERA® Intragastric Balloon.
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.
Cautionary Note on 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. Important factors that could cause actual results to differ materially include: reports of adverse events related to our products, outcomes of clinical studies, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2018 and its Form 10-Q for the three months ended March, 31, 2019. 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.