Study results show that the ESG procedure provides significant and lasting weight loss with improvements in obese health conditions
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The MERIT study met its primary endpoints of safety and efficacy, with patients undergoing endoscopic tube gastroplasty (ESG) experiencing an excessive body weight loss of 49.2% at 12 months and a serious adverse event rate of 2%.
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Patients who underwent ESG also had clinically significant reductions in diabetes, hypertension, and metabolic syndrome at 12 months
AUSTIN, TX / ACCESSWIRE / October 22, 2021 / Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ: APEN), a leading global provider of minimally invasive medical devices for gastrointestinal and bariatric surgery, announced today that the investigators in the Multi-Center ESG Randomized Interventional Trial (MERIT) have received positive results have submitted.
Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at Mayo Clinic, presented the data to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) during the Top 10 Papers at IFSO session.
The most important highlights include:
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Study methods: The study enrolled 208 patients from nine US centers. Patients were randomized between ESG and moderate lifestyle changes. The mean BMI at admission was 35.7 ± 2.6 kg / m2. The primary efficacy endpoint was percent weight loss (% EWL) and responders were defined as those who achieved an EWL of at least 25% after 12 months. The study targeted a serious adverse event rate of <5%, which was the primary safety endpoint. Patients were followed up for 24 months, with controls having the option to switch after 12 months.
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effectiveness: Patients who underwent endoscopic sleeve gastroplasty (ESG) showed a weight loss (EWL) of 49.2% (+ 32%) after 12 months, which is a difference of 45% in% EWL compared to patients with moderate Lifestyle change equates. In addition, 77% of patients who underwent ESG achieved an EWL of at least 25%, and the percent total body weight loss (% TBWL) for this responder group was 16.3% (+ 7%).
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Effects on comorbidities: Patients who underwent ESG showed improvements in diabetes, hypertension, and metabolic syndrome, as well as improvement and no incidence of gastroesophageal reflux disease (GERD) compared to controls.
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safety: ESG met the primary safety endpoint with a serious adverse event rate of 2.0% (3/150), all of which resolved and did not require intensive care or surgery[i].
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durability: Despite the global pandemic in the second year, cross-over patients had similar results to the first treatment group, and those who received treatment retained most of their weight loss after 24 months.
“The MERIT results are compelling and the medical community is eager to find new treatment options to address the global obesity problem,” said Dr. Abu Dayyeh. “Endoscopic sleeve gastroplasty offers a scalable, safe, effective and organ-preserving solution that can be performed in an outpatient facility by either a gastroenterologist or a bariatric surgeon. In addition, the ESG procedure can be combined with other therapeutic options to further improve patient outcomes. “
The story goes on
ESG is a minimally invasive (non-surgical) weight loss procedure that uses the OverStitch ™ endoscopic suturing system to reduce a person’s stomach volume. The MERIT data complement a larger ESG evidence from more than 200 publications and abstracts reporting positive results in over 6,500 patients[ii].
Global obesity has almost tripled since 1975, with more than 650 million people now considered obese[iii]. In the US, more than 100 million adults are obese, more than 40 percent of the adult population[iv]. Obesity-related diseases such as heart disease, stroke, type 2 diabetes and certain cancers are among the leading causes of preventable, premature death. Obesity costs the US healthcare system more than $ 170 billion annually[v]. Yet less than one percent of obese patients are treated with bariatric weight loss surgery each year.
“This is a significant milestone for Apollo in our mission to dramatically affect chronic obesity and obesity-related health conditions that continue unabated around the world,” said Chas McKhann, President and CEO of Apollo Endosurgery. “The MERIT results confirm that the ESG procedure offers a compelling value proposition of clinically significant weight loss through a safe, convenient, outpatient procedure. We look forward to our continued collaboration with the FDA following our recently filed De Novo 510 (k) filing as we seek regulatory approval to recognize ESG as a potential treatment option for people with obesity. “
About the MERIT study
The MERIT Study (NCT03406975, FDA IDE G190189) is a multicenter, prospective, randomized clinical trial evaluating the safety and effectiveness of the ESG procedure, a minimally invasive, endoscopic weight loss procedure that uses the OverStitch® Endoscopic Suturing System from Apollo Endosurgery im Compared to a medically supervised diet and healthy lifestyle. The lead investigators are Dr. Erik Wilson, University of Texas at Houston (Houston, TX) and Dr. Barham Abu Dayyeh, Mayo Clinic (Rochester, MN) as part of an Apollo Endosurgery sponsored research collaboration. The primary efficacy endpoint of the study is to achieve a weight loss of at least 25% (% EBWL) at 12 months and an EWL of at least 15% compared to control at 12 months, and the primary safety endpoint is a rate of serious adverse reactions less than 5%. Serious adverse events were those that scored a “3” or higher on the Clavien-Dindo classification. In addition, patients undergoing ESG will be assessed for improvement in high blood pressure and type 2 diabetes after 24 months.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on developing next generation minimally invasive devices to advance therapeutic endoscopy, which has been developed to treat a variety of gastrointestinal disorders, including gastrointestinal occlusion Defects, the treatment of gastrointestinal complications, and the treatment of obesity. Apollo’s device-based therapies provide an alternative to invasive surgical procedures, reducing complication rates and lowering overall healthcare costs. Apollo’s products are now available in over 75 countries and include the X-Tack® endoscopic HeliX stapling system, OverStitch® endoscopic suture system, OverStitch Sx® endoscopic suture system and the ORBERA® intragastric balloon.
Legal notice on forward-looking statements
Certain statements in this press release are forward-looking statements that involve risks and uncertainties that could cause results to differ materially from expectations, including Apollo’s expectations regarding the final publication of the MERIT study data, the presentation and use of the MERIT -Study leads to an application to the FDA to potentially add a new indication for ESG. Important factors that could cause actual results to differ materially are: Further analysis and full publication of the MERIT study data may lead to additional information, conclusions or a characterization of the achievement of the study objective and endpoints; the impact of the ongoing COVID-19 pandemic and the potential impact on Apollo’s operations, demand for Apollo’s products, Apollo’s liquidity position, global supply chains, and economic activity in general; Reports of adverse events related to our products, results of clinical studies related to our products; Development of competitive products or processes; regulatory approvals and extensive regulatory oversight from the FDA or other regulatory agencies; unfavorable media coverage regarding our products or related processes; Coverage and reimbursement decisions by private or government payers; Apollo’s ability to support the launch of its products and expand its product portfolio; the potential size of Apollo’s addressable markets; the execution of our gross margin improvement projects; the availability of cash for Apollo’s future operations; and other factors identified in Apollo’s periodic reports filed with the Securities and Exchange Commission (SEC), including Form 10-K as of December 31st Year ended 2020 and Form 10-Q for the period ends June 30, 2021. Copies of the reports filed with the SEC will be posted on the Apollo website and are available free of charge from Apollo. These forward-looking statements are not guarantees of future performance and speak only as of the date of this release and, except as required by law, Apollo disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
[i] There were three serious adverse events (2%): a perigastric abscess, bleeding, and malnutrition. All were successfully endoscopically treated without the need for an intensive care unit or formal surgery. While most of the patients received ESG on an outpatient basis, six patients (4%) were admitted to hospital for a short period of time because of non-serious side effects in order to cope with their difficulties with the accommodation of a reduced stomach volume. [ii] Apollo Endosurgery internal meta-analysis of published ESG studies [iii] World Health Organization (June 2021) [iv] Centers for Disease Control and Prevention (February 2020) [v] US News and World Report (March 2021)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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