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

Rhea-AI Summary

Apollo Endosurgery (NASDAQ:APEN) announced the successful preliminary analysis of the MERIT study, which compares the Endoscopic Sleeve Gastroplasty (ESG) procedure to medically supervised lifestyle modifications. The study achieved its primary endpoints for both effectiveness and safety, with results presented by Dr. Barham Abu Dayyeh at the 2021 Surgical Disruptive Technologies Summit. The study aims to provide insights into significant weight loss and improved health outcomes over 24 months. Apollo plans to use these results for potential FDA submissions.

Positive

• Successful preliminary analysis of the MERIT study achieving primary efficacy and safety endpoints.
• Potential for new indication submission to the FDA based on positive study results.

Negative

• Future analyses of MERIT data may yield different conclusions on efficacy and safety.
• Ongoing COVID-19 pandemic could impact operations and product demand.

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."

About Apollo Endosurgery, Inc.

Apollo Endosurgery, Inc. is a medical technology company focused on development of next-generation, less invasive devices to advance therapeutic endoscopy designed to treat a variety of gastrointestinal conditions including closure of gastrointestinal defects, managing gastrointestinal complications and the 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 X-Tack™ Endoscopic HeliX Tacking System, 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, including Apollo's expectations regarding the final analysis of the MERIT study data supporting the conclusions of the preliminary analysis and Apollo's plan to utilize the MERIT study results in a submission to the FDA to potentially add a new indication for ESG. Important factors that could cause actual results to differ materially include: further analysis of the MERIT study data may result in a different conclusion regarding the achievement of the primary endpoints for weight loss and safety; the impact of the ongoing COVID-19 pandemic and the effect it may have on Apollo's operations, the demand for the Apollo's products, Apollo's liquidity position, global supply chains and economic activity in general; reports of adverse events related to our products, outcomes of clinical studies related to our products; development of competitive products or procedures; regulatory approvals and extensive regulatory oversight by the FDA or other regulatory authorities; unfavorable media coverage related to our products or related procedures; coverage and reimbursement decisions by private or government payors; Apollo's ability to support the adoption of its products and broaden 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 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, 2020 and its Form 10-Q for the period ending March 31, 2021. 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.

Contact:

Apollo Endosurgery, Inc.
Stefanie Cavanaugh, 512-279-5100
investor-relations@apolloendo.com

Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
mkreps@darrowir.com

SOURCE: Apollo Endosurgery, Inc.

View source version on accesswire.com:
https://www.accesswire.com/651562/MERIT-Study-Investigators-Announce-Successful-Achievement-of-the-Studys-Primary-Efficacy-Safety-Endpoints

FAQ

What were the results of the MERIT study related to APEN?

The MERIT study reported successful achievement of its primary efficacy and safety endpoints, comparing the ESG procedure to lifestyle modifications.

When will the full results of the MERIT study be presented?

The full results are expected to be presented at the IFSO annual meeting in October.

What is the significance of the MERIT study for Apollo Endosurgery?

The MERIT study's positive results could support a submission to the FDA for a new indication for the ESG procedure.

Who conducted the MERIT study for APEN?

The study was co-led by Dr. Erik Wilson from the University of Texas and Dr. Barham Abu Dayyeh from Mayo Clinic.

What are the primary endpoints of the MERIT study?

The primary endpoints are percent excess body weight loss and a serious adverse event rate of less than 5%.