Apollo Endosurgery Announces Two Important Milestones in the Advancement of Endoscopic Procedures for Patients Living with Obesity

Rhea-AI Summary

Apollo Endosurgery (NASDAQ:APEN) announced two significant milestones in its operational progress: the MERIT trial was recognized as a 2022 Top Story in Gastroenterology, highlighting a 77% success rate in weight loss with Apollo's ESG procedure, and four Apollo systems were approved by the ASMBS as FDA Approved Bariatric Devices. These advancements aim to enhance treatment options for obesity, facilitating procedures without IRB approval. The company's commitment to minimizing invasive treatments is reflected in its continued growth in the gastrointestinal and bariatric sectors.

Positive

• MERIT trial recognized as 2022 Top Story in Gastroenterology.
• 77% of ESG participants achieved 25% weight loss compared to 12% in the control group.
• Four Apollo systems added to the ASMBS list as FDA Approved Bariatric Devices.
• Procedures can now be performed without IRB approval at accredited centers.

Negative

• None.

MERIT Trial Selected as 2022 Top Story in Gastroenterology and ASMBS adds Apollo Systems to List of Approved Bariatric Devices

AUSTIN, TX / ACCESSWIRE / December 13, 2022 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today that the MERIT trial, published in The Lancet earlier this year⁽¹⁾, was selected as 2022 Top Story in Gastroenterology.⁽²⁾ Additionally, the American Society for Metabolic and Bariatric Surgery (ASMBS) formally added four Apollo systems to its list of FDA Approved Bariatric Devices on December 5.⁽³⁾ These milestones come only months after Apollo received FDA marketing authorization for Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx to facilitate weight loss in patients with obesity (BMI 30-50 kg/m²).

In the Expert Opinion article published in Gastroenterology announcing the selection of the MERIT trial as the 2022 story of the year, Dr. Steven A. Edmundowicz, Past President and Master of the American Society for Gastrointestinal Endoscopy (ASGE), highlighted the outcomes of the MERIT trial, including 77% of the ESG group reaching 25% or more excess weight loss versus 12% in control group, low adverse event rate managed without ICU care or surgery, and 80% of ESG group with improvement in one or more metabolic comorbidity. Dr. Edmundowicz also called for a "unified approach" among gastroenterology and surgical societies to support patients with obesity and in the pursuit of insurance coverage.

The selection of the MERIT trial follows just days after Endoscopic Sleeve Gastroplasty (Apollo ESG™, Apollo ESG Sx™ Endoscopic Suturing System) and Transoral Outlet Reduction (TORe) (Apollo Revise™ and Apollo Revise Sx™ Endoscopic Suturing System) were added to the FDA Approved Bariatric Devices list by ASMBS. ASMBS endorsed procedures and FDA approved medical devices do not require IRB approval in accredited MBSAQIP-Accredited centers. Physicians will now be able to perform these procedures with the FDA authorized devices at MBSAQIP accredited centers without the need for IRB approval; procedures will also be included in the MBSAQIP database.

"Apollo celebrates these important milestones and recognizes the diligence, efforts, and advocacy of many in advancing endobariatrics into the mainstream of care for patients with obesity," commented Chas McKhann, President and CEO of Apollo. "We are grateful for the continued support of both the gastroenterology and bariatric surgery communities in bringing awareness to the issue of obesity and the importance of expanded treatment options for patients."

About the MERIT Study

The MERIT study was 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's OverStitch® Endoscopic Suturing System, compared to a medically monitored regimen of diet and healthy lifestyle. The co-principal 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. More information can be found at clinicaltrials.gov (NCT03406975).

About Apollo ESG™ and Apollo REVISE™

The Apollo ESG^TM and Apollo REVISE^TM 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.

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 Sx^TM Endoscopic Suturing System, the Orbera® Intragastric Balloon System, the X-Tack® Endoscopic HeliX Tacking System, as well as the Apollo ESG^TM, Apollo ESG Sx^TM, Apollo REVISE^TM and Apollo REVISE Sx^TM 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.

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 September 30, 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. Edmundowicz, Steven A. 2022 Top Story in Gastroenterology: Endoscopic Sleeve Gastroplasty for Obesity. https://www.practiceupdate.com/content/2022-top-story-in-gastroenterology-endoscopic-sleeve-gastroplasty-for-obesity/143611/55/9/3
3. American Society for Metabolic and Bariatric Surgery. ASMBS Endorsed Procedures and FDA Approved Devices. Updated December 5, 2022. https://asmbs.org/resources/endorsed-procedures-and-devices

CONTACT:
Apollo Endosurgery, Inc.
Jeff Black, Chief Financial Officer, 512-279-5126
investor-relations@apolloendo.com

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

SOURCE: Apollo Endosurgery, Inc.

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FAQ

What is the significance of the MERIT trial for Apollo Endosurgery (APEN)?

The MERIT trial was recognized as the 2022 Top Story in Gastroenterology, showcasing a 77% success rate in weight loss for participants.

What devices were approved by ASMBS for Apollo Endosurgery (APEN)?

Four Apollo systems received approval from ASMBS as FDA Approved Bariatric Devices, enhancing treatment options for obesity.

What does the recognition of the MERIT trial mean for the treatment of obesity?

The recognition underscores the effectiveness of Apollo's ESG procedure, indicating a significant advancement in minimally invasive weight loss options.

How do the new approvals affect the use of Apollo devices in clinical settings?

The approvals allow for the use of Apollo devices in accredited centers without requiring IRB approval, streamlining procedures.

What are the next steps for Apollo Endosurgery (APEN) following these milestones?

Apollo may focus on expanding its market presence and promoting the use of its newly approved devices within the healthcare community.