Apollo Endosurgery's Innovative OverStitch(TM) Endoscopic Suturing System Highlighted During Digestive Disease Week 2021

Rhea-AI Summary

Apollo Endosurgery (Nasdaq: APEN) highlighted its OverStitch Endoscopic Suturing System at the Digestive Disease Week (DDW) 2021 from May 21-23. Key presentations included the sub-study from the MERIT Trial showing significant weight loss with Endoscopic Sleeve Gastroplasty (ESG), both alone and combined with Semaglutide, with %TBWL up to 26.7%. Additionally, endoscopic procedures demonstrated lower adverse event rates compared to surgical revisions. The ongoing research aims to expand the indications for ESG with FDA collaboration.

Positive

• ESG showed %TBWL of 26.7% with Semaglutide, enhancing weight loss outcomes.
• Endoscopic procedures had a lower adverse event rate (5.7%) compared to surgical revisions (25.7%).
• Ongoing FDA collaboration may lead to new indications for ESG.

Negative

• None.

AUSTIN, TX / ACCESSWIRE / May 24, 2021 / Apollo Endosurgery, Inc. ("Apollo") (Nasdaq:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced highlights from Digestive Disease Week (DDW) 2021 which was held May 21-23. During the 3-day virtual event, there were more than 30 different presentations featuring the use of the OverStitch™ Endoscopic Suturing System in a variety of endoscopic procedures.

"We are very pleased that the unique and enabling capabilities of OverStitch were featured in several key presentations during DDW 2021. These included a sub-study from the MERIT Trial and a new, additional randomized controlled trial studying the Endoscopic Sleeve Gastroplasty (ESG) procedure and the incremental benefit when supplemented with Semaglutide," commented Chas McKhann, President and CEO of Apollo Endosurgery. "We look forward to the publication of the complete results from the MERIT Trial later this year and working with FDA to potentially add a new indication for ESG."

Highlights from the 2021 DDW Meeting include:

THE ENDOSCOPIC SLEEVE GASTROPLASTY PRODUCES DURABLE PHYSIOLOGIC CHANGES: RESULTS FROM A RANDOMIZED US CLINICAL TRIAL^[1]

Single-center, sub-study from the large, ongoing, US multicenter randomized control trial (MERIT Trial) comparing ESG to medically managed lifestyle (LS) modification alone. Weight loss was reported at 3, 6, and 12 months. 36 patients were randomized to ESG (n=18) and LS (n=18).

• ESG resulted in an 82% delay in gastric emptying compared to baseline.
• ESG also resulted in favorable changes in fasting hormones, including Ghrelin, GLP-1, and PYY.
• % TBWL for the ESG group was 13.1%, 16.1% and 16% at 3, 6 and 12 months respectively (p<0.05), while it was 2.5%, 2.6% and 1% (p>0.05) in the LS group at the same time points respectively.
• Authors conclude: "The ESG produces durable weight loss through dynamic physiologic alterations in appetite regulatory pathways. While changes in GE [gastric emptying] are predictive of initial weight loss, the favorable hormonal changes may promote weight maintenance."

SEMAGLUTIDE IN ASSOCIATION TO ENDOSCOPIC SLEEVE GASTROPLASTY: TAKING ENDOSCOPIC BARIATRIC PROCEDURES OUTCOMES TO THE NEXT LEVEL^[2]

Researchers from Sao Paolo Brazil, Johns Hopkins University, and Weill Cornell reported results from a double-blind, randomized, prospective study of ESG compared to a combination of ESG and Semaglutide; 58 subjects were randomized and followed for 12 months.

• Patients treated with ESG had a percent total body weight loss (%TBWL) of 19.6% and percent excess body weight loss (%EBWL) of 60%.
• Patients treated with ESG combined with Semaglutide had %TBWL of 26.7%. and %EBWL of 86%.
• All endoscopic sleeve gastroplasty cases were generally well tolerated with no new safety concerns.
• In the presentation of the trial results, Dr. Hoff stated, "Excellent results are particularly exciting because ESG can be performed at an earlier stage of the disease and at a lower BMI, meaning more patients can get the treatment they need before their disease progresses."

ENDOSCOPIC VERSUS SURGICAL GASTROJEJUNAL REVISION FOR WEIGHT REGAIN IN ROUX-EN-Y GASTRIC BYPASS PATIENTS: 5-YEAR SAFETY AND EFFICACY COMPARISON^[3]

Single institution (Brigham & Women's) retrospective matched cohort study comparing surgical (SURG) and endoscopic (ENDO) revision of R&Y Gastric Bypass procedures

• 70 subjects followed for 5 years.
• Adverse event rate of 5.7% in the ENDO group vs. 25.7% in the SURG; there were no serious adverse events (SAEs) in the ENDO group vs. an SAE rate of 14.3% in the SURG group
• There was no significant difference in %TBWL at 1, 3 and 5 years; at 5 years the ENDO group had a TBWL of 11.9% vs. TBWL in the SURG group of 13.3% (p=ns)
• Authors conclude: "Endoscopic revision of the gastrojejunal anastomosis (Transoral Outlet Reduction- TORe) is associated with significantly fewer serious adverse events than surgery and similar weight loss at 1, 3, and 5 years."

THE CLINICAL OUTCOMES OF ENDOSCOPIC CLOSURE OF GASTROINTESTINAL TRACT LEAKS, AND FISTULAS USING THE OVERSTITCH DEVICE: A SYSTEMATIC REVIEW AND META-ANALYSIS^[4]

Meta-analysis of 10 studies and 268 patients looking at the clinical success rate of endoscopic closure of GI leaks and fistulas using OverStitch. Clinical success was defined as radiologic or clinical evidence of complete closure of leaks or fistulas at the conclusion of the follow-up period.

• The pooled overall clinical success rate was 75.8%.

• Subgroup analysis was performed for leaks and fistulas demonstrating clinical success rates of 80.4% and 64.8%, respectively.

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. In addition, there is uncertainty about the continued spread of the COVID-19 virus and the impact it may have on the Company's operations, 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: 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

¹ Eric J. Vargas, Michael Camilleri, Monika Rizk, et al. THE ENDOSCOPIC SLEEVE GASTROPLASTY PRODUCES DURABLE PHYSIOLOGIC CHANGES: RESULTS FROM A RANDOMIZED US CLINICAL TRIAL.; Digestive Disease Week; May 21-23, 2021; virtual

² Anna Carolina Hoff, Sergio Barrichell, Dilhana Badurdeen, et al. SEMAGLUTIDE IN ASSOCIATION TO ENDOSCOPIC SLEEVE GASTROPLASTY: TAKING ENDOSCOPIC BARIATRIC PROCEDURES OUTCOMES TO THE NEXT LEVEL. Digestive Disease Week.; May 21-23, 2021; virtual.

³ R. D. Dolan, P. Jirapinyo, C. C. Thompson., et al. ENDOSCOPIC VERSUS SURGICAL GASTROJEJUNAL REVISION FOR WEIGHT REGAIN IN ROUX-EN-Y GASTRIC BYPASS PATIENTS: 5-YEAR SAFETY AND EFFICACY COMPARISON. Digestive Disease Week.; May 21-23, 2021; virtual

⁴ Azizullah Beran, Sami Ghazaleh, Yasir Alabboodi, et al. THE CLINICAL OUTCOMES OF ENDOSCOPIC CLOSURE OF GASTROINTESTINAL TRACT LEAKS, AND FISTULAS USING THE OVERSTITCH DEVICE: A SYSTEMATIC REVIEW AND META-ANALYSIS. Digestive Disease Week.; May 21-23, 2021; virtual.

SOURCE: Apollo Endosurgery, Inc.

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FAQ

What were the highlights of Apollo Endosurgery's presentation at DDW 2021?

Apollo Endosurgery showcased significant findings on the OverStitch system, emphasizing weight loss results from ESG and promising collaborations for expanded indications.

What is the significance of the ESG study presented by Apollo at DDW 2021?

The ESG study indicated substantial weight loss with %TBWL of 26.7% when combined with Semaglutide, suggesting enhanced treatment options for obesity.

What are the safety outcomes of endoscopic procedures compared to surgical revisions discussed in the PR?

The endoscopic procedures demonstrated a 5.7% adverse event rate, significantly lower than the 25.7% observed for surgical revisions over a 5-year period.

How does Apollo plan to expand its ESG indications?

Apollo is working with the FDA to potentially add new indications for the Endoscopic Sleeve Gastroplasty based on ongoing clinical findings.