Digestive Disease Week 2022 Adds to the Growing Wave of Clinical Evidence Supporting Significant Opportunity for Apollo Endosurgery Products

AUSTIN, TX / ACCESSWIRE / May 31, 2022 / Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced highlights today from data presented at Digestive Disease Week May 21-24.

"With more than 120 lectures, presentations, and posters featuring Apollo products, DDW 2022 exemplified Apollo's commitment to building a robust body of clinical evidence supporting the safe and effective use of OverStitch®, X-Tack®, and Orbera®," said Chas McKhann, President and CEO of Apollo. "We want to thank all of the investigators helping to propel this field forward with high quality scientific evidence supporting advanced endoscopic interventions using Apollo products."

Apollo's Top 5 highlights include:

Novel through-the-scope suture closure of colonic EMR defects1

Multicenter retrospective cohort study conducted in 13 leading academic institutions designed to evaluate the rate of delayed bleeding following use of X-Tack® Endoscopic HeliX Tacking System in closing colonic EMR defects. 100 patients with colon polyps measuring 35±11 mm were included in the study.

  • Complete closure was achieved in 73% of cases using a median of 1 system.
  • Delayed bleeding occurred in only 1% of cases.
  • X-Tack® was effective in achieving complete closure of post-EMR defect sites, despite large lesion size.

A novel through-the-scope helix tack and suture device for mucosal defect closure following colorectal endoscopic submucosal dissection (ESD): a multicenter study2

Retrospective, multi-center cohort study of consecutive patients undergoing closure of colorectal ESD site using X-Tack® Endoscopic HeliX Tacking System. 52 patients with colonic lesions measuring a median size of 30 mm were included.

  • Technical success was achieved in 94% of cases.
  • No delayed bleeds, delayed perforations, or device related adverse events were reported.
  • Authors' conclusion on X-Tack®- "An effective and safe tool for the closure of large mucosal defects after colorectal ESD, achieving technical success in almost all cases. This has important clinical implications as the TTSS system facilitates the closure of larger defects that otherwise may not be amenable to closure by other endoscopic closure devices."

Efficacy, feasibility and safety of the X-Tack Endoscopic HeliX Tacking System: a multicenter experience3

Multicenter retrospective study conducted in several leading academic institutions performing endoscopic suturing with the X-Tack® Endoscopic HeliX Tacking System. 56 patients across 9 centers were included.

  • The study included a variety of applications, including fistula closure, polypectomy, leaks, POEM site closure, perforation, ulcers.
  • Technical and clinical success rates were 93% and 73%, respectively.
  • For polypectomies, POEM-site closures, and ulcers, technical and clinical success rates were both 100%.
  • X-Tack® is safe and feasible tool to repair partial thickness GI defects, such as EMR, ESD, and POEM.

Endoscopic sleeve gastroplasty in class III obesity: weight loss and metabolic outcomes in 339 consecutive patients4

Retrospective, international, multicenter study of prospectively followed patients with class III obesity undergoing ESG. At the time of presentation, 404* patients undergoing ESG between 2018-2021 were followed 6-36 months.

  • Mean total body weight loss 12 months after ESG was 21%, and total body weight loss of more than 20% was maintained out to three years.
  • Improvement in patients with hypertension, hyperlipidemia, and diabetes.
  • Overall adverse event rate was <1%, with no surgical or endoscopic interventions required.
  • Authors' conclusion - "For patients with class III obesity, ESG provides clinically meaningful, long-term weight loss, with maintenance of 21% TBWL at 3 years and improvement in metabolic comorbidities in a majority of patients."

Endoscopic sleeve gastroplasty impact on obesity and comorbidities: results from a US prospective, multicenter, randomized clinical trial with 104 weeks follow-up5

Multi-center, prospective randomized clinical trial evaluating the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) compared to a medically monitored regimen of diet and healthy lifestyle (LS). 208 patients were randomized to ESG (n=85) and LS (n=123), with 72 crossing over at 52 weeks.

  • ESG group achieved an excess body weight loss of 49% at 12 months and a 77% responder rate (defined as an excess body weight loss > 25%).
  • Average total body weight loss in the responder group was 16%.
  • 91% maintenance of weight loss at two years.
  • 2% SAEs all resolving without sequelae.
  • Improvement in patients with diabetes and hypertension.
  • Authors' conclusion - "ESG is ready for expanded clinical adoption to augment the spectrum of obesity and metabolic care."

Dr. Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, presented the above data from the landmark Multi-center ESG Randomized Interventional Trial (MERIT) during the ASGE Presidential Plenary Session. "The results of this trial substantiate our conclusion that ESG is ready for expanded clinical adoption to provide more options for the treatment of obesity," commented Dr. Abu Dayyeh. "This was validation of the tremendous opportunity ahead to greatly impact patients' lives."

About ESG and the MERIT Study

Endoscopic Sleeve Gastroplasty (ESG) is a minimally invasive procedure that uses the OverStitch® Endoscopic Suturing System to reduce the volume of a person's stomach. Apollo has submitted a De Novo classification request to the U.S. Food and Drug Administration seeking 510(k) classification and clearance for the Apollo ESGTM and Apollo REVISETM devices. More information on the MERIT study can be found at clinicaltrials.gov (NCT03406975). 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.

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 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 SxTM Endoscopic Suturing System, and the Orbera® Intragastric Balloon System.

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 March 31, 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.

1Danse Bi, Linda Yun Zhang, Jose Antonio Almario, et al. Novel through-the-scope suture closure of colonic EMR defects. Digestive Disease Week; May 22, 2022. Poster presentation.

2Jad Farha, Amit Mehta, Camille Hage, et al. A novel through-the-scope helix tack and suture device for mucosal defect closure following colorectal endoscopic submucosal dissection (ESD): a multicenter study. Digestive Disease Week; May 22, 2022. Poster presentation.

3Malorie Simons, Sanad Maher Dawad, Donevan Richard Westerveld, et al. Efficacy, feasibility and safety of the X-Tack Endoscopic HeliX Tacking System: a multicenter experience. Digestive Disease Week; May 22, 2022. Oral presentation.

4Christina S. Gainey, Anna Carolina Hoff, Bechtler Stevens Addison, et al. Endoscopic sleeve gastroplasty in class III obesity: weight loss and metabolic outcomes in 339 consecutive patients. Digestive Disease Week; May 24, 2022. Oral presentation. *

5Barham K. Abu Dayyeh, Eric J. Vargas, Michael Ujiki, et al. Endoscopic sleeve gastroplasty impact on obesity and comorbidities: results from a US prospective, multicenter, randomized clinical trial with 104 weeks follow-up. Digestive Disease Week; May 24, 2022. Oral presentation.

*Data updated at the time of presentation to include 404 patients reaching at least 6 months of follow-up.

CONTACT:

Investor / Media Contact:

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

Company Contact:

Apollo Endosurgery, Inc.
Jeff Black, 512-279-5126
investor-relations@apolloendo.com

SOURCE: Apollo Endosurgery, Inc.

 


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