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AUSTIN, TX / ACCESSWIRE / April 13, 2020 / Apollo Endosurgery, Inc. ("Apollo") (APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures announced today that the US Food and Drug Administration (FDA) has completed the review of the final Post-Approval Study (PAS) Report for the Orbera Intragastric Balloon System and accepted that all post-approval study requirements have been fulfilled.
The ORBERA Post Approval Study was a requirement following the US FDA's approval of ORBERA in August of 2015. The study was a multi-center, open label, prospective study with a primary safety endpoint and its secondary endpoint being effectiveness. All study endpoints were successfully met.
Notable study statistics include:
11 Study Sites
258 Patients with BMI between 30-40 kg/m2 at the time of their enrollment
Serious Adverse Event (SAE) rate for the study was 8.9%
Primary endpoint of the study was a SAE rate of less than 15%
ORBERA's pivotal trial SAE rate was 9.6%
Total Body Weight Loss (TBWL) results of patients in the study was 12.5%
Secondary endpoint of the study was TBWL at time of balloon removal of at least 7.5%
TBWL at the time of balloon removal in the ORBERA pivotal study was 10.2%
No risks outside of ORBERA's Direction-for-Use were identified by the study.
There were no instances of death, gastric perforation, bowel obstruction or acute pancreatitis. The most common SAE were nausea and vomiting, which tended to resolve within the first month after placement.
"As anticipated, the conclusion of the ORBERA post approval study confirms the impressive, medically-relevant weight loss from ORBERA that physicians can expect for their patients with underlying medical conditions that require them to lose up to 10% of their total body weight. The study also confirms a predictable safety result for properly selected and managed patients. The ORBERA balloon is the most studied intragastric balloon globally and the post approval study results are very consistent with ORBERA's long-standing published literature from Europe, Latin America and Asia Pacific regions," said Christopher Gostout, MD, Chief Medical Officer at Apollo Endosurgery.
Obesity affects over 650 million people globally. An independent review by the American Society for Gastrointestinal Endoscopy identified ORBERA as the only intragastric balloon that met their threshold standards for the treatment of obesity.1 More than 300,000 ORBERA balloons have been distributed worldwide in over 75 countries and the medical community has been using intragastric balloons from the makers of ORBERA for over twenty years.
ORBERA® is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering surgery, but for whom diet, and exercise or pharmaceutical interventions have not worked.
In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA balloon is placed into the stomach. It is then filled with saline until it's about the size of a grapefruit. The procedure typically takes about 20 minutes and the patient can generally go home a few hours later. After up to 6 months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
Once the balloon is in place, the patient works with their physician and their staff in a formal lifestyle modification program to meet their long-term weight loss goals. Coaching takes place over 12 months while the balloon is in place. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies to treat various gastrointestinal conditions, ranging from gastrointestinal complications to the interventional 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™ 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.
© 2019 Apollo Endosurgery, Inc. All rights reserved. Any third-party trademarks used herein are the property of their respective owners.
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 spread of the COVID-19 virus and the impact it may have on the Company's operations, the demand for the Company's products, 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, developments in medical technology, regulatory approvals and extensive regulatory oversight by the FDA or other regulatory bodies, unfavorable media coverage related to our products or related procedures, reimbursement decisions by private or government payors, physician adoption and recommendations of procedures utilizing our products 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, 2019. 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) ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015 Sep; 82(3):425-38.
Apollo Endosurgery, Inc.
Stefanie Cavanaugh, 512-279-5100
Darrow Associates Investor Relations
Matt Kreps, 214-597-8200
SOURCE: Apollo Endosurgery, Inc.
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