AUSTIN, Texas--(BUSINESS WIRE)--Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced completion of enrollment in the ORBERA® Post Approval Study evaluating the ORBERA intragastric balloon.
The ORBERA Post Approval Study is a multi-center, open-label, prospective study of the safety and efficacy of the ORBERA system within the US. The study was a requirement of the US FDA’s approval of ORBERA in August of 2015. The study has enrolled 281 patients across 11 centers. The endpoints include the patient’s percentage of total body weight loss at 26 weeks and 12 months after balloon placement and the rate of adverse events at 26 weeks, the indwell time allowed for the balloon. This study includes 12 months of follow-up after balloon placement: six months with the balloon and an additional six months of follow-up after the balloon’s removal. Patient follow up and final study results are expected in early 2020.
“The ORBERA balloon is the most studied intragastric balloon globally with impressive weight loss and safety results based on its experience in Europe, Latin America and Asia Pacific regions. Reported US clinical results have shown an improvement in both the weight loss and safety data since the initial US pivotal study as US physicians gain experience with patient management. Outcomes consistently exceed criteria identified in guidelines published by our professional societies,” said Christopher Gostout, MD, Chief Medical Officer at Apollo Endosurgery.
Apollo has met all the milestones associated with the study and the FDA has assessed the current study status as “progress adequate”.
Obesity affects over 650 million people globally. An independent review by the American Society for Gastrointestinal Endoscopy identified ORBERA as the only endoscopic treatment that met their threshold standards for the treatment of obesity.1 More than 295,000 ORBERA balloons have been distributed worldwide in over 70 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 invasive 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 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the ORBERA balloon is deflated and then removed.
Once the balloon is in place, the patient receives an individually tailored support program through the ORBERA Managed Weight Loss System team of experts to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.
For more than 20 years, the global medical community has been using intragastric balloons from the makers of ORBERA to help thousands of people lose weight. More than 295,000 ORBERA balloons have been distributed worldwide in over 70 countries.
For additional information regarding ORBERA, please visit www.orbera.com.
For full safety information please visit www.orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA.
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical technology company focused on less invasive therapies for the treatment of obesity, a condition facing over 650 million people globally, as well as other gastrointestinal conditions. 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 70 countries today and include the OverStitch™ Endoscopic Suturing System, the ORBERA® Intragastric Balloon, and the LAP-BAND® Adjustable Gastric Banding System.
Apollo’s common stock is traded on Nasdaq Global Market under the symbol "APEN." For more information regarding Apollo, go to: www.apolloendo.com.
© 2018 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. 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 and other factors detailed from time to time in the reports Apollo files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2017, Form 10-Q for the three months ended June 30, 2018 and the FORM 424B5 Prospectus filed June 21, 2018. 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.