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 that the Saudi Food and Drug Authority (SFDA) has approved the ORBERA365™ Managed Weight Loss System and has issued a Medical Device Marketing Authorization (MDMA) for the product. This MDMA allows Apollo Endosurgery to market ORBERA365 in the Kingdom of Saudi Arabia with its exclusive distribution partner, AL-Nozha Medical.
The ORBERA365 Managed Weight Loss System doubles the indwell period of the #1 intragastric balloon in the world from 6 months to a 12 month treatment period. “Patients are looking for longer term endoscopic weight loss treatments. ORBERA365 now provides patients a greater probability of losing more weight and keeping it off. The additional 6 months gives us more time with the patient to ensure better outcomes,” said Aayed AlQahtani, Professor of Surgery at King Khalid University Hospital and Director of Obesity Chair at King Saud University, Riyadh, Saudi Arabia.
This approval expands the reach of ORBERA365 into the largest bariatric market in the Middle East with over 15,000 procedures performed per year. The prevalence and cost of obesity in the Kingdom of Saudi Arabia are rapidly increasing and the country currently ranks as the 15th most obese nation with an overall obesity rate of 33.7% and projected to reach 59.5% by 2022.1 Obesity is one of the most common health issues globally and is the source of various diseases including hypertension, diabetes and obstructive sleep apnea.
ORBERA365 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 ORBERA365 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 twelve months, through another non-surgical procedure, the ORBERA365 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.
For additional information regarding ORBERA365, please visit http://www.orbera.com/365
For full safety information please visit http://apolloendo.com/patient-labeling-and-dfus/#
About Apollo Endosurgery, Inc.
Apollo Endosurgery, Inc. is a medical device company focused on less invasive therapies for the treatment of obesity, a condition facing over 600 million people globally, as well as other gastrointestinal disorders. 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.
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.
© 2018 Apollo Endosurgery, Inc. All rights reserved.
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: price levels for established and innovative medical devices compared to the costs of procedures utilizing our products; developments in medical technology; regulatory approvals; reimbursement decisions by private or government payers or other government actions; physician adoption and recommendations of procedures utilizing our products; misuse or off label use of our products by physicians and other factors detailed from time to time in the reports Apollo Endosurgery files with the Securities and Exchange Commission, or SEC, including its Form 10-K for the year ended December 31, 2017. Copies of reports filed with the SEC are posted on Apollo Endosurgery’s website and are available from Apollo Endosurgery 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 Endosurgery disclaims any obligation to update these forward-looking statements to reflect future events or circumstances or to update any information referenced by hyperlink.
1) Alqarni, Saad Salman M. “A Review of Prevalence of Obesity in Saudi Arabia”, Journal of Obesity and Eating Disorders, 2016.