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Product approval

Apollo’s Orbera365 approved in the Kingdom of Saudi Arabia

The Orbera365 Managed Weight Loss System doubles the indwell period from a six to a 12 month treatment period

Apollo Endosurgery has 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 from a six to a 12 month treatment period.

Professor Aayed AlQahtani/p>

“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 six months gives us more time with the patient to ensure better outcomes,” said Professor 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. Obesity is one of the most common health issues globally and is the source of various diseases including hypertension, diabetes and obstructive sleep apnoea.

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.

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. After up to twelve months, through another non-surgical procedure, the Orbera365 balloon is deflated and then removed.

Apollo Endosurgery previously received the CE Mark approval for the Orbera365 Managed Weight Loss System to market the device in the EU in September 2017.

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