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Product approval

Apollo Endosurgery gains CE Mark for Orbera365 System

Approval expands the indwell period from six months to 12 months with the gastric balloon category leader

Apollo Endosurgery has received the CE Mark approval for the Orbera365 Managed Weight Loss System, which doubles the indwell period of the Orbera intragastric balloon in the world from six months to a 12-month treatment period. The approval enables Apollo to market and sell the Orbera365 Weight Loss Balloon in European Union and the European Economic Area member countries. The Company expects Orbera365 to be commercially available starting in the fourth quarter of 2017.

“I’ve been using Orbera since 1999 and have helped thousands of patients lose weight with my Orbera programme,” said Professor Alfredo Genco, Sapienza University, Rome, Italy. “Now with Orbera365 patients will have the possibility of getting better weight loss results because in my experience the longer the treatment the more weight patients tend to lose. Actually, using Orbera365 our patients will now have twice as long to change their eating behaviours and ensure long lasting results

Orbera365 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 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.

“The CE Mark approval of Orbera365 has been a significant accomplishment for Apollo and involved a comprehensive review of clinical and non-clinical data by a regulatory body in a market with deep understanding and experience with intragastric balloon therapy,” said Todd Newton, CEO of Apollo Endosurgery. “Obtaining CE Mark approval now for Orbera365 is a strong testimony of the relevance and significance of more than a decade of the Orbera system’s safety and efficacy data as supported by more than 277,000 distributed implants and 230 published peer-reviewed papers.”

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