Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced CE (Conformité Européene) Mark approval for the ORBERA365 Managed Weight Loss System.
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. 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.
Professor Alfredo Genco, Sapienza University, Rome, Italy said, “I’ve been using ORBERA since 1999 and have helped thousands of patients lose weight with my ORBERA program. 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. He notes, “Actually, using ORBERA365 our patients will now have twice as long to change their eating behaviors and ensure long lasting results.”
Regarding the accomplishment, Todd Newton, CEO of Apollo Endosurgery highlights, “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.” Newton concluded, “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.”