Apollo Endosurgery said today it won an expanded CE Mark approval for its Orbera weight loss system, extending the indwell period of the gastric balloon from 6 months to a 12 month treatment period.
The balloon device is designed to be inserted non-surgically in obese patients with body mass indexes of 30 to 40, the Austin, Texas-based company said. After insertion, the balloon is inflated to fill space in the stomach.
“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. Actually, using Orbera365 our patients will now have twice as long to change their eating behaviors and ensure long lasting results,” Alfredo Genco of Rome’s Sapienza University said in a prepared statement.
Apollo Endosurgery said it expects to begin commercialization of the Orbera365 device in the 4th quarter of 2017.
“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. 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,” Apollo CEO Todd Newton said in a press release.
In July, Apollo Endosurgery said it closed its recently announced public offering, raising $36 million.