The RheOx Bronchial Rheoplasty system has received a CE Mark in the European Union, according to Gala Therapeutics Inc. The minimally invasive bronchoscopic system delivers non-thermal energy to the airways to reduce mucus-producing cells in patients with chronic bronchitis.
The RheOx technology includes an electrosurgical generator and a single-use catheter that together deliver non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in the lungs, making way for new normal cells to redevelop.
Chronic bronchitis affects over 9 million people in the US, occurring in people with COPD and in individuals with normal lung function.
The device is not yet FDA-approved in the US but is under evaluation in an early feasibility study.
Following CE marking, Gala Therapeutics plans to launch a post-market study at key European respiratory centers of excellence to expand clinician experience and patient access to Bronchial Rheoplasty using RheOx, the company said via press release.
“Cough and excess sputum can be debilitating in patients diagnosed with Chronic Bronchitis, and until now, no therapy has been available to target these symptoms,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. “We are pleased to achieve CE Mark, which allows us to market the first interventional therapy for Chronic Bronchitis. This milestone is a tremendous achievement in our journey to help improve quality of life and outcomes for people with Chronic Bronchitis around the world.”