Gala’s RheOx System to Treat Chronic Bronchitis Receives CE Mark for Health and Safety in EU

The RheOx system for the treatment of chronic bronchitis has received the CE mark, an indication that it has met high health, safety, and environmental protection requirements, in the European Union.

Developed by Gala Therapeutics, the RheOx system is a minimally invasive tool used to perform a procedure called bronchial rheoplasty. In this procedure, a series of electrical pulses are delivered to cells in the lungs in an attempt to kill off cells that are producing excessive mucus and clear the way for normal cells to grow in their place.

The procedure is being investigated as a therapeutic intervention in chronic bronchitis, a disease characterized by ongoing inflammation in the lungs. Chronic bronchitis is diagnosed when a person has experienced a persistent cough that produces mucus and phlegm for at least three months per year in two consecutive years.

Chronic bronchitis can develop in people who do not have a history of lung disease, and is particularly common among people with chronic obstructive pulmonary disease (COPD). Risk factors for developing this condition include smoking, and regular exposure to pollutants and other lung-damaging chemicals.

“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,” Jonathan Waldstreicher, MD, CEO of Gala, said in a news release.

Preliminary analyses of bronchial rheoplasties on people with chronic bronchitis suggested that the procedure was reasonably safe and improved symptoms. In one study, participants with chronic bronchitis saw their average scores on the St. George’s Respiratory Questionnaire decrease by 16.9 points one year after treatment, indicating fewer/less severe respiratory symptoms.

“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,” Waldstreicher said.

In the future, Gala plans to launch a post-market study at top European respiratory centers to expand clinician experience on its RheOx system to perform bronchial rheoplasty, and to give patient access.

Currently, the RheOx system is still an investigational product in the United States, where an ongoing clinical trial (NCT03631472) is investigating its use in people with chronic bronchitis.