Gala Therapeutics, a clinical-stage developer of medical devices to treat pulmonary disease, has secured CE Mark for its RheOx system in the European Union.
With the CE marking approval, the company is planning to launch a post-market study at European respiratory centres of excellence to expand clinician experience and patient access to Bronchial Rheoplasty using its RheOx System.
Gala Therapeutics CEO Jonathan Waldstreicher said: “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.
“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.”
Chronic Bronchitis is condition characterised by chronic inflammation of the air passages in the lungs and accumulation of phlegm and mucus due to a persistent cough, lasting up to three months in a year.
It occurs in people with chronic obstructive pulmonary disease (COPD) and with normal lung function, and its risk factors include smoking tobacco, indoor and outdoor air pollution and occupational exposures.
RheOx device reduces mucus-producing cells in Chronic Bronchitis patients
Gala has developed its RheOx to deliver non-thermal energy to the airways to reduce mucus-producing cells in patients with Chronic Bronchitis in a minimally invasive procedure called Bronchial Rheoplasty.
The company said that its RheOx is a bronchoscopic system designed to reduce mucus-producing cells in patients with Chronic Bronchitis.
The advanced technology deploys an electrosurgical generator and a single-use catheter to 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.
RheOx is currently being evaluated in an early feasibility study in the US, and its availability is limited to investigational use by the US federal law.
