Gala Therapeutics said today that it won breakthrough device designation from the FDA for its RheOx bronchial rheoplasty device for patients with chronic bronchitis. Menlo Park, Calif.-based Gala’s RheOx system is designed for the minimally invasive delivery of non-thermal energy to airways, reducing mucus-producing cells associated with chronic bronchitis. Current treatments target bronchodilation and inflammation […]
galatherapeutics
Gala Therapeutics launches RheOx chronic bronchitis trial
Gala Therapeutics said today that it launched an early feasibility study of its RheOx system for treating chronic bronchitis, and that the first two patients in the trial have already been enrolled. Initial patient enrollment took place at the University of Pittsburgh Medical Center, with RheOx bronchial rheoplasty procedures performed by Dr. Frank Sciurba and Roy […]
Gala Therapeutics wins FDA IDE nod for early feasibility trial of RheOx system
Gala Therapeutics said today it won FDA investigational device exemption approval to conduct an early feasibility study of its RheOx system designed to treat individuals with chronic bronchitis. The study will look to enroll up to 15 patients at five sites in the US, the Menlo Park, Calif.-based company said. “Patients with Chronic Bronchitis suffer […]
