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 reduction but do not address mucus, the company said.
Gala received investigational device exemption from the FDA for the RheOx system in July 2018 and launched an early feasibility trial the following November, planning to enroll 15 patients across five U.S. sites.
“Today there are no treatments to address the debilitating symptoms impacting the quality of life in patients with Chronic Bronchitis,” CEO Dr. Jonathan Waldstreicher said in prepared remarks. “We are excited by FDA’s decision to designate RheOx as a breakthrough device, underscoring the significant unmet need for these patients. We look forward to working with FDA to bring a solution that improves the lives of these patients.”
The trial is designed to treat the right lung airways in one session and the left lung airways in a second procedure one month later. The estimated primary completion date is August 30, 2020, with an estimated study completion date of August 30, 2024, according to ClinicalTrials.gov.