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 daily with mucus hypersecretion and cough. We developed the bronchial rheoplasty procedure to directly treat the abnormal airway cells responsible for chronic bronchitis, which are not impacted by inhaled medications. We appreciate the FDA’s commitment to encouraging clinical development of medical devices in the United States through the EFS process,” CEO Jonathan Waldstreicher said in a prepared statement.
“In our early clinical work outside of the United States, we have demonstrated the safety and profound impact of bronchial rheoplasty in relieving chronic cough and mucus production, which has been confirmed with other objective measures of improvement. As a pulmonologist, I see these patients daily. We are now one step closer to offering them an outpatient minimally-invasive procedure to alter the usual downward spiral of this disease, which could become first-line therapy,” chief medical officer Dr. Bill Krimsky said in a press release.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
Use code WOMENSHEALTH to save an additional 10%.