Menlo Park, Calif, July 12, 2018 – Gala Therapeutics (Gala) today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to conduct an Early Feasibility Study (EFS) to examine the safety of the RheOxTM system in subjects with Chronic Bronchitis. The study will enroll up to 15 patients at 5 clinical trial sites in the United States.
“Patients with Chronic Bronchitis suffer daily with mucus hypersecretion and cough,” stated Jonathan Waldstreicher, MD, Chief Executive Officer of Gala. “We developed the Bronchial RheoplastyTM 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.”
“In our early clinical work outside of the United States, we have demonstrated the safety and profound impact of Bronchial RheoplastyTM in relieving chronic cough and mucus production, which has been confirmed with other objective measures of improvement,” commented Bill Krimsky, MD, Chief Medical Officer of Gala. “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.”
Gala Therapeutics is the first company to bring an interventional pulmonary procedure targeting Chronic Bronchitis to the United States. A form of COPD, the Centers for Disease Control and Prevention (CDC) estimates that 8.94 million patients in the United States are diagnosed with Chronic Bronchitis, defined as chronic inflammation of the airways associated with over-production of mucus. Risk factors for Chronic Bronchitis include smoking, vaping, secondhand smoke, exposure to airborne chemicals, pollution and other irritants. RheOxTM is under clinical investigation and not available for sale or distribution.
About Gala Therapeutics
Gala Therapeutics is a privately-held medical device company based in Menlo Park, CA that was formed by Apple Tree Partners, a healthcare-focused venture capital firm based in New York. Gala is dedicated to developing disease modifying therapies that improve survival, quality of life, and outcomes for patients with lung cancer, COPD, asthma, and other pulmonary diseases. Gala is building a portfolio of technologies to address the needs of interventional pulmonologists, thoracic surgeons, and all physicians who treat pulmonary disease.