Gala Therapeutics Receives FDA IDE Approval for a US Early Feasibility Study of Its RheOx™ System to Treat Chronic Bronchitis
Published: Jul 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 RheOx™ 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 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."
"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," 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. RheOx™ 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.
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SOURCE Gala Therapeutics, Inc.