Therapy Areas: Inflammatory Diseases
Gala Therapeutics passes US FDA IDE approval of RheOx System for early feasibility study in chronic bronchitis subjects
16 July 2018 -

Medical device company Gala Therapeutics reported on Friday the receipt of US Food and Drug Administration (FDA) 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.

Defined as chronic inflammation of the airways associated with over-production of mucus, chronic bronchitis risk factors include smoking, vaping, secondhand smoke, exposure to airborne chemicals, pollution and other irritants.

The company added that the EFS study will enrol up to 15 patients at five clinical trial sites in the US. The RheOxis is under clinical investigation and not available for sale or distribution.

According to the company, it is the first company to bring an interventional pulmonary procedure targeting chronic bronchitis to the US. The Centers for Disease Control and Prevention (CDC) estimates that 8.94 million patients in the US are diagnosed with chronic bronchitis.