
Galvanize RheOx -Investigational Device for Chronic Bronchitis Treatment
The RheOx System is an innovative medical device designed to alleviate symptoms associated with chronic bronchitis. It combines a specialized electrosurgical generator and a single-use catheter to deliver Pulsed Electric Field (PEF) energy non-invasively. This system targets and ablates abnormal mucus-producing cells within the airways, while preserving the integrity of the extracellular matrix, thus facilitating rapid epithelial regeneration. Initial clinical trials have demonstrated the system's feasibility and significant improvements in patient quality of life metrics, while maintaining a favorable safety profile. The system is particularly engineered for bronchial rheoplasty procedures, aiming to reduce mucus production and cough frequency significantly. Although the RheOx System is CE certified, it remains an investigational device in the United States and is subject to federal restrictions for investigational use only. Ongoing studies continue to explore its potential in managing chronic bronchitis symptoms.
The RheOx® system for the treatment of the symptoms of chronic bronchitis consists of a proprietary electrosurgical generator and a single-use catheter. The minimally-invasive bronchoscopic therapy delivers short bursts of Pulsed Electric Field (PEF) energy to induce non-thermal ablation of the abnormal mucus-producing cells in the airways, leaving the extracellular matrix intact so that the epithelium may rapidly regenerate.