- FDA has awarded breakthrough device status to Gala Therapeutics for its minimally invasive procedure to treat chronic bronchitis, the Menlo Park, California-based company said Monday.
- The RheOx device delivers non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in patients’ lungs, making way for new normal cells to develop.
- The device received CE mark certification earlier this year and is being evaluated in an early feasibility study in the United States.
Gala was formed by Apple Tree Partners, a healthcare-focused venture capital firm based in New York.
Chronic bronchitis, an inflammation of the air passages, affects more than nine million people in the United States and occurs in people with chronic obstructive pulmonary disease as well as individuals with normal lung function, according to the Centers for Disease Control and Prevention.
Patients with chronic bronchitis experience persistent cough, excess mucus production and impaired quality of life. Current treatments are directed at bronchodilation and reduction in inflammation and don't address the overproduction of mucus.
The Gala Therapeutics system consists of an electrosurgical generator and a single-use catheter. In May, the company announced results from an initial study evaluating the device in 33 patients with chronic bronchitis. The study found an acceptable safety profile and clinically meaningful improvements in patient quality of life at three months and 12 months, Gala said. That included a 16.3-point mean reduction in the St. George's Respiratory Questionnaire and an 8.6-point mean reduction in the COPD Assessment Test.
At three months, patients saw symptom improvements including a 39% reduction in cough and a 44% reduction in mucus. High-resolution computed tomography also showed a 20% increase in airway volume and a 15.6% increase in identifiable airways, Gala said. The findings were presented in May at the 2019 American Thoracic Society International Conference in Dallas.
Gala Therapeutics has also said it plans to launch a post-market study at European respiratory centers to expand clinician experience and patient access to the RheOx treatment.
FDA’s breakthrough device program is designed to streamline the regulatory pathway to speed development of first-of-a-kind medical devices.
In April, the agency granted a breakthrough designation to a cryotherapy spray for patients with moderate to severe COPD who suffer from chronic bronchitis. The RejuvenAir system made by CSA Medical sprays liquid nitrogen to rapidly freeze the epithelial layer of airway walls, to destroy mucus-producing goblet cells but preserve the extracellular matrix that can regrow healthy cells.