The US FDA has granted Breakthrough Device Designation for the RheOx Bronchial Rheoplasty system, according to Gala Therapeutics. RheOx uses a minimally invasive procedure to deliver non-thermal energy to the airways to reduce mucus-producing cells in patients with chronic bronchitis.
The Breakthrough Device Program is intended to streamline the regulatory pathway for first-of-its-kind medical devices that can provide more effective treatment for patients suffering from life-threatening or irreversibly debilitating diseases to ensure that patients have timely access to vital treatments.
Chronic bronchitis affects over 9 million people in the US, occurring in people with COPD and in individuals with normal lung function,1 according to Gala Therapeutics. Patients with chronic bronchitis experience persistent cough, excess mucus production, and impaired quality of life with an increased risk of exacerbations and mortality.2 Current treatments are directed at bronchodilation and reduction in inflammation only, without addressing the overproduction of mucus.
“Today there are no treatments to address the debilitating symptoms impacting the quality of life in patients with Chronic Bronchitis. We are excited by FDA’s decision to designate RheOx as a breakthrough device, underscoring the significant unmet need for these patients,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. “We look forward to working with FDA to bring a solution that improves the lives of these patients.”
Currently under evaluation in an early feasibility study in the United States, RheOx is limited by federal law to investigational use. RheOx received CE certification earlier this year.