Results Published from Multicenter Study of Gala Therapeutics' Minimally Invasive RheOx™ System in Patients with Chronic Bronchitis
MENLO PARK, Calif., Sept. 3, 2020 /PRNewswire/ -- Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, today announced the publication of the results from its initial study evaluating the RheOx (TM) Bronchial Rheoplasty System for chronic bronchitis. The 12-month data published in the American Journal of Respiratory and Critical Care Medicine, the official journal of the American Thoracic Society, demonstrate the safety and feasibility of the novel therapy.
The prospective multi-center study evaluated the use of RheOx in patients with moderate to severe chronic bronchitis, a phenotype of Chronic Obstructive Pulmonary Disease (COPD), which affects more than 9 million Americans. The study assessed safety, changes in airway histopathology and quality of life. Performed using a minimally invasive bronchoscopic procedure called Bronchial Rheoplasty, the RheOx System delivers non-thermal pulsed energy to the airways in the lungs to reduce mucus-producing cells, improving the symptoms of cough and mucus.
"Chronic bronchitis is a debilitating disease that severely impacts a patient's quality of life, and there is little we can do to treat these patients today," said Arschang Valipour, MD, FCCP, Associate Professor, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Wien, Austria. "These study results demonstrate the technical feasibility of the procedure and a favorable safety profile. The improvements in symptoms and quality of life are compelling."
Bronchial Rheoplasty was performed successfully in 30 patients from five centers, with no device-related serious adverse events. Clinically meaningful improvements in quality of life were demonstrated through 12 months as measured using the COPD Assessment Test (CAT) and St. George's Respiratory Questionnaire (SGRQ). Mean reductions from baseline in the CAT and SGRQ total scores were 7.0 and 15.2 points, respectively, exceeding the minimal clinically important differences of 2 points for CAT and 4 points for the SGRQ. These improvements were driven by a 28% reduction in cough and 41% reduction in mucus symptoms. Histopathological analysis of the airway mucosa showed a 39% reduction in mucus-producing goblet cell hyperplasia scores in the airways.
"There is a significant unmet need for a therapy that can improve the quality of life for chronic bronchitis patients," said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. "We are pleased with the results and are dedicated to continuing to build the clinical evidence for this therapy."
RheOx is a bronchoscopic system designed to reduce mucus-producing cells in patients with Chronic Bronchitis. The revolutionary technology includes an electrosurgical generator and a single-use catheter that together deliver non-thermal energy to the airways to reduce the number of abnormal mucus-producing cells in the lungs, making way for new normal cells to redevelop. Patients treated with RheOx have reported improvements in symptoms and quality of life (www.galatherapeutics.com/patient-stories/). Currently under evaluation in an early feasibility study in the United States, RheOx is limited by federal (or United States) law to investigational use. RheOx received CE certification in 2019.
About Gala Therapeutics
Gala Therapeutics is a privately held medical device company based in Menlo Park, CA, that is dedicated to developing disease-modifying therapies that improve survival, quality of life, and outcomes for patients with pulmonary diseases. Formed by Apple Tree Partners, a healthcare-focused venture capital firm based in New York, Gala is building a portfolio of technologies to address the needs of interventional pulmonologists, thoracic surgeons, and all physicians who treat pulmonary disease.
SOURCE Gala Therapeutics