Data from Multiple Studies Show Positive Outcomes with Gala Therapeutics' RheOx™ System for Chronic Bronchitis
SAN CARLOS, Calif., Aug. 31, 2021 /PRNewswire/ -- Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, today announced new data from multiple clinical studies that demonstrate improvements in chronic bronchitis symptoms after patients received bronchial rheoplasty therapy using Gala's first-of-its kind, endoscopic RheOx™ system. The study results will be presented during the European Respiratory Society (ERS) International Congress 2021, taking place virtually on September 6, and the results are now published online at https://k4.ersnet.org/prod/v2/Front/Program/Session?e=262&session=13641.
Chronic bronchitis, a phenotype of COPD, affects an estimated 9 million people in the U.S.1,2 Patients experience prolonged inflammation and excess mucus in the lung airways, causing severe coughing spells, wheezing, chest pain and shortness of breath.1 Chronic bronchitis can develop after exposure to cigarette smoke, vaping, airborne chemicals, and other pollutants and irritants.
The endoscopic RheOx system is designed to improve the cough and mucus symptoms of chronic bronchitis by delivering non-thermal pulsed electric field (PEF) energy to mucus-producing cells in the lung airways. Clinical study outcomes described in two virtual ERS presentations include:
- One year after bronchial rheoplasty, the 21 treated patients in the US Early Feasibility study had a 36% reduction in moderate COPD exacerbations, defined as requiring steroids or antibiotics, and a 63% reduction in severe COPD exacerbations, defined as requiring hospitalization, compared to the 12 months prior to receiving the bronchial rheoplasty procedure.
- In a pooled analysis of one year outcomes following bronchial rheoplasty treatment in 60 patients from three studies, statistically significant improvements from baseline were observed in all of the COPD Assessment Test (CAT) component scores. The greatest improvements in individual CAT component scores were in phlegm, cough, chest tightness, and sleep quality, with relative improvements from baseline of 42%, 35%, 43%, and 33%, respectively.
"Patients with chronic bronchitis have insufficient treatment options and therefore endure a wide range of challenging symptoms and reduced quality of life. The study results we've seen to date using the RheOx system are promising, and we continue to gather evidence in support of bronchial rheoplasty to deliver meaningful quality of life improvements for these patients," explained Victor Kim, M.D., ATSF, AASM, Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University. Dr. Kim is an investigator in the RheOx system U.S. Early Feasibility Study and the ongoing RheSolve pivotal clinical trial, which is enrolling 270 patients at up to 40 U.S. and 10 international centers.
RheOx is designed to reduce mucus-producing cells in patients with chronic bronchitis through a minimally invasive bronchoscopic procedure called bronchial rheoplasty. The revolutionary RheOx 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. RheOx is limited by U.S. federal law to investigational use only. In 2019, RheOx received CE Mark in the European Union and U.S. FDA Breakthrough Device Designation.
About Gala Therapeutics®
Gala Therapeutics is a privately held medical device company based in San Carlos, Calif., that is dedicated to developing disease-modifying therapies that improve survival, quality of life, and outcomes for patients with pulmonary diseases. Formed by ATP, a leader in life sciences venture capital, Gala builds technologies to address the needs of interventional pulmonologists, thoracic surgeons, and all physicians who treat pulmonary disease.
Editor's Note: Dr. Victor Kim is a consultant for Gala Therapeutics. If you have any questions or concerns regarding these interests, you may contact the Lewis Katz School of Medicine at Temple University COI Office at email@example.com
1 Chronic Bronchitis. Retrieved April 06, 2021, from https://www.lung.org/lung-health-diseases/lung-disease-lookup/chronic-bronchitis
2 FastStats - Chronic Lower Respiratory Disease. Centers for Disease Control (CDC) / National Center for Health Statistics (NCHS) 2017; https://www.cdc.gov/nchs/fastats/copd.htm