Initial Study of the Minimally Invasive RheOx™ Device Demonstrates Positive Results for Chronic Bronchitis Patients
DALLAS, May 23, 2019 /PRNewswire/ -- Gala Therapeutics, Inc. (Gala), a clinical-stage developer of medical devices to treat pulmonary disease, today announced new results from the initial study of its investigational RheOxTM device, demonstrating the safety and feasibility of Bronchial RheoplastyTM therapy to provide clinical benefit to patients with chronic bronchitis. The findings were presented at the 2019 American Thoracic Society (ATS) International Conference, which was held May 17-22, 2019 in Dallas.
The initial study evaluated the investigational use of RheOx in 33 patients with chronic bronchitis, a type of Chronic Obstructive Pulmonary Disease (COPD). The device is designed to reduce cough and mucus production through a minimally invasive, bronchoscopic procedure.
"More than 9 million Americans suffer from chronic bronchitis without a therapy to reduce excess mucus production. Our Bronchial Rheoplasty procedure with RheOx is the first therapy designed to reduce mucus-producing cells and provide a better day-to-day quality of life for these patients," said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. "We are excited by the results and intend to continue clinical development of the technology in the United States."
Data presented by study investigator Arschang Valipour, MD, FCCP, Associate Professor, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto Wagner Spital, Vienna, Austria, demonstrated:
- Feasibility of Bronchial Rheoplasty, with 100% procedure success and an acceptable safety profile;
- Clinically meaningful improvements in patient quality of life at 3 months, based upon a 16.3-point mean reduction (p<0.001) in the St. George's Respiratory Questionnaire (SGRQ) and an 8.6-point mean reduction (p<0.001) in the COPD Assessment Test (CAT), with sustained quality-of-life benefits in the patients who reached 12 months;
- Symptomatic improvements at 3 months: 39% reduction in cough (p<0.0001) and 44% reduction in mucus (p<0.0001); and
- A 20% increase in airway volume (p=0.001) and a 15.6% increase in identifiable airways (p=0.005), according to high-resolution computed tomography (HRCT) imaging data.
"The RheOx study showed that this innovative approach for treating the symptoms of chronic bronchitis is technically viable, with limited device-related complications, and provides meaningful quality-of-life improvements," said Dr. Valipour. "These findings strongly support the utility of this novel therapy, and I look forward to continuing clinical evaluation of RheOx."
The initial study also showed a meaningful reduction of mucus-producing cells in the airways following treatment with RheOx, according to histopathology data presented by study investigator Sebastian Fernandez-Bussy, MD, Interventional Pulmonologist, Mayo Clinic hospital in Jacksonville, FL. The histopathology findings included a 39% reduction in goblet cell hyperplasia (p<0.001).
About RheOxTM
RheOx is a bronchoscopic therapy designed to deliver non-thermal energy to the airways to reduce mucus-producing cells in patients with chronic bronchitis. The technology consists of a unique 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 re-develop. Currently under evaluation in an early feasibility study in the United States, RheOx is limited by federal (or United States) law to investigational use.
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 lung cancer, COPD, asthma, and other 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.
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SOURCE Gala Therapeutics, Inc.