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12-Month Data Published in the American Journal of Respiratory and Critical Care Medicine, Demonstrate the Safety and Feasibility of RheOx ™ Bronchial Rheoplasty System for Chronic Bronchitis

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September 3, 2020

RheoOX: 12-month data published in the American Journal of Respiratory and Critical Care Medicine, the official journal of the American Thoracic Society, demonstrates the safety and feasibility of the RheOxBronchial Rheoplasty System for chronic bronchitis as reported by Gala Therapeutics, developer of medical devices to treat pulmonary disease.

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.”

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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