November 7, 2018 PR-M11-18-NI-023
MENLO PARK, Calif., Nov. 5, 2018 /PRNewswire/ -- Gala Therapeutics (Gala), a clinical-stage developer of medical devices to treat pulmonary disease, today announced that the first two patients in the Early Feasibility Study of RheOx™ for Chronic Bronchitis were treated at University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania. Drs. Frank Sciurba and Roy Semaan performed the procedures, in the first US patients to undergo RheOx Bronchial Rheoplasty™, on November 1, 2018.
"We are pleased to partner with Gala in treating the first US patients and thus continuing the contribution of UPMC as a leader in the development of novel devices for our patients with COPD" said Frank Sciurba, MD, FCCP, Director of the Emphysema/COPD Research Center at UPMC in Pittsburgh, Pennsylvania. "RheOx offers a potential solution for an unmet need for so many patients who suffer with the persistent symptoms of chronic bronchitis, representing a personalized therapy for our patients with one type of COPD."
RheOx, an electrosurgical system developed by Gala Therapeutics, targets the abnormal, mucus-producing cells in the airways. In a minimally invasive procedure, a pulmonologist guides an endoscope into the airways and inserts the RheOx catheter, delivering short bursts of electrical energy to the airway walls. Within days, the abnormal cells that produce large volumes of mucus are replaced by new cells, which produce less mucus. At the European Respiratory Society in Paris in September 2018, data presented from studies outside the United States demonstrated RheOx significantly improves Quality of Life scores, reduces the mucus-producing cells on biopsy specimens and resolves mucus plugging on CT scans.
Chronic bronchitis is the most common subtype of Chronic Obstructive Pulmonary Disease (COPD), a condition which impacts over 15 million people, mostly smokers and former smokers, in the United States. Secondhand smoke, vaping, exposure to airborne chemicals, pollution, and other irritants can contribute to the disease. Chronic bronchitis is associated with increased cough, excessive phlegm and shortness of breath for greater than 3 months of each year. Despite treatment with inhalers many patients have persistent symptoms.
In July 2018, the U.S. Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval to conduct an Early Feasibility Study (EFS) to examine the safety of RheOx in subjects with chronic bronchitis. Fifteen subjects at 5 clinical trial sites in the United States will undergo Bronchial Rheoplasty. The procedure is performed in two treatments sessions, the first to treat the right lung airways and the second, one month later, to treat the left lung airways. The primary endpoint of the study is safety. Secondary endpoints include changes in Quality of Life as measured by the Saint George's Respiratory Questionnaire and COPD Assessment Test, as well as pulmonary function testing and CT scans.
"Treatment of the first subjects in the United States through the novel EFS pathway is a significant milestone for Gala Therapeutics," said Jonathan Waldstreicher, MD, Founder and CEO of Gala. "We look forward to enrolling additional patients at new US clinical sites in the coming weeks."
Individuals in the United States diagnosed with chronic bronchitis who are interested in participating in the study can assess eligibility at www.bronchitisstudy.com. RheOx is an investigational medical device limited by United States law to investigational study only.
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