Galvanize Therapeutics Completes Enrollment in Pivotal Trial of RheOx® System for Chronic Bronchitis
REDWOOD CITY, Calif., June 19, 2023 /PRNewswire/ -- Galvanize Therapeutics, Inc., a leader in developing pulsed electric field (PEF) therapies for COPD, soft tissue, and cardiac arrhythmias, has completed enrollment in the RheSolve pivotal trial evaluating the RheOx® Bronchial Rheoplasty System as a treatment for chronic bronchitis symptoms.
"Closing our RheSolve study enrollment is a major step towards transforming the lives of patients with chronic bronchitis using an entirely new therapeutic approach," said Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics. "We look forward to reporting RheSolve trial results and submitting them to the FDA in a Premarket Approval (PMA) application, while simultaneously advancing our other unique PEF energy platform applications across disease categories."
The minimally invasive RheOx System delivers non-thermal pulsed electric field (PEF) energy to destroy abnormal, mucus-producing cells on the surface of the lung airways. RheSolve is a double-blind, randomized, sham-controlled study evaluating RheOx's impact on chronic bronchitis symptoms and other disease measures in 270 COPD patients with moderate to severe chronic bronchitis in the U.S. and Europe. The primary efficacy endpoint is the validated COPD Assessment Test, a patient-reported outcome, measured at 6-months.
"Chronic bronchitis significantly impacts quality of life, as patients suffer from a persistent cough and overproduction of mucus," explained Frank Sciurba, M.D., Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Pittsburgh, and RheSolve Co-Principal investigator. "Currently there are no FDA-approved chronic bronchitis treatments targeting the airway cells that over-secrete mucus. I eagerly await the results of RheSolve and the possibility to offer RheOx as new therapy for affected patients."
Co-principal investigator Arschang Valipour, M.D., FCCP, Associate Professor, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Wien, Austria, also commented: "We see a lot of patients with severe chronic bronchitis symptoms, which can develop after exposure to pollutants and irritants such as cigarette smoke, vaping, airborne chemicals and more. I am pleased to help lead this international study for RheOx, a novel therapy which we have seen deliver important quality-of-life improvements for patients in Europe in the early commercial launch of the product. I am hopeful that the RheSolve study will show similar benefits."
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. RheOx is limited by U.S. law to investigational use only. RheOx received CE certification in 2019 and has U.S. FDA Breakthrough Device Designation.
About Galvanize Therapeutics
Galvanize Therapeutics aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, starting with treating chronic bronchitis symptoms, cardiac arrhythmias, and solid tumors. Formed by ATP (Apple Tree Partners), Galvanize is based in Redwood City, Calif., and is researching and commercializing its revolutionary AliyaTM Pulsed Electric Field (PEF) energy platform in the United States and Europe. For more information, please visit www.galvanizetx.com.