Tuesday, June 20, 2023
Galvanize Therapeutics, a pioneering company specializing in pulsed electric field (PEF) therapies for conditions like COPD, soft tissue disorders, and cardiac arrhythmias, has successfully concluded participant enrollment for the RheSolve pivotal trial. This trial aims to evaluate the efficacy of the RheOx® Bronchial Rheoplasty System in treating chronic bronchitis symptoms.
Dr. Jonathan Waldstreicher, the founder and CEO of Galvanize Therapeutics, expressed enthusiasm, stating, "Closing our RheSolve study enrollment is a significant milestone in our mission to revolutionize the treatment of chronic bronchitis and improve patients' lives through an entirely innovative therapeutic approach." The company is eagerly awaiting the trial results, which will be submitted to the FDA through a Premarket Approval (PMA) application. Galvanize Therapeutics also continues to advance its unique PEF energy platform for various diseases.
The RheOx System is a minimally invasive solution that delivers non-thermal pulsed electric field (PEF) energy to target and eliminate abnormal mucus-producing cells on the lung airways' surface. The RheSolve trial is a double-blind, randomized, sham-controlled study involving 270 COPD patients with moderate to severe chronic bronchitis in the United States and Europe. The primary efficacy endpoint is the COPD Assessment Test, a validated patient-reported outcome measure assessed at the 6-month mark.
Dr. Frank Sciurba, a Professor of Medicine in the Division of Pulmonary and Critical Care Medicine at the University of Pittsburgh and co-principal investigator of the RheSolve trial, emphasized the impact of chronic bronchitis on patients' quality of life. He highlighted the lack of FDA-approved treatments targeting the excessive mucus-secreting airway cells. Dr. Sciurba eagerly anticipates the RheSolve trial results and the potential for RheOx to offer a new therapy for affected patients.
Co-principal investigator Dr. Arschang Valipour, an Associate Professor at the Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology in Wien, Austria, mentioned the prevalence of severe chronic bronchitis symptoms caused by exposure to pollutants such as cigarette smoke and airborne chemicals. Dr. Valipour is optimistic about the RheSolve study and its potential to demonstrate improvements in patients' quality of life, drawing from the positive experiences observed during the early commercial launch of RheOx in Europe.