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
RheOx is a bronchoscopic system designed to reduce mucus-producing cells in patients with chronic bronchitis. (Credit: CDC on Unsplash)
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.”
Source: Company Press Release