US-based medtech company Galvanize Therapeutics has completed enrolment in its RheSolve trial to evaluate the RheOx bronchial rheoplasty system as a treatment for the symptoms of chronic bronchitis.
Chronic bronchitis is caused by inflammation and irritation of the bronchial tubes. The irritation of the tubes causes the build-up of mucus, which, along with swollen tubes, makes it harder for the lungs to transport oxygen and carbon dioxide.
Galvanize Therapeutics specialises in developing pulsed electric field (PEF) therapies for chronic obstructive pulmonary disease (COPD), soft tissues and cardiac arrhythmias.
The RheOx system is minimally invasive and delivers non-thermal PEF energy to destroy abnormal, mucus-producing goblet cells on the lung airway surface.
The RheSolve study will evaluate the safety and effectiveness of the system for reducing the symptoms of chronic bronchitis such as cough and phlegm.
Initiated in 2021, the trial is a double-blind, randomised, sham-controlled study, which will follow 270 COPD patients with moderate to severe chronic bronchitis across the US, Canada and Europe for two years.
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The primary efficacy endpoint is the validated COPD Assessment Test. This is a patient-reported outcome, measured at six months.
Galvanize Therapeutics CEO Jonathan Waldstreicher said: “Closing our RheSolve study enrolment is a major step towards transforming the lives of patients with chronic bronchitis using an entirely new therapeutic approach.
“We look forward to reporting RheSolve trial results and submitting them to the FDA in a premarket approval application, while simultaneously advancing our other unique PEF energy platform applications across disease categories.”
Eager to see the results of the study, RheSolve co-principal investigator Frank Sciurba commented: “Currently, there are no FDA-approved chronic bronchitis treatments targeting the airway cells that over-secrete mucus.”