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Gala Therapeutics Receives FDA Approval to Commence Pivotal Trial to Evaluate the RheOx™ System for Chronic Bronchitis News provided by Share this article Share this article SAN CARLOS, Calif., Feb. 22, 2021 /PRNewswire/  Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to commence its pivotal clinical trial called RheSolve, which is designed to evaluate the RheOx Bronchial Rheoplasty System for chronic bronchitis. Performed using a minimally invasive, bronchoscopic procedure called Bronchial Rheoplasty, the RheOx System is designed to deliver non-thermal pulsed energy to the airways in the lungs to reduce mucus-producing cells, thereby improving the cough and mucus symptoms of chronic bronchitis.

United statesJonathan waldstreicherFrank sciurbaDivision of pulmonaryUniversity of pittsburghDrug administrationGala therapeutics incGala therapeuticsInvestigational device exemptionRheox bronchial rheoplasty systemBronchial rheoplastyRheox systemRhesolve trialCritical care medicineSan carlosஒன்றுபட்டது மாநிலங்களில்