MuReva Phototherapy has announced that the company has initiated a prospective, multi-center, randomized, double-blind, and placebo controlled pivotal clinical study. This study is designed to evaluate the safety and the efficacy of the MuReva Phototherapy System to reduce the incidence of severe oral mucositis in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving concurrent radiation and chemotherapy. The study will enroll 69 patients with head and neck cancer at 6 centers in the U.S. A summary of the study can be found at www.murevapt.com/clinical-study. The results of this study will be used to support the company’s planned future regulatory filing with the U.S. Food and Drug Administration (FDA).
More detailed information regarding the study can be found on the clinicaltrials.gov website at https://clinicaltrials.gov/ct2/show/NCT03972527.