Randomized, sham-controlled trial shows Mureva OM significantly reduced severe oral mucositis
BRECKSVILLE, Ohio, Sept. 10, 2026 /PRNewswire-PRWeb/ -- Mureva Phototherapy Inc. today announced that the U.S. Food and Drug Administration (FDA) granted De Novo authorization for Mureva OM™, and that results from its pivotal clinical trial have been published in Supportive Care in Cancer1. The De Novo authorization established a new Class II device classification for intraoral phototherapy devices, and Mureva OM previously received FDA Breakthrough Device Designation.
Mureva OM is the first FDA-authorized device indicated to lower the severity of radiation-induced oral mucositis and associated complications in adult patients receiving radiation to less than 75% of their oral cavity, with or without chemotherapy.
Pivotal trial results
The randomized, double-blind, sham-controlled trial enrolled 85 patients (42 Mureva OM; 43 sham) across 12 U.S. cancer centers. Patients undergoing high-dose intensity-modulated radiation therapy (IMRT) over six to eight weeks, with or without concurrent chemotherapy, received a daily 10-minute Mureva OM or sham treatment immediately before each radiation treatment.
Among patients within the FDA-authorized indication who received radiation to less than 75% of the oral cavity (n=40), severe oral mucositis through two weeks after IMRT occurred in 37% of patients treated with Mureva OM compared with 81% of patients receiving sham, representing a 54% relative reduction (p=0.016).
"Severe oral mucositis remains a major challenge during head and neck radiation because it can impair eating and swallowing and add substantially to the burden of treatment," said Kenneth S. Hu, MD, lead author of the study, Professor of Radiation Oncology and Otolaryngology-Head and Neck Surgery at NYU Grossman School of Medicine, and Co-Director of the Head and Neck Center at NYU Langone Health's Perlmutter Cancer Center. "This randomized, sham-controlled trial demonstrated that Mureva OM significantly reduced severe oral mucositis, including in the FDA-indicated patient population, while achieving a very high treatment completion rate. These findings support a standardized and practical approach to incorporating photobiomodulation into supportive care."
Significant reductions in severe oral mucositis were also observed in the full intent-to-treat population. Severe oral mucositis occurred in 36.8% of Mureva OM-treated patients compared with 57.1% of patients receiving sham during the first six weeks of IMRT (p=0.046), and in 10.8% compared with 36.4% at two weeks after IMRT (p=0.042).
Safety and patient-reported outcomes
In per-protocol analyses, patients treated with Mureva OM also reported better taste preservation and smaller increases in mouth and throat soreness and throat pain. No device-related adverse events were observed, and 99.5% of initiated treatment sessions were completed in full.
Addressing a long-standing delivery gap
MASCC/ISOO global guidelines recommend intraoral photobiomodulation (PBM) for the prevention of oral mucositis in adults receiving radiation therapy for head and neck cancer, with or without chemotherapy. Mureva OM provides a standardized, dose-controlled 10-minute treatment designed to fit into the daily radiation oncology workflow.
"PBM has decades of evidence supporting its use in the prevention and treatment of oral mucositis, but practical delivery barriers have limited routine adoption," said Vedang Kothari, Founder and President of Mureva. "FDA authorization and peer-reviewed pivotal data now give radiation oncology teams an evidence-based, practical path to bring PBM into routine care."
"This publication represents the culmination of a multi-year collaborative effort by multidisciplinary clinical care teams at 12 cancer centers across the country," said Michael Marotta, Vice President of Clinical Affairs at Mureva. "The dedication of these teams to conducting rigorous clinical research, delivering the best possible care, and supporting patients throughout their cancer treatment has been extraordinary."
Mureva at ASTRO 2026
Mureva will be featured at the 2026 ASTRO Annual Meeting, where Pratish Shah, MD, MBA, of St. Elizabeth Healthcare, will present additional subgroup findings from the pivotal trial. Radiation oncology teams can visit Mureva at booth 1150 or learn more at murevapt.com.
1 Hu K, Shah P, Nguyen MC, et al. Randomized, double-blind, sham-controlled trial of an intraoral photobiomodulation device for oral mucositis and associated complications due to radiotherapy for head and neck cancer. Support Care Cancer. 2026;34:696. doi:10.1007/s00520-026-10904-7
About Mureva Phototherapy
Mureva Phototherapy Inc. is a privately held medical device company developing and commercializing photobiomodulation solutions for patients receiving cancer treatment. Its flagship device, Mureva OM™, is the first FDA-authorized intraoral phototherapy device for radiation-induced oral mucositis and previously received FDA Breakthrough Device Designation. The company's pivotal trial (NCT03972527) was published in Supportive Care in Cancer in 2026. Mureva is preparing for the U.S. commercial launch of Mureva OM.
Media Contact
Michelle Joiner, Mureva, 1 678-938-4163, [email protected], https://murevapt.com/
SOURCE Mureva
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