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CLINICAL EVIDENCE

Meaningful reductions in severe oral mucositis

The Mureva pivotal trial was a randomized, double-blind, sham-controlled study involving 85 patients across 12 U.S. cancer centers. The study evaluated a 10-minute daily Mureva treatment administered immediately before intensity-modulated radiation therapy (IMRT).
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CLINICAL EVIDENCE

Meaningful reductions in severe oral mucositis

The Mureva pivotal trial was a randomized, double-blind, sham-controlled study involving 85 patients across 12 U.S. cancer centers. The study evaluated a 10-minute daily Mureva treatment administered immediately before intensity-modulated radiation therapy (IMRT).
View publication details
RANDOMIZED PATIENTS
42 Mureva • 43 Sham
U.S CANCER CENTERS
Multicenter Pivotal Trial
MIN DAILY TREATMENT
Immediately Before IMRT
WEEKS OF RADIATION
With or Without Chemo
DE NOVO AUTHORIZATION

First FDA-authorized device for radiation-induced oral mucositis

Severe OM through two weeks post-IMRT in the FDA-indicated population
RELATIVE REDUCTION
in severe oral mucositis
p=0.016

Percent of Patients with Severe OM

Sham81%
81%
Mureva37%
37%
Severe oral mucositis (WHO grade 3 or higher) incidence through two weeks post-IMRT; adults received radiation to less than 75% of the oral cavity: FDA-indicated subgroup (n=40)
SUPPORTIVE OUTCOMES

Clinical impact beyond oral mucositis severity

Preserving function, reducing pain, and maintaining treatment continuity
SWALLOWING
Fewer patients lost ability to swallow
ORAL PAIN
Reduction in pain and soreness
TASTE
Preserved the ability to taste
FEEDING SUPPORT
Fewer surgical feeding tubes placed
No oral mucositis related radiation interruptions were observed in the Mureva group
Secondary and exploratory outcomes in the subtotal oral cavity radiation subgroup (n=40). The study was not powered to establish statistical significance for these outcomes. FDA reviewed these results and permitted their inclusion in the authorized device labeling.
Protecting function can help patients stay stronger during and after their cancer treatment.
TREATMENT EXPERIENCE AND SAFETY

High treatment completion across more than 2,500 study treatments

of initiated pivotal trial treatments were completed
Mureva and Sham treatments were delivered
Device-related adverse events were observed
ADDITIONAL CLINICAL FINDINGS

Less time with severe OM. Fewer patients affected after radiation.

Additional analyses looked beyond whether severe OM occurred to examine how long it lasted and how many patients had severe OM two weeks after IMRT
DURATION
50% Relative Reduction in the Duration of Severe OM

Percent of Time with Severe OM

Mureva14%
14%
Sham28%
28%
Patients treated with Mureva experienced a 50% relative reduction in the duration of severe oral mucositis compared with sham through two weeks after IMRT.
POST-RADIATION RECOVERY
73% Relative Reduction in Severe OM Incidence 2 Weeks After Radiation

Percent of Patients with Severe OM

Mureva11%
11%
Sham40%
40%
Patients treated with Mureva experienced a 73% relative reduction in incidence of severe oral mucositis compared with sham two weeks after IMRT.
Secondary and exploratory outcomes in the subtotal oral cavity radiation subgroup (n=40). The study was not powered to establish statistical significance for these outcomes. FDA reviewed these results and permitted their inclusion in the authorized device labeling.
PARTICIPATING PIVOTAL TRIAL SITES

Conducted across 12 U.S. cancer centers

Academic and community cancer centers participated in the multicenter study

Miami Cancer Institute

MIAMI, FLORIDA

NYU Langone

NEW YORK, NEW YORK

Erie County Medical Center

BUFFALO, NEW YORK

MetroHealth

CLEVELAND, OHIO

James Cancer Hospital at The Ohio State University

Columbus, ohio

University of Alabama at Birmingham

BIRMINGHAM, ALABAMA

The Christ Hospital

CINCINNATI, OHIO

St. Elizabeth Healthcare

Edgewood, kentucky

University of Mississippi Medical Center

JACKSON, MISSISSIPPI

Willis-Knighton Cancer Center

Shreveport, louisiana

Oklahoma Cancer Specialists and Research Institute

tulsa, oklahoma

The Oncology Institute

long beach, california
Participating research sites are shown for study transparency and do not imply current commercial use or endorsement.
REGULATORY AND EVIDENCE SOURCES

FDA Authorization and evidence you can review directly

FDA DE NOVO AUTHORIZED
Class II Intraoral Phototherapy Device
The Mureva OM™ received FDA De Novo Authorization on November 26, 2025, and previously received Breakthrough Device Designation.
INDICATION FOR USE
The Mureva OM™ is intended for use during radiation treatment to lower the severity of oral mucositis and associated complications with radiation induced oral mucositis in adult patients receiving radiation to less than 75% of their oral cavity with or without chemotherapy. This device is prescription use only (Rx only).
PEER REVIEWED PUBLICATION
Hu K, Shah P, Nguyen MC, et al.
doi:10.1007/s00520-026-10904-7
VIEW PUBLICATION DETAILS
TRIAL REGISTRATION
ClinicalTrials.gov
NCT03972527
VIEW TRIAL RECORD
FDA DOCUMENTATION
De Novo Authorization
DEN240077
FDA DOCUMENTATION

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