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Non-Invasive Intraoral LED Phototherapy Device for the Prevention and Treatment of Oral Mucositis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44DE026082-02A1
Agency Tracking Number: R44DE026082
Amount: $1,488,768.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDCR
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-13
Award End Date (Contract End Date): 2020-08-31
Small Business Information
8443 DOW CIR
Strongsville, OH 44136-1759
United States
DUNS: 108631797
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (440) 243-8401
Business Contact
Phone: (216) 299-7281
Research Institution

PROJECT SUMMARY ABSTRACT The goal of this SBIR is to create a novel phototherapeutic light delivery device which will advance the standard of care for the prevention and treatment of Oral MucositisOMOM is one of the most common and highly significant toxicities of cancer therapyApproximatelypatients are affected by OM in the United States each yearOM is an extremely painful condition which breaks down the lining of the mouth and is associated with increased treatment breaksincreasedday mortality and a considerable increase in healthcare costsThe standard of care for patients with OM is mainly palliativeaiming to reduce paininflammationand risk of infectionA new and proven approach for treatment and prevention of OM is PhotobiomodulationPBMTherapySpecific dosages of red light demonstrate increased production of ATP which protects the mucosa from cell deathCurrent barriers to the use of PBM Therapy include the cost of laser equipmentlabor intensivenessinter operator variabilityand lack of dose controlAs the result of the successful completion of the Phase I grantLumitex developed the OralGloa flexiblebiocompatible silicone light guide to irradiate OM susceptible regions of the oral mucosa with therapeutic lightThe key innovation is the simultaneous irradiation of the entire oral cavity with minimal clinical supervision while significantly increasing patient comfortOur light delivery technology can be integrated into a mouthpiece that safely deliversJ cmof light directly to the oral mucosa in under ten minutesTo complete the preclinical validation of the OraGlowe created these aimsAimIncorporate design refinements and validate performanceCompletion of this aim will result indevices that haveuniformity to all targeted delivery zones and certification to applicable safety standardsAimPerform a doseescalation study in vitro to determine the optimal therapeutic dosage rangeSuccessful completion of this aim will result in the determination for the maximum dosage before cell death occurs and determine the dosage for peak cellular responseAimConfirm no tumor progression due to LED PBM therapy in a mouse modelA study of mice implanted with squamous cell carcinomas and undergoing PBM therapy will be conductedCompletion of this aim will result in no statistically significant increase in tumor growth rate associated with our device compared to controlUpon completion of Phase IIwe will successfully have refined and validated a phototherapeutic mouthpiece capable of delivering the therapeutic light dosage in an effectivecontrolled mannerNext steps will be to conduct clinical studies using the OraGlo in Head and Neck cancer patientsThe long term goal for the product is to shift the paradigm for OM management from palliativeto treatment and preventionThis technology would be the first PBM product approached for treatmentenabling many new light based wound healing applications PROJECT NARRATIVE In this Phase II SBIRLumitex plans to refine and preclinically validate the performance of an intraoral phototherapeutic device for the treatment and prevention of Oral MucositisOral Mucositis is one of the most severe and debilitating side effects of chemoand radio therapy affecting more thanpeople annually and can often prevent patients from eatingsleepingor speakingthus lowering their quality of lifeWe expect our non invasive device can provide a safeeffective and tolerable treatment to eliminate this serious side effect

* Information listed above is at the time of submission. *

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