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Infant NeuroLUX: A Novel Non-invasive Therapeutic Device for Neonatal Hypoxic Brain Injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42NS105238-01
Agency Tracking Number: R42NS105238
Amount: $248,042.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-04-01
Award End Date (Contract End Date): 2019-03-31
Small Business Information
Saline, MI 48176-9276
United States
DUNS: 080534131
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (313) 993-5707
Business Contact
Phone: (313) 993-5707
Research Institution
5057 Woodward Avenue
DETROIT, MI 48202-4050
United States

 Nonprofit College or University

Neonatal hypoxia ischemia is a known cause of cerebral damage resulting from inadequate blood flow and or
oxygen delivery to the infant brain beforeduringor after birthThe occurrence among hospital deliveries isperfull term births with a drastic increase among premature newbornsThe deficit in oxygen
delivery to the brain results in extensive damage and severe disabilitiesRestoration of blood flow critical for
salvage of ischemic tissuehoweveralso causes significant cerebral damage due in part to cytotoxic reactive
oxygen speciesROSgenerated upon reintroduction of oxygenThe current standard treatment for neonatal
hypoxia ischemia is therapeutic hypothermia applied on averagehours after restoration of blood
flow oxygen deliveryA safe and effective neuroprotective intervention that specifically targets reperfusion
injury during the early phase of reoxygenation would fill a critical unmet need in the treatment of infants
exposed to hypoxia ischemiaOur molecular studies on mitochondrial function uncovered a novel method to prevent ROS generation during
early reoxygenationIndeedour studies havefor the first timeiidentified two wavelengths of infrared lightIRLthat specifically and reversibly reduce mitochondrial respiration by acting on cytochrome c oxidaseandiidocumented that IRLapplied at the time of reoxygenationis neuroprotective and limits ROS generationBased on these datawe propose develop iNeuroLUXa device that will safely deliver therapeutic IRL to the
infant brainTo achieve this goalPhase I will proposeexperimental aimsConduct ex vivo molecular investigation to define the safe therapeutic IRL dose that can be applied in ourlarge animal studiesAimEstablish the effect of IRL on HIE in a large animal model of neonatal hypoxia ischemiaAimWe willdetermine the effects of IRL on neurologic damage in a neonate swine model of hypoxia ischemia andinvestigate safety of IRL in undamaged tissuesPhase II will build upon the findings in the first phase andDesign and construct a iNeuroLUX light delivery prototype for testing IRL therapyAimEstablish the efficacy of iNeuroLUX and evaluate the concept of iNeuroLUX combination therapy withhypothermiaAimDocument critical safety parameters of iNeuroLUX to move forward with FDA approvalAimThis proposal combines multi disciplinary expertisecompelling preliminary dataand state of the art resources
available to our research team to address a highly significant health problem Delivery of newborns is sometimes accompanied by complications that cause a
reduction in blood flow or oxygen delivery to their brainresulting in brain damage
and disorders such as epilepsy and cerebral palsyRestoration of oxygen back to
the brain also worsens brain damage by generating highly toxic agents called
free radicalsWe have discovered that treatment with specific wavelengths of
infrared lightapplied non invasively at the time when blood flow is restored to
the brainsubstantially reduces the production of free radicals and brain damageand we propose to develop this therapy for a clinical treatment for newborns

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

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