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

> **NIH NIH R42** · MITOVATION, INC. · 2020 · $768,981

## Abstract

Neonatal hypoxia/ischemia is a known cause of cerebral damage resulting from inadequate blood flow and/or
oxygen delivery to the infant brain before, during, or after birth. The occurrence among hospital deliveries is
~2-4 per 1000 full-term births with a drastic increase among premature newborns. The deficit in oxygen
delivery to the brain results in extensive damage and severe disabilities. Restoration of blood flow critical for
salvage of ischemic tissue, however, also causes significant cerebral damage due in part to cytotoxic reactive
oxygen species (ROS) generated upon reintroduction of oxygen. The current standard treatment for neonatal
hypoxia/ischemia is therapeutic hypothermia applied on average 4-6 hours after restoration of blood
flow/oxygen delivery. A 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/ischemia.
Our molecular studies on mitochondrial function uncovered a novel method to prevent ROS generation during
early reoxygenation. Indeed, our studies have, for the first time: (i) identified two wavelengths of infrared light
(IRL) that specifically and reversibly reduce mitochondrial respiration by acting on cytochrome c oxidase; and
(ii) documented that IRL, applied at the time of reoxygenation, is neuroprotective and limits ROS generation.
Based on these data, we propose develop iNeuroLUX, a device that will safely deliver therapeutic IRL to the
infant brain. To achieve this goal, Phase I will propose 2 experimental aims:
• Conduct ex vivo molecular investigation to define the safe therapeutic IRL dose that can be applied in our
 large animal studies (Aim 1).
• Establish the effect of IRL on HIE in a large animal model of neonatal hypoxia/ischemia (Aim 2). We will
 determine the effects of IRL on neurologic damage in a neonate swine model of hypoxia/ischemia and
 investigate safety of IRL in undamaged tissues.
Phase II will build upon the findings in the first phase and:
• Design and construct a iNeuroLUX light-delivery prototype for testing IRL therapy (Aim 3).
• Establish the efficacy of iNeuroLUX and evaluate the concept of iNeuroLUX combination therapy with
 hypothermia (Aim 4).
• Document critical safety parameters of iNeuroLUX to move forward with FDA approval (Aim 5).
This proposal combines multi-disciplinary expertise, compelling preliminary data, and state-of-the-art resources
available to our research team to address a highly significant health problem.

## Key facts

- **NIH application ID:** 10017347
- **Project number:** 5R42NS105238-03
- **Recipient organization:** MITOVATION, INC.
- **Principal Investigator:** MAIK HUETTEMANN
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $768,981
- **Award type:** 5
- **Project period:** 2019-09-15 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10017347

## Citation

> US National Institutes of Health, RePORTER application 10017347, Infant NeuroLUX: A Novel Non-invasive Therapeutic Device for Neonatal Hypoxic Brain Injury (5R42NS105238-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10017347. Licensed CC0.

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