# Development and Testing of LUCID: A Therapeutic Device for Brain Injury Following Infant Cardiac Arrest

> **NIH NIH U44** · MITOVATION, INC. · 2024 · $99,400

## Abstract

U44 NS125160 - Abstract:
Cardiac arrest in infants is a medical emergency requiring rapid resuscitation to restore circulation. However,
resuscitation often results in significant brain injury, caused by ischemia/reperfusion injury. Only 36% of infants
(<1yr old) treated for out-of-hospital cardiac arrest and 69% of infants that suffer in-hospital cardiac arrest are
successfully resuscitated. These infants currently have no therapeutic options to limit brain injury. The current
standard treatment for post-cardiac arrest brain injury is therapeutic hypothermia. Unfortunately, recent
studies demonstrated that use of therapeutic hypothermia in pediatric cardiac arrest patients does not provide
significant benefit beyond what is achieved with controlled normothermia. A safe and effective neuroprotective
intervention that specifically targets reperfusion injury would fill a critical unmet need in the treatment of these
vulnerable patients.
Our molecular studies on mitochondria uncovered a novel method to non-invasively modulate mitochondrial
function during reperfusion and reduce brain injury following resuscitation from cardiac arrest. Indeed, our
studies have, for the first time: (i) identified two wavelengths of near infrared light (NIR) that specifically and
reversibly reduce mitochondrial respiration by acting on cytochrome c oxidase (COX); (ii) documented that
NIR, applied at the time of reoxygenation, is neuroprotective in rodent and swine models of infant and pediatric
cardiac arrest/resuscitation; and (iii) developed a NIR-delivery system capable of providing therapeutic doses
to patients up to 1 year old. Based on these data, we propose to produce the clinical Light Utilizing COX-
Inhibitory Device (LUCID), a medical device that will safely deliver therapeutic NIR to the infant brain. To
achieve this goal, Phase I will focus on device development and validation of LUCID in 3 experimental aims:
• Develop LUCID engineered for clinical use (Aim 1).
• Evaluate safety and efficacy of LUCID (Aim 2).
• LUCID clinical trial development and HUD and IDE approval (Aim 3).
Phase II will utilize the LUCID clinical device and execute the “LUCID Therapy for Infant Cardiac Arrest”
(LUTICA) clinical trial (Aim 4).
This proposal combines multi-disciplinary expertise, compelling preliminary data, and state-of-the-art
resources available to our team to address a significant health problem in a highly vulnerable patient
population.

## Key facts

- **NIH application ID:** 11013199
- **Project number:** 3U44NS125160-02S1
- **Recipient organization:** MITOVATION, INC.
- **Principal Investigator:** MAIK HUETTEMANN
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $99,400
- **Award type:** 3
- **Project period:** 2024-02-05 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11013199

## Citation

> US National Institutes of Health, RePORTER application 11013199, Development and Testing of LUCID: A Therapeutic Device for Brain Injury Following Infant Cardiac Arrest (3U44NS125160-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11013199. Licensed CC0.

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