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Pre-FDA SubmissionNIH / NIA & NINDSCo-Investigator
CBOT-P
Chronic Pain Neurosensory Therapeutic Platform
FDA Breakthrough Device designated electromechanical neurostimulation platform for chronic pain. ISO 13485 QMS compliant. Real-time neural feedback with electromechanical precision actuation.
$2.79MR44AG061981
Project Facts
- Role
- Co-Investigator
- Phase
- Phase II
- Status
- Pre-FDA Submission
- Funding
- $2.79M
- Grant Number
- R44AG061981
- Agency
- NIH / NIA & NINDS
NIH Award History
$225KPhase I2018
1R43AG061981-01
$225KPhase I2019
5R43AG061981-02
$1.25MPhase II2021
2R44AG061981-03A1
$98KSupplement2022
3R44AG061981-04S2
$50KTABA2022
3R44AG061981-04S1
$1.25MPhase II2022
5R44AG061981-04
Engineering Challenges
- Achieving electromechanical precision actuation within FDA-compliant device architecture
- Real-time neural feedback integration with hardware control-loop latency requirements
- Battery and power management for therapeutic device usage patterns
- IEC 60601 electrical safety compliance across all hardware revisions
- Building ISO 13485 QMS documentation infrastructure alongside active R&D
Technology Domains
Electromechanical EngineeringNeurostimulationISO 13485IEC 60601FDA 21 CFR 820Real-Time Control
Intellectual Property
USPTO 18/753,722
Pain Treatment Apparatus and Methods — Co-Inventor. Intl. PCT/US2025/033753