Milestones & Roadmap

Current Stage (2025)

Concept & Development:

NeuroMirror therapeutic platform and NeuroLoop Engine fully designed at concept and prototype level.
Regulatory:

IRB submission completed — review in progress.
Funding: SBIR Fast-Track (Phase I/II) application submitted — under review.
Preparation: Caregiver and child consent/assent forms drafted per Revised Common Rule.

 

Next Milestones (2025–2026)

Q4 2025: IRB approval and launch of pilot feasibility study (20 participants).
Q1 2026: Phase I SBIR funding decision and initiation of MVP development with clinical testing.
Q2 2026: Interim data analysis from pilot, refinement of AI personalization algorithms.
Q3–Q4 2026: Begin Phase II expansion — larger study, 100+ participants, multi-site validation.

 

Long-Term Vision (2027–2028)

Regulatory Pathway:

Pre-Submission (FDA) for device classification.
Clinical Validation: Larger-scale trials to demonstrate efficacy and usability.
Commercialization: Early partnerships with clinics, schools, and digital health distributors.
Scaling: International adaptation (multilingual), continuous AI upgrades.