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.