Milestones

Completed

IRB submission for first-in-human feasibility study — Approved
SBIR Fast-Track (Phase I/II) application — submitted, pending decision.
Core docs: protocol, device profile, ICF/assent, privacy & data-security plan (HIPAA-aligned).
Technical prep: NeuroLoop Engine specs, MVP architecture, vendor SOW draft with Scientsoft USA Corp.
Go-to-market groundwork: brand/website, partner outreach to ABA centers, clinics, and schools.

 

In Progress (Q4 2025)

IRB clarifications (therapist involvement, stable services definition, device provision, stopping rules) — responding via tracked changes.
Finalize development contract and sprint plan for MVP v0.9 (Emotion, Speech, Task Coach, Parent/Therapist Portal).
Site onboarding for pilot (training materials, device logistics, secure data environment).

 

Next Milestones (2025–2026)

Q4 2025 — Conditional IRB approval; lock pilot protocol; complete security/HIPAA checks.
Q1 2026 — SBIR Phase I decision; complete MVP v0.9; internal QA & human-factors checks; deploy pilot devices (loaners where needed).
Q2 2026 — Launch IRB-approved pilot (≈20 participants, 8-week dosing); interim analysis and algorithm refinement.
Q3–Q4 2026 — Expand to multi-site Phase II (100+ participants); establish external Data/Safety monitoring; start payer & provider pilot MOUs.

 

Regulatory Pathway (2026–2028)

Q-Submission (FDA Pre-Sub) to confirm device classification and clinical evidence plan (SaMD).
Clinical validation: multicenter study focused on efficacy, safety, and usability endpoints.
De Novo or 510(k) strategy (final path based on Pre-Sub feedback).
Compliance: Quality system for SaMD lifecycle, post-market monitoring, SOC 2 Type I/II.
Target: US market entry after authorization/clearance; subsequent CE/UKCA for international expansion.

 

Commercialization & Reimbursement

Initial customers: ABA providers, pediatric clinics, school districts, tele-therapy networks.
Reimbursement: explore coding pathways (e.g., Remote Therapeutic Monitoring/behavioral digital therapy routes) and value-based pilots with Medicaid/commercial payers.
Licensing/Pricing: per-seat/site licensing for institutions; family access via provider prescription or sponsored programs.

 

Key Success Metrics

Engagement ≥70% of prescribed sessions;
Safety: 0 device-related SAEs;
Clinically meaningful gains in communication/attention measures;
Caregiver/therapist NPS ≥50;
Multi-site reproducibility of outcomes.

 

Long-Term Vision (2027–2029)

National roll-out with early partners across ABA centers, clinics, and schools.
International adaptation (multilingual UX, cultural norms), local regulatory filings.
Continuous AI improvement with privacy-preserving learning and bias monitoring.