Pipeline
From published science to a validated digital program.
Our roadmap is sequenced around evidence: lock the protocol, prove digital fidelity, pilot in clinics, then pursue authorization.
- Stage
- Investigational · Research build
- Regulatory status
- Not FDA authorized
- Lead indication
- Chronic low back pain (> 3 months), adults 18+
- 01
Scientific foundation & protocol design
Literature review, digital OLP rationale and ritual protocol, patient-reported endpoints, and draft intended use.
Complete - 02
Version-locked iOS research build
Rationale, daily ritual, symptom tracking, and adherence logging in a locked build with a traceable data pipeline.
In progress - 03
Digital fidelity validation
Independent remote study testing whether fully digital delivery preserves expectancy, comprehension, adherence, and retention.
Up next - 04
Clinic RTM pilot
Pilot with spine, pain, and PT practices using remote therapeutic monitoring workflows between visits.
Roadmap - 05
Controlled clinical study
Controlled study of the locked program on pain and pain-interference endpoints.
Roadmap - 06
FDA engagement & submission
Pre-Submission feedback followed by a De Novo-oriented strategy, guided by the established Class II pathway for prescription behavioral therapy in chronic low back pain.
Roadmap
FDA has created a Class II device category for prescription behavioral therapy in chronic low back pain (21 CFR 890.5800). Rxpect cites it as public regulatory precedent only and is not affiliated with any other device maker.
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Hear about study openings, clinic pilots, and new research on open-label placebo.