MyndBlue.ai

First continuous, AI-built, FDA-tracked biosignature for MDD/PTSD. Detects distress before visible. 92% Nature - severity accuracy, US Army/Navy peer-reviewed. $230B TAM. $9M/45% non-dil. Pre-Series A

7 years of R&D, ~$9M deployed (~45% non-dilutive), 4 peer-reviewed papers, patents pending. FDA Breakthrough submission under review; De Novo study ready; US reimbursement codes already operational; Delaware entity incorporated. US partners: MGH Home Base (100 veterans), Naval Health Research Center (PTSD trials), US Army Research Lab and ONR; advisors from MGH, NHRC Only French startup selected for SelectUSA 2026. Closing a $5.5M pre-Series A (Q4 2026) for the De Novo study and US launch.

Psychiatry still runs without a thermometer. Depression (MDD) and PTSD are tracked with subjective questionnaires every 2–4 weeks, so decline is caught too late — ~70% of relapses go undetected and 70% of patients fail their first treatment. Depression is the world's leading cause of disability and costs the US ~$326B/year; PTSD drives suicide risk and lost readiness in military and veteran populations. Despite decades of research, no objective biomarker of mood-disorder severity has ever reached the clinic — leaving pharma and payers with no way to prove a treatment actually works.

MyndBlue delivers the first continuous, individual, predictive biosignature of depression and PTSD. A passive medical-grade wristband captures 150+ physiological signals (heart, respiration, activity, sleep) with zero data entry; our AI, SiBaMoD (a Neural-ODE model), learns each patient's baseline and outputs a daily objective severity score on the clinical MADRS scale — the 'glucometer of the mind.' Reaching 92% accuracy, it's validated in a prospective multicentre study and published in Nature Portfolio.

MyndBlue isn't a consumer app — it's the measurement infrastructure pharma, payers and providers need to prove a treatment works. We monetise one validated biosignature across channels. Providers/payers bill continuous MDD/PTSD monitoring via already-codified CPT codes — no reimbursement to negotiate. Pharma licenses it as an objective efficacy endpoint for CNS trials. VA/DoD deploy at scale with near-zero CAC. The biosignature also licenses to wearable OEMs — reimbursed revenue plus a defensible $230B-market position.