EMPIRA: A Funding & Investment Opportunity in Digital Biomarkers for Multiple Sclerosis

EMCare represents a compelling funding and investment opportunity in the fast-growing digital biomarker space for neurological disease. Developed by Mautilus eHealth, EMCare is an AI-based Software as a Medical Device (SaMD) that passively monitors smartphone typing and tapping patterns to detect Progression Independent of Relapse Activity (PIRA) in Multiple Sclerosis patients earlier than current clinical assessments allow — addressing a major unmet need in a disease affecting hundreds of thousands of patients across Europe.

The underlying EMPIRA algorithm has already demonstrated strong predictive performance in a pilot cohort, and is now advancing toward prospective, multicenter clinical validation through the ValEMPIRA study, planned with leading centers including Charité Berlin and Hospital Ramón y Cajal. This positions EMCare with a de-risked, evidence-based pathway toward CE marking, targeted for 2028, followed by commercial launch in Spain (2028–2029) and phased expansion across the EU5 markets (France, Italy, Germany, UK) from 2030.

EMCare's go-to-market strategy is designed for capital efficiency, routing initial adoption through scientific societies and pharma-brokered funding agreements rather than direct hospital budget sales, with public payer reimbursement as a longer-term growth driver. Combined with an experienced founding team with direct clinical expertise in MS care, EMCare offers investors early entry into a scalable, evidence-backed digital health platform with a clear route to regulatory approval and market adoption.