MAUTILUS EHEALTH SL

Mautilus eHealth is a Spanish digital-health company developing EMCare, a Software as a Medical Device (SaMD) for the early detection of disability progression in Multiple Sclerosis (MS). Our founding team combines deep clinical expertise — including a neurologist from a national MS reference centre (CSUR) — with backgrounds in enterprise software delivery, data science, and healthcare market access, giving us a product built by clinicians for clinical practice.

MS disability increasingly accumulates through Progression Independent of Relapse Activity (PIRA) — a process responsible for 80-90% of long-term disability, often present from the first years after diagnosis. The current clinical standard detects it late: diagnosis relies on subjective disability scales assessed every 6-12 months, followed by a 6-month confirmation visit, meaning treatment decisions are made only after significant, often irreversible, neurological damage.

EMCare closes this gap. It turns the smartphone patients already use every day into a continuous, passive monitoring tool: the app silently captures typing dynamics during normal phone use, with no active tests and no added burden on the patient. Our predictive algorithm, EMPIRA, analyses these behavioural time series and generates risk alerts on a clinician-facing dashboard, supporting — never replacing — the neurologist's decision. Our most recent validation shows high sensitivity (0.94), meaning EMCare misses very few real progression events, positioning it as a rigorous clinical screening and prioritisation tool between scheduled visits.

Clinical credibility is central to our approach. Mautilus collaborates with leading MS reference centres, including Charité (Berlin) and Ramón y Cajal/IRYCIS (Madrid), and our prospective, multicentre ValEMPIRA study — backed by EIT Health — will further validate EMCare's ability to anticipate progression against objective serum biomarkers and MRI, alongside standard clinical scales. We are advancing under ISO 13485, with a clear regulatory pathway toward CE marking as a Class IIa clinical decision-support device.

For the pharmaceutical industry, EMCare's relevance is direct and practical. Earlier, more reliable detection of progression risk means neurologists can consider therapeutic decisions months earlier than the standard diagnostic pathway allows — translating into earlier access to disease-modifying therapy for patients who need it. For pharma partners, this supports two concrete needs: more precise patient selection and stratification in clinical trials targeting progression, and real-world evidence generation that strengthens the value case for progression-slowing therapies with payers and health systems. Because MS units rarely hold dedicated budgets for new digital tools, our go-to-market model is built around structured partnerships: scientific societies act as credible intermediaries, working with pharmaceutical companies to fund monitoring programmes deployed across multiple centres at once — reducing friction for everyone involved and accelerating adoption.

Our roadmap is deliberately phased: software validation and RUO (Research Use Only) commercialisation in Spain now, CE marking and first clinical sales in Spain from 2028, followed by expansion across the EU5 (France, Italy, Germany, UK) from 2030. Spain serves as our clinical and commercial proving ground, built on the reference centres already engaged in validation.

We come to this event looking to connect with pharmaceutical companies developing or commercialising progression-focused MS therapies, scientific societies, and other stakeholders who share our conviction that earlier, passively-gathered evidence of disease progression can change outcomes for people living with Multiple Sclerosis — and create measurable value across the care and treatment pathway.