Mely combines clinically validated cognitive and motor testing with advanced AI to generate secure, actionable digital biomarkers. We empower clinicians to detect earlier and monitor patient progress with confidence.
Mely's digital biomarkers capture the full spectrum of brain health. We provide precise insights for neurodegenerative diseases (Parkinson's, Alzheimer's, Amyotrophic Lateral Sclerosis (ALS), Huntington's) and neuroevolutive conditions (Multiple Sclerosis, Schizophrenia). By mapping subtle changes, our platform supports early detection and personalised care pathways.
A seamless, secure pipeline that transforms quick tests and medical data into clinically actionable digital biomarkers.
Novel cognitive and motor tests are administered through our accessible, proprietary digital platform. Non-invasive and highly efficient, complete assessments take under 15 minutes.
Both raw test data and patient medical histories are encrypted end-to-end within our GDPR & HIPAA-compliant infrastructure. Built with clinical-grade security, our platform ensures all data remains immutable, auditable, and anonymized to protect patient privacy.
Proprietary AI models analyze multimodal patient data, detecting subtle patterns invisible to the human eye across thousands of data points.
Computationally derived and clinically validated, our multimodal digital biomarkers offer objective, high-fidelity phenotypic signatures of neurocognitive and neuromotor integrity across distinct pathophysiological trajectories.
Mely provides interpretable reports identifying early risk and disease evolution. As an objective assistive tool, we deliver longitudinal data to help doctors intervene sooner and tailor patient care.
Mely is a Software as a Medical Device (SaMD) platform engineered with clinical rigor, scientific validity, and medical-grade security to meet the exacting requirements of European healthcare systems.
Scientifically validated cognitive and motor tests delivered via an intuitive digital interface. By capturing granular temporal and kinematic data, our platform identifies subtle performance variances to provide an objective window into neurological function.
An end-to-end encrypted architecture engineered for EU MDR (2017/745) and GDPR alignment. Our pipeline ensures high-fidelity data integrity through hardware-rooted pseudonymization at the point of capture, persisting data within a sovereign, ISO-certified Common Data Environment (CDE).
Proprietary multimodal ML architecture integrating continuous telemetry, patient histories, and standard-of-care diagnostics. Our models identify early disease phenotypes and track complex longitudinal progression, continuously validating against real-world clinical data.
Multi-dimensional biomarker extraction framework rigorously validated against diagnostic gold standards. The system produces stratified clinical reports that scale from macroscopic disease probabilities down to granular, domain-specific neurological signatures.
Mely's platform provides distinct value across the neurology ecosystem.
Receive objective, quantitative early-warning indicators designed to augment clinical judgment across the entire neurodegenerative care pathway. Identify at-risk patients well before they reach conventional diagnostic thresholds, facilitating earlier, targeted interventions and improved long-term outcomes.
Partner through shared R&D consortiums to leverage our validated biomarker platform. Whether complementing existing observational cohorts or conducting new studies in emerging neurodegenerative disorders, our infrastructure accelerates collaborative discovery into disease mechanisms, progression, and therapeutic targets.
Leverage accessible, highly accurate digital biomarkers to accelerate the development of novel neurodegenerative therapeutics. Our platform provides cost-effective, quantifiable endpoints that optimize trial design—from initial precision screening to continuously measuring drug efficacy across Phase II through Phase IV clinical studies.
Patient data is our foundation. Every layer of our Software as a Medical Device (SaMD) is built to be compliance-ready from conception — protecting data by default by decoupling patient identifiers at ingestion.
Architecture inherently designed for EU MDR (2017/745) and the EU AI Act from day one, with AI governance aligned to ISO/IEC 42001.
Development governed by a Quality Management System built to ISO 13485 standards, ensuring full readiness for formal medical device certification.
Engineered for full alignment with European data protection regulations. Data minimisation, right to erasure, and consent management built in. Pipelines operate exclusively on pseudonymised or anonymised data.
Technical and administrative safeguards built to meet US HIPAA standards, incorporating strict de-identification protocols for protected health information.
Information security management systematically aligned with the ISO 27001 international standard, ready for future certification.
AES-256-GCM encryption at rest, TLS 1.3 in transit. Data is encrypted at capture and never stored in plain text.
Immutable, timestamped audit logs for all operations, enabling full regulatory traceability.
Neurodegenerative diseases are among the most challenging conditions in medicine. By the time symptoms are clinically apparent, significant neurological damage has already occurred — and the window for meaningful intervention has narrowed.
Mely was founded to change this timeline. We build digital tests that are radically simple and accessible for patients yet backed by uncompromising scientific rigor. We refuse to cut corners on data security or clinical truth, ensuring that every tool we create is transparent, easy to use, and fundamentally reliable.
Our mission is twofold: to equip doctors with the precise tools they need to diagnose patients earlier, and to provide clinical researchers with the quantitative biomarkers required to accelerate the development of new life-saving therapies.
We are engineers, data scientists, neuroscientists, and clinicians united by a single goal. We are building these solutions with absolute urgency and unwavering precision — because patients and their families deserve a future they can believe in.
We are advancing our Proof of Concept for the early detection of neurological disorders. Join us as we validate and build our SaMD platform.
We are seeking alliances with pharma companies, research clinics, and university hospitals. Let's discuss pilot programs and advancing early neurological screening together.
We are actively looking for neurologists, psychologists, and clinical researchers to collaborate on data validation and joint studies for our platform.
Connect with our founding team to discuss our successful PoC, upcoming funding rounds, and our regulatory roadmap in France.