Multiple Sclerosis (MS) is a chronic autoimmune disease that affects the central nervous system (CNS), which includes the brain, spinal cord, and optic nerves. MS silently progresses in over 50% of patients, often without visible symptoms, escalating healthcare costs by up to 70%—rising from $30,000 to $100,000 annually per patient. Despite the availability of 25 approved MS treatments, 42% of patients remain undertreated.
Traditional monitoring methods like MRI scans are costly, invasive, and ineffective at predicting treatment responses or disease progression.
Myelin-H SARL aims to bridge this gap by introducing a Software-as-a-Medical Device (SaMD) that offers a real-time, at-home solution for tracking MS progression and treatment efficacy by combining:
The device translates biosignals into digital biomarkers and a novel clinical score, enabling physicians to monitor silent disease progression, predict relapses, and tailor treatment plans.
In the Remote Monitoring of Multiple Sclerosis (R-MMS) project, LIST joins forces with Myelin-H to improve the state-of-the-art SaMD with enhanced trustworthiness and robustness while complying with the privacy regulations such as the European GDPR in the light of the following objectives:
R-MMS exemplifies how technology can transform healthcare, making it more accessible, efficient, and patient-centered. The project will provide the following outcomes:
The project includes a pivotal clinical trial across Europe and the US to validate the SaMD’s safety, effectiveness, and cost benefits. It will benchmark its performance against current gold-standard practices, such as MRI scans and EDSS clinical scores. The trial's results will pave the way for the device's CE certification and reimbursement in European healthcare systems.