Seizure Cluster Relief through Smart Therapeutic Management

Objective

Epileptic seizures significantly impair patients' quality of life and autonomy. Despite recent advancements in wearable monitoring of brain activity, patients still struggle with seizures management and their pharmacological mitigation. CLUSTREL addresses this problem. It will develop a smart, non-invasive oral device for on-demand delivery of rescue medication to treat epileptic seizure clusters, a critical unmet need of ~15 million patients with drug-resistant epilepsy worldwide. The technology uses a patented, graphene-based system that releases medication within minutes of seizure onset, triggered manually or automatically by an existing external EEG sensor. The project's objective is to advance this technology from a lab-validated proof-of-concept (TRL 4) to a clinically relevant prototype demonstrated in a relevant environment (TRL 6). This will be achieved by: - Optimizing the graphene-drug pharmaceutical formulation for stability and rapid mucosal absorption; - Engineering a miniaturized, biocompatible, and user-friendly prototype for use in animal models; - Conducting comprehensive preclinical validation of the device's safety and efficacy in vitro, in rodent models of epilepsy, and in large animal models; - Establishing a spin-off company to manage IP, define the regulatory pathway, and secure strategic partnerships for commercialization. CLUSTREL aligns perfectly with EIC's TRANSITION vision, as it addresses a significant healthcare challenge by translating a breakthrough European technology into a market-ready medical device. It promises to reduce hospitalizations, lower healthcare costs, and significantly improve patient autonomy and quality of life, strengthening Europe's leadership in MedTech innovation.