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Seizure Cluster Relief through Smart Therapeutic Management

Project description

Bringing a revolutionary epilepsy treatment to market

The EIC-funded CLUSTREL project aims to address a critical therapeutic gap for approximately 15 million patients with drug-resistant epilepsy. To do so, it will develop a non-invasive, graphene-based oral device for on-demand rescue medication. Integrating with external EEG sensors, the system enables rapid drug release triggered either manually or automatically when a seizure starts. The project will advance this technology by optimising pharmaceutical formulations, engineering biocompatible prototypes and conducting rigorous preclinical validation in rodent and large animal models. By establishing a commercial spin-off and defining regulatory pathways, CLUSTREL will translate laboratory innovation into a market-ready medical solution, ultimately improving patient autonomy and reducing the systemic healthcare burden.

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.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-EIC - HORIZON EIC Grants

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Call for proposal

(opens in new window) HORIZON-EIC-2025-TRANSITIONOPEN

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Coordinator

CONSORZIO INTERUNIVERSITARIO NAZIONALE PER LA SCIENZA E TECNOLOGIA DEI MATERIALI
Net EU contribution
€ 470 738,75
Address
VIA GIUSTI 9
50121 Firenze
Italy
Region
Centro (IT) Toscana Firenze
Activity type
Research Organisations
Links
Total cost
No data

Participants (3)