The first real-time monitoring and non-invasive medical device for personalised brain damage prevention during cardiac surgery

Informations projet

BrainProtect

N° de convention de subvention: 101218547

DOI

10.3030/101218547

Date de signature de la CE 30 Juin 2025

Date de début 1 Juin 2025

Date de fin 31 Mai 2027

Financé au titre de

• The European Innovation Council (EIC)

Coût total

Aucune donnée

Contribution de l’UE

€ 2 499 999,00

Coordonné par

Scienceforbrain, UAB
Lithuania

Periodic Reporting for period 1 - BrainProtect (The first real-time monitoring and non-invasive medical device for personalised brain damage preventionduring cardiac surgery)

Période du rapport: 2025-06-01 au 2026-05-31

Résumé du contexte et des objectifs généraux du projet

Over 2 million cardiopulmonary bypass (CPB) surgeries are performed worldwide each year. Despite being life-saving, up to 83% of these surgeries result in neurological complications such as delirium and postoperative cognitive dysfunction (POCD), contributing to increased morbidity, disability, reduced quality of life, and mortality rates of up to 33% within one year. Only 45% of patients fully recover within a year, and the resulting brain damage is often irreversible. The associated economic burden amounts to an estimated €8.4 billion in direct healthcare costs per year across the EU and US.
The underlying cause is impaired cerebral blood flow autoregulation (CA) - the brain's ability to maintain stable perfusion despite changes in blood pressure during surgery. No existing technology can detect CA impairment quickly enough: neurons begin to die within four to five minutes of inadequate perfusion, and current monitoring methods are too slow or indirect to support timely intervention.
ScienceForBrain has developed BrainProtect, built around a patented method of periodic rectangular blood flow modulation during CPB. This makes it possible, for the first time, to monitor the brain's autoregulatory response in near real time, identifying brain insults in individual patients with only a 15–30 second delay and enabling targeted, personalised intervention. BrainProtect has the potential to reduce the risk of POCD and delirium by 50%, improving patients' quality of life and reducing direct healthcare costs by an estimated €231 million annually.
BrainProtect has now reached Technology Readiness Level 9 (TRL9), with a multicentre clinical investigation initiated across the EU involving more than 300 patients. The project's objective is to complete this clinical investigation and demonstrate the safety, accuracy, and clinical benefit of the BrainProtect system, secure regulatory approval in the EU and US, and launch BrainProtect commercially.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

During the first 12 months of the project, BrainProtect advanced from a clinical-grade prototype to a finalised, validated system ready for multicentre clinical investigation, with all technical work packages for this period completed.
During this period, the company's quality management system also achieved ISO 13485 certification, confirming that BrainProtect's development, manufacturing, and clinical preparation activities meet the international quality standard for medical devices.
On the algorithm and software side, the project optimised the core signal-processing and artificial intelligence algorithms underlying cerebral autoregulation and intracranial pressure waveform detection. Multiple AI architectures, feature engineering approaches, and signal-processing techniques were systematically evaluated, leading to improved artifact filtering, more robust signal quality assessment, and refined trend classification. These improvements were consolidated into a final algorithm specification, implementing the system's core autoregulation indices and a closed-loop blood flow modulation and telemetry architecture. Performance validation testing, combining technical verification in laboratory conditions with clinical-environment testing, confirmed that safety, usability,and operational performance requirements were met, and that AI-assisted monitoring performance aligned with clinical expectations.
On the hardware and manufacturing side, the BrainProtect system components, including the Archimedes 02 sensor units, contact modules, and the BrainProtect Plugin, successfully passed all in-process and final quality inspections, with no non-conformances identified. Five complete BrainProtect system sets were assembled, verified, and formally released for deployment to clinical investigation sites, with full traceability established through Device History Records within the company's quality management system.
In parallel, the project completed the documentation required to prepare for clinical investigation: training materials for clinical trial staff covering device setup, signal verification, safety procedures, and incident reporting; and a clinical trial protocol defining patient inclusion and exclusion criteria, safety monitoring, informed consent procedures, and adverse event reporting, developed in line with ISO 14155 and Good Clinical Practice principles, GDPR and relevant medical device data standards.
Underpinning all technical activities, a comprehensive risk management framework was completed in accordance with ISO 14971, through which all risks initially assessed as high were reduced to acceptable residual levels, supporting an overall favourable benefit-risk assessment for the system ahead of clinical investigation.
Together, these achievements mark the transition of BrainProtect from technical development into active clinical evaluation, with the system, documentation, and trained personnel now in place to support the ongoing multicentre clinical investigation.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

BrainProtect introduces a fundamentally different approach to monitoring brain perfusion compared to existing technologies. Current non-invasive methods such as near-infrared spectroscopy and transcranial Doppler ultrasound provide only indirect, partial, or operator-dependent information about cerebral blood flow, and none of them can detect cerebral autoregulation impairment quickly enough to enable timely clinical intervention. BrainProtect's combination of intracranial pressure pulse waveform sensing with controlled blood flow modulation allows cerebral autoregulation status to be identified with a delay of only 15–30 seconds, compared to the several minutes typically required by conventional approaches.
The technology has now reached Technology Readiness Level 9, with the system manufactured, quality-assured, and deployed across clinical investigation sites. A multicentre clinical investigation involving more than 300 patients is underway across the EU, designed to generate the robust clinical evidence required to confirm the system's safety, accuracy, and clinical benefit in real-world surgical settings. The achievement of ISO 13485 certification further strengthens the foundation for regulatory submission, confirming that the quality management system underpinning the device's development and manufacturing meets the international standard required for medical devices.
Looking ahead, successful translation of these results into clinical and commercial impact depends on several key enabling factors. Completion of the ongoing multicentre clinical investigation is essential to generate the level of clinical evidence required by regulators in both the EU and the US. In parallel, continued engagement with regulatory bodies is needed to navigate the CE marking process under the EU Medical Device Regulation and the FDA clearance pathway, given the system's novel combination of hardware, software, and a new clinical monitoring paradigm. Access to growth finance and strategic industry partnerships will be important to support manufacturing scale-up and market entry once regulatory approval is achieved. Finally, broader adoption will benefit from continued dialogue with the clinical and standardisation community to establish cerebral autoregulation monitoring as a recognised component of best practice during cardiac surgery, supporting both patient safety and the long-term uptake of this new category of medical technology.