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

Project description

Real-time brain protection against ischemic and hyperemic insults during heart bypass surgery

Cardiopulmonary bypass (CPB) temporarily takes over the function of the heart and lungs, facilitating blood circulation and oxygenation. Although it is a life-saving procedure used in millions of surgeries every year, it can cause irreversible neurological complications in most patients. The EIC-funded BrainProtect project will introduce an innovative technology designed to monitor cerebral blood flow autoregulation (CA) in real-time during CPB. CA is the brain’s intrinsic mechanism for maintaining a stable blood supply despite fluctuations in systemic blood pressure. Unlike existing solutions, BrainProtect detects early signs of brain injury within 15–30 seconds, facilitating timely intervention to prevent damage. The technology has already shown promising results in clinical trials and is projected to reach the market by 2027.

Objective

Over 2M Cardiopulmonary bypass (CPB) surgeries are carried out each year globally. Up to 83% of CPB surgeries result in neurological complications such as delirium and post-operative cognitive dysfunction (POCD) which significantly contribute to increased morbidity, disability, decreased quality of life and mortality rates up to 33% after 1 year. Only 45% of patients fully recover from neurological complications after 1 year post cardiac surgery, and in many cases severe brain damage is irreversible. Economic burden is huge amounting to €8.4B direct costs/year in the EU & US.
Monitoring Cerebral blood flow autoregulation (CA) and maintaining adequate patient specific brain perfusion during CPB surgery is critical to prevent neurological injury. However, none of the current technologies is capable to identify cerebral blood flow autoregulation impairments before the neurons die within 4-5 minutes. This calls for the need for advanced solutions to protect patients’ brain and optimize neurological outcomes during CPB.
ScienceForBrain has developed BrainProtect, a patented, novel periodic rectangular modulation of blood flow during CPB, making it possible for the first time to monitor CA transient functions almost in real- time and to identify start and finish moments of brain insults in individual patient with only 15-30 second delay. This enables targeted interventions to restore optimal personalised brain perfusion and protect the brain during CPB surgery. BrainProtect has the potential to reduce the risk of POCD and delirium by at least 50%, saving lives, improving QoL for patients and reducing €231M annually in direct healthcare costs.
BrainProtect is currently at TRL6, we obtained excellent preliminary results in clinical trials with 173 patients, and we now need support from the EIC to perform a multi-centred, double-blinded, clinical trial including 300 patients in the EU to get regulatory approval and successfully launch BrainProtect in the market by 2027.

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-EIC-ACC - HORIZON EIC Accelerator

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Call for proposal

(opens in new window) HORIZON-EIC-2024-ACCELERATOR-02

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Coordinator

Scienceforbrain, UAB
Net EU contribution
€ 2 499 999,00
Address
Zanavykų str. 8-7
LT-44145 Kaunas
Lithuania
SME
Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
No data