Cardiology start-up Acorai has secured a €2.3m ($2.46m) grant with a follow-on €10m ($10.70m) investment from the European Innovation Council (EIC) to advance its non-invasive intracardiac pressure monitoring device.
Sweden-based Acorai said the funding will go towards a clinical validation trial – which it is currently enrolling for.
The EIC was set up by the European Commission to support start-ups and SMEs with transformative products. Medical devices are a target of the funding programme, which is under Horizon Europe, to help bring innovative health technologies to market.
The validation trial – called the Acorai Machine Learning Generalisation (MLG) study – plans to enrol a total of 1,200 patients. The first portion of the study will be used to finalise the machine learning algorithms of the device. The latter, which will commence in early 2024, will support the final software validation and regulatory applications.
The first patient was enrolled at England’s Royal Brompton and Harefield hospitals in August 2023.
The funding will also go towards regulatory applications, with Acorai targeting 2025 for US Food and Drug Administration (FDA) submission and clearance.
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The device, which was designated as a breakthrough device by the FDA, uses a mixture of sensor modalities to generate data that is then decoded into cardiac insights by machine learning software. The device is called the SAVE sensor system which stands for the seismic, acoustic, visual, and electrical sensors it uses.
Acorai states the device is small enough to fit in a pocket and that healthcare professionals can use it with little to no training.
A market model by GlobalData estimates the external cardiology remote monitoring device global market will reach $1.1bn by 2030.