Cardiology start-up Acorai has secured $4.5m in an oversubscribed series seed equity round to advance its non-invasive intracardiac pressure monitoring device in clinical trials.

The round, which was led by Solardis Health Ventures, will aid in the Swedish company’s goal of completing its CAPTURE-HF clinical study in 2024.

The seed round follows Acorai securing a €2.3m ($2.46m) grant with a follow-on investment of €10m from the European Innovation Council (EIC) late last year.

The CAPTURE-HF study aims to demonstrate the performance of the cardiac monitoring device in 1,200 patients undergoing catheterisation procedures as part of their standard of care.

The company activated the final site in the study last week, according to a social media post. Acorai is targeting the end of March 2024 for recruitment completion.

The device, which was designated as a breakthrough device by the US Food and Drug Administration (FDA) in August 2023, is built upon the company’s SAVE Sensor. The solution uses a mixture of sensor modalities to generate data that is then decoded into cardiac insights by machine learning software. The SAVE acronym represents the seismic, acoustic, visual, and electrical sensors it uses.

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By GlobalData

Acorai states the device is small enough to fit in a pocket and that healthcare professionals can use it with little to no training to help manage patients with heart failure.

Acorai is targeting US market access by 2025. A market model by GlobalData estimates the external cardiology remote monitoring device global market will reach $1.1bn by 2030.

The company said it is planning a larger capital raise before launch.

Nearly 6.5 million Americans over 60 years of age have heart failure. The condition costs the US around $30.7bn in 2012, according to the Centers for Disease Control and Prevention.

Abbott’s CardioMEMS HF system remotely monitors changes in pulmonary artery (PA) pressure, an early indicator of the onset of worsening heart failure. The system was initially FDA-approved in 2014 for use in New York Heart Association (NYHA) Class III heart failure patients with a prior heart failure hospitalisation within the last year. An expanded approval followed in 2022 for earlier-stage heart failure patients.