Acorai, a Swedish health tech company pioneering non-invasive medical devices for the management of heart failure, has secured $4.5 million to support the completion of its pivotal clinical studies of its heart failure management device, CAPTURE-HF.
The funding round was backed by the European Innovation Council (EIC) Fund, with significant contributions from Taiwan Medical University, as well as private investors, giving the company enough financial backing to finalize its clinical studies, which are crucial for the device’s approval in Europe and the United States.
Acorai’s CAPTURE-HF device holds great potential in cardiac care, making the once-impossible techniques in managing heart failure possible. The product received FDA Breakthrough Device Designation and later participated in the FDA’s Tap Pilot.
This paved the way for its clinical trials, which included 1,600 participants from 20 hospitals in six countries, to a certain its effectiveness and secure regulatory approvals in the US and Europe.
According to Coral CEO, Filip Peters, the latest investment will support the company’s regulatory and clinical efforts to scale up its non-invasive cardiac care device to the market, positively transforming the lives of over 60 million patients across the globe.
With the new capital infusion, Acorai aims to submit regulatory approval and launch its product on the market by 2026.
