Acorai announced today that it received a $2.5 million (€2.3 million) grant to support its non-invasive intracardiac pressure monitoring system.
The European Innovation Council (EIC) selected Helsingborg, Sweden-based Acorai for the grant. It also features a follow-on investment offer worth $10.7 million (€10 million) for the maximum funding amount.
Acorai develops a first-of-its-kind device aimed to improve heart failure management. It received FDA breakthrough device designation in August after demonstrating promising results in a 350-patient pilot study in Sweden.
“Acorai’s receipt of funding from EIC clearly indicates the company’s potential to significantly impact both the health and economic fronts, not only in Europe but globally,” the company said in a news release. “The grant funding will support and help accelerate the progress toward the company’s goals, which are focused on clinical validation and regulatory submissions to enable commercialization.”
The EIC accelerator funds companies to support the progression of their technologies through to their final form. It ultimately aims to create new markets or disrupt existing ones to enhance healthcare outcomes and increase Europe’s competitiveness and growth.
Acorai says next steps include taking part in the pilot FDA TPLC advisory program. It’s currently enrolling in a global clinical validation study for 1,200 patients across 11 sites. The sites spread across Sweden, Denmark, Belgium, Great Britain, the U.S. and Canada. The company plans to end the study in 2024 and use it to support FDA submission and clearance by 2025.
“We’re thrilled to announce that we have secured funding from EIC Accelerator, propelling us further towards our vision and mission to develop ‘the new standard in heart failure management.’ This not only validates our dedication and hard work but also provides us with the resources to innovate, grow, and better serve our community,” said Filip Peters, Acorai CEO.
