Acorai, a medical device startup based in Helsingborg, has received a significant grant of €2.3 million from the European Commission, coupled with an investment offer of €10 million from the European Innovation Council (EIC). This funding will be crucial for Acorai to further develop their groundbreaking non-invasive intracardiac pressure monitoring device, specifically designed to improve the management of heart failure. With this financial support, Acorai aims to conduct extensive clinical validation studies involving 1200 patients across various countries.
The company intends to use the funds to advance their technology, gain FDA clearance by 2025, and refine their device based on promising results from an initial pilot study conducted with 350 patients in Sweden. Acorai’s investors, including Bayer, KHP Ventures, Life Science Invest, and Golden Angel Investors, provide essential backing for their mission to positively impact the lives of over 64 million heart failure patients globally through their innovative heart monitoring solution.
Acorai is building a first-of-its-kind device for non-invasive intracardiac pressure monitoring to improve heart failure management after having demonstrated promising results in their Swedish 350-patient Pilot Study. Acorai received a Breakthrough Device Designation from the FDA in August 2023. This enables the company to interact with FDA experts to efficiently address topics arising during the premarket review phase and receive expedited reviews prior to their regulatory submission.
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 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.
“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.” says Filip Peters, CEO
After the news of being designated a breakthrough device, Acorai was also selected to be part of the pilot FDA TPLC advisory program (TAP). The pilot allows only a handful of companies worldwide to increase the frequency of dialogue with the FDA to further aid the device’s access to market. Acorai is currently enrolling in its global clinical validation study, for 1200 patients across 11 sites in Sweden, Denmark, Belgium, Great Britain, the US, and Canada. This study is planned to endin 2024 and will support FDA submission and clearance by 2025.
Acorai is developing a scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure management for more than 64 million patients worldwide. The Acorai’s Heart Monitor was designated a breakthrough device by the FDA and uses the patented SAVE Sensor System and proprietary machine learning models,
Acorai is backed by Bayer, KHP Ventures, Life Science Invest, and Golden Angel Investors, with a seasoned medical device team and corporate advisory board with experiences from GE Healthcare, Occlutech, Abbott & AstraZeneca, and clinical partnerships with world-leading hospitals.
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Originally published on ArcticStartup : Original article