Acorai, a Helsingborg, Sweden-based medical device manufacturer, raised €2.3M in Grant funding, with a followed-on €10m investment offer from the European Innovation Council (EIC).
Led by CEO Filip Peters, Acorai is building a device for non-invasive intracardiac pressure monitoring to improve heart failure management after having demonstrated promising results in their Swedish 350-patient Pilot Study. The company 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.
The company intends to use the funds to accelerate the progress of its goals, which are focused on clinical validation and regulatory submissions to enable commercialization.
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 company 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 backed by Bayer, KHP Ventures, Life Science Invest, and Golden Angel Investors
FinSMEs
08/11/2023