HELSINGBORG, Sweden, Nov. 8, 2023 /PRNewswire/ — Today, Acorai, a start-up medical device manufacturer from Sweden, announces selection for a €2.3m grant with a follow-on €10m investment offer from the European Innovation Council (EIC). Only a handful of companies who apply for the EIC accelerator are successful, and Acorai was among the top applicants who received the maximum funding Amount.
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.
What is the European Innovation Council (EIC) accelerator
The EIC Accelerator is a funding program under Horizon Europe that supports start-ups and SMEs with an innovative, game-changing product, service, or business model that could create new markets or disrupt existing ones in Europe and worldwide. The Accelerator’s funding for medical devices aims to foster the development and commercialization of innovative health technologies.
The funding is specifically designed to support the progression of technologies, validated in a relevant environment, to their final form, ready for full commercial deployment in their relevant operating environment. The ultimate goal is to create new markets or disrupt existing ones, thereby enhancing healthcare outcomes and contributing to Europe’s competitiveness and growth.
“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.” – Filip Peters, CEO
The next milestone targets for Acorai
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.
Visit https://acorai.com/ to learn more about Acorai’s potential to become the new standard in heart failure management and a leader in non-invasive patient care.