TL;DR:
- Acorai, a Swedish cardiology start-up, obtained a €2.3 million grant from the European Innovation Council (EIC) to advance its non-invasive intracardiac pressure monitoring device.
- The funding will support a 1,200-patient clinical validation trial, refining machine learning algorithms and regulatory applications.
- Acorai aims for FDA submission and clearance by 2025.
- The SAVE sensor system, a breakthrough device, combines various sensors to decode cardiac insights.
- Market projections estimate the global cardiology remote monitoring device market to reach $1.1 billion by 2030.
Main AI News:
In a significant development for the cardiology sector, Acorai, the innovative start-up based in Sweden, has successfully secured a substantial €2.3 million grant, coupled with an impressive €10 million follow-on investment, courtesy of the European Innovation Council (EIC). This financial boost is aimed at propelling the development of Acorai’s groundbreaking non-invasive intracardiac pressure monitoring device, marking a significant stride in the realm of medical technology.
The EIC, a dynamic initiative established by the European Commission, is dedicated to nurturing start-ups and SMEs with pioneering products poised to make transformative impacts. Specifically, it supports medical device ventures like Acorai, aligning with the broader goals of Horizon Europe to usher in innovative health technologies into the market.
Acorai’s primary focus with this funding is to drive forward a crucial clinical validation trial, which is actively enrolling participants. Dubbed the “Acorai Machine Learning Generalisation (MLG) Study,” this endeavor seeks to recruit a total of 1,200 patients. The initial phase of the study will be instrumental in refining the machine learning algorithms that power the device, while the latter phase, scheduled to commence in early 2024, will facilitate the final software validation and pave the way for regulatory applications.
Notably, the journey commenced in August 2023 when the first patient was enrolled at the prestigious Royal Brompton and Harefield hospitals in England. Acorai’s vision extends beyond this milestone; the funding will also be channeled towards securing regulatory approvals, with an ambitious target set for a US Food and Drug Administration (FDA) submission and clearance by 2025.
The heart of this groundbreaking technology is Acorai’s SAVE sensor system, a device designated as a “breakthrough” by the FDA. This innovative system harnesses a blend of sensor modalities, including seismic, acoustic, visual, and electrical sensors, to capture data. Subsequently, sophisticated machine learning software decodes this data into valuable cardiac insights. Remarkably, the SAVE sensor system is compact enough to fit in a pocket and requires minimal training for healthcare professionals.
Market analysts at GlobalData have projected that the global market for external cardiology remote monitoring devices will surge to an impressive $1.1 billion by 2030. Acorai’s unwavering commitment to innovation and its strategic partnership with the EIC signifies a promising future for the advancement of healthcare technology, potentially revolutionizing the cardiology landscape. Stay tuned for more updates as Acorai paves the way toward a healthier and more connected world of cardiac care.
Conclusion:
Acorai’s substantial grant and strategic partnership with the EIC represent a significant step forward in the cardiology market. Their innovative SAVE sensor system, coupled with a robust clinical trial plan and ambitious FDA submission timeline, positions Acorai for success in the rapidly growing cardiology remote monitoring device market, which is projected to reach $1.1 billion by 2030. This development underscores the potential for transformative advancements in cardiac care.
