HELSINGBORG, Sweden, Aug. 10, 2023 /PRNewswire/ — Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai’s Heart Monitor, a device for the non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery pressure (mPAP) in patients with Stage C Heart Failure who have been referred for hemodynamic monitoring.

Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system. The device is intended as a companion test for qualified healthcare professionals (HCPs). It is designed to be used alongside standard-of-care assessment in a hospital or clinical setting to identify hemodynamic congestion and support personalized treatment of HF.

The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure. The full analysis of this study is currently being prepared for publication. Acorai has ethics approval in 5 countries, including the U.S., to conduct a larger 1200-patient study to ensure the device is generalizable across a global heart failure population. [NCT05835024] 

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“A massive inflection point in our device development journey”

Acorai’s CEO and Co-Founder Filip Peters said, “We could not be more delighted with the decision from the FDA, and it constitutes a huge milestone for us as a company. Congratulations to the entire Acorai team who have worked hard to enable this.” Kasper Bourdette, Chief Operating Officer and Co-Founder added that “receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision. This provides further signaling that we are on the right path and motivation for the [Acorai] team to take the device to approval in the coming few months.” Jakob Gelberg, Chief Technology Officer and Co-Founder, commented, “From ideation to assembling such a talented group of individuals in our team, we are convinced that we have what it takes to bring our device to the patients who need it the most. Regular reviews by the FDA in this development stage are crucial to ensuring we can meet the challenges ahead”.

Acorai was founded in 2019 and has an experienced and diverse team across hardware, software, clinical, finance, and machine learning from 11 different nationalities. Matthew Mace, Chief Scientific Officer (previously at Abbott), noted, “We have an extremely capable team at Acorai; from my time with CardioMEMS at Abbott to Filip’s machine learning experience from the finance sector, to our clinical and regulatory team’s extensive class II and Class III device experience. The secret to our continued success is that we can remotely leverage the best talent from all over the globe, united in one common goal. All credit in achieving this designation goes to the hard work of the entire team working round the clock to realize our company’s vision to define The New Standard in Heart Failure Management.”

Implications of the Breakthrough Device Designation:

Receiving the Breakthrough Device Designation accelerates the development and review process, underscoring the potential of Acorai to address unmet medical needs in heart failure management. The designation is a testament to Acorai’s commitment to driving innovation in patient care.

“Andrew J. Sauer, MD, Acorai’s Chief Clinical Advisor, stressed that “Intracardiac pressure monitoring (ICPM) is a proven way to manage heart failure patients, but existing non-invasive methods are unsuitable for routine clinical use. If continually proven in larger studies, Acorai’s non-invasive device could drastically improve access to hemodynamic monitoring in a hospital or clinic without waiting for an invasive procedure. It would be expected that with accuracies similar to invasive alternatives, system-wide use would almost certainly lead to resource savings while simultaneously improving outcomes for patients with heart failure.”

To get in touch with the team or learn about collaboration or investment opportunities, e-mail: [email protected]

About Acorai

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 system uses the patented SAVE Sensor System and proprietary machine learning models, which have clinically demonstrated accuracies equal to the invasive gold standards.

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.

Brief Summary: The Acorai Intracardiac Monitoring System is not cleared for use by the FDA for clinical use in the U.S. and is an investigational device. Granting a Breakthrough Device Designation does not constitute clearance by the FDA or a guarantee that the device will be approved.

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