Acorai, a startup medical device manufacturer from Sweden, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai’s Heart Monitor.

The Acorai Heart Monitor is 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 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.

“Receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision,” said Kasper Bourdette, chief operating officer and co-founder. “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.”

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.

“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,” said Jakob Gelberg, chief technology officer and co-founder. “Regular reviews by the FDA in this development stage are crucial to ensuring we can meet the challenges ahead.”