Positive preliminary data from Acarix’s exploratory heart failure study SEISMO

Press release

Malmö, Sweden, January 13, 2021

Positive preliminary data from Acarix’s exploratory heart failure study SEISMO

Acarix AB (publ) today announced positive preliminary data from the exploratory SEISMO study, using its modified CADScor^®System on a potential heart failure application.

The SEISMO trial was initiated in June 2018 to evaluate the possibility of developing an algorithm that can differentiate patients referred with suspicion of heart failure. The study, with in total 199 patients at two sites in Denmark, included the last patient in 2020.

"Completing the inclusion to the exploratory heart failure study was a great milestone for all involved. The new data looks promising for early heart failure rule out and will be important for all affected patients today waiting all too long for a final diagnosis. The data could warrant a follow-up study to consolidate findings and bring more data for algorithm development,” said Professor Peter Søgaard, MD and primary investigator.

The SEISMO study showed a low prevalence of heart failure in patients referred for heart failure evaluation at an outpatient clinic, making a reliable and fast rule-out method highly relevant.

“Heart failure affects more than 60 million people worldwide, and with a technology that can help simplify the diagnosis pathway, reducing waiting time and complexity for our patients and at the same time reduce cost is worth a continued investigation,” said Per Persson, CEO of Acarix.

The devices used in the SEISMO study are modified CADScor^®Systems obtaining additional seismocardiographic data, and the results from the final analysis of the study data is expected to be submitted for publication in Q2 2021.

  “With these promising – yet early – results from the study population, this is another significant milestone in our value creation. Over the last quarters, we have been able to demonstrate significant progress on our key objectives, including Real Life Data (1,070 patients), the completed enrolment of the DAN-Nicad II trial, obtaining recognition from both the US and German authorities of acoustic methodologies as an innovation requiring its own segment; and finally, the approval from the US Food and Drug Administration (FDA) is an outstanding achievement in itself”, Per Persson continued.

For further information, please contact:

Per Persson, CEO, E-mail: per.persson@acarix.com, Phone: +46 73 600 59 90

The information was released for public disclosure, through the agency of the contact person above, on January 13, 2021 at 10.00 CET.

About Acarix:
Acarix was established in 2009 and is listed on Nasdaq First North Premier Growth Market (ticker: ACARIX). Acarix’s CADScor^®System uses an advanced sensor placed on the skin above the heart to listen to the sounds of cardiac contraction movement and turbulent flow. It has been designed to be an all-in-one system in the sense that the heart signal will be recorded, processed, and displayed as a patient specific score, the CAD-score, on the device screen. Readout is obtained in less than 10 minutes. Safe and suitable for use in both out- and inpatient settings, the CADScor^®System thus has the potential to play a major role in patient triage, avoiding the need for many patients to undergo stressful invasive diagnostic procedures. Redeye AB (+46 (0)8 121 576 90, certifiedadviser@redeye.se) is Certified Adviser to Acarix. For more information, please visit www.acarix.com.

Attachment

• Acarix PR SEISMO ENG 210113