Acarix progresses with the German authorities

Press release
Malmö, Sweden September 3, 2020

Acarix progresses with the German authorities

Acarix AB (publ) today announced that the German Ministry of Health has stated that phonocardiography for ruling out coronary artery disease has potential for general use in Germany. The German Federal Joint Committee (G-BA) has outlined basic elements of a possible study to be conducted by an independent scientific institution in accordance with the guidelines from G-BA.

“The guidance from G-BA confirms the clinical value and relevance of our CADScor® technology and is the result of a persistent and constructive dialogue with the authorities during the last few years. The guidance from G-BA provides clarity and direction combined with a recognition of our clinical work to date,” said Per Persson, CEO of Acarix.

The German Ministry of Health has published guidance stating that phonocardiography for ruling out stable coronary artery disease (CAD) has the potential for general use in Germany. According to G-BA further evidence is needed and could be collected in a study, designed, carried out and evaluated by an independent scientific institution in accordance with the guidelines from G-BA. The exact scope and final design of such a study will be determined in the near future. The outcome of the study could form the basis of a reimbursement approval for phonocardiography as an alternative diagnostic technology for ruling out stable CAD.

Per Persson continues “The commercial potential in Germany is significant and we see the value of complementary clinical evidence to the already ambitious programs that we are currently running. To meet the timelines of response to the G-BA, we intend to have intense dialogue with key stakeholders to define the most relevant clinical endpoints to comply with G-BA guidance. We will submit our response to G-BA later this month.”

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

This press release has been made public through the agency of the contact person set out above, at the time stated by the Company’s news distributor, GlobeNewswire, at the publication of this press release.

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. Wildeco Ekonomisk Information AB (+46 8 545 271 00, info@wildeco.se) is Certified Adviser to Acarix. For more information please visit www.acarix.com.

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• Acarix_PM_G-BA ENG