Acarix CADScor System Multi-center Trial Results Confirm Previous Preliminary Results Ruling out CAD With 97% Negative Predictive Value

MALMO, Sweden, March 17, 2017 /PRNewswire/ --

Acarix AB (publ) ("Acarix") today announced the results from a newmulti-centertrial of its hand held CADScor®System for non-invasive, non-radiation acoustic detection of Coronary Artery Disease ("CAD"). The results arepresented at the American College of Cardiology 2017 Annual Scientific Meeting in Washington, 17-19 March 2017 and showed that the CADScor®System rules out CAD with 97% negative predictive value. The results confirm previously announced figures by Acarix.

The CADScor®System combines acoustic detection of turbulent arterial flow and myocardial movement with advanced algorithms in a handheld device to provide a patient specific CAD-score in less than 10 minutes. The research was led by Principal Investigator Morten Böttcher, MD PhD FESC and by Simon Winther, MD PhD, Department of Cardiology, Aarhus University Hospital, Denmark: "Despite the availability of improved risk stratification algorithms, the incidence of normal investigations such as nuclear or CTimaging remains high. We therefore tested the diagnostic accuracy of the CADScor®System for ruling out CADtosee if it could be used to reduce demand for more advanced diagnostic modalities. We have concluded that, with its ability to rule out CAD witha97% negative predictive value, this advanced, easy to use, stethoscope like device could indeed be deployed as a frontline test ."

A CAD-score was recorded in all 1,675 patients enrolled in the trial. Low risk was indicated by a CAD-score value ≤20. Diagnostic performance evaluated by receiver operating characteristic curve showed an accuracy of: 72% (CI: 67% - 77%). CAD-score cut-off ≤20 had an accuracy of:

• Sensitivity: 81% (CI: 74% to 88%)

• Specificity: 53% (CI: 50% to 56%)

• PPV: 15% (CI: 13% to 18%)

• NPV: 97% (CI:95% to 98%)

Acarix CEO Søren Rysholt Christiansen commented: "Coronary Artery Disease affects more than 120 million people worldwide but the current diagnostic pathway, which can rapidly escalate to expensive imaging and coronary angiography, is inefficient. A recent Danish study showed that more than 90% of patients presentingwith chest painsymptoms to their general practitioner do not have CAD. If adopted, the CADScor®System can provide rapid frontline assessment which could translate into a potentialreduction inpatient referrals by ~50%.- a win-win for patients, payers and physicians."

For a comprehensive press release, see http://www.acarix.com.

Contacts:
Acarix A/S
Søren Rysholt Christiansen, CEO
E-mail: dksrc@acarix.com
Phone: +45-2777-1112

SOURCE Acarix

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