30 aug, 2018
Acarix AB (publ) (“Acarix”), today announced that two major Swedish hospitals – Kristianstad and Sunderbyn - have evaluated the CADScor®System for rule-out of Coronary Artery Disease. The evaluation compares favorably against existing methods and offers the possibility of avoiding expensive invasive methods. Kristianstad will now integrate the CADScor®System in daily clinical practice while Sunderbyn will move to a second evaluation phase with the aim of adoption by year end.
Kristianstad Central Hospital validated the CADScor®System by comparing it to a well-established reference method, Myocardial Perfusion Scan. The clinical outcome was in line with the outcomes in previously published studies for the handheld device. The clinic is planning to start using the CADScor®System as a complementary assessment in selected patients from the fourth quarter 2018.
Senior consultant Magnus Simonsson commented: "We have had the opportunity to evaluate the CADScor®System over the last six months and we are pleased to confirm the promising results from earlier publications. By using the CADScor system we will now be able to offer our patients an alternative to the traditional pathway of ruling out potential CAD. Furthermore, the expected positive impact on waiting lists for evaluation of chest pain, which often are quite long, are most welcome.”
Sunderbyn Hospital in Luleå has during the second quarter finalized the first phase of evaluating the CADScor®System. The results are in line with the reported sensitivity, specificity and negative predictive value for ruling out Coronary Artery Disease. Therefore, the clinic will, during the fall, continue with the second phase of evaluation which is planned to be finalized during the fourth quarter.
“The outcome from the first phase of evaluation is very promising. It showed that the results from previous clinical trials can be trusted in clinical settings. Now we are moving on to the second phase to finalize our local evaluation. We are looking forward to the results, and to implement the CADScor®System in our daily, clinical practice if also the second phase of evaluation confirms previous published clinical data,” says Kambiz Shahgaldi, PhD, Associate Professor at the Department of Clinical Physiology in Luleå.
“We are delighted with the results of the evaluations from these highly regarded Swedish hospitals and expect to achieve significant market penetration by the end of the year,” says Acarix Chief Commercial Officer Per Persson.
The CADScor®System provides a non-invasive ultra-sensitive detection of turbulent arterial flow and myocardial movement in a portable device to provide a patient-specific score to assess the risk for Coronary Artery Disease (CAD) in less than 8 minutes. This provides physicians with a rapid first line tool for early assessment before moving on to more expensive invasive methods.
Christian Lindholm, interim CEO, E-mail: email@example.com, Phone: +46 705 118 333
Acarix, CADScor®System and cardiac sound measurement
Acarix was established in 2009 and is listed on Nasdaq First North Premier. 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. Readings are obtained in less than 8 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.
Acarix is a Swedish medical device company that innovates solutions for rapid AI-based rule out of Coronary Artery Disease (CAD). The CE approved and FDA DeNovo cleared Acarix CADScor®System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive and costly diagnostic procedures. The CADScor system calculates a patient-specific CAD-score non-invasively in less than10 minutes and can help rule out more than one third of patients with at least 96% certainty of not being sick (in a population with approx. 10% CAD prevalence). Acarix is listed on the Nasdaq First North Premier Growth Market (ticker: ACARIX). Redeye AB (+46 (0)8 121 576 90, firstname.lastname@example.org) is Certified Advisor of Acarix.