30 aug, 2018
Acarix AB (publ) (“Acarix”), today reported positive feedback for the clinical study program in order to validate and expand the performance of the CADScor®System.
At the Advisory Board meeting in parallel to the ESC congress the company presented its clinical plan moving forward with additional performance and cost-benefit trials as well as new exploratory studies.
“The strength of the Acarix CADScor®System has been proven in a number of clinical studies and the overall findings support the concept of using CADScor®System as a frontline test for early rule-out of stable CAD (Coronary Artery Disease). Today’s presented clinical program even expands the basis for clinical evidence.” says Professor Dr. Christian Hamm from UKGM Giessen, Germany.
Acarix has recently reported the positive results of the DAN-Nicad study, a large-scale study in a relevant patient population showing the high sensitivity and negative predictive value of the CADScor®System as a first line test for CAD rule out.
“With our ambitious clinical study program Acarix strives to further strengthen the position as an effective, cost saving and game changing CAD rule-out device. It is therefore a great pleasure to get confirmation from our renowned advisors who have been supporting our clinical development for the last three years”, says Acarix COO Claus Bo Vöge Christensen.
Christian Lindholm, interim CEO, E-mail: firstname.lastname@example.org, 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, email@example.com) is Certified Advisor of Acarix.