First patient enrolled in the new clinical study FILTER-SCAD targeting 2,000 patients – Yahoo Finance

Press release

Malm, Sweden February 18, 2020

First patient enrolled in the new clinical study FILTER-SCAD targeting 2,000 patients

Acarix AB (publ) today announced the initiation of the randomized, multi-center clinical study FILTER-SCAD to examine the cost effectiveness and safety of adding the CADScorSystem as a rule-out test in patients referred with symptoms suggestive of stable coronary artery disease.

In the FILTER-SCAD study, 2,000 patients referred on suspected stable coronary disease are to be consecutively enrolled at four hospitals in Denmark and Lunds University Hospital in Sweden.

All patients will undergo an initial assessment, prior to being randomized into a standard care or CADScor System pathway for evaluation. The cost effectiveness will be calculated as reduction in number of evaluation procedures between the two patient pathways. Patients will be followed over 12 months to assess secondary endpoints of safety.

Having the CADScorSystem in the right phase of the care process is essential for demonstrating the real-life clinical use and the cost-effectiveness of the system. The commitment to adopt the Acarix technology in the FILTER-SCAD study is important to show alternatives to both reducing overall patient testing costs and to reduce the use of costly evaluation methods, said Acarixs CEO Per Persson.

In addition, the FILTER-SCAD protocol has been adjusted to the new guidelines from the European Society of Cardiology thus incorporating the latest recommendations.

Stable Coronary Artery Disease is affecting millions of people worldwide and despite a decreasing incidence, even more testing is done to diagnose and especially rule-out the presence of CAD. For the patients this means today both extended waiting time from first contact into the healthcare system to final diagnosis, but also a higher risk from more complex evaluation procedures. There is therefore a substantial need for a simple and reliable tool to guide the clinicians in their evaluation of patients.

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 February 18, 2020 at 13.00 CET.

About the study: The FILTER-SCAD trial is designed as a randomized, controlled, multi-centre, superiority trial with two parallel groups including patients with symptoms suggestive of stable CAD. Approximately 2000 subjects will be randomized 1:1 to either (1) standard pre-test probability stratification according to current guidelines, followed by Non-Invasive Testing (NIT), if indicated, or (2) CAD-score stratification followed by NIT, if indicated. An estimated 5 centres will participate in this study. Each centre is expected to randomize approximately up to 300-500 patients.

The first patients have been included into the clinical investigation, and the patient inclusion is expected to run for 12-18 months from inclusion start. A one-year post-inclusion follow-up period for safety data collection is planned.

About Acarix: Acarix was established in 2009 and is listed on Nasdaq First North Premier Growth Market (ACARIX.ST). Acarixs CADScorSystem 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 CADScorSystem 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 http://www.acarix.com.

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