Press release
Malmö, 13 June, 2017
Acarix receives its first commercial order for CADScor®System for the early detection of coronary heart disease from the Danish hospital
Kommersialiseringsprogrammet follow the plan
Acarix AB (publ) (“Acarix” or the “Company”) today announced that the hospital in Herning is the first commercial client of the CADScor®System for non-invasive acoustic detection of coronary artery disease (CAD). Researchers at the hospital have done extensive testing of CADScor®System and recently presented results at the American College of Cardiology 2017 Annual Scientific Meeting shows that CADScor®System can exclude CAD with a 97% negative predictive value. The timing of this first order is a sign of a successful commercial development for Acarix after the övertecknade ipo on Nasdaq First North Premier in Stockholm at the end of 2016. The company is now in dialogue with a number of other potential customers in Germany and Scandinavia.
CADScor®System combines the acoustic detection of turbulent arterial flow and myokardrörelse with advanced algorithms in a handheld device to provide a patient-specific CAD-score of less than 10 minutes. The decision to buy CADScor®System was commented on by Morten Bøttcher, MD, PhD, FESC, director of Cardiac Imaging Center at the sjukhusenheten West in Denmark and associate professor at Aarhus University: “Despite access to improved algorithms for riskstratifiering is the use of established surveys, such as nuclear stress test or CT continued to be extensive. We tested, therefore, the diagnostic accuracy of the CADScor®Systems for the exclusion of CAD in order to see if it could be used to reduce the demand for more advanced diagnostic methods. We have come to the conclusion that, with its ability to exclude CAD with a 97% negative predictive value, can this advanced, easy-to-use, stetoskopliknande instrument may be used as an initial test.We now look forward to evaluating the instrument performance in routine clinical use.”
In the study that Dr. Bøttchers research team implemented was documented with a CAD score of 1,675 patients. Low risk indikerades of a CAD-score less than or equal to 20. The diagnostic performance had an accuracy of: 72% (CI: 67% – 77%). CAD-score cut-off of less than or equal to 20 showed 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 forms of diagnostics which can easily escalate to include expensive investigations in the form of imaging and coronary angiography, are ineffective. We are very pleased that the hospital in Herning, where the conclusion has evaluated CADScor®System, will be our first commercial customer. Dr. Bøttcher and his team are internationally renowned for their outstanding research in the field of coronary artery disease and we look forward to continuing our close cooperation with them.”
Contact:
Acarix A / S
Søren Rysholt Christiansen, CEO E-mail: dksrc@acarix.com Telephone: +45 2777 1112
The information above is such that Acarix AB (publ) is obliged to publish in accordance with the EU market abuse regulation 596/2014. The information was submitted for publication, through the agency of the contact person listed above, at 11:00 on 13 June 2017.
To the editors:
Acarix, CADScor®System and the measurement of heart sounds
Acarix was founded in 2009 and since 2010, the Danish venture capital companies, Seed Capital (DK) and Sunstone Life Science Ventures (DK) funded the development of the company and supported it against an introduction on the market. Acarix has also strengthened its management team with new people with experience from senior positions within the international medtech company – the CEO Søren Rysholt Christiansen previously worked at ELOS Medtech, GN ReSound and Cook Medical.
Acarix CADScor®System is based on cutting-edge research in the ljuddetektion and signalprocess. It has long been known that both the heart’s contraction and turbulent blood flow gives rise to sound. Kontraktionsrelaterade sound occurs in the lower frequencies, while the turbulent sounds of blood flow (caused by partial obstruction (stenosis) in the kransartärerna) causes a sound of higher frequency. The detection of these murmurs require devices with high sensitivity because the energy of the murmur is very weak. To detect and register the murmur arising from the coronary arteries requires not only an advanced sensor, but also that the detector placement on the skin over the heart is such that the recorded signal is optimized and that the external noise is avoided.
Acarix CADScor®System is built as an all-in-one system comprehensive recording of blåsljuden, signal processing and presentation of p.k. patient-specific CAD-score, on the device’s screen.
CADScor®System also includes the necessary electronics to instruct the staff and guide the patient through the mätperioderna directly on the screen. The system also includes a docking station for the daily test and calibration of the sensor. The system is integrated with an adhesive plate that locks the CADScor®sensor in a fixed position above the heart during the measurement.
The software in the Acarix CADScor®System ensures that the recording is made under controlled conditions.
CADScor®System is CE-certified (by TÜV 2015). Photos: http://www.acarix.com/about-us/press-downloads/press-photos/.
See more at www.acarix.com.
20170613 Press release first customer_SE
