Handheld system rules out coronary arterial stenosis, saving valuable time in frontline triage and avoiding the need for expensive diagnostics.
Acarix AB (publ) (“Acarix” or the “Company”) announced the initiation of a multi-center trial of its handheld CADScor®System for non-invasive, non-radiation acoustic detection of Coronary Artery Disease (“CAD”). The results from the extensive study are expected to be available early 2020. Acarix believes the device has the potential to both greatly improve triaging of patients and reduce the need for costly further invasive diagnostic investigations. The new study is intended to further support eligibility, document the positive effects on health economics and also expand applicability to patients 30-39 years of age. The estimated market for frontline CAD diagnostics is Euros 100 M in Germany alone with an option to expand the market further.
The CADScor®System combines ultra-sensitive phonocardiography to detect turbulent arterial flow and myocardial movement in a handheld device to provide a patient specific CAD-score in less than 8 minutes. The Principal Investigator is Morten Böttcher, MD PhD FESC, Department of Cardiology, Aarhus University Hospital, Denmark concluded:
The acoustic-based recording device, the CADScor®System, enables improved risk stratification in suspected CAD patients. With a negative predictive value of 96%, this new acoustic ruleout system could potentially supplement clinical assessment to guide decisions on the need for further investigation and thereby reduce the demand for more advanced, costly and invasive diagnostic modalities.
The trial results are expected to involve 1,500-2,000 patients with a low-to-intermediate likelihood of CAD from four Danish hospitals.
The study results are expected to improve on the negative predictive value of 96% which suggests using the CADScor®System as a first-line CAD rule-out method; thus, avoiding expensive and/or invasive diagnostic modalities for many of those patients.
Today, patients are referred for CAD evaluation by Cardiac Computed Tomography Angiogram (CTA) which involves injection of contrast media and X-ray exposure. Using the non-invasive and risk-free CADScor®System, features from the audiogram is automatically combined with clinical risk factors (e.g. gender, age and hypertension) to provide a CAD-score, which correlates with the CAD risk.
Acarix CEO Søren Rysholt Christiansen commented:
The existing data already show that the CADScor®System quickly and cost-effectively can provide answers to the pressing issues in CAD diagnosis. Coronary Artery Disease affects more than 120 million people worldwide, but the current diagnostic pathway, which can rapidly escalate to expensive imaging and invasive coronary angiography, can be improved and patient anxiety can be reduced. With the DAN-NICADII study we expect to gather performance and economic date supporting the CADScor®System as a fast and safe frontline assessment to reduce patient referrals by approximately 50% – a win-win for patients, payers and physicians.