Clinical Studies and Research

Acarix Clinical
Development Program

The clinical program behind CADScor®System is comprehensive, with the Adopt CAD, BIO-CAC and Dan-NICAD clinical studies with 2,591 patients forming the basis for CE marking and FDA De Novo clearance. Overall, the clinical studies include 8,000 patients, of which 6,800 are in the clinical development program. Additional studies are underway to further strengthen the performance metrics and the algorithm and expand the product portfolio.

Key Clinical Publications

The Dan-NICAD I trial was initiated in September 2014 to assess non-invasive methods in patients referred for coronary computed tomography angiography (cCTA) due to symptoms suggestive of obstructive CAD.
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Follow-up to Dan-NICAD I. Clinically relevant prognostic data were assessed with a median follow-up time of three years to evaluate the correlation between CAD- score and prognosis in patients treated by the current standard of care. The long-term prognostic data from the Dan-NICAD I trials was first presented at the ESC Congress in September 2019 by Simon Winther, MD, Ph.D. from Aarhus University Hospital, Denmark, and later published in European Heart Journal – Digital Health.
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The Dan-NICAD II study, with 1,726 patients referred for cCTA with symptoms suggestive of stable CAD, will further establish the diagnostic accuracy of CADScor®System compared to other stratification alternatives commonly used today and add more validated clinical data for further development of the CADScor® algorithm. The study also includes patients below the age of 40, which may provide the opportunity for an expansion of the currently identified patient group, thus enabling patients as young as 30 to use CADScor®System. The first data were presented at ESC 2021, confirming a high negative predictive value and thus the potential of CADScor®System for early rule-out of CAD. The results of the final analysis of the study data were published in the BMJ Journal, Heart (July 2023), concluding in a large contemporary cohort of patients with low CAD likelihood, the additional use of an acoustic rule-out device showed a clear potential to downgrade likelihood and could supplement current strategies for likelihood assessment to avoid unnecessary testing.
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The FILTER-SCAD study objective is to evaluate CADScor®System in a randomized study directly comparing CAD-score evaluation to standard evaluation. The study expects to enroll approximately 2,000 patients recruited from six different clinical study sites, including one Swedish center. The study results are expected by 2024.
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This study objective was to assess the cost utility of CADScor®System for the diagnosis of CAD at an early stage in the diagnostic testing pathway in England.
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CADScor®System

CADScor®System is a point-of-care diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze the patient’s coronary blood flow. The system calculates a patient-specific CAD-score, and couples it with risk factors to rapidly indicate the patient’s risk of significant coronary stenosis for immediate risk stratification, prior to potential secondary evaluation.1 CADScor®System has been used in over 29,000 patient assessments 2 and has CE-marking and FDA De Novo clearance.

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  1. User manual US-FDA v.12.Y, prevalence 10,7%
  2. Based on commercial patch use since 2017