”After six months at Acarix, I clearly see our market evolving and a growing opportunity for our products aimed at revolutionizing cardiac diagnostics. At congresses and scientific events, an increasing number of presentations focus on the need for accurate tools that physicians can rely on to make quick and appropriate decisions.” Extract from CEO Per Persson’s commentary to the Report
In February 15 Acarix announced that it is adapting pathway for German reimbursement and submitting new dossier by the end of February 2019, aiming for full reimbursement. Thereafter, the authorities require eight weeks to assess the dossier and give eedback on requirements and potential complementary data.
Previously, Acarix was aiming for full reimbursement in Germany by the end of 2019, after initial discussions with relevant associations. However, a new legislation is underway which will impact the local reimbursement process and result in delays.
The above does not change Acarix abilities to achieve full reimbursement, it only impacts timing that will depend on the feedback and potential questions the company’s submission will render into. In parallel, Acarix has also commenced a dialogue with channels in relation to the larger German statutory sickfunds, which independently may decide about reimbursing the CADScor®System. As a large part of hospital expenses is funded by independent statutory sick-funds this activity could significantly increase healthcare access to the CADScor®System. Furthermore, private reimbursement is not affected by the above changes.
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, firstname.lastname@example.org) is Certified Advisor of Acarix.