Press

MAR | Submission of new dossier by the end of February 2019

 

Jan 15, 2019

Acarix AB (publ) (ACARIX: FN Stockholm) today announced it will file for German reimbursementdirectly with the Federal Joint Committee (G-BA) for its CADScorSystem®.

Previously, Acarix was aiming for full reimbursement in Germany by the end of 2019, after initialdiscussions with relevant associations. However, a new legislation is underway which will impact thelocal reimbursement process and result in delays.

Acarix is now intensifying its contact with the Federal Joint Committee, G-BA, about the furtherpathway and has prepared a dossier for submission by the end of February, aiming for fullreimbursement. Thereafter, the authorities require eight weeks to assess the dossier and givefeedback on requirements and potential complementary data.

“Before new legislation was being considered, we were in line with our expected timeline for a late2019 reimbursement, but this will now be delayed. In order to keep momentum, we immediatelyinitiated a discussion process with the G-BA and will have more information by the end of April”, saidPer Persson, CEO of Acarix.

In parallel, Acarix has also commenced a dialogue with channels in relation to the larger Germanstatutory sick-funds, which independently may decide about reimbursing the CADScorSystem®. As alarge part of hospital expenses is funded by independent statutory sick-funds this activity couldsignificantly increase healthcare access to the CADScorSystem®.

Furthermore, private reimbursement is not affected by the above changes.

For further information, please contact:
Per Persson, CEO
E-mail per.persson@acarix.com
Phone: +46 73 600 59 90

Acarix is listed on Nasdaq First North in Stockholm.

Wildeco Ekonomisk Information AB (+46 8 545 271 00, info@wildeco.se) is Certified Adviser toAcarix.

This information is such that Acarix (publ) is obliged to disclose pursuant to the EU Market AbuseRegulation. The information was released for public disclosure, through the agency of the contactpersons above, on February 15, 2019 at 20.30 (CET).

Acarix adapts pathway for German reimbursement

About Acarix
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, certifiedadviser@redeye.se) is Certified Advisor of Acarix.

For more information, please visit www.acarix.com.