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 was establish in 2009 and is listed on Nasdaq First North Growth Market. Acarix's CADScor@System uses an advanced sensor placed on the skin above the heart to listen to the sounds of cardiac contraction movement and turbulent flow. It has been designed to be an all-in-on system in the sense that the heart signal will be recorded, processed, and displayed as a patient specific score, the CAD-score, on the device screen.