2019-02-15 20:30
Acarix adapts pathway for German reimbursement - Submission of new dossier by the end of February 2019

Press release
Malmö, February 15, 2019

Acarix adapts pathway for German reimbursement
- Submission of new dossier by the end of February 2019

Acarix AB (publ) (ACARIX: FN Stockholm) today announced it will file for German reimbursement directly 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 initial discussions with relevant associations. However, a new legislation is underway which will impact the local reimbursement process and result in delays.

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

"Before new legislation was being considered, we were in line with our expected timeline for a late 2019 reimbursement, but this will now be delayed. In order to keep momentum, we immediately initiated a discussion process with the G-BA and will have more information by the end of April", said Per Persson, CEO of Acarix.

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

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

About Acarix
Acarix was established in 2009 and is listed on Nasdaq First North Premier. 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-one 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. Readings are obtained in less than 8 minutes. Safe and suitable for use in both out- and inpatient settings, the CADScor®System thus has the potential to play a major role in patient triage, avoiding the need for many patients to undergo stressful invasive diagnostic procedures. Please visit www.acarix.com for more information.

PR DE 20190215 ENG.

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Source: Acarix AB via Globenewswire