Malmö, Sweden - Acarix, a global leader in AI- and acoustics-based cardiac diagnostics, today announce that G-BA reached a negative decision on the possibility for CADScor System to receive reimbursement on the German market.
We believe the decision was influenced by not having all relevant data available at the time for the decision by G-BA. Acarix has initiated dialogue with the G-BA to provide additional information for review, with the aim of achieving a more informed and favorable outcome.
Although Acarix's main focus is now on the U.S. market, we remain committed to supporting partners in other regions where collaboration and patient access make sense. In Germany, we also recognize the relevance of supporting ongoing reimbursement efforts to ensure continued access for existing customers.
However, it is important to emphasize, that this unfavorable outcome does not effect our momentum in the US, our financial goals or our overall strategy as Germany does not play a critical role at this point in time.
About Acarix
| Acarix is a Swedish medical device company that innovates solutions for rapid rule out of coronary artery disease (CAD) at point of care. 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 has been used on more than 40,000 patients. Acarix recommends CADScor System as a first-line diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze coronary blood flow to rule out significant coronary artery disease (CAD), with at least 96% certainty at point of care. Acarix is listed on the Nasdaq First North Premier Growth Market in Stockholm (ticker: ACARIX) and cross-traded on the OTCQB market in the US (ticker: ACIXF). Carnegie Investment Bank is the Certified Advisor of Acarix. For more information, please visit www.acarix.com |
For more information, contact
Macie May, phone +1 405 517 5161, email mmay@saxum.com