Acarix Receives Regulatory Approval for the CADScor®System in the United Arab Emirates

Approval opens market access across the UAE through commercial partner UniTech Solutions, bringing rapid, non-invasive coronary artery disease rule-out to point of care.

Acarix AB (publ) today announced that the CADScor®System has received regulatory approval from the Emirates Drug Establishment (EDE) and the Ministry of Health and Prevention (MOHAP), clearing the way for commercial availability of the technology across the United Arab Emirates.

The approval marks Acarix's entry into the Gulf region and extends the reach of the CADScor System, a point-of-care diagnostic aid that uses highly sensitive acoustics and advanced computational analysis and AI to assess coronary blood flow and rule out significant coronary artery disease (CAD) in patients presenting with chest pain or shortness of breath. The system delivers a patient-specific result in under 10 minutes, supporting earlier risk stratification and reducing reliance on more invasive and costly downstream testing.

"Coronary artery disease is a leading health burden across the Gulf, and the diagnostic pathway remains longer and more resource-intensive than it needs to be," said Aamir Mahmood, Chief Executive Officer of Acarix. "Bringing the CADScor System to the UAE gives frontline clinicians a fast, non-invasive way to rule out CAD at the point of care. This matters for the patients and clinicians we serve."

The UAE also gives Acarix a platform for the wider Gulf Cooperation Council (GCC), where high case volumes and established clinical infrastructure drive demand for tools that improve triage and ease pressure on cardiac imaging and catheterization labs.

"Entering the UAE is a deliberate step in our strategy to establish the CADScor System as a first-line diagnostic aid in high-value markets," said Beji George, Head of Global Strategy at Acarix. "The market has the infrastructure, the case volume, and the appetite for technology that improves the pathway, and it gives us a strong base to build from across the region."

Acarix will bring the CADScor System to market in the UAE through its commercial partner, UniTech Solutions, which will lead distribution, clinical support, and account development across the region.

"We are proud to bring the CADScor System to healthcare providers across the UAE," said Majed Aboalazm, Chief Executive Officer of UniTech Solutions. "It addresses a clear unmet need, giving clinicians a rapid, reliable way to rule out coronary artery disease early in the pathway. We look forward to working alongside Acarix to put it into the hands of cardiologists and emergency teams."

About the CADScor®System
The CADScor System is a point-of-care diagnostic aid that uses highly sensitive acoustics and advanced computational analysis and AI to assess a patient's coronary blood flow. It calculates a patient-specific CAD-score and combines it with clinical risk factors to rapidly indicate the risk of significant coronary stenosis, prior to potential secondary evaluation. The system produces a result in under 10 minutes and is designed to rule out significant CAD with at least 96% negative predictive value at point of care. The CADScor System has been used in over 60,000 patient assessments, is built on 15+ years of R&D covered by 45 patents, is CE-marked in accordance with EU MDR 2017/745, and has received FDA De Novo clearance as a diagnostic aid for symptomatic patients with suspected CAD.

About Acarix

For more information, contact
Macie May, phone +1 405 517 5161, email mmay@saxum.com