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

Rhea-AI Summary

Acarix (Nasdaq First North: ACARIX, OTCQB: ACIXF) announced that its CADScor® System has received regulatory approval from the Emirates Drug Establishment and the UAE Ministry of Health and Prevention, enabling commercial availability across the United Arab Emirates through partner UniTech Solutions.

The approval marks Acarix's entry into the Gulf region and a platform for broader GCC expansion. The CADScor System is a point-of-care diagnostic aid that uses acoustics, computational analysis, and AI to assess coronary blood flow and help rule out significant coronary artery disease in under 10 minutes, with at least 96% negative predictive value. The technology is CE-marked, FDA De Novo cleared, backed by over 15 years of R&D, 45 patents, and usage in more than 60,000 patient assessments.

Positive

• UAE regulatory approval enables CADScor System commercialization via UniTech Solutions
• At least 96% negative predictive value for ruling out significant coronary artery disease at point of care
• 60,000+ patient assessments demonstrating real-world use of the CADScor System
• 45 patents and 15+ years of R&D underpinning the CADScor technology platform
• CE-marked and FDA De Novo cleared status supporting global clinical and regulatory validation

Negative

• None.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

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

OKLAHOMA CITY, Aug. 10, 2026 /PRNewswire/ -- 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, President & CEO 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

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 60,000 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 U.S. (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
+1 405 517 5161
mmay@saxum.com 

View original content to download multimedia:https://www.prnewswire.com/news-releases/acarix-receives-regulatory-approval-for-the-cadscor-system-in-the-uae-united-arab-emirates-302846444.html

SOURCE Acarix

FAQ

What did Acarix (ACARIX, ACIXF) announce about the CADScor System in the UAE on August 10, 2026?

Acarix announced UAE regulatory approval for its CADScor System, enabling commercial availability nationwide through UniTech Solutions. According to Acarix, approvals from the Emirates Drug Establishment and the Ministry of Health and Prevention open market access and mark the company’s entry into the Gulf region.

What does UAE regulatory approval mean for Acarix (ACIXF) shareholders?

UAE approval allows Acarix to commercialize the CADScor System across the country via UniTech Solutions. According to Acarix, the UAE also provides a strategic platform for expansion into Gulf Cooperation Council markets, potentially broadening the installed base and regional adoption of its technology.

How does the Acarix CADScor System work for coronary artery disease rule-out?

The CADScor System uses sensitive acoustics, computational analysis, and AI to assess coronary blood flow and calculate a CAD-score. According to Acarix, it combines this with clinical risk factors to rapidly indicate the risk of significant coronary stenosis before further testing is considered.

How fast is the CADScor System and what is its negative predictive value?

The CADScor System delivers a patient-specific result in under 10 minutes at point of care. According to Acarix, it is designed to rule out significant coronary artery disease with at least 96% negative predictive value, supporting earlier risk stratification and reduced downstream testing.

What clinical and regulatory validation does the Acarix CADScor System have?

The CADScor System is CE-marked under EU MDR 2017/745 and has FDA De Novo clearance. According to Acarix, it is built on more than 15 years of R&D, protected by 45 patents, and has been used in over 60,000 patient assessments globally.

Who will distribute the CADScor System in the UAE and Gulf region?

UniTech Solutions will lead distribution of the CADScor System in the UAE, including clinical support and account development. According to Acarix, this partnership provides a base for broader Gulf Cooperation Council expansion, targeting high case volumes and established clinical infrastructure.

For which patients is the Acarix CADScor System intended?

The CADScor System is intended for patients experiencing chest pain or shortness of breath with suspected coronary artery disease. According to Acarix, it is recommended as a first-line diagnostic aid at point of care to help rule out significant CAD and reduce unnecessary invasive procedures.