Acarix AB Stock Price, News & Analysis

Acarix AB (ACIXF) is a Swedish medical device company focused on non-invasive cardiac diagnostics, with a particular emphasis on the rapid rule out of coronary artery disease (CAD) at the point of care. The company’s core technology is the CADScor® System, a CE-approved and FDA De Novo-cleared diagnostic aid designed for patients experiencing chest pain with suspected CAD. Acarix is listed on the Nasdaq First North Premier Growth Market in Stockholm under the ticker ACARIX and its shares are also traded on the US-based OTCQB market under the symbol ACIXF.

The CADScor System is intended to help reduce unnecessary, invasive, and costly diagnostic procedures by enabling clinicians to assess the risk of obstructive coronary artery disease in a matter of minutes. According to company disclosures, the system uses highly sensitive acoustics and advanced computational processing to analyze coronary blood flow and can rule out significant CAD with at least 96% certainty at the point of care. The system is non-invasive and radiation-free, and has been used on tens of thousands of patients with symptomatic chest pain.

Business focus and core technology

Acarix positions itself as a pioneer in AI- and acoustics-based cardiac diagnostics. Its CADScor System combines high-fidelity acoustic detection with proprietary algorithms and advanced computational analysis to generate a risk score for obstructive coronary artery disease. The company describes the CADScor approach as a first-line diagnostic aid for low-risk chest pain patients, intended to support clinicians in deciding which patients require further non-invasive imaging or invasive testing.

Peer-reviewed research cited by Acarix indicates that a “CADScor-first” strategy in US emergency departments may be cost-effective compared to standard non-invasive cardiac imaging methods. One independent study using an economic model found that using the CADScor System as the initial diagnostic tool for low-risk chest pain patients could substantially reduce hospital costs per 10,000 patients without significantly increasing patient risk or compromising diagnostic safety. The study also reported a high negative predictive value for the CADScor System, supporting its role in safely ruling out significant coronary artery disease in low-risk populations.

Clinical use and patient pathway

The CADScor System is designed for use at the point of care, including emergency and outpatient settings, where clinicians evaluate patients with chest pain and suspected CAD. Acarix recommends CADScor as a first-line diagnostic aid to identify low-risk patients who may be safely discharged earlier and to reduce the need for further testing. Company materials note that the system can provide a CAD risk assessment in under 10 minutes and that its acoustic and algorithmic approach allows clinicians to achieve high certainty in low-risk stratification.

The device has been used in clinical practice and studies involving tens of thousands of patients. Acarix highlights that the CADScor System has been applied in both European and US healthcare environments and that it is supported by clinical and health-economic research, including peer-reviewed publications. The company also reports that the system is covered by a substantial patent portfolio.

Regulatory and reimbursement environment

Acarix states that the CADScor System is CE-marked in Europe and FDA De Novo-cleared in the United States. In the US, the system is associated with a dedicated CPT code (0716T). The US Centers for Medicare & Medicaid Services (CMS) has decided that this code shall be assigned to APC 5733 with a status indicator of “S” (separately payable) for a specified calendar year, enabling standalone fixed reimbursement for CADScor use in outpatient settings. According to Acarix, this decision allows healthcare providers to submit reimbursement claims for CADScor procedures via their standard billing processes when the system is used in applicable outpatient and emergency room settings.

Acarix has indicated that this CMS reimbursement status is an important factor for expanding CADScor adoption in the US, and that it may also influence reimbursement decisions by private payers who often look to CMS rulings as a reference. The company has also reported ongoing progress with reimbursement and describes this environment as supportive of broader accessibility of its technology.

Commercial strategy and market presence

Acarix describes itself as a global leader in rapid AI- and acoustics-based cardiac diagnostics, with the US identified as a key commercial market. The company has reported growing sales of CADScor Systems and single-use patches, particularly in the US, and has highlighted a consignment-based business model for system placements in that market. In its financial communications, Acarix has noted record-breaking patch sales, increased gross margins, and growth in the number of CADScor Systems installed at customer sites.

To support its expansion, Acarix has entered into strategic partnerships. One example is a partnership with Geo-Med, LLC, a Service-Disabled Veteran-Owned Small Business that supplies medical and surgical products to the US Department of Veterans Affairs and Department of Defense. This collaboration is intended to extend the availability of the CADScor System to US veterans through federal medical facilities. Acarix has also referenced agreements with healthcare providers across multiple US states and clinical study collaborations with large health systems.

Recognition and awards

Acarix and its CADScor System have received recognition in the cardiovascular field. The company has been named a Digital Innovation Award winner by the Global Cardiovascular Awards, with an additional honorable mention for Innovation in Cardiac Imaging. This award acknowledges the use of digital, mobile, and AI technologies that influence the future of cardiovascular care. The recognition highlights the CADScor System’s non-invasive, AI-driven approach to early cardiac diagnostics and its role in enabling rapid and accurate risk assessment of coronary artery disease.

Capital markets and trading

Acarix shares trade on the Nasdaq First North Premier Growth Market in Stockholm under ticker ACARIX. The company has also arranged for its shares to be cross-traded on the OTCQB Market in the United States under the symbol ACIXF. OTCQB is operated by OTC Markets Group and provides a trading venue for US and global securities. Acarix has indicated that cross-trading on OTCQB is intended to broaden its reach to US investors and increase accessibility to the US capital market while maintaining its primary listing in Stockholm.

Position within the medical device and cardiac diagnostics industry

Within the healthcare sector, Acarix is classified as a medical device company focused on cardiovascular diagnostics. Its activities center on the development and commercialization of the CADScor System as a diagnostic aid for coronary artery disease. The company emphasizes its use of AI, acoustic sensing, and computational analysis to support clinicians in managing patients with chest pain, aiming to reduce unnecessary diagnostic procedures and optimize resource use in emergency and outpatient care.

According to Acarix, the CADScor System has been used on more than 29,000 patients in earlier disclosures and more than 40,000 patients in later communications, reflecting continued uptake over time. The company highlights that its technology is intended to address the large volume of patients presenting with chest pain and suspected CAD, many of whom ultimately do not have obstructive coronary artery disease but still undergo extensive testing.

Investor information and reporting

Acarix publishes interim and year-end financial reports, which include information on revenue, patch and system sales, gross margins, operating costs, and cash flows. The company has reported growth in CADScor system placements, increases in patch volumes, and improvements in gross margin, alongside cost-reduction measures. It also communicates about share issues and cash positions in its financial reports. These disclosures provide investors with insight into the company’s operational progress, commercialization efforts, and financial development over time.

Key points for ACIXF investors

• Acarix AB is a Swedish medical device company focused on non-invasive, AI- and acoustics-based cardiac diagnostics.
• The company’s flagship product is the CE-marked and FDA De Novo-cleared CADScor System for rapid rule out of significant coronary artery disease at the point of care.
• Acarix is listed on the Nasdaq First North Premier Growth Market in Stockholm (ACARIX) and its shares are cross-traded on the US OTCQB market under the symbol ACIXF.
• The CADScor System is supported by clinical and health-economic research, including peer-reviewed studies on cost-effectiveness and diagnostic performance.
• Acarix reports growing adoption of the CADScor System and patches, with a focus on the US market and partnerships that extend access to specific patient groups, such as US veterans.
• US CMS reimbursement decisions for the CADScor System in outpatient and emergency settings are an important component of the company’s commercialization strategy.