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About Acarix AB (ACIXF)
Acarix AB is a Swedish medical device company revolutionizing the field of cardiac diagnostics with its innovative, non-invasive solutions. The company specializes in leveraging artificial intelligence (AI) and advanced acoustics to develop cutting-edge tools for the rapid and accurate assessment of coronary artery disease (CAD). Its flagship product, the CADScor System, is a CE-approved and FDA-cleared diagnostic aid designed to rule out significant CAD with at least 96% certainty in less than 10 minutes, making it a first-line diagnostic tool for patients experiencing chest pain.
Core Technology and Value Proposition
The CADScor System is powered by advanced computational processing and highly sensitive acoustic sensors that analyze coronary blood flow. This non-invasive, radiation-free technology reduces the need for costly and invasive diagnostic procedures, offering significant benefits to both patients and healthcare providers. By providing rapid, reliable results at the point of care, Acarix addresses a critical need in the healthcare industry to improve diagnostic efficiency and reduce unnecessary resource utilization.
Market Position and Industry Context
Acarix operates within the rapidly growing medical device and healthcare technology sectors, focusing on cardiovascular health—a market segment with increasing demand due to the global prevalence of heart disease. The company is strategically positioned as a disruptor in the cardiac diagnostics space, offering a unique alternative to traditional methods such as stress tests and angiography. Its innovative approach not only enhances diagnostic accuracy but also aligns with healthcare systems' goals of cost reduction and improved patient outcomes.
Revenue Model and Growth Strategy
Acarix generates revenue through the direct sale of its CADScor System, licensing agreements, and reimbursement from healthcare providers. The company's growth strategy includes expanding its presence in key markets, such as the United States and Europe, where regulatory approvals and reimbursement frameworks are in place. The recent decision by the U.S. Centers for Medicare & Medicaid Services (CMS) to assign a standalone reimbursement code for the CADScor System underscores its growing adoption and market potential.
Competitive Landscape and Differentiation
In a competitive landscape that includes traditional diagnostic methods and emerging technologies, Acarix differentiates itself through its non-invasive, AI-driven approach. Its ability to deliver rapid, accurate results without radiation or invasive procedures positions it uniquely in the market. Additionally, its extensive patent portfolio and regulatory clearances provide a strong foundation for long-term growth and competitiveness.
Global Reach and Investor Appeal
Listed on the Nasdaq First North Growth Market in Stockholm and cross-traded on the OTCQB Market in the U.S., Acarix is accessible to a broad base of international investors. This dual listing strategy reflects the company's commitment to transparency and compliance with high financial and corporate governance standards. With the U.S. being its most significant commercial market, Acarix is well-positioned to capitalize on growing demand for innovative cardiac diagnostics solutions.
Acarix reported strong financial results for 2024, marked by significant growth in its U.S. operations. The company achieved a 333% increase in system placements and an 88% surge in patch sale revenue in Q4 2024 compared to Q4 2023. Total revenue for Q4 reached SEK 1,700 thousand, up 45% year-over-year.
The company delivered 62 CADScor systems throughout 2024, a 51% increase from 2023, with 60 systems deployed in the U.S. market. Patch sales grew 27% annually, reaching 11,734 units. The gross margin improved to 90%, up 5 percentage points from 2023. Operating costs decreased by 27% in Q4, and the company reduced its adjusted loss by 32% compared to the previous year.
A favorable CMS ruling allowing standalone fixed reimbursement for the CADScor System in outpatient settings positions Acarix for significant U.S. growth in 2025. The company also secured strategic partnerships, including with Geo-Med, , to expand the CADScor System's reach to U.S. Veterans.
Acarix has announced a strategic partnership with Geo-Med, , a Service-Disabled Veteran-Owned Small Business, to expand the availability of its CADScor System within federal medical facilities serving veterans. The partnership aims to enhance access to advanced cardiac diagnostic technology through the Department of Veterans Affairs and Department of Defense.
The CADScor System, known for its acoustic-based cardiac diagnostic capabilities and accurate low-risk stratification in assessing coronary artery disease (CAD) at the point of care, will become more accessible to veterans through Geo-Med's established expertise in VA procurement and distribution of medical products.
Acarix announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned CPT code 0716T for the CADScor System to APC 5733 with 'S' (separately payable) status for 2025. This decision enables standalone fixed reimbursement for CADScor in outpatient settings, including emergency rooms and ambulatory surgery centers. The CADScor System is a non-invasive, AI-powered diagnostic tool that rules out Coronary Artery Disease with 97% accuracy in under 10 minutes. The system is FDA-cleared, CE-marked, protected by over 40 patents, and has been used on more than 40,000 patients with symptomatic chest pain.
Acarix AB, a leader in AI-based cardiac diagnostics, reported strong Q2 2024 financial results. Key highlights include:
- Revenue increased 27% to SEK 1,958 thousand
- Gross profit rose 38% to SEK 1,788 thousand (91% margin)
- 15 CADScor Systems installed (2 sold, 13 consigned)
- 3,530 patches sold (62% increase in US)
- Operating costs reduced by 25% (excluding one-time expenses)
- Loss before tax: SEK –16,661 thousand
For H1 2024, revenue was SEK 3,509 thousand, with 28 CADScor Systems and 6,054 patches sold. The company's cash position stood at SEK 48,271 thousand. These results reflect Acarix's growing market presence and successful implementation of its new sales model and strategic initiatives.
Acarix, a leader in AI and acoustics-based cardiac diagnostics, has begun trading on the US-based OTCQB Market under the ticker symbol ACIXF. This move allows Acarix shares to be traded in USD alongside its existing Nasdaq First North Growth market listing in Stockholm. The OTCQB Market, operated by OTC Markets Group, serves as an alternative to Nasdaq New York and NYSE listings for 12,000 US and global securities.
CEO Aamir Mahmood expressed excitement about expanding the company's reach beyond the Stockholm listing, particularly as the US is Acarix's most important commercial market. The OTCQB listing is expected to increase accessibility to US capital markets and satisfy growing interest from US investors. Companies listed on OTCQB must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with US securities laws.
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