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Overview of Acarix AB
Acarix AB is a Swedish medical device company specializing in rapid AI-enhanced and acoustics-based cardiac diagnostics. Its innovative approach focuses on transforming the detection and management of coronary artery disease (CAD) at the point of care. By utilizing state-of-the-art technology, Acarix has developed the CADScor System, a non-invasive diagnostic tool designed to quickly and accurately rule out significant CAD, thereby reducing the need for invasive, costly diagnostic procedures.
Advanced Diagnostic Technology
The heart of Acarix's innovation lies in its combination of advanced acoustic sensors and AI-driven computational processing. The system operates by analyzing coronary blood flow using highly sensitive acoustics, offering a diagnostic accuracy that helps clinicians confidently exclude the presence of severe coronary conditions. Keywords such as rapid AI solutions, acoustics-based diagnostics, and point-of-care technology have become integral to understanding the technological differentiation that supports the company’s competitive position in the rapidly evolving medical diagnostics industry.
Business Model and Market Presence
Acarix's core business model is built upon the integration of its diagnostic technology within clinical settings. The primary revenue streams come from the sale of the CADScor System, together with associated diagnostics and services that support its use. The company targets a broad spectrum of healthcare providers, including emergency departments, outpatient clinics, and ambulatory surgical centers, where rapid decision-making is crucial for patient care. Trading on multiple prominent financial platforms, including the Nasdaq First North Growth Market in Stockholm and OTCQB in the U.S., enables Acarix to access a global pool of investors and maintain an internationally recognized market presence.
Regulatory Approvals and Clinical Impact
The CADScor System has achieved significant regulatory milestones, holding both CE approval and FDA DeNovo clearance. These approvals attest to the rigorous clinical validation and safety standards met by the system. Its adoption in clinical practices is supported by extensive usage on thousands of patients presenting with symptoms of chest pain, reinforcing its role as an effective first-line diagnostic aid. The recent assignment of a CPT code by the U.S. Centers for Medicare & Medicaid Services (CMS) further underscores its clinical credibility and facilitates a more streamlined reimbursement process in outpatient settings.
Clinical Applications and Healthcare Efficiency
By delivering results in less than 10 minutes and providing diagnostic certainty with high accuracy, the CADScor System is positioned as a critical tool in emergency and acute care scenarios. It helps healthcare providers make informed decisions rapidly, which is essential in reducing unnecessary invasive procedures and optimizing patient care pathways. With a design that prioritizes user-friendliness and operational efficiency, the system fits seamlessly into various healthcare settings, thus enhancing overall diagnostic workflows.
Competitive Landscape and Industry Differentiation
Acarix operates in a competitive landscape that includes traditional imaging modalities and emergent digital health solutions. However, the integration of acoustics-based diagnostics with rapid AI analysis sets the company apart. Unlike conventional methods that often require extensive processing time and may involve radiation or invasive testing, the CADScor System delivers swift, reliable results that resonate with modern clinical needs. This distinctive approach not only improves patient safety but also reduces operational costs, making it an attractive option for healthcare providers seeking efficient diagnostic alternatives.
Commitment to Quality and Innovation
Central to Acarix's value proposition is its commitment to continuous innovation and adherence to high quality and safety standards. The data-driven performance of the CADScor System is supported by an extensive portfolio of intellectual property, including multiple patents that protect its technological advancements. This robust foundation reinforces the company’s expertise and positions Acarix as a trusted entity in the realm of medical diagnostics. By rigorously evaluating clinical efficacy and ensuring compliance with international regulatory standards, Acarix maintains a reputation rooted in expertise and reliability.
Impact on Healthcare Delivery
The potential impact of Acarix's solutions extends beyond immediate clinical benefits. In reducing the dependency on invasive diagnostic procedures, the CADScor System contributes to more streamlined healthcare delivery systems, fostering cost efficiency and improved patient outcomes. The device’s ease of use and rapid implementation underscore its relevance in busy clinical environments, where time is a critical factor. This aligns with the broader industry shift toward minimally invasive, technology-driven healthcare solutions that prioritize both patient safety and operational efficiency.
Investor and Market Considerations
While not a financial advisory, the strategic market positioning and innovative technology of Acarix provide a compelling narrative for those interested in understanding the evolving dynamics of the medical diagnostics sector. The company’s dual-listing strategy on established stock markets highlights its global outreach and strengthens its profile among international investors. By carving out a niche in rapid, non-invasive CAD diagnosis, Acarix not only enhances clinical decision-making processes but also positions itself as a significant player in the digital transformation of healthcare diagnostics.
Conclusion
Acarix AB exemplifies how technology and innovation can converge to create substantial improvements in clinical diagnostics. Its comprehensive approach—merging advanced acoustic technology, AI-driven analysis, and a commitment to quality—delivers a diagnostic solution that is both efficient and reliable. The detailed validation of its system through regulatory approvals and widespread clinical use underscores the company’s role in reshaping cardiac diagnostics. For stakeholders and industry observers, Acarix represents a noteworthy integration of medical technology and operational efficiency aimed at enhancing patient care in a cost-effective manner.
Acarix has been awarded the 2025 Digital Innovation Award at the Global Cardiovascular Awards in London for its CADScor® System. The company also received an honorable mention for Innovation in Cardiac Imaging.
The CADScor System represents a breakthrough in early cardiac diagnostics, utilizing non-invasive AI and acoustic technology for rapid coronary artery disease (CAD) risk assessment. The system achieves over 96% certainty in low risk stratification, helping reduce unnecessary procedures and optimize patient care pathways.
The Global Cardiovascular Awards, judged by international experts including CEOs and clinical leaders, recognizes innovations making measurable impacts on global cardiovascular health.
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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