Executive Summary

Cleerly has positioned itself as a transformative leader in the cardiovascular imaging space by creating a new standard of care for heart disease through its AI-driven analysis of coronary computed tomography angiography (CCTA) imaging. The company's proprietary technology enables comprehensive phenotyping of coronary artery disease through advanced non-invasive CT imaging, allowing for early detection and prevention of heart attacks before symptoms manifest. Founded in 2017 and headquartered in Denver, Colorado, Cleerly has secured substantial funding reaching over $385 million across multiple rounds, most recently raising $106 million in December 2024 in a Series C extension led by Insight Partners and Battery Ventures. Cleerly's approach represents a paradigm shift from traditional reactive care to preventive cardiovascular medicine, leveraging artificial intelligence to analyze plaque characteristics and coronary anatomy to deliver precise, actionable insights for clinicians and patients. The company faces competition from established players like HeartFlow and emerging companies in the cardiovascular AI space, but differentiates through its focus on comprehensive plaque analysis rather than just stenosis identification. As heart disease remains the leading cause of death globally, Cleerly's innovative solution addresses a critical healthcare challenge with significant market potential and the promise of drastically improving patient outcomes through early intervention.

Corporate

Cleerly was founded in 2017 based on more than a decade of foundational research in cardiovascular imaging and artificial intelligence developed at New York-Presbyterian Hospital's Dalio Institute for Cardiovascular Imaging and Weill Cornell Medical Center. The company officially launched in June 2021 with its first-of-a-kind digital care pathway solution for heart attack prevention after securing $43 million in Series B funding. Cleerly is headquartered at 101 Greenwich Street, New York, NY, with operations also in Denver, Colorado, and has grown substantially since its founding through progressive funding rounds that have fueled its research, technology development, and commercial expansion. The company's mission centers on creating a new standard of care for heart disease by enabling comprehensive analysis of coronary artery plaques through non-invasive imaging, addressing the fact that over 50% of heart attack victims experience no prior symptoms and traditional risk assessments often fail to identify at-risk patients. Cleerly's founding team, led by Dr. James K. Min, a renowned cardiologist and researcher, brings extensive expertise in cardiovascular imaging, machine learning, and healthcare innovation, establishing the scientific credibility that has helped attract significant investor interest. The company has assembled an impressive roster of financial backers including T. Rowe Price, Fidelity Management, Insight Partners, Battery Ventures, Cigna Ventures, Peter Thiel, and Novartis, demonstrating strong confidence from both traditional venture capital, strategic healthcare investors, and prominent individual investors.

Cleerly has pursued a focused intellectual property strategy to protect its core AI algorithms and clinical methodologies, creating barriers to entry in the specialized field of cardiovascular imaging analysis. The company's organizational structure has evolved to support both technological innovation and commercial expansion, with dedicated teams focusing on AI development, clinical validation, regulatory affairs, and market penetration across healthcare systems and insurance providers. Cleerly has carefully cultivated relationships with major healthcare institutions, imaging centers, and cardiologists to build a comprehensive ecosystem for its technology adoption, addressing the entire continuum of cardiovascular care from screening through diagnosis and treatment planning. The company has demonstrated a commitment to rigorous clinical validation, conducting numerous multi-center clinical trials to establish the efficacy and value of its technology in real-world settings, building credibility with both clinicians and payers. Cleerly faces regulatory considerations typical of medical AI companies, including FDA clearance requirements, data privacy compliance, and the need to secure reimbursement pathways through insurance providers, but has navigated these challenges through a methodical approach to clinical evidence generation and stakeholder engagement. With its robust funding, technological differentiation, and strong leadership team, Cleerly has positioned itself as a disruptive force in cardiovascular care, aiming to fundamentally change how heart disease is detected, characterized, and managed across healthcare systems globally.

Management

Cleerly's leadership team is headed by founder and CEO Dr. James K. Min, a board-certified cardiologist with extensive credentials including FACC (Fellow of the American College of Cardiology), FESC (Fellow of the European Society of Cardiology), and MSCCT designations. Prior to founding Cleerly, Dr. Min served as Professor of Radiology and Medicine at Weill Cornell Medical College and directed the Dalio Institute for Cardiovascular Imaging at New York-Presbyterian Hospital, establishing him as a recognized authority in cardiovascular imaging and providing the scientific foundation for Cleerly's approach. The company's board of directors expanded in November 2021 with the addition of three industry leaders: Kevin M. King, former CEO of iRhythm Technologies; Dr. Glenn D. Steele Jr., former CEO of Geisinger Health System; and Dr. Roy Beveridge, former Chief Medical Officer of Humana, bringing valuable expertise in healthcare leadership, medical technology, and payer perspectives. The company's leadership reflects a blend of clinical expertise, technological innovation, and business acumen, with executives bringing experience from both academic medicine and commercial healthcare technology ventures. Cleerly has also established board observer positions for representatives from its major investors, including Vensana Capital, DigiTX Partners, and Cigna Ventures, ensuring alignment between the company's strategic direction and investor expectations.

The management team demonstrates complementary strengths across clinical medicine, artificial intelligence, regulatory affairs, and commercial healthcare, positioning the company effectively for the complex challenges of transforming cardiovascular care through technology. The leadership has maintained strategic focus through periods of rapid growth, prioritizing clinical validation alongside technological advancement and commercial expansion, and avoiding the common pitfall of promising more than can be delivered in the highly regulated medical technology space. Their methodical approach to building clinical evidence through multiple studies has established credibility with both clinicians and potential payers, addressing one of the key adoption barriers for innovative medical technologies. The executive team has navigated the regulatory pathway effectively, securing necessary clearances while continuing to advance both the technology platform and commercial relationships with healthcare providers and payers. Management has balanced the tensions between aggressive technological innovation and the need for thorough validation required in healthcare, establishing a foundation for sustainable growth rather than pursuing rapid but potentially unsustainable market penetration. The team's stability and consistent strategic vision has been a key factor in attracting continued investor confidence through multiple funding rounds, culminating in the substantial Series C and its extension that position the company for expanded commercial deployment.

Market

The global cardiovascular diagnostics market is experiencing substantial growth, valued at approximately $5.9 billion in 2023 and projected to reach $9.7 billion by 2033, growing at a CAGR of 5.1%. This growth is driven by multiple factors including the increasing prevalence of cardiovascular diseases globally, technological advancements in diagnostic capabilities, and the rising geriatric population. North America dominates the market with over 52% market share as of 2023, fueled by well-established healthcare infrastructure, higher adoption rates of advanced technologies, and significant healthcare spending. The market encompasses various product segments including electrocardiogram (ECG) devices, cardiac imaging technologies, monitoring systems, and biomarker tests, with ECG devices currently holding the largest market share. Technologies such as artificial intelligence, machine learning algorithms, and IoT-enabled remote monitoring systems are revolutionizing the industry, enabling early identification of arrhythmias and more accurate diagnosis of heart conditions.

Hospitals remain the dominant end-user segment, holding approximately 30.5% market share in 2022, due to their comprehensive cardiac care facilities, availability of skilled professionals, and advanced diagnostic equipment. The cardiovascular diagnostics market is experiencing a paradigm shift with rapid adoption of wireless cardiac monitoring devices and remote diagnostic capabilities that allow for continuous patient monitoring outside traditional clinical settings. The Asia-Pacific region is positioned as the fastest-growing market, driven by improving healthcare infrastructure, increasing healthcare expenditure, and rising awareness about cardiovascular health. Diagnostic imaging technologies for coronary heart disease alone represented a $2 billion market in 2024, with a projected CAGR of 6.6% from 2025 to 2030. Market growth is further propelled by the increasing focus on preventive healthcare and early intervention strategies aimed at reducing the massive global burden of cardiovascular diseases.

Cleerly represents an optimal investment for healthcare organizations seeking to establish preventive cardiology programs focused on earlier detection and more precise characterization of coronary artery disease before patients experience symptoms or adverse events. The company's AI-driven analysis of coronary CT angiography addresses a critical gap in traditional cardiovascular assessment by providing comprehensive plaque characterization beyond simple stenosis evaluation, directly addressing the fact that approximately 70% of heart attacks occur in arteries without significant narrowing. Organizations will achieve greatest return on investment by developing standardized clinical pathways that define how Cleerly results influence management decisions across different patient scenarios, moving beyond ad hoc interpretation to systematic approaches that leverage the detailed plaque characterization for personalized risk stratification and treatment selection. As the cardiovascular diagnostics market continues its robust growth trajectory, Cleerly's innovative solution is well-positioned to capture significant market share by delivering on the critical need for more accurate, preventive approaches to cardiovascular care that can reduce the enormous clinical and economic burden of heart disease through earlier intervention and more targeted treatment strategies.

The cardiovascular diagnostics market is dominated by established medical technology giants GE Healthcare and Phillips Healthcare, which together command approximately 50% of the global market share through their extensive product portfolios and worldwide distribution networks. Competition intensifies with the presence of other major players including Siemens Healthineers, Abbott Laboratories, Boston Scientific, Medtronic, and Biotronik, who collectively control a significant portion of the remaining market through specialized offerings in ECG systems, cardiac imaging technologies, and remote monitoring solutions. The competitive landscape is characterized by substantial barriers to entry due to high R&D costs, stringent regulatory requirements, and the need for extensive clinical validation, although emerging players are finding opportunities by focusing on technological innovation and niche applications. Strategic mergers and acquisitions remain a prominent competitive strategy as companies seek to expand their technological capabilities and geographical reach, exemplified by recent moves such as Abbott's acquisition of Cardiovascular Systems Inc. Competition is increasingly focusing on AI integration and remote monitoring technologies as differentiators, with companies racing to develop more accurate, user-friendly, and portable diagnostic solutions that can capture market share in the growing home healthcare segment.

Product Analysis

Cleerly has developed an AI-driven platform that analyzes coronary CT angiography (CCTA) images to provide comprehensive assessment of coronary artery disease, focusing not simply on stenosis (narrowing) but on detailed plaque characterization that better predicts future cardiac events. The technology leverages advanced machine learning algorithms trained on millions of annotated images from over 40,000 patients to automatically identify and quantify different types of coronary plaque, including calcified, non-calcified, and mixed compositions, as well as positive remodeling and other high-risk features associated with future heart attacks. This approach addresses a fundamental limitation in traditional coronary disease assessment, which has focused primarily on identifying severe narrowing despite evidence that approximately 70% of heart attacks occur in arteries without significant stenosis, making Cleerly's comprehensive plaque analysis particularly valuable for identifying patients at risk who might be missed by conventional approaches. The platform integrates seamlessly with existing clinical workflows, receiving standard CCTA images from imaging centers and returning detailed, actionable reports that help physicians make more informed treatment decisions based on the specific characteristics and distribution of a patient's coronary disease. The system is designed to be both highly sensitive in detecting early disease and specific in characterizing its nature, allowing for personalized risk stratification that can guide appropriate interventions ranging from lifestyle modifications to medication adjustments or, when necessary, invasive procedures.

Cleerly's product portfolio has evolved to address different stakeholder needs across the cardiovascular care continuum, with solutions tailored for screening healthy individuals, evaluating symptomatic patients, and monitoring disease progression over time in those with established coronary artery disease. The platform's visualization capabilities are particularly noteworthy, translating complex three-dimensional vessel analysis into intuitive displays that help clinicians quickly grasp the extent and nature of disease, while also providing educational tools that enable effective communication with patients about their condition and treatment options. The company has secured FDA clearance for its core analysis capabilities while continuing to expand its feature set through ongoing development and validation efforts that address additional clinical use cases and enhance integration with other cardiology workflows. Cleerly distinguishes itself from competitors through the comprehensiveness of its analysis, examining the entire coronary tree rather than focusing on isolated segments, and through its emphasis on tissue characterization rather than just hemodynamic significance, providing complementary rather than redundant information to other common cardiac tests. The software employs sophisticated quality control mechanisms to ensure accurate analysis even with varying image quality, addressing a common challenge in the practical implementation of advanced image analysis in real-world clinical settings where ideal imaging conditions cannot always be guaranteed.

The system's architecture allows for continuous improvement through a feedback loop that incorporates new imaging data and clinical outcomes, enabling the AI algorithms to become increasingly refined and accurate over time as the database of analyzed cases expands. Cleerly has invested substantially in clinical validation, conducting multiple studies demonstrating the technology's ability to identify disease with accuracy comparable to invasive coronary angiography (the traditional gold standard), while providing additional prognostic information about plaque vulnerability that is not readily available through conventional approaches. The product roadmap includes expanded capabilities for longitudinal tracking of disease progression or regression in response to therapy, integration of additional data sources beyond imaging to enhance risk prediction, and development of clinical decision support features that can help guide appropriate treatment selection based on a patient's specific disease pattern. Integration capabilities with major electronic health record systems and cardiovascular information systems have been a priority, recognizing that adoption depends heavily on seamless workflow incorporation rather than creating additional steps for busy clinicians. Pricing models have been structured to align with the value created, with options for per-scan analysis, enterprise licensing for health systems, and exploration of risk-sharing arrangements with payers based on the technology's ability to reduce downstream costs through earlier intervention and avoided cardiac events. The platform has been designed with scalability in mind, utilizing cloud computing infrastructure that can accommodate growing volumes while maintaining rapid turnaround times, typically delivering comprehensive analysis within 24 hours of scan completion to support timely clinical decision-making.

Radar Explanation

The cardiovascular diagnostic market features fierce competition among established medical technology giants and innovative newcomers like Cleerly, with the comparative analysis revealing distinct strengths across vendors. Cleerly demonstrates exceptional capabilities in AI-powered diagnostics where it scores a perfect 10, leveraging advanced machine learning algorithms for comprehensive plaque characterization that extends beyond traditional stenosis assessment, while also excelling in cardiac imaging and data integration with scores of 9 in each category. GE Healthcare maintains dominant market position through superior performance in ECG analysis, interoperability, clinical validation, and workflow integration, with all scoring 9, reflecting their long-established expertise and extensive integration into hospital systems worldwide. Phillips Healthcare presents a balanced profile with consistent scores of 8-9 across most categories, particularly strong in cardiac imaging and cloud architecture, making them a reliable full-spectrum provider. Siemens Healthineers shows particular strength in cardiac imaging with a score of 9, while Abbott distinguishes itself with industry-leading biomarker testing capabilities scoring 9, reflecting their specialization in laboratory diagnostics. The overall scoring indicates a three-way tie at the top between Cleerly, GE Healthcare, and Phillips (each with 95 points), demonstrating that despite being a newer entrant, Cleerly has rapidly achieved technical parity with established market leaders through its innovative approach to AI-driven cardiovascular diagnostics.

The second radar chart visualization compares key capabilities across major ECG monitoring system vendors against industry averages, revealing significant insights about market leadership and technological advancement. Market leaders GE Healthcare and Philips Healthcare demonstrate particular strength in real-time ECG analysis and security & compliance, scoring 9/10 in these critical areas compared to industry averages of 6/10 and 7/10 respectively, reflecting substantial investments in core technology and regulatory compliance. The greatest capability gaps appear in predictive analytics and AI/ML integration, where industry averages lag at 4/10 and 5/10 respectively, while leading vendors achieve scores of 8-9/10, highlighting the technological sophistication required to compete effectively in the modern ECG monitoring market. Siemens Healthineers maintains competitive parity in most categories but shows slightly lower scores in workflow automation and predictive analytics, areas where additional investment could strengthen their market position. The comprehensive capabilities assessment demonstrates that leading vendors have established significant competitive advantages through technological innovation, particularly in areas requiring sophisticated software development and data analytics expertise, while maintaining strong performance in traditional ECG monitoring functionalities. The visualization clearly illustrates the substantial gap between market leaders and industry averages, particularly in advanced capabilities like AI integration and predictive analytics, suggesting significant opportunities for market differentiation through technological innovation.

Technical Architecture

Cleerly's technical architecture centers on a sophisticated artificial intelligence framework that incorporates deep learning convolutional neural networks specifically optimized for the analysis of three-dimensional coronary CT angiography datasets. The system employs a multi-stage processing pipeline that begins with automated vessel extraction and segmentation, proceeds through detailed tissue characterization of vessel walls and plaques, and culminates in comprehensive quantification of disease burden throughout the coronary tree. This architecture relies on proprietary algorithms developed through years of research at leading academic institutions and refined through the analysis of tens of thousands of clinical cases, creating models capable of identifying subtle plaque characteristics that human readers might miss or find too time-consuming to quantify manually. The platform's machine learning backbone has been trained on rigorously annotated datasets that incorporate ground truth from multiple imaging modalities, including intravascular ultrasound and optical coherence tomography, establishing correlations between non-invasive CT findings and the gold-standard invasive assessments that have traditionally guided treatment decisions. Cleerly's processing framework incorporates sophisticated motion correction and artifact reduction techniques that address common challenges in cardiac CT interpretation, such as calcification-related blooming artifacts, partial volume effects, and coronary motion that can complicate accurate assessment in conventional visual analysis.

The cloud-based deployment architecture enables secure, scalable processing of imaging studies submitted from healthcare facilities worldwide, with robust encryption and compliance with healthcare data protection standards including HIPAA and GDPR. The system maintains separation between processing components and protected health information, with secure APIs facilitating integration with hospital PACS (Picture Archiving and Communication Systems), electronic health records, and cardiovascular information systems to support seamless clinical workflows. Computational resources are dynamically allocated based on analysis demands, allowing the system to handle varying workloads efficiently while maintaining consistent performance benchmarks, including average processing times of less than 30 minutes for complete coronary tree analysis despite the computational intensity of the underlying algorithms. The platform incorporates continuous quality monitoring that automatically flags studies with technical limitations that might affect analysis reliability, providing feedback to imaging centers to improve acquisition protocols and ensure optimal image quality for AI interpretation. The architecture includes built-in version control and model management systems that enable controlled deployment of algorithm improvements while maintaining regulatory compliance, addressing the challenge of implementing AI systems that continue to learn and evolve in the highly regulated medical device environment.

Cleerly's technical infrastructure incorporates a sophisticated data pipeline for managing the flow of imaging studies from acquisition through analysis and reporting, with careful attention to maintaining data integrity throughout the process. The system employs extensive validation checks to ensure compatibility with images from diverse CT scanner manufacturers and protocol variations, maximizing the platform's utility across heterogeneous healthcare environments where equipment standardization is impractical. Visualization components translate complex analytical results into intuitive, interactive displays that support both detailed expert review and effective communication with patients, rendering three-dimensional vessel representations alongside quantitative metrics that contextualize findings relative to established risk thresholds and population norms. The architecture enables both synchronous integration through direct system connections and asynchronous workflows through secure web portals, accommodating varying levels of IT infrastructure sophistication across healthcare delivery organizations. Security features include comprehensive audit logging, role-based access controls, and regular penetration testing to protect sensitive patient information while facilitating appropriate clinical access to analytical results. The technical foundation supports ongoing research applications through anonymized data aggregation capabilities (with appropriate consent), enabling continuous refinement of algorithms and development of new clinical insights from patterns observed across large patient cohorts, while maintaining strict controls against re-identification of individual patients.

Strengths

Cleerly's primary strength lies in its scientifically robust approach to coronary artery disease assessment, moving beyond the traditional focus on stenosis to comprehensive plaque characterization that more accurately reflects the biological mechanisms of heart attacks. The company's technology has demonstrated clinical validity through multiple peer-reviewed studies showing high correlation with invasive imaging modalities like intravascular ultrasound, establishing credibility in the medical community that is essential for adoption of new diagnostic approaches. Cleerly's founding team brings exceptional domain expertise in cardiovascular imaging and AI, led by Dr. James Min, a recognized authority whose previous academic work forms the scientific foundation for the company's approach and provides credibility in both clinical and investment communities. The platform's ability to detect and quantify non-obstructive plaque addresses a critical gap in conventional cardiac care, where approximately 70% of heart attacks occur in arteries without significant narrowing, enabling identification of at-risk patients who might be missed by traditional stenosis-focused approaches. Cleerly has secured substantial funding totaling over $385 million across multiple rounds, providing the financial resources necessary to pursue rigorous clinical validation, regulatory clearance, and commercial expansion in the capital-intensive medical technology sector. The company's timing is advantageous as healthcare systems increasingly recognize the limitations of reactive approaches to cardiovascular disease and the enormous costs associated with late intervention, creating receptivity to preventive technologies that align with value-based care imperatives.

Cleerly's partnerships with major healthcare institutions, imaging centers, and strategic investors like Cigna Ventures create a supportive ecosystem for technology adoption and pathway to reimbursement, addressing key commercialization challenges in healthcare. The technology offers workflow benefits beyond diagnostic accuracy, automating time-consuming analytical tasks and enabling consistent, objective quantification that reduces inter-reader variability inherent in visual interpretation of cardiac images. The company has methodically built a substantial intellectual property portfolio protecting its core algorithms and methodologies, creating defensible competitive barriers in the specialized field of cardiovascular imaging analysis. Cleerly's platform addresses multiple stakeholder needs simultaneously: providing physicians with more detailed disease characterization, offering patients better risk stratification and treatment guidance, and giving payers a tool to potentially reduce unnecessary procedures and prevent costly adverse events. The technology is designed for seamless integration with existing clinical imaging infrastructure, requiring no special equipment beyond standard CT scanners that are already widely deployed, minimizing adoption barriers compared to technologies requiring new capital equipment. The company's focus on comprehensive coronary tree analysis rather than isolated lesions aligns with emerging understanding of coronary artery disease as a systemic condition requiring holistic assessment and management rather than a series of discrete blockages requiring mechanical intervention.

Cleerly has built a powerful data asset through analysis of thousands of cases, creating network effects where algorithm performance improves with growing utilization, establishing a virtuous cycle that becomes increasingly difficult for competitors to replicate as the company's market share expands. The platform provides unique visualization capabilities that translate complex three-dimensional analysis into intuitive displays that facilitate both clinical decision-making and patient education, addressing the challenge of communicating abstract risk concepts in ways that drive behavior change and treatment adherence. The comprehensive nature of Cleerly's analysis creates multiple potential revenue streams across the care continuum, from initial disease detection to therapy selection and longitudinal monitoring of treatment response, establishing the platform as a recurring rather than one-time diagnostic tool. The company's approach aligns with broader healthcare trends toward precision medicine, enabling more targeted interventions based on specific disease characteristics rather than one-size-fits-all approaches determined primarily by symptom severity. Cleerly benefits from growing recognition in cardiology guidelines of the importance of coronary plaque characteristics beyond stenosis, creating tailwinds for adoption as clinical practice evolves toward more sophisticated risk assessment models that the company's technology is uniquely positioned to support.

Weaknesses

Despite its innovative approach, Cleerly faces adoption challenges related to established clinical workflows and physician habits, as cardiologists have traditionally relied on visual stenosis assessment and may resist transitioning to AI-driven plaque analysis without substantial education and evidence of improved outcomes. The company's technology, while powerful, represents a paradigm shift in coronary disease evaluation that requires significant clinician education and potential changes to established care pathways, creating friction in implementation despite the scientific merits. Reimbursement pathways for advanced AI analysis of cardiac imaging remain variable and incomplete, potentially limiting commercial uptake despite clinical value if healthcare providers cannot readily secure payment for the service, particularly in fee-for-service environments where prevention is less financially rewarded than intervention. As a relatively young company in a field dominated by established medical device and imaging corporations with extensive sales and distribution networks, Cleerly faces challenges in achieving market penetration and building the commercial infrastructure necessary to reach a broad physician audience. The company's focus on CT-based analysis, while scientifically sound, makes it dependent on the continued growth and availability of high-quality coronary CT angiography, which remains less universally accessible than other cardiac tests like stress testing or calcium scoring in many healthcare settings, particularly outside major urban centers.

While Cleerly's technology is designed to enhance clinical decision-making, it does not directly guide specific therapeutic interventions, requiring integration with treatment selection frameworks that remain primarily driven by physician judgment rather than algorithmic recommendation, potentially limiting the perceived immediate value compared to technologies with more explicit treatment directives. The company faces potential competition from both established medical imaging giants that could develop or acquire similar capabilities and other AI startups targeting the cardiovascular space, creating pressure to establish market position rapidly despite the methodical pace typically required for healthcare adoption. Cleerly's business model assumes that healthcare systems and payers will recognize and compensate for the value of preventive analytics, which requires demonstration of long-term outcome improvements and cost savings that may take years to conclusively establish, creating tension with investor expectations for near-term revenue growth. The regulatory landscape for AI-based medical technologies continues to evolve, creating uncertainty about future requirements for clinical validation, algorithmic transparency, and post-market surveillance that could impose additional costs or constraints on Cleerly's technology deployment. As with any AI-based medical technology, there are inherent limitations in algorithm performance and edge cases where human oversight remains essential, requiring careful positioning to set appropriate expectations and avoid overreliance on automated analysis, particularly in clinically ambiguous situations where the stakes of misdiagnosis are high.

The company's technology, while innovative, operates in a field where the evidence base linking detailed plaque characterization to clinical outcomes is still evolving, requiring ongoing research investment to strengthen the case for widespread adoption as the standard of care. Cleerly faces the double challenge of both clinical and technical integration across diverse healthcare IT environments, creating implementation complexity that can slow deployment despite the inherent value of the analytical capabilities. The company's imaging-centric approach, while providing unique insights, does not directly incorporate other relevant data sources like genomics, biomarkers, or patient-reported symptoms that may ultimately prove essential for comprehensive cardiovascular risk assessment, potentially creating openings for more integrated competitors. While the recent $106 million funding round provides substantial runway, the capital-intensive nature of medical technology development combined with potentially extended timelines for broad clinical adoption could create future financing needs if revenue growth does not accelerate in parallel with ongoing research and development investments. Despite strong initial partnerships, Cleerly will need to expand its collaboration network to include major payer organizations capable of driving reimbursement policies and large health systems with the scale to meaningfully impact practice patterns, requiring sophisticated stakeholder management beyond the purely clinical validation focus of the company's early years.

Client Voice

Healthcare providers utilizing Cleerly have reported significant improvements in their ability to detect and characterize coronary artery disease at earlier, more treatable stages, with several cardiologists noting that the detailed plaque analysis has identified high-risk patients who would have been classified as low-risk by traditional stenosis-focused assessment. Clinicians particularly value the system's ability to quantify non-calcified and low-density plaque components that are often difficult to assess visually but carry substantial prognostic significance, enabling more informed decisions about intensification of preventive therapies in patients who might otherwise receive less aggressive management. The comprehensive visualization capabilities have been highlighted as particularly valuable for patient education, with physicians reporting that the intuitive display of coronary disease distribution and characteristics helps patients better understand their condition and increases adherence to recommended lifestyle changes and medications. Early adopters have noted that the technology integrates well with existing cardiac CT workflows, providing valuable additional information without disrupting established clinical processes or requiring significant changes to imaging acquisition protocols, minimizing implementation barriers compared to other advanced imaging technologies. Users appreciate the system's ability to provide objective, reproducible quantification that reduces the inter-reader variability inherent in visual assessment, creating more consistent risk stratification and treatment recommendations regardless of which cardiologist interprets the scan.

Imaging centers and hospitals implementing Cleerly have reported varied experiences with reimbursement, with some successfully securing payment through existing advanced imaging codes while others continue to navigate coverage determinations with local payers, highlighting the evolving reimbursement landscape for AI-enhanced imaging analysis. Clinicians with experience tracking patients longitudinally have noted the technology's value in objectively measuring disease progression or regression in response to therapy, providing motivation for patients when plaque burden decreases and prompting reconsideration of treatment approaches when disease continues to advance despite standard interventions. Some users have observed that the detailed anatomical assessment provided by Cleerly sometimes reveals coronary anomalies or variants that were not apparent on conventional reading, providing additional diagnostic value beyond the primary atherosclerotic disease evaluation. Healthcare systems utilizing the technology have reported mixed experiences with IT integration, with those having modern PACS and cardiovascular information systems generally achieving smoother implementation than facilities with legacy infrastructure, though most eventually establish functional workflows regardless of starting point. Early clinical experience suggests particular value in specific patient populations, including those with suspected coronary disease but equivocal stress test results, symptomatic patients with moderate cardiovascular risk factors, and individuals with strong family histories who are highly motivated for preventive assessment despite not meeting traditional criteria for advanced cardiac testing.

Medical practices have reported varying timeframes for incorporation into routine clinical workflows, with those led by early-adopter physicians achieving faster integration while more traditional practices sometimes experience longer adjustment periods as clinicians adapt to incorporating the detailed analytical results into their decision-making processes. Cardiology groups experienced with the technology over longer periods have increasingly integrated Cleerly results into their clinical discussions and treatment planning sessions, suggesting growing confidence in the value of the detailed plaque analysis for guiding patient management. Administrators at healthcare institutions using the technology have noted the potential for reduced downstream costs through more appropriate allocation of invasive procedures and preventive interventions, though most acknowledge that conclusive economic validation requires longer-term outcome tracking than has been possible to date. Patients who have received Cleerly analysis as part of their cardiac care generally report high satisfaction with the detailed information provided, often describing greater peace of mind from the comprehensive assessment and clearer understanding of their specific cardiovascular risk profile compared to traditional testing approaches. Healthcare providers working in preventive cardiology settings particularly value the technology's ability to identify "vulnerable patient" characteristics beyond traditional risk factors, enabling more personalized approaches to primary prevention in individuals who might otherwise receive only generic lifestyle recommendations based on population-level risk estimates.

Bottom Line

Cleerly represents an optimal investment for healthcare organizations seeking to establish preventive cardiology programs focused on earlier detection and more precise characterization of coronary artery disease before patients experience symptoms or adverse events. The technology is particularly well-suited for integrated delivery networks and risk-bearing entities operating under value-based care models, where the potential cost savings from avoided cardiac events and more targeted interventions can directly benefit the organization's financial performance while improving quality metrics related to cardiovascular outcomes. Healthcare systems should approach implementation with a clear strategy for clinician education and pathway integration, recognizing that the paradigm shift from stenosis-focused to comprehensive plaque analysis requires both technical integration and clinical workflow adaptation to realize the full value of the technology. Success requires executive-level commitment spanning cardiology, radiology, and primary care leadership, with aligned performance metrics that reward appropriate use of advanced preventive assessment rather than focusing exclusively on procedural volumes or traditional testing approaches. Organizations should anticipate a 6-12 month implementation period for full integration and adoption, with initial focus on specific high-value clinical use cases such as evaluation of patients with atypical symptoms, risk stratification of those with strong family histories but without current symptoms, and assessment of individuals with known coronary disease to guide intensity of preventive therapy.

Implementation teams should include representation from cardiology, radiology, IT, and revenue cycle management to address the multifaceted challenges of clinical, technical, and financial integration, with particular attention to establishing clear documentation and coding practices that support appropriate reimbursement. While the technology itself has demonstrated clinical validity, healthcare organizations should establish their own quality monitoring mechanisms to track both technical performance metrics like scan adequacy rates and clinical outcome measures such as correlation between Cleerly findings and subsequent cardiovascular events or procedures. Organizations will achieve greatest return on investment by developing standardized clinical pathways that define how Cleerly results influence management decisions across different patient scenarios, moving beyond ad hoc interpretation to systematic approaches that leverage the detailed plaque characterization for personalized risk stratification and treatment selection. Financial justification should consider not only direct reimbursement for the analysis but also the potential downstream value from avoided unnecessary invasive procedures, more appropriate allocation of expensive preventive medications, improved patient engagement, and enhanced cardiovascular quality metrics that increasingly impact overall healthcare organization performance ratings and reimbursement. Organizations that have successfully integrated coronary CT angiography into their cardiac evaluation pathways will likely experience smoother implementation than those still heavily reliant on functional testing alone, suggesting that Cleerly adoption may be most efficient when sequenced after establishment of a robust CCTA program rather than attempting simultaneous implementation of both capabilities.

Strategic Plannings Assumptions

Because cardiovascular disease remains the leading cause of death globally with enormous associated healthcare costs, by 2027, advanced AI-based cardiac imaging analysis will be incorporated into major cardiovascular society guidelines as a recommended approach for comprehensive coronary disease assessment in intermediate-risk patients. (Probability: 0.8)
Because traditional stenosis-focused cardiac assessment misses approximately 70% of patients who will experience heart attacks, by 2028, comprehensive plaque characterization technologies like Cleerly's will capture at least 40% of the cardiac CT analysis market, representing over $900 million in annual revenue opportunity. (Probability: 0.7)
Because healthcare systems are increasingly accountable for long-term outcomes and preventable events under value-based care arrangements, by 2026, at least 65% of large integrated delivery networks will implement advanced coronary imaging analytics to improve cardiovascular risk stratification and reduce costly adverse events. (Probability: 0.8)
Because reimbursement pathways for AI-enhanced medical imaging are still evolving, by 2027, Medicare and at least 70% of major private insurers will establish specific coverage and payment for AI-based cardiovascular image analysis, driven by demonstrated improvements in appropriate utilization of invasive procedures. (Probability: 0.7)
Because clinical validation is essential for medical technology adoption, by 2026, Cleerly will publish results from at least three large-scale outcome studies demonstrating that its technology improves prediction of cardiac events compared to traditional risk assessment methods, solidifying its market position. (Probability: 0.8)
Because preventive care requires engaged patients, by 2028, technologies that provide intuitive visualization of personalized cardiovascular risk, like Cleerly's plaque analysis, will demonstrate at least 30% improvement in medication adherence and lifestyle modification compared to standard approaches. (Probability: 0.6)
Because cardiovascular imaging technology continues to advance rapidly, by 2029, the integration of AI-based coronary analysis with complementary modalities including advanced cardiac MRI and molecular imaging will establish new multimodality standards for comprehensive cardiac risk assessment. (Probability: 0.6)
Because competitive pressures in healthcare technology drive consolidation, by 2027, at least one major medical imaging or healthcare technology corporation will attempt to acquire Cleerly or a direct competitor for a valuation exceeding $1.5 billion, recognizing the strategic importance of AI-enhanced cardiac analysis. (Probability: 0.7)
Because successful clinical implementation requires workflow integration, by 2026, Cleerly will establish partnerships with at least three major electronic health record vendors to enable seamless incorporation of coronary plaque analysis into standard cardiovascular care pathways. (Probability: 0.8)
Because detailed plaque analysis enables personalized treatment selection, by 2028, clinical trials will demonstrate at least 25% reduction in cardiac events among high-risk patients managed with therapy regimens guided by comprehensive plaque characterization compared to standard risk-factor based approaches. (Probability: 0.7)

Research Note: Cleerly