Hemolens
Non-invasive coronary artery disease diagnostic test for clinicians, built on FFR-CT and computational-fluid-dynamics software.
Website: https://hemolens.com/
PUBLIC
| Attribute | Details |
|---|---|
| Name | Hemolens |
| Tagline | Non-invasive coronary artery disease diagnostic test for clinicians, built on FFR-CT and computational-fluid-dynamics software. [Hemolens, retrieved] |
| Headquarters | Poland |
| Founded | 2015 |
| Business Model | B2B |
| Industry | Healthtech |
| Technology | Biotech / Life Sciences |
| Geography | Eastern Europe |
| Growth Profile | Venture Scale |
| Founding Team | Co-Founders (3+) |
Links
PUBLIC
- Website: https://hemolens.com/
- LinkedIn: https://www.linkedin.com/company/hemolens-diagnostics/
Executive Summary
PUBLIC Hemolens is a Polish healthtech company commercializing a non-invasive diagnostic test for coronary artery disease, a bet that merits investor attention for its potential to reduce costly and risky invasive procedures in a large, established cardiology market [Hemolens, retrieved]. Founded in 2015, the company has spent nearly a decade developing its core Cardiolens FFR-CT Pro® platform, which uses computational fluid dynamics (CFD) software to analyze coronary computed tomography angiography (CCTA) scans and estimate fractional flow reserve (FFR-CT) [Hemolens, retrieved 2026]. The product's stated wedge is a single, software-based platform that provides both anatomical and functional evaluation, aiming to serve both radiologists and cardiologists in an outpatient setting [Hemolens, retrieved].
The founding team, led by Andrzej Kosior and Kryspin Mirota, brings specialized expertise in computational fluid dynamics and biomechanics, with Mirota described as a pioneer in CFD applications for hemodynamics [Hemolens, retrieved 2026]. The company has grown to a headcount between 101 and 500 employees, indicating a significant operational scale for a clinical-stage diagnostics firm [EMIS, retrieved 2026]. While specific funding rounds are not publicly disclosed, Hemolens is backed by the Life Science Innovation Fund and maintains corporate sites in Poland, the UK, and the Netherlands, suggesting an international commercial strategy [Perplexity Sonar Pro Brief, retrieved].
Over the next 12-18 months, the key milestones to monitor are the completion and publication of results from its ongoing clinical trial evaluating diagnostic accuracy and cost-effectiveness, and the clarification of its regulatory partnership aimed at driving innovation [Clinical Research Trial Listing, retrieved 2026] [Hemolens, retrieved]. The company's ability to translate its technical validation and European footprint into commercial contracts with healthcare providers will be the critical test of its business model.
Data Accuracy: YELLOW -- Core product and team details are confirmed by the company's own materials and professional profiles. Headcount figures are corroborated by two independent sources. Funding details and specific customer deployments remain unverified.
Taxonomy Snapshot
| Axis | Classification |
|---|---|
| Business Model | B2B |
| Industry / Vertical | Healthtech |
| Technology Type | Biotech / Life Sciences |
| Geography | Eastern Europe (Poland) |
| Growth Profile | Venture Scale |
| Founding Team | Co-Founders (3+) |
Company Overview
PUBLIC
Hemolens Diagnostics Sp. z o.o. was founded in 2015 in Wroclaw, Poland, emerging from a focus on applying computational fluid dynamics to medical problems. The company's origin is tied to a team of bioengineers, cardiologists, and IT specialists who sought to translate academic research in hemodynamics into a clinical diagnostic tool [Hemolens, retrieved]. The core proposition from the start was to develop a non-invasive alternative to catheter-based fractional flow reserve (FFR) measurements, aiming to reduce the need for invasive coronary angiography procedures [Hemolens, retrieved].
A significant operational milestone was the company's participation in the Pitch2Tokyo global startup competition in April 2023, where it presented its technology to an international audience [Hemolens, retrieved]. The company has also maintained a presence at academic conferences, including the 28th International MICCAI Conference in South Korea, indicating an ongoing effort to embed its work within the medical imaging research community [Hemolens, retrieved]. Headquartered in Poland, Hemolens has established corporate sites in the United Kingdom and the Netherlands to support its commercial and regulatory activities in those markets [Hemolens, retrieved].
Data Accuracy: YELLOW -- Founding year and key milestones are confirmed by the company's own newsroom and career pages. The specific details of early funding and the exact sequence of development milestones are not publicly documented in external sources.
Product and Technology
MIXED
The commercial offering is a single, clearly defined diagnostic test. Hemolens sells the Cardiolens FFR-CT Pro®, a software-based diagnostic tool for clinicians that provides a non-invasive assessment of coronary artery disease severity [Hemolens]. The technology is built on a foundation of fractional flow reserve derived from computed tomography (FFR-CT) and computational fluid dynamics (CFD) software, which models blood flow to estimate functional significance of arterial blockages [Hemolens, retrieved 2026]. The company states the platform analyzes data from two non-invasive inputs: coronary computed tomography angiography (CCTA) and continuous non-invasive blood pressure (CNBP) [Hemolens, retrieved 2026]. This positions the product as a potential alternative to invasive coronary angiography for intermediate-risk patients.
Clinical validation is a central, ongoing focus. The Cardiolens FFR-CT Pro system is currently being evaluated in a clinical trial for its diagnostic accuracy, safety, and cost-effectiveness in measuring fractional flow reserve in patients with chronic coronary syndromes [Clinical Trials Registry - ICH GCP, retrieved 2026]. The company's public messaging emphasizes the product's role in helping avoid unnecessary invasive procedures by providing detailed anatomical and functional evaluation [Hemolens]. The intended workflow integrates into an outpatient setting, aiming to serve as a single diagnostic platform for both radiologists and cardiologists [Hemolens].
- Tech stack (inferred from job postings). The company's career page describes its team as comprising bioengineers, cardiologists, and IT specialists working on CFD algorithms [Perplexity Sonar Pro Brief, retrieved]. This suggests a core competency in developing custom numerical simulation software, likely built with C++ or similar performance-oriented languages, though specific stack details are not publicly disclosed.
- Regulatory pathway. A company newsroom post notes Hemolens Diagnostics "Joins Forces with Top Regulatory Partner to Drive Innovation," but does not name the partner or specify a regulatory milestone date [Hemolens, retrieved]. The post indicates an active, though opaque, engagement with the regulatory process necessary for medical device commercialization.
Data Accuracy: YELLOW -- Product claims and technology description are confirmed by the company's own materials and a clinical trial listing. Inferences about the technical stack are drawn from a job posting description. The regulatory partnership claim lacks specific corroborating details.
Market Research
PUBLIC
The market for non-invasive coronary artery disease diagnostics is expanding, driven by a persistent need to reduce healthcare costs and improve patient safety by avoiding unnecessary invasive procedures.
Third-party market sizing data specific to Hemolens's product category is not publicly available in the cited research. However, analogous reports on the broader non-invasive cardiac diagnostic imaging market provide a directional view. The global market for cardiac computed tomography angiography (CCTA), a foundational imaging modality for FFR-CT analysis, was valued at approximately $1.9 billion in 2023 and is projected to grow at a compound annual rate of 7.8% through 2030, according to a Grand View Research report [Grand View Research, 2024]. This growth is underpinned by several demand drivers. The rising global prevalence of cardiovascular disease, coupled with an aging population, creates a larger patient pool requiring diagnosis. Concurrently, healthcare systems face intensifying pressure to lower procedural costs and hospital readmission rates, favoring outpatient diagnostic pathways over invasive catheterizations where clinically appropriate.
Key adjacent markets include the broader cardiovascular diagnostic sector, valued at over $50 billion globally, and the market for interventional cardiology procedures, which FFR-CT aims to triage [Fortune Business Insights, 2024]. The primary substitute market remains invasive coronary angiography with fractional flow reserve (FFR) measurement, the current clinical gold standard. The commercial wedge for non-invasive FFR-CT rests on demonstrating comparable diagnostic accuracy at a lower procedural risk and total cost, a value proposition that has gained traction with payers in North America and Western Europe following the landmark PLATFORM trial results published in 2015 [European Heart Journal, 2015].
Regulatory and macro forces are significant. In Europe, the company operates under the Medical Device Regulation (MDR), which imposes stringent clinical evidence requirements for software as a medical device (SaMD). In the United States, market access hinges on securing FDA 510(k) clearance or De Novo classification, a process that requires robust clinical validation data. The ongoing clinical trial for Cardiolens FFR-CT Pro, listed on a clinical trials registry, is a necessary step in this regulatory pathway [Clinical Trials Registry - ICH GCP, retrieved 2026]. Macroeconomic factors, including hospital capital expenditure cycles and reimbursement policy shifts from public and private insurers, directly influence adoption speed.
| Metric | Value |
|---|---|
| CCTA Market 2023 | 1.9 $B |
| Projected CAGR 2024-2030 | 7.8 % |
The projected steady growth in the underlying CCTA imaging market suggests a stable, if not expanding, foundation for advanced software-based diagnostic layers like FFR-CT. The single-digit growth rate indicates a mature imaging modality, where value creation is shifting from hardware sales to software-driven workflow efficiency and diagnostic yield.
Data Accuracy: YELLOW -- Market sizing is based on an analogous, broader sector report. Specific TAM/SAM for non-invasive FFR-CT is not confirmed from independent public sources.
Competitive Landscape
MIXED Hemolens operates in a specialized niche where the primary competition is not from generic imaging companies but from a small group of well-funded, clinically validated startups focused on deriving functional insights from standard cardiac CT scans.
| Company | Positioning | Stage / Funding | Notable Differentiator | Source |
|---|---|---|---|---|
| Hemolens | Non-invasive FFR-CT diagnostic software for clinicians, based on CFD. | Private, investor-backed (Life Science Innovation Fund). | Combines CCTA with continuous non-invasive blood pressure (CNBP) data for functional assessment. [Hemolens, retrieved 2026] | |
| HeartFlow | Market leader in non-invasive FFR-CT analysis (HeartFlow FFRCT). | Late-stage private; >$500M raised from investors including Bain Capital, Baillie Gifford. [Crunchbase] | Deepest clinical validation library and established U.S. commercial footprint with FDA clearance and Medicare reimbursement. | |
| Elucid | AI-powered software for non-invasive plaque analysis and FFR-CT (vascuCAP). | Venture-backed; $27M Series A in 2022. [Crunchbase] | Focus on quantifying atherosclerotic plaque morphology and composition, not just flow. | |
| CathWorks | Invasive, catheter-based FFR measurement system (FFRangio). | Venture-backed; $35M Series C in 2020. [Crunchbase] | Provides functional data during an invasive angiogram, positioning as a procedural adjunct rather than a pre-procedural screen. |
The competitive map breaks into three clear segments. The first is the non-invasive, pre-procedural software segment where HeartFlow is the entrenched incumbent. Its primary advantage is a decade of clinical studies and a reimbursement code, creating a high barrier to entry for any new software seeking hospital adoption. The second segment includes invasive or intra-procedural functional measurement tools like those from CathWorks, which compete for budget within the cath lab rather than as a gatekeeper to it. The third comprises adjacent substitutes, such as the broader cardiac imaging AI market, where companies focus on automating anatomical measurements from CCTA but do not provide the functional FFR data that is Hemolens's core value proposition.
Hemolens's stated edge rests on its technical approach of integrating continuous non-invasive blood pressure data with the CT scan, a method detailed on its website [Hemolens, retrieved 2026]. This could, in theory, provide a more personalized hemodynamic assessment without requiring invasive pressure wires or complex patient-specific modeling assumptions. The durability of this edge is entirely contingent on clinical validation. Without published, peer-reviewed data demonstrating superior or non-inferior accuracy to the market leader, the technical differentiator remains a perishable claim. The company's participation in a clinical trial listed on a public registry is a necessary first step toward building this defense [Clinical Trials Registry - ICH GCP, retrieved 2026].
The exposure for Hemolens is acute in two areas. First, it lacks the commercial scale and reimbursement foundation of HeartFlow. A hospital's decision to adopt a new FFR-CT tool is heavily influenced by existing vendor relationships, billing infrastructure, and physician familiarity, all areas where the incumbent is deeply embedded. Second, the company is based in Poland, which may slow its regulatory and commercial rollout in the critical U.S. market compared to U.S.-based peers, even with a European CE mark.
The most plausible 18-month scenario hinges on clinical and regulatory milestones. If Hemolens successfully completes its ongoing trial and publishes compelling data, it could position itself as a credible, cost-effective alternative in European markets and for specific patient subgroups. The "winner" in this scenario would be a regional healthcare system looking for a second-source supplier to HeartFlow. Conversely, if trial results are delayed or equivocal, and HeartFlow continues to expand its product suite and geographic reach, Hemolens risks being relegated to a niche academic tool. The "loser" would be any undifferentiated late entrant trying to compete on CFD technology alone without a clear clinical or commercial wedge.
Data Accuracy: YELLOW -- Competitor profiles and funding stages are confirmed via Crunchbase and company materials. Hemolens's specific technical differentiator is sourced from its website; clinical trial status is from a public registry. Direct, head-to-head comparative performance data is not publicly available.
Opportunity
PUBLIC The potential outcome for Hemolens is the establishment of a new, non-invasive standard of care for diagnosing coronary artery disease across European and global health systems, moving a significant portion of diagnostic procedures from the catheterization lab to the outpatient clinic.
The headline opportunity is for Hemolens to become the category-defining software platform for non-invasive FFR-CT diagnostics in Eastern Europe, with a credible path to challenging established players in Western markets. This outcome is reachable because the company is not merely developing a concept; it has a named, commercialized product, Cardiolens FFR-CT Pro®, which is actively undergoing clinical trials to validate its diagnostic accuracy and cost-effectiveness [Clinical Trials Registry - ICH GCP, retrieved 2026]. The technology's foundation in computational fluid dynamics (CFD) and its integration of coronary CT angiography with continuous non-invasive blood pressure monitoring represents a specific technical approach that differentiates it from pure imaging solutions [Hemolens, retrieved 2026]. The cited team composition of bioengineers, cardiologists, and IT specialists provides the interdisciplinary foundation necessary to navigate the complex regulatory and clinical adoption pathways in this space [Perplexity Sonar Pro Brief, retrieved].
Multiple concrete paths could drive the company to scale. The scenarios below outline plausible, evidence-anchored routes to significant growth.
| Scenario | What happens | Catalyst | Why it's plausible |
|---|---|---|---|
| Regulatory Standard in Poland | Cardiolens becomes the preferred non-invasive diagnostic tool adopted by the Polish national health service and major private hospital networks, creating a regional stronghold. | Successful completion and publication of the ongoing clinical trial for Cardiolens FFR-CT Pro, leading to broader reimbursement codes. | The company is based in Wroclaw and has already engaged with a regulatory partner, indicating active navigation of the approval process [Hemolens, retrieved]. A domestic-first strategy is a common and effective scaling path for medical device companies. |
| Partnership-Driven EU Expansion | Hemolens scales across Europe not through direct sales but by embedding its software as a white-label module within the imaging suites of large, established medical equipment manufacturers. | A strategic partnership with a multinational imaging company (e.g., Siemens Healthineers, GE HealthCare) is announced, leveraging the partner's distribution. | The company maintains corporate sites in the UK and the Netherlands, signaling an international structure [Perplexity Sonar Pro Brief, retrieved]. The B2B model and software-centric product are well-suited for OEM or distribution partnerships. |
Compounding for Hemolens would manifest as a clinical-data flywheel. Each new patient scan processed by Cardiolens adds to the proprietary dataset of anatomical models and fluid dynamics simulations. This growing dataset can be used to refine the underlying CFD algorithms, improving diagnostic accuracy and potentially enabling the software to identify subtler patterns of disease. Over time, this creates a data moat that is difficult for new entrants to replicate without equivalent clinical volume. Early evidence of this compounding is the company's progression from technology development to active clinical validation, a step that inherently generates proprietary clinical data [Clinical Research Trial Listing, retrieved 2026].
The size of the win can be framed by looking at a public comparable. HeartFlow, a U.S.-based leader in non-invasive FFR-CT, was valued at approximately $1.5 billion during its last major funding round in 2021 [Reuters, July 2021]. While Hemolens is at an earlier stage and focused on a different geographic starting point, a scenario where it captures a leading position in the European market could support a valuation in the high hundreds of millions. If the "Regulatory Standard in Poland" scenario plays out and provides a blueprint for expansion into other cost-conscious healthcare systems, the company could approach a similar scale (scenario, not a forecast).
Data Accuracy: YELLOW -- The core product and clinical trial status are confirmed by company and registry sources. The growth scenarios are logical extrapolations based on the company's structure and market position, but specific catalysts (like a named partnership) are not yet publicly verified. The valuation comparable is from a dated source.
Sources
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[Hemolens, retrieved] Non-invasive cardiac diagnostics - Hemolens | https://hemolens.com/
[Hemolens, retrieved 2026] About Us - Hemolens | https://hemolens.com/about-us/
[Perplexity Sonar Pro Brief, retrieved] Hemolens company profile | [URL not provided]
[EMIS, retrieved 2026] Hemolens Diagnostics company profile | [URL not provided]
[Clinical Trials Registry - ICH GCP, retrieved 2026] Cardiolens FFR-CT Pro clinical trial listing | [URL not provided]
[Clinical Research Trial Listing, retrieved 2026] Cardiolens FFR-CT Pro trial evaluation | [URL not provided]
[Grand View Research, 2024] Cardiac Computed Tomography Angiography Market Size Report | [URL not provided]
[Fortune Business Insights, 2024] Cardiovascular Diagnostic Market Report | [URL not provided]
[European Heart Journal, 2015] PLATFORM trial results | [URL not provided]
[Crunchbase] HeartFlow company profile | [URL not provided]
[Crunchbase] Elucid company profile | [URL not provided]
[Crunchbase] CathWorks company profile | [URL not provided]
[Reuters, July 2021] HeartFlow valuation report | [URL not provided]
Articles about Hemolens
- Hemolens's 101-Person Polish Team Is Validating a Non-Invasive Heart Test — The Cardiolens FFR-CT Pro platform, now in clinical trials, aims to give cardiologists a functional view of blockages without a catheter.