Caristo Diagnostics

What Caristo Diagnostics does

Caristo Diagnostics is a privately held biotech company founded in 2018 as a spin-out from the University of Oxford, headquartered in Oxford with a US regional office in Stamford, Connecticut. The company develops AI-powered diagnostic platforms that analyze routine Coronary Computed Tomography Angiography (CCTA) scans to quantify previously invisible coronary inflammation via perivascular fat attenuation imaging and characterize plaque composition, generating individualized 8-year risk scores for fatal cardiac events. Its core products are the cloud-based CaRi-Heart SaaS medical device, the proprietary FAI-Score inflammation biomarker, the FDA-cleared CaRi-Plaque analysis module, and the composite CaRi-Heart Risk Score predictive model. The technology is grounded in over two decades of Oxford research and is validated across the ORFAN registry, which contains more than 135,000 patients and targets 250,000, with peer-reviewed publications in The Lancet, JACC, and European Heart Journal.

Caristo generates revenue through multiple streams. Hospitals and healthcare providers order CaRi-Heart analysis by uploading CCTA scans to the cloud platform and pay through subscription or per-analysis arrangements, with results delivered after human verification typically within 48 hours; this service is commercially available in the UK, Europe, and Australia. Following FDA 510(k) clearance of CaRi-Plaque in March 2025 and finalized Medicare reimbursement effective January 2026, the company is scaling US commercialization through hospital systems and cardiology practices. A second revenue stream is professional services contracts serving as worldwide imaging core lab for pharmaceutical clinical trials, currently including NewAmsterdam Pharma's REMBRANDT trial across 50 sites in 7 countries and Abcentra's FORTIFY trial across 40 sites in the US and Europe, where FAI-Score has been selected as a primary outcome measure. Additional channels include employer wellness programs, preventive/longevity clinics, and self-pay preventive screening services.

The company has raised over $30 million in venture capital from Oxford Science Enterprises, Longwall Venture Partners, BGF Ventures, Oxford Investment Consultants, and Oxford University Innovation, with a Series A of $16.3 million in April 2023. In 2026 the company installed a new senior executive team — CEO Stephen Deitsch (former CFO of OrganOx, $1.5 billion Terumo exit), CCO David Vort (former CCO of iRhythm Technologies, 2016 IPO), and CFO Chris Louk (Piper Sandler healthcare investment banking) — alongside continued scientific leadership from Oxford co-founders Charalambos Antoniades, Keith Channon, Stefan Neubauer, and Cheerag Shirodaria. The company was recognized as a 2026 World Economic Forum Technology Pioneer.

Name

Caristo Diagnostics

Legal name

Caristo Diagnostics Ltd.

Website

https://caristo.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Caristo Diagnostics is an Oxford-based biotech that provides AI-powered diagnostic platforms for cardiovascular disease, analyzing routine CCTA scans to quantify coronary inflammation and predict fatal cardiac events up to 10 years in advance for hospitals and pharmaceutical companies.

Ownership category

akta.pro rank

Product category

AI Cardiovascular Diagnostics Software

NAICS

Medical and Diagnostic Laboratories (62151), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Services-Medical Laboratories (8071), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Non-Invasive Cardiac Imaging (Echo/CT/MRI/Nuclear) (HLAKABAE)

akta.pro secondary industries

Imaging & Cardiac Safety Core Labs (ECOG/EEG/ECG) (HLAGAAAJ), Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management (HLACAOAI)

Keywords

• AI cardiac diagnostics
• Coronary inflammation imaging
• CCTA image analysis
• Cardiovascular risk prediction
• Medical imaging SaaS

Headquarters

HQ city

Oxford

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Operations, Infrastructure

Revenue model

1. CaRi-Heart Analysis Services: Healthcare professionals and hospitals order CaRi-Heart analysis by sending CCTA scans to Caristo's cloud platform. The company charges per analysis or through subscription arrangements with hospital systems. Results are delivered after human verification, typically within 48 hours. Available in UK, Europe, and Australia commercially; research use only in US pending FDA clearance.
2. CaRi-Plaque Analysis Services: FDA-cleared coronary plaque analysis service. Hospitals and clinics bill Medicare starting January 2026 following Medicare reimbursement finalization. Category I CPT code 75XX6 effective January 2026. Enables hospitals to generate revenue through insurance reimbursement while Caristo provides the analysis platform.
3. Clinical Trial Imaging Core Lab Services: Caristo serves as worldwide imaging core lab for pharmaceutical clinical trials, providing coronary plaque and inflammation measurements. Engaged by NewAmsterdam Pharma for REMBRANDT trial (50 sites, 7 countries) and Abcentra for FORTIFY trial (40 sites, US and Europe). Generates revenue through professional services contracts with pharma/biotech companies.

Pricing tiers

Go-to-market motion1 record

Distribution channels6 records

Marketing channels7 records

Core offering

Caristo Diagnostics develops and sells CaRi-Heart®, a cloud-based SaaS medical device that applies AI algorithms to routine Coronary Computed Tomography Angiography (CCTA) scans to quantify coronary inflammation (FAI-Score), characterize plaque (CaRi-Plaque), and generate an individualized 8-year fatal cardiac event risk score. The company delivers results to hospitals, NHS trusts, and clinicians within 48 hours and additionally provides imaging core lab services to pharmaceutical companies conducting cardiovascular clinical trials.

Product overview

Caristo Diagnostics offers CaRi-Heart®, a unified AI-powered cardiovascular diagnostics platform comprising three integrated components: (1) FAI-Score™ for proprietary measurement of coronary inflammation from peri-vascular adipose tissue changes on CCTA scans, (2) CaRi-Plaque™ for FDA-cleared quantitative plaque characterization and stenosis assessment, and (3) CaRi-Heart Risk Score for composite 8-year fatal cardiac event prediction. The cloud-based SaaS platform processes routine CCTA images to transform cardiac imaging from diagnostic triage into preventive risk assessment, predicting heart attacks up to a decade in advance. Additional services include drug clinical trial support as worldwide imaging core lab for pharmaceutical partners (NewAmsterdam Pharma REMBRANDT, Abcentra FORTIFY trials), preventive screening programs for employers, and clinical research collaborations.

Differentiator

Problem solved

Functional benefit

Brands

• CaRi-Heart: AI-powered technology that quantifies coronary inflammation and characterizes plaque based on routine Coronary Computed Tomography Angiography (CCTA) to predict cardiac risk.
• CaRi-Plaque
• FAI-Score

Products and services

• CaRi-Heart® Platform Cloud-based SaaS medical device that applies AI algorithms to routine Coronary Computed Tomography Angiography (CCTA) scans to quantify coronary inflammation (FAI-Score), characterize plaque (CaRi-Plaque), and deliver an individualized 8-year fatal cardiac event risk score. Delivered to hospitals and healthcare professionals with results within 48 hours; commercially available in UK, Europe, and Australia, with CaRi-Plaque FDA-cleared in the US.
• FAI-Score™

Quantifiable outcome

• High FAI-Score showed 20x increased risk of cardiac mortality
• +6 more outcomes

Named customers13 records

Segments6 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability4 records

Feature4 records

Partnerships

Eleven partnerships are on record, tiered core and minor.

• NCH Rooney Heart Institute (Naples Comprehensive Health)coreStrategic or Co-development Partner · 5 November 2025NCH Rooney Heart Institute became first US hospital to deploy both CaRi-Plaque and CaRi-Heart technologies. Collaboration positions NCH at forefront of preventive cardiology. NCH also launching self-pay preventive heart health service for proactive cardiac care. Cardiologists presenting at AHA 2025 Scientific Sessions.
• NewAmsterdam PharmacoreStrategic or Co-development Partner · 14 October 2025Caristo appointed as worldwide imaging core lab for NewAmsterdam Pharma's REMBRANDT clinical trial assessing obicetrapib and ezetimibe on coronary plaque and inflammation. Trial involves 50 sites across 7 countries (US, Poland, UK, Czech Republic, Hungary, Italy, Spain), measuring changes over 18 months. Primary endpoint is percent change in noncalcified plaque volume; secondary endpoints include FAI-Score changes.
• BiographcoreStrategic or Co-development Partner · 30 September 2025Biograph, world's most advanced preventive health and diagnostics clinic, partnered with Caristo as first US clinic to study CaRi-Heart technology for early detection of coronary artery disease in asymptomatic patients. Initial study phase enrolls 100 Black Tier members beginning October 2025. Study evaluates both CaRi-Heart and CaRi-Plaque technologies.
• AbcentracoreStrategic or Co-development Partner · 16 September 2025Caristo selected as worldwide imaging core lab for Abcentra's FORTIFY Phase 2b clinical trial evaluating orticumab in patients with cardiovascular disease. FAI-Score selected as primary outcome measure. Trial enrolls 240 adults at 40 sites in US and Europe. Caristo supports patient selection through elevated coronary inflammation measurement.
• Surrey Cardiovascular Clinic (SCVC)coreStrategic or Co-development Partner · 23 April 2024SCVC partnered with Caristo to offer CaRi-Heart AI technology as central part of employee wellness initiative for UK employers. Partnership includes imaging provider VCL Surrey. SCVC provides comprehensive health screening packages including CaRi-Heart analysis for early heart attack prediction.
• HeartX Cardiovascular AcceleratorminorGTM or Marketing Partner · 1 January 2024Caristo selected by HeartX cardiovascular accelerator for its 2024 program, receiving support for clinical trials and pilot projects in Arkansas and beyond alongside other cardiovascular startups including Haermonics, MultiplAI Health, and Peerbridge Health.
• Agepha PharmaminorStrategic or Co-development PartnerAgepha Pharma, maker of LODOCO (FDA-approved anti-inflammatory cardiovascular treatment), partnered with Caristo to improve awareness and clinical education about the central role of inflammation in coronary artery disease. Collaboration focuses on educating clinicians about targeting inflammation as a treatment pathway.
• NHS EnglandcoreStrategic or Co-development PartnerNHS England supported pilot deploying CaRi-Heart technology in five NHS trusts: University Hospitals of Leicester, Liverpool Heart and Chest, Milton Keynes University Hospital, Oxford University Hospitals, and Royal Wolverhampton NHS Trust. Patients in Rapid Access Chest Pain Clinics receive enhanced CCTA analysis.
• University of OxfordcoreStrategic or Co-development PartnerCaristo founded in 2018 as spin-out from University of Oxford. Co-founders (Charalambos Antoniades, Keith Channon, Stefan Neubauer, Cheerag Shirodaria) are Oxford faculty. ORFAN registry led by Oxford. Ongoing collaboration on research and clinical validation studies.
• SimonMed ImagingcoreStrategic or Co-development PartnerLargest independent radiology practice in the United States planning collaboration with Caristo. Founder and CEO Dr. John Simon stated commitment to prevent hundreds of thousands of deaths through cardiac CT combined with Caristo's AI technologies.
• MedpaceminorGTM or Marketing PartnerJoint webinar partnership with Medpace on advancing ASCVD trials through innovative imaging endpoints. Medpace is a contract research organization (CRO) specializing in cardiovascular clinical trials.

Scale indicators14 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• HeartFlow: HeartFlow applies AI to CCTA scans to compute FFR-CT for non-invasive assessment of coronary artery disease. It is the most direct competitor to Caristo in CCTA-AI, with an established US commercial footprint and substantially more capital raised, although its core focus is hemodynamic/ischemic assessment rather than inflammation.
• Cleerly Health: Cleerly is a venture-backed CCTA-AI platform that characterizes coronary plaque and stenosis to predict heart attack risk — overlapping directly with Caristo's CaRi-Plaque product. Both target US hospital systems and cardiology practices with AI-augmented CCTA reporting.
• Elucid Bioimaging: Elucid offers FDA-cleared AI software (vascuCAP) for quantitative plaque characterization from CCTA, including composition and stenosis. It competes most directly with CaRi-Plaque in the US and Europe.

Emerging players

• Artrya: Australia-based AI cardiac imaging startup applying deep learning to CCTA for plaque and risk assessment. Artrya targets a similar cardiology customer base as Caristo and has overlapping geographic presence in Australia and the UK.
• Anumana: Anumana is an AI-driven ECG-based cardiac diagnostics company spun out from Mayo Clinic. It is an emerging competitor in AI cardiovascular diagnostics, addressing risk detection via a different modality (ECG) but targeting the same cardiology prescribers and pharma services customers.

Broad incumbents

• GE HealthCare: GE HealthCare manufactures CT scanners and broad cardiac imaging AI tools integrated into its imaging platforms. As a broad incumbent, it competes indirectly by bundling AI features into PACS and scanner ecosystems used by the same hospital customers Caristo targets.
• Siemens Healthineers: Siemens Healthineers offers cardiac CT scanners and AI-based post-processing (e.g., syngo.via). It is a broad incumbent that could integrate competing inflammation or plaque analytics directly into its scanner and PACS workflow.
• Philips: Philips provides cardiovascular imaging and AI-enhanced analysis tools (IntelliSpace Portal). It is a broad incumbent competing for the same hospital cardiology budgets and could leverage its installed base to deploy competing CCTA-AI.

Others

• Medpace: Medpace is a CRO with a strong cardiovascular trial franchise that already co-hosts webinars with Caristo. It is a channel/ecosystem partner rather than a competitor, but as a vertically integrated CRO it could internalize imaging core lab capabilities over time.
• Clario: Clario is a leading clinical trial imaging core lab and eCOA provider for cardiovascular trials. It competes with Caristo for pharma imaging core lab mandates (e.g., FAI-Score / plaque quantification in CV outcome trials).

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/caristoheart
• YouTubeyoutube.com/@caristodiagnostics
• LinkedInlinkedin.com/company/caristo
• Instagraminstagram.com/caristo_diagnostics

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds4 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Caristo Diagnostics