What Hart Biologicals does

Hart Biologicals Limited is a UK-based in vitro diagnostic (IVD) manufacturer founded in 2002 and headquartered in Hartlepool, England, specializing in reagents, instruments, and consumables for haemostasis and platelet function analysis. Its product portfolio spans coagulation analysers (Thrombi-Stat MC1 and Thrombi-Stat Plus single-channel mechanical coagulometers), the T-TAS 01 total thrombus-formation analysis system (distributed under licence from Fujimori Kogyo in the UK and Republic of Ireland only), and the next-generation IMPACT analyser based on whole blood impedance aggregometry (WBIA). The reagent catalogue covers PT/INR testing, Clauss fibrinogen assays, aPTT reagents, a comprehensive platelet agonist range for Light Transmission Aggregometry (LTA) and Multiple Electrode Aggregometry (MEA), control and deficient plasmas, and calibrants, supplemented by bespoke contract manufacturing services for OEM partners and international EQA/PT schemes.

The company operates a horizontal go-to-market serving clinical and hospital laboratories, GP surgeries and primary care providers, and OEM/EQA scheme partners in the UK (directly) and across Europe, South America, and Asia (through distributor channels). Revenue is generated through one-time instrument sales, recurring reagent and consumable sales tied to the installed instrument base, and professional-services revenue from contract/OEM reagent development. Pricing is quote-based and not publicly disclosed. The business holds BS EN ISO 13485:2016 certification with MDSAP coverage for Australia, Canada, and USA, complies with FDA Title 21 CFR Part 820, and is working toward EU IVDR Class C compliance ahead of the May 2026 transitional deadline. In 2021 the company acquired Hart Innovations and in 2022 completed a £500k expansion programme, with the IMPACT analyser launching at ISTH 2025.

Name

Hart Biologicals

Legal name

Hart Biologicals Limited

Website

https://hartbio.co.uk

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

11–50 employees

Short description

UK-based IVD manufacturer founded in 2002, producing coagulation analysers, platelet function testing instruments, and a broad reagent portfolio for haemostasis diagnostics, serving NHS and hospital laboratories, GP surgeries, and OEM/EQA scheme partners across Europe, South America, and Asia.

Ownership category

akta.pro rank

Product category

Coagulation and Platelet Function Diagnostics (In Vitro Diagnostics)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Hematology & Coagulation Diagnostics (HLAHAAAB)

akta.pro secondary industries

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM), Laboratory Automation, Sample Prep & Liquid Handling (IVD Lab Diagnostics) (HLAHAAAN)

Keywords

• Coagulation diagnostics
• In vitro diagnostics
• Haemostasis reagents
• Platelet function testing
• INR monitoring

Headquarters

HQ city

Hartlepool

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Reagent Sales: Sale of high-quality reagents for haemostasis and platelet function analysis including INR testing reagents, coagulation reagents, platelet agonists (MEA and LTA formats), control plasmas, calibrants, and deficient plasmas. Both standard catalog products and bespoke formulations are offered.
2. Instrument Sales: Sale of coagulation analysers and platelet function testing instruments including Thrombi-Stat MC1, Thrombi-Stat Plus, T-TAS 01, and IMPACT analyser, along with associated consumables, accessories, and spare parts.
3. Contract/ OEM Reagent Development and Manufacturing: Bespoke reagent manufacturing services for OEM partners and international EQA/PT schemes. Services cover the full product lifecycle from concept to completion, including validation and optimisation support.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels5 records

Core offering

Hart Biologicals manufactures and globally supplies high-quality in vitro diagnostic (IVD) reagents and proprietary instruments for haemostasis and platelet function analysis. Its catalogue spans INR testing reagents, Clauss fibrinogen assays, coagulation reagents, a comprehensive platelet agonist portfolio for LTA/MEA/WBIA methods, control and deficient plasmas, and dedicated coagulometers (Thrombi-Stat MC1/Plus) plus the next-generation IMPACT whole blood impedance aggregometry analyser and the T-TAS 01 total thrombus formation system. The company also offers bespoke contract reagent development and manufacturing services for OEM partners and international EQA/PT schemes.

Product overview

Hart Biologicals is a UK-based manufacturer and global supplier of high-quality diagnostic reagents for haemostasis and platelet function analysis. The product portfolio comprises: (1) Coagulation instruments including the Thrombi-Stat MC1 and Thrombi-Stat Plus single-channel coagulometers, the T-TAS 01 Total Thrombus Formation Analysis System, and the IMPACT analyser (next-generation whole blood impedance aggregometry); (2) Reagents including PT/INR testing reagents (Manchester Capillary Reagent, ULTRASENSE PT), Clauss fibrinogen assays (Fiix Test Kit), aPTT reagents (ULTRASENSE EA), comprehensive platelet aggregation reagents for Light Transmission Aggregometry (Arachidonic Acid, ADP, Collagen, Ristocetin, TRAP-6, Epinephrine, U46619, Prostaglandin E1, Acetylsalicylic Acid), MEA reagents for Multiple Electrode Aggregometer systems, control plasmas, factor deficient plasmas, and calibrants; (3) Consumables and accessories including lancets, pipettes, tubes, dispensers, and instrument spare parts; (4) Contract manufacturing services for bespoke reagent development and OEM partnerships.

Differentiator

Problem solved

Functional benefit

Products and services

• Thrombi-Stat MC1 Coagulation Analyser One-channel mechanical coagulation analyser used in smaller laboratories and GP surgeries for processing routine tests such as PT, aPTT, fibrinogen and clotting assays. Test results are indicated in %, INR, ratio and seconds. Available in battery-powered portable configuration for point-of-care use.
• Thrombi-Stat Plus Single Channel Coagulometer One-channel mechanical analyser used in smaller laboratories and GP surgeries for processing routine tests such as PT, aPTT, fibrinogen and clotting assays.
• T-TAS 01 Total Thrombus Formation Analysis System In vitro diagnostic device comprising a tabletop instrument controlled by a dedicated PC using a disposable, single-use flow chamber microchip (PL Chip) with 26 microcapillary channels. Specifically measures platelet thrombus formation (PTF) under arterial flow conditions, with results calculated within 10 minutes as AUC10. Available in the UK and Republic of Ireland only under licence from Fujimori Kogyo Co. Ltd.
• IMPACT Analyser Next-generation platelet function testing instrument powered by whole blood impedance aggregometry (WBIA) technology, designed for speed, accuracy and efficiency with a modern, compact design and standardised reagents.
• Manchester Capillary Reagent Capillary prothrombin time test reagent for point-of-care INR testing.
• ULTRASENSE PT PT reagent for determination of prothrombin time in citrated plasma.
• ULTRASENSE EA Liquid soy phosphatides with ellagic acid plasma activator for determination of activated partial thromboplastin time (aPTT) in citrated plasma. Particularly suited for intrinsic factor assays and heparin monitoring.
• Fiix Test Kit Clauss fibrinogen assay kit - fully compliant IVD for determination of fibrinogen levels in plasma, using the proprietary Fiix (Factor II + X) approach to anticoagulation monitoring.
• MEA Reagents (Multiple Electrode Aggregometry) Comprehensive range of platelet agonists for use on Multiple Electrode Aggregometer (MEA) systems using whole blood samples, including ADP MEA, Arachidonic Acid MEA, Collagen MEA, Ristocetin MEA, TRAP-6 MEA, and Acetylsalicylic Acid MEA.
• Platelet Aggregation Reagents (LTA) Comprehensive range of platelet agonists for Light Transmission Aggregometry (LTA) including Arachidonic Acid, ADP, Collagen, Ristocetin, Epinephrine, TRAP-6, U46619, Prostaglandin E1, and Acetylsalicylic Acid.
• Control Plasmas Quality control materials including Normal Standard Plasma, Normal/Abnormal Assay Controls, Vericon 1/2 Control Plasmas, and Capillary Precision Control Plasmas (Normal, Level 1, Level 2).
• Factor Deficient Plasmas Human source plasma immunodepleted of specific coagulation factors for use in clot-based factor assays. Includes Factor VIII Deficient Plasma.
• Calcium Chloride 0.025M Reagent for use in intrinsic clotting assays alongside aPTT reagents. Triggers the coagulation process enabling accurate clot time measurement.
• Poller Calibrants PT/INR Line Plasma Set Universal PT/INR calibration solution with calibrations for plasma (rabbit brain), plasma (recombinant), and whole blood (capillary and venous).
• Consumables and Accessories Laboratory consumables and accessories including lancets (ActiLance, Haemolance), pipette tips, coagulometer tubes, reagent tubes, hand-held dispensers, thermal paper, ball dispensers, cases, dust covers, cables, and batteries for Thrombi-Stat instruments.
• Contract Manufacturing and Bespoke Reagent Development Services Bespoke reagent manufacturing and contract reagent development services for OEM partners, including INR clinic solutions and DOAC blood test development, covering the full product lifecycle from concept to completion, including validation and optimisation support.
• International EQA/PT Schemes Supply Supply of reagents and support for international External Quality Assessment (EQA) and Proficiency Testing (PT) schemes supporting laboratory quality assurance programmes worldwide.

Quantifiable outcome

• 90% cost savings achievable with Thrombi-Stat for INR monitoring

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Two partnerships are on record, tiered core.

• Fujimori Kogyo Co.LtdcoreTechnology or IntegrationHart Biologicals holds a distribution licence for the T-TAS (Total Thrombus-formation Analysis System) product line in the United Kingdom and Republic of Ireland. T-TAS is a registered trademark of Fujimori Kogyo Co.Ltd. The T-TAS 01 is an IVD device comprising a tabletop instrument with a disposable PL Chip flow chamber microchip for measuring platelet thrombus formation.
• International Distributor NetworkcoreChannel Partner/ Reseller/ DistributorHart Biologicals has established a robust network of trusted distributors across Europe, South America, and Asia. These distributors enable the company to deliver consistent service and high-quality products to laboratories worldwide, complementing the company's direct sales activities in the UK.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Sysmex: Major IVD incumbent with a leading position in haematology and haemostasis including the CS-series coagulation analysers and broad reagent menus. Comparable to Hart's IVD reagent and instrument offering but at significantly larger scale and broader portfolio.
• Siemens Healthineers: Global diagnostics incumbent with a comprehensive haemostasis portfolio including the Sysmex CS systems under partnership, plus automation and informatics. Overlaps with Hart but at vastly broader scale and footprint.
• Werfen (Instrumentation Laboratory): Specialised diagnostics division covering haemostasis (ACL TOP family), platelet function, and critical care diagnostics. Direct overlap with Hart's coagulation and platelet function testing product lines; operates at much greater scale globally.
• Abbott Diagnostics: Major IVD manufacturer with haemostasis and core laboratory offerings across hospital and reference lab settings. Relevant broader incumbent comparable on customer type rather than specific coagulation specialty.

Direct peers

• Diagnostica Stago: Global specialist in haemostasis and coagulation diagnostics, manufacturing coagulation analysers, reagents, and platelet function testing consumables. Direct overlap with Hart Biologicals across coagulation instruments, reagents, and platelet function reagents.
• Bio/Data Corporation: Specialist manufacturer of platelet aggregation reagents and instruments (PAP-8E, Aggregometer) used in clinical and research coagulation labs. Highly comparable niche specialty peer focused on platelet function testing.
• Sentinel Diagnostics: Italy-based IVD manufacturer focused on clinical chemistry and haemostasis reagents including coagulation and control materials. Directly comparable product portfolio of specialty IVD reagents and OEM capabilities.
• Haemochrom Diagnostica: European manufacturer of coagulation reagents and controls with a comparable focus on bespoke and OEM reagent supply. Similar mid-sized, niche-specialist profile to Hart Biologicals.
• Helena Biosciences: UK and European supplier of haemostasis and haemostasis reagents including platelet aggregation reagents for LTA and Plateletworks formats. Closely matches Hart's reagent catalogue and customer base in clinical laboratories.

Regional players

• EKF Diagnostics: UK-based diagnostics manufacturer with adjacent IVD, haematology, and point-of-care testing product lines including coagulation-related offerings. Comparable UK manufacturing base and customer mix though with a broader diagnostics portfolio.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/hartbio
• Facebookfacebook.com/HartBio
• LinkedInlinkedin.com/company/hart-biologicals-limited

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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 Hart Biologicals