Enzyre B.V.
Enzyre is a pioneering company focused on blood coagulation management through innovative point-of-care diagnostic solutions. Their mission is to save patients from bleeding to death by developing portable, easy-to-use devices that enable real-time blood analysis outside traditional laboratory settings. Supported by grants and strategic partnerships, Enzyre aims to revolutionize disease management, improve patient quality of life, and reduce healthcare costs.
Industries
Nr. of Employees
small (1-50)
Enzyre B.V.
Transistorweg 5, 6534-AT Nijmegen, The Netherlands
Products
Handheld near-patient micro-laboratory (portable coagulation analyzer)
A compact reusable processor that runs assays from single-use microfluidic cartridges, performs optical detection and processing, and transmits encrypted results to a cloud backend via a mobile app.
Disposable microfluidic diagnostic cartridges
Single-use cartridges with sub-microliter reagent reservoirs capable of running a multiplexed panel (up to 16 reactions) from a small whole-blood sample and containing internal controls.
Handheld near-patient micro-laboratory (portable coagulation analyzer)
A compact reusable processor that runs assays from single-use microfluidic cartridges, performs optical detection and processing, and transmits encrypted results to a cloud backend via a mobile app.
Disposable microfluidic diagnostic cartridges
Single-use cartridges with sub-microliter reagent reservoirs capable of running a multiplexed panel (up to 16 reactions) from a small whole-blood sample and containing internal controls.
Services
Development of disease-specific biochemical assays from feasibility through verification and validation to support IVD registration.
Support for clinical trial registrations and activities needed to generate evidence for regulatory submissions and market entry.
Development of modular pilot production capabilities for microfluidic cartridges and device assembly to bridge prototype and small-series manufacturing.
Collaborative programs with pharmaceutical and industry partners to co-develop assays and clinical implementations of the platform.
Implementation and maintenance of a medical device quality management system aligned with ISO 13485:2016 requirements.
Development of disease-specific biochemical assays from feasibility through verification and validation to support IVD registration.
Support for clinical trial registrations and activities needed to generate evidence for regulatory submissions and market entry.
Development of modular pilot production capabilities for microfluidic cartridges and device assembly to bridge prototype and small-series manufacturing.
Collaborative programs with pharmaceutical and industry partners to co-develop assays and clinical implementations of the platform.
Implementation and maintenance of a medical device quality management system aligned with ISO 13485:2016 requirements.
Expertise Areas
- Point-of-care diagnostic development
- Assay development and validation for IVDs
- Microfluidic cartridge design and manufacturing
- Optical detection and chemiluminescence assays
Key Technologies
- Chemiluminescent enzyme-activity assays
- Disposable microfluidic cartridges
- Photon-counting nano-optical sensors
- Multiplexed reaction panels (≤16 reactions)
News & Updates
Enzyre received its certificate of registration from BSI, confirming that its quality management system complies with ISO13485:2016 standards.
Enzyre successfully raised EUR 12 million in a Series A funding round to develop its diagnostic platform for hemophilia patients.
Enzyre appointed Marcel van Kasteel as independent Chairman of the Supervisory Board, bringing extensive experience in diagnostics and point-of-care solutions.
Enzyre’s Enzypad technology was recognized as the best blood coagulation analysis product by Global Health and Pharma.
A documentary featuring Enzyre and its biochip technology was broadcasted on Nijmegen TV, highlighting the company's innovative approach to managing hemophilia.
An article about Enzyre was published in Biotech News, discussing its mission and technological advancements.
Enzyre received its certificate of registration from BSI, confirming that its quality management system complies with ISO13485:2016 standards.
Enzyre successfully raised EUR 12 million in a Series A funding round to develop its diagnostic platform for hemophilia patients.
Enzyre appointed Marcel van Kasteel as independent Chairman of the Supervisory Board, bringing extensive experience in diagnostics and point-of-care solutions.
Enzyre’s Enzypad technology was recognized as the best blood coagulation analysis product by Global Health and Pharma.
A documentary featuring Enzyre and its biochip technology was broadcasted on Nijmegen TV, highlighting the company's innovative approach to managing hemophilia.
An article about Enzyre was published in Biotech News, discussing its mission and technological advancements.