Trajan's Microsampling Devices Meet IVDR Compliance in Europe, UK

Mitra® and hemaPEN® receive regulatory certification as medical devices for remote blood sample collection in healthcare,clinical trials and home monitoring programs in Europe and United Kingdom.

MELBOURNE,Australia,June 2,2023 -- Trajan Scientific and Medical,a leading provider of analytical and life sciences products and solutions,today announced the regulatory approval of its Neoteryx remote blood microsampling devices,Mitra® and hemaPEN® for clinical use in Europe and the United Kingdom.

Trajan has successfully fulfilled the required product safety and performance requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR) in Europe and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. Having earned this CE Mark regulatory compliance,Trajan expands the capabilities of its Neoteryx® microsampling products to provide decentralised,person-centered,minimally invasive blood collection in both clinical and research settings.

The Mitra device,based on volumetric absorptive microsampling with VAMS® technology,is a finger-stick blood collection solution for the delivery of dried samples to the lab. The hemaPEN® device,based on volumetric microsampling with capillary and next-generation DBS technology,uses a single finger-stick to simultaneously collect 4 DBS blood samples of equal volume.

Mitra® and hemaPEN® devices can be used remotely to collect blood samples through an easy,virtually painless process. The devices can be used to ship dried samples via standard mail and deliver precise volumes and high sample quality compared to traditional DBS or other remote blood sampling technologies. The samples fit seamlessly into laboratory analysis workflows,as shown in studies conducted by pharmaceutical companies,healthcare organisations,and academic institutions around the world.

"The updated regulatory approval of Trajan's blood microsampling devices in the UK and European Union is another step forward towards our vision of personalized,preventative data-based healthcare," said Stephen Tomisich,CEO and founder of Trajan. "Our growing range of microsampling technologies allows almost anyone to take an analytically viable sample outside the clinical setting,anytime,anywhere. In our view,that is essential to enable the healthcare systems of the future."

About Trajan Scientific and Medical

Trajan is a global developer and manufacturer of analytical and life sciences products and devices founded to enrich personal health through scientific tools and solutions. We aim to support science that benefits people. Trajan's products and solutions are used in the analysis of biological,food,and environmental samples. Trajan has a portfolio and pipeline of new technologies which support the move towards decentralised personalized data-based healthcare. Trajan comprises more than 680 people with seven manufacturing sites across the US,Europe,and Malaysia,and operations in Australia,the US,Asia,and Europe. Trajan's products and solutions are marketed under multiple product brands,including Neoteryx,serving a range of industries in countries around the world. For more information,visit www.trajanscimed.com. For more information on Trajan's Neoteryx range of microsampling solutions,visit www.neoteryx.com.