Calmark’s test Neo-LDH enters verification and validation phase to obtain CE mark
Calmark Sweden AB (publ) announces today that the development project for the Company's product for newborns, Neo-LDH, is now progressing to verification and validation. This phase, which is one of the final elements of the process, is estimated to last for approximately two months. When it is completed, regulatory documentation will be compiled in order to achieve the CE Mark approval.
"Today's decision marks an important milestone for Calmark. Our preliminary results show that we meet our technical requirements for the product. We are confident to bring the project into the final phases, starting the verification and validation processes." says Anna Söderlund, CEO of Calmark. "We hope to be able to CE mark the product before the regulations are changed on 26 May."
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
For more information about Calmark Sweden AB, please contact:
Anna Söderlund, CEO
Telefon: +46 70 214 98 93
E-post: anna.soderlund@calmark.se
www.calmark.se
Calmark Sweden AB is a medical technology company that develops and markets a point-of-care (POC) analysis method with easier and faster diagnostics of medical conditions in newborns. The unique test platform consists of a portable instrument and test cassettes for various biomarkers. The first test, Neo-Bilirubin, was launched to the market in 2020. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter care chains. In less developed healthcare systems, the product will offer a decision support which is currently lacking, since the access to hospital laboratories often is limited. Calmark aims to become the global leader in POC diagnostics for newborns and, in the long term, to offer all relevant tests for the first period of life. In addition to products for newborns, Calmark sells a POC test for assessment of COVID-19 disease severity. The B share is listed on the Spotlight Stock Market and is traded under the CALMA B ticker. Read more at www.calmark.se/eng/home.
