Calmark’s product Neo-Bilirubin will obtain CE Mark approval in January 2020
Calmark’s product for the bilirubin biomarker will obtain its CE conformity marking after the turn of the year. A partial study of the verification and validation process still remains, and the study at Södersjukhuset is not finished.
The majority of verification and validation testing, which is the final stage of the CE conformity marking process, has now been successfully performed. A couple of days of laboratory testing remain, however, and some of the planned children have not yet been included in the Södersjukhuset study.
“We are very happy about the results so far. It is unfortunate that we did not manage to complete the entire process for the CE Mark approval before the turn of the year, but this will not affect the market launch of the products,” says Anna Söderlund, CEO.
This information is information that Calmark Sweden AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 23 December 2019, 16:30 CET.
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 70 213 25 35
E-post: anna.soderlund@calmark.se
www.calmark.se
Calmark Sweden AB is a medical technology company developing a point-of-care (POC) analyzis method with easier and faster sampling of medical conditions in newborns. The unique test platform, which consists of a reader and single-use products, is expected to be ready for launch in 2020 when three important POC tests are introduced. The WHO estimates that 1.5 billion children will be born worldwide by 2030. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter healthcare chains. In less developed healthcare systems, the product helps save lives. Calmark aims to become the global leader and ultimately to offer all relevant POC tests for the first period of life, regardless of where in the world a baby is born. Read more about Calmark www.calmark.se/eng/home.