Calmark extends the time plan for CE-mark of the biomarkers LDH and Glucose - market launch as according to plan
Calmark Sweden AB (publ) announces today that the Company's products for biomarkers, LDH and glucose, will not obtain their CE conformity markings until the first quarter of 2020, the market launch of products will not be affected. The Company has focused its efforts on the first biomarker, bilirubin, whose CE-mark is on schedule, and on ramping up the production lines to facilitate market launch. As a consequence, the projects for the other biomarkers have lagged behind slightly. The update of the IVDR regulatory requirements, which will go into effect in 2022, has also had an impact, primarily on the planned clinical trials.
The Company's first product, bilirubin, will obtain its CE marking according to plan before the end of this year, and market launch will commence during Q1 2020. Since the reader obtains its CE marking together with each respective biomarker, the initial project is also the most extensive. The second and third biomarkers, glucose and LDH, will obtain CE marking in the first quarter of 2020, instead of previously communicated before the end of 2019. The market launch will commence shortly thereafter. The standards that the Company complies with are currently being revised, and the Company has therefore chosen to conform to the new regulatory framework; this minimizes the risk of having to repeat the studies once the new regulatory framework enters into force in 2022. The decision has involved some additional effort, causing the project to be somewhat delayed.
"We have considered it vital to prioritize bilirubin, since this product translates to the biggest market potential for us. We have also made it a priority to finalize the production lines for both the reader and the single-use item, so that we can proceed to launch our first product and begin to generate revenue as soon as possible. At the same time, we have chosen to adopt a long-term approach in our plan, to avoid having to perform some parts of the project all over again when the new regulation goes into effect two years from now. All this adds up to a delay of approximately one quarter for biomarkers two and three, which we consider to be the right priority given these circumstances," explains Anna Söderlund, CEO.
This information is information that Calmark Sweden AB 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 18 October 2019.
For more information about Calmark Sweden AB, please contact:
Anna Söderlund, CEO
Telefon: +46 70 213 25 35
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.