Calmark re-prioritizes resources to focus on sales of existing products
Calmark Sweden AB announced today that it has resolved to re-prioritize resources, which entails that the timetable for the development project relating to Neo-LDH is updated; the product will not obtain CE marking before May 26.
As previously disclosed on March 22, the development project relating to the Company's test Neo-LDH has reached the verification and validation phase. This was estimated to last for a period of approximately two months. To ensure that the product is stable and has a long shelf life, Calmark assesses, however, that additional testing is required and that the current phase must be extended. With the new in vitro diagnostic medical device regulations (IVDR) coming into effect on May 26, this implies that the CE marking will fall under the new regulations. As such, the new timetable is currently not clear.
The focus is switched to prioritizing customer contacts, registrations, and sales of the existing products Neo-Bilirubin and COVID19-LDH.
“Calmark is a company with limited resources and a small organization, and we have to make optimum use of them in both the short and long term,” says Anna Söderlund, CEO of Calmark.
“We see a risk in diverting all our resources to the CE marking of a novel product prior to May 26, as the regulatory framework will change as of that date. We want to avoid a negative impact on the launch of Neo-Bilirubin, and we have, therefore, decided to re-prioritize our resources and timetables.”
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.