Calmark CE marks product for assessing COVID-19 severity
Calmark Sweden AB (publ) announces today that the product Calmark COVID19-LDH has obtained its CE marking in accordance with the IVD directive. The product is now ready for sale and use in healthcare, including in the EU.
The IVD directive encompasses requirements regarding safety, performance and function. The quality assurance of Calmark's product COVID19-LDH, for assessment of disease severity, is now successfully completed in all these regards.
In addition to giving Calmark authorization to sell the product within the EU, the CE Mark further opens up opportunities for accelerated registration on other markets, which have special regulations for COVID-19 products.
”It is with deep satisfaction that we announce the CE conformity marking of our product COVID19-LDH,” says Anna Söderlund, CEO. "When the pandemic struck, we reorganized the company to develop a point-of-care LDH-test adapted for covid-19 in record time on the same platform as the products for newborns. I would like to extend my gratitude to my fabulous team for their competence and the massive effort they have invested in this product."
Calmark POC - Covid is a platform that consists of an instrument, a related software and a single-use test cassette, intended for the biomarker lactate dehydrogenase (LDH). The platform can be used on e.g. emergency rooms and wards in hospitals. Calmark has several distributor agreements regarding the product, including with the company P.R.I.S.M.A. Srl in Italy, where the agreement covers a minimum volume of SEK 4.6 million.
This disclosure contains information that Calmark Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014) and the Swedish Securities Markets Act (2007:528). The information was submitted for publication, through the agency of the contact person, on 15-04-2021 17:50 CET.
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 developing and selling 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.
