Calmark's trial at Södersjukhuset completed
Calmark Sweden AB (publ) announces today that the clinical trial with the product Neo-Bilirubin, which commenced in September 2021 in cooperation with the research entity of the children's hospital Sachsska barn- och ungdomssjukhuset, Södersjukhuset AB, Stockholm, is now successfully completed. All patients have been included and all that remains now is to prepare the final report. Monitoring of the trial was conducted by Scandiavian CRO.
The study was conducted at SÖS during the winter months, with an intermission due to the RSV outbreak. Infants with suspected elevated levels of bilirubin were included, and when blood tests were taken to be sent to the laboratory, tests were also performed using Calmark Neo. The respective test results were then compared. Preliminary findings indicate a good correlation between the test methods. Additional analysis and the final report remain to be completed.
“The rapid results provided immediately upon sampling by Calmark's Neo-Bilirubin test can facilitate the process and save time for both parents and professionals in maternity wards and healthcare units,” says Ulrika Hellberg, Research Nurse, Sacchska Children's & Youth Hospital.
“We are very pleased with the positive feedback received from the medical staff of SÖS,” says Anna Söderlund, CEO of Calmark. “This highlights the great value of our product in the healthcare system.”
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.
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