Significant milestone reached – product tested on patient
Today, the first patient was included in the clinical study underway at the children's hospital Sachsska barnsjukhuset, part of Södersjukhuset. For Calmark, this marks the reaching of one of the last remaining milestones for 2019, out of the ones previously disclosed.
The study will include 40 children with suspected elevated levels of bilirubin (risk of jaundice), where blood tests have to be taken.
The existing point-of-care (POC) analysis methods for bilirubin assessment employ transcutaneous measurement or blood gas analyzers, but these methods fail to address the needs of all infants. The reason is that transcutaneous measurement is only viable up to a certain bilirubin level and fails to generate reliable results above that. Blood gas analyzers for bilirubin assessment do not reveal deteriorations of the sample such as haemolysis, which may result in erroneous measurements and clinically unreliable analysis results. To detect that, a traditional laboratory analysis is required, with all the disadvantages that entails: more blood is needed, it takes longer time and the laboratory staff must perform the task manually.
Calmark Neo-Bilirubin provides faster results than laboratory analysis and requires lower quantities of blood. Contrary to blood gas analyzers, Calmark's product alerts the user if the blood sample is damaged.
“It is really gratifying that we have now been able to include the first patient in the study on Neo-Bilirubin,” says Emma Lif, Clinical Director at Calmark. “The study's principal investigator, Cecilia Pegelow Halvorsen, and her team at Södersjukhuset have made a remarkable job to set this in motion, and I would like to extend my gratitude to them for their commitment!”
The study is conducted in cooperation with the research unit, which is not receiving special compensation for it.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
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, 11:50 CET.
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.