Calmark receives approval from the Swedish Ethical Review Authority to conduct clinical trial at Södersjukhuset
The Swedish Ethical Review Authority has decided to approve Calmark Sweden AB's application regarding a study on newborns. The application covers the Company’s three biomarkers and comprises three parts, which will be conducted within the next few months.
The Swedish Ethical Review Authority’s approval is a prerequisite for conducting a clinical trial involving patients. Calmark is planning three study parts on each of the Company's biomarkers, which will be carried out in cooperation with the children's hospital Sachsska barn- och ungdomssjukhuset, a part of Södersjukhuset. The application to conduct these trials was submitted to the Ethical Review Authority at the end of August, and has now been granted.
The study part relating to Calmark’s first product, Bilirubin, is estimated to commence within a month, and marks one of the final stages of the CE conformity marking process. The study is planned to include 40 newborn infants, and is projected to be concluded before the turn of the year.
“Conducting clinical studies on patients with our products is essential for of our verification and validation. I am delighted that our study design has now received the Swedish Ethical Review Authority’s approval, so that we can begin to include patients shortly. Södersjukhuset is an important partner for us, and the research teams there are highly skilled and experienced,” says Anna Söderlund, CEO.
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.
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