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.