Updated timetable for the clinical trial at Södersjukhuset
Calmark Sweden AB announces today that the timetable for the clinical trial underway at Södersjukhuset has been updated. The first patient was included on 23 December, and the rate of inclusion has thus far been lower than expected. The study is now estimated to be finished within six weeks. As a consequence, the Company's first product, Neo-Bilirubin, will obtain its CE conformity marking during the first quarter instead of in January as previously disclosed. This will not impact the market launch.
The clinical trial shall include 40 children, and is designed as a method-comparison study, where bilirubin analyzed with Calmark Neo is compared with the hospital laboratory’s analytical results. The latter is used as the reference method in the comparison.
The inclusion criterion is for the infant to have a suspected elevated level of bilirubin (risk of jaundice), requiring a blood test to be taken. The launch of the study coincided with the Christmas and New Year holiday period, and all units did not receive the information. As from this week, all units at Södersjukhuset are involved in the trial, and the infant inclusion rate is rising.
"We are satisfied that the trial now has gotten off the ground, and that the recruitment of patients is proceeding as intended", says Anna Söderlund, CEO of Calmark. "The market launch effort comprises many parts that are commencing in parallel; hence, it is our assessment that this minor delay will not impact the launch of sales."
This information is information that Calmark Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on 28 January 2020, 18:40 CET.
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 70 213 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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