AroCell has filed TK 210 ELISA for the CE-mark registration at the Swedish Medical Products Agency (Läkemedelsverket).
The CE-mark registration is important for the on going clinical development program and an accepted diagnostic product. ”This is a major milestone for AroCell” states Jan Stålemark, AroCell CEO. “As communicated earlier, we will continue the intensive efforts for clinical documentation for the product by supporting clinical studies. This is important in order to achieve full market acceptance”.
“The ongoing process of establishing evidence-based clinical documentation for our product TK 210 ELISA will be key components which support product benefits for the patients and the healthcare providers. This is what will drive value for our products and services long term” summarizes Jan Stålemark.
For additional information please contact:
Jan Stålemark, CEO
AroCell AB (publ)
Tel: +46 706 926206