BrainCool

BrainCool AB (publ) has now received market approval for the BrainCool™ System in Thailand. This has been announced by the Thai Medical Agency. This means that ZOLL®, which has a distribution agreement with BrainCool, now can start marketing and sell the BrainCool™ System in the Thai market.
 
Under the terms of a distribution agreement between ZOLL® and BrainCool, ZOLL® will market and sell the BrainCool™ System in five ASEAN countries – Thailand, Malaysia, Singapore, Indonesia, and the Philippines – as well as Taiwan and Pakistan.
 
BrainCool's CEO Jon Berg comments:
-“Thailand was selected as the first market for approval under our regulatory plan and we have worked intensively with the Thai authorities to meet the requirements. With the approval, we are now ready to deliver the first systems to ZOLL® for the Thai market.”
 
The regulations for the ASEAN countries are harmonized in common directives for medical products according to The ASEAN Medical Device Directive (AMDD). The harmonization process is at different stages in the countries. BrainCool is now starting the application processes for approval in the other countries. The approval in Thailand can facilitate the processes in the other ASEAN countries according to the directives in AMDD.