Swedish medical device company BrainCool AB (Nasdaq First North Growth Market:BRAIN) revealed on Tuesday that it has received market approval for its BrainCool System in Malaysia, allowing its distributor, ZOLL, to begin commercialisation.

The system provides precision temperature management to improve survival and reduce permanent disability in patients suffering from sudden cardiac arrest or stroke.

Medtech company ZOLL has a dedicated sales force for BrainCool System in the United States and the DACH region (Germany, Austria and Switzerland). Under an extended distribution agreement, ZOLL will market and sell the system in Thailand, Malaysia, Singapore, Indonesia, the Philippines, Taiwan and Pakistan. BrainCool will begin deliveries following regulatory approval in each country.

With Malaysia now approved, BrainCool aims to leverage its existing approvals to accelerate regulatory processes in other ASEAN nations. The ASEAN Medical Device Directive (AMDD) provides a harmonised framework for medical product approvals, with each country at different stages of implementation.

BrainCool has already initiated approval applications in additional markets covered by its agreement with ZOLL, reinforcing its expansion strategy in the region.