Cortical Dynamics Limited Update
Perth, Dec 7, 2020 AEST (ABN Newswire) - ASX Listed BPH Energy Limited (
ASX:BPH) is pleased to announce that its investee company Cortical Dynamics Limited has secured approval by the South Korean regulator, The Korean Ministry for Food and Drug Safety (KMFDS), to sell its advanced Brain Anaesthesia Response Monitor (BARM(TM)) in the South Korean Market.
BARM(TM) and Cortical Dynamics met the stringent KMFDS requirements both for the BARM(TM) technology and for medical device manufacturers, including the requirements related to the Quality Management System (QMS). In particular, the QMS established by the manufacturer should comply with the national requirements based on the international standard ISO 13485.
South Korea's medical device market ranks as the ninth largest in the world at an estimated US$6.8 billion 2019, showing continuous grow with 8.1% annual increase. Cortical Dynamics will now work with its South Korean distributor, Global Luck, to introduce BARM(TM) to the Korean market.
This approval by KMFDS complements the existing CE and TGA approvals already in place.
About BPH Energy Limited
BPH Energy Limited (ASX:BPH) is an Australian Securities Exchange listed company developing biomedical research and technologies within Australian Universities and Hospital Institutes.
The company provides early stage funding, project management and commercialisation strategies for a direct collaboration, a spin out company or to secure a license.
BPH provides funding for commercial strategies for proof of concept, research and product development, whilst the institutional partner provides infrastructure and the core scientific expertise.
BPH currently partners with several academic institutions including The Harry Perkins Institute for Medical Research and Swinburne University of Technology (SUT).
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