BPH Energy (ASX: BPH) has revealed its investee company Cortical Dynamics has secured approval from the appropriate regulator to sell its advanced Brain Anaesthesia Response Monitor (BARM) in the South Korean market.
Cortical met the stringent requirements of the South Korean regulator, the Korean Ministry for Food and Drug Safety (KMFDS), both for the BARM technology and for medical device manufacturers.
This included requirements relating to the Quality Management System (QMS), which specifies that the manufacturers’ QMS complies with the national requirements based on the international standard ISO 13485.
This latest approval by KMDFS complements the existing CE marking and Therapeutic Goods Administration (TGA) approvals already in place for sales of the monitoring system in Europe and Australia.
The BARM system
Cortical’s core product BARM is a “next generation” electronic device that improves on existing electroencephalogram (EEG) technologies to measure the effects of anaesthesia on brain activity, thus assisting clinicians in keeping patients optimally anaesthetised at all times.
According to Cortical, the device’s approach is “fundamentally different” from other devices currently available because its underlying algorithm produces EEG indexes directly related to the physiological state of a patient’s brain rather than statistics.
In July, Cortical filed a new international patent application under the designation “apparatus and process for measuring brain activity”.
The BARM system is already protected by five patent families, consisting of 22 granted patents in multiple jurisdictions including Australia, New Zealand, Japan, China, Europe and the United States. Its patents cover both the composite cortical state (CCS) and cortical input.
South Korean distributor
According to BPH Energy, South Korea’s medical device market ranks as the ninth largest in the world at an estimated US$6.8 billion (A$9.15 billion) in 2019.
The market has also been showing continuous growth at an annual rate of 8.1%, the investment company said.
Cortical is working with its South Korean distributor Globaluck, to introduce BARM to the Korean market.
The distributor previously received Korea Good Manufacturing Practice certification for the device in late 2019, meaning the KMDFS declared it complied with design, risk, technical and quality requirements.
BPH is a diversified company with varying investments including a 22.6% interest in oil and gas explorer Advent Energy.
The company also has a 10% stake in Chile-based medical cannabis company Patagonia Genetics SPA, with the potential to boost this to 49%.