BPH Energy investee Cortical Dynamics secures Korean regulatory approval for core BARM product
Cortical Dynamics’ brain anaesthesia response monitoring system is now certified for distribution in South Korea.
BPH Energy’s (ASX: BPH) investee Cortical Dynamics, which has developed the brain anaesthesia response monitoring (BARM) device, has received news that its South Korean distributor Globaluck has received Korea Good Manufacturing Practice certification.
The class II medical device certification follows an independent audit that was undertaken at Cortical’s facility in Victoria during July.
Achieving this certification means the Korean Ministry of Food and Drug Safety has deemed the device complies with design, risk, technical, and quality KPMG quality requirements.
Brain anaesthesia response monitoring system
Australia-based Cortical’s core product is the BARM system was developed to better-detect the effect of anaesthetic on brain activity – assisting anaesthetists in keeping patients optimally anaesthetised.
The device works by measuring a patient’s rhythmic brain electric activity (EEG) in order to understand how deeply a patient is anaesthetised during an operation.
During an operation, the brain anaesthesia response adhesive sensor is applied to a patient’s forehead and monitors EEG activity, which helps anaesthetists and intensive care staff to ensure a patient doesn’t wake unexpectedly as well as reducing potential side effects.
According to Cortical, the device’s approach is “fundamentally different” from other devices currently available, because its underlying algorithm produces EEG indexes that are directly related to the physiological state of a patient’s brain rather than statistics.
The device provides a reading within three seconds of start-up and updates are produced every second, while competing systems provide 30 second updates.
In addition to monitoring anaesthesia, Cortical anticipates its technology can be used in other EEG-based applications including neuro-diagnostic, drug discovery, and drug evaluation sectors as well as the emerging brain computer interface market.
Cortical’s BARM system is protected by five patent families in multiple regions worldwide.
Other investments
BPH is a diversified company with varying investments including a 22.6% interest in oil and gas explorer Advent Energy.
The company also recently entered the medical cannabis space after acquiring a 10% stake in Chile-based Patagonia Genetics SPA, with the potential to boost this to 49%.
Shares in BPH were steady at $0.002 in early afternoon trade.