BPH Energy’s investee Cortical Dynamics on path to FDA approval for BARM technology
Cortical Dynamics already has regulatory clearance for BARM in the EU, Australia and Korea.
BPH Energy’s (ASX: BPH) investee Cortical Dynamics has filed a submission with the United States Food and Drug Administration to have its brain anaesthesia response monitor (BARM) listed as an approved medical device.
The FDA submission follows approvals for BARM with other regulatory bodies including the European Union CE mark, Australia’s Therapeutic Goods Administration and Korea’s Ministry for Food and Drugs Safety.
BPH holds a 16.7% interest in Cortical, which is an Australian based medical device technology company.
BARM technology
Cortical’s main device is the BARM, which has been designed to better detect the effect of anaesthetic products on brain activity.
It was developed to assist anaesthetists in keeping patients’ optimally anaesthetised.
BPH says Cortical’s approach with BARM is “fundamentally different” from other devices on the market.
The next generation BARM device takes physiological approach to measuring the effects of anaesthetic on brain electric activity.
It uses an algorithm from a model of how human electric activity of the brain is generated (EEG).
The device describes the electrical activity of populations of excitatory and inhibitory neurons within the brain’s cerebral cortex.
It then establishes physiological parameters such as the number of connections between neuronal populations, conduction velocities, and firing rates and thresholds.
BPH says the model can produce the main features of spontaneous human EEG and the effects of anaesthesia on EEG and provide “valuable feedback” on the depth of anaesthesia a patient is experiencing.
It is anticipated Cortical’s next generation device will address the shortcomings of existing EEG-based monitoring depth of anaesthesia technologies.
Brain monitoring market and versatility
According to BPH, the global brain monitoring market was estimated at $1.6 billion in 2020.
Worldwide, there are about 312 million major surgical procedures undertaken each year that require anaesthesia.
Meanwhile, the pain monitoring market is expected to be valued at more than $8.6 billion by 2022.
Cortical’s initial marketing for BARM is focusing on total intravenous anaesthesia which induces anaesthesia without any inhalants.
As well as anaesthesia, other uses for BARM have been identified.
BPH says the technology can be applied to other EEG-based markets such as neuro-diagnostic, drug discovery and evaluation and the emerging brain computer interface.
By expanding on its core technology, Cortical plans to develop it further to carry out additional functions such as monitoring changes in brain and memory functions to provide early warning of degenerative diseases.
It could also be used to measure pain response and tranquilisers in intensive care patients.