- BPH Energy’s (BPH) ) investee company Cortical Dynamics secures US FDA clearance for its flagship Brain Anaesthesia Response Monitor (BARM) tech
- Newly appointed Chief Scientific Officer Dr Sunil Nagaraj is spearheading the new technology into US markets
- Cortical will manufacture an enhanced version of BARM with its partner, the Austrian Institute of Technology to include software upgrades to hardware and firmware
- BPH shares are up 10.9 per cent, trading at 2.6 cents at 11:28 am AEST.
BPH Energy’s (BPH) investee, Cortical Dynamics, has secured US Food and Drug Administration (FDA) clearance for its flagship Brain Anaesthesia Response Monitor (BARM) technology.
To spearhead the new technology into US markets the company has hired a new Chief Scientific Officer, Dr Sunil Nagaraj.
Dr Nagaraj boasts one patent and 21 high-impact journal articles, with a portfolio of over 650 pioneering research papers to his name.
This approval marks the culmination of two years of effort following the initial submission.
Cortical has already penetrated the markets in Australia (TGA), Europe (CE), and South Korea (KMFDS).
Additionally, the company is collaborating with AIT (the Austrian Institute of Technology) in Vienna to manufacture an enhanced version of BARM, featuring software upgrades to the hardware and firmware.
“The 510(k) clearance by the FDA is a major milestone in the development of the Company which lays the foundation for the commercialisation of the BARM™ system in the USA,” BPH and Cortical Director David Breeze said.
BPH shares were up 10.9 per cent, trading at 2.6 cents at 11:28 am AEST.