‘Major milestone’ in development: BPH Energy’s investee company gets US FDA clearance
Health & Biotech
Health & Biotech
BPH Energy’s investee company Cortical Dynamics has achieved a major milestone, securing US Food and Drug Administration (FDA) clearance for its flagship tech, the Brain Anaesthesia Response Monitor (BARM) system version 1.
In addition to being an energy explorer, BPH Energy (ASX:BPH) is also invested in biotechnology and resources. It is currently involved in bringing to market cutting-edge biomedical technologies originating from collaborative research conducted by prominent universities, medical institutes, and hospitals throughout Australia.
BPH says the 510(k) clearance in the USA for BARM system version 1 is a result of two years’ work post submission with FDA in 2021 with Cortical being assisted by MCRA, a leading Washington-based medical global full-service device, diagnostics, and biologics CRO and consulting advisory firm.
Neurotech company Cortical has developed BARM, a next generation certified class II personalised depth of anaesthesia monitoring device for use in operating theatres and ICUs.
BARM is complemented by Cortical’s trademarked CORDYAN (Cortical Dynamics Analytics), a proprietary deep learning system/app focusing on anaesthesiology.
The BARM Pec “plug and play” version 1 was approved compatible by Philips with its IntelliView operating room monitors earlier this year.
Cortical is working on an enhanced version of BARM with its partner, the Austrian Institute of Technology (AIT)m based in Vienna which will include upgrades to the software, hardware, and firmware.
BPH and Cortical director David Breeze says Cortical has achieved a major milestone in its work to get BARM to market.
The 510(k) clearance for trademarked BARM version 1 in the US is complemented by existing regulatory approvals in Australia (TGA), Europe (CE) and South Korea (KMFDS).
“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,” Breeze said.
Furthermore, leveraging the advancements in both technical and regulatory aspects, Cortical has appointed Dr Sunil Nagaraj, PhD, as its new chief scientist.
Nagaraj earned his Masters degree from Canada’s University of Victoria in 2010 and completed his Doctoral Degree at University College Cork in Ireland in 2015.
His doctoral research focused on AI-based real-time brain monitoring using EEG recordings.
After a postdoctoral role at the Harvard Medical School/Massachusetts General Hospital in the USA, Nagaraj served as an Assistant Professor of Medicine at the University Medical Centre Groningen in The Netherlands for two years.
Simultaneously, he spent three years as a scientist at Royal Philips, specialising in sleep disorders and their potential insights into heart-brain connectivity.
Throughout his career, Nagaraj has demonstrated outstanding research skills, with a patent and 21 high-impact journal articles to his credit, along with over 650 research papers.
He has received recognition through numerous national and international grants, enabling him to conduct ground-breaking studies that significantly advance medical technology.
This article was developed in collaboration with BPH Energy, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.