BPH investee Cortical Dynamics applies for BARM FDA approval
BPH Energy (ASX:BPH) investee Cortical Dynamics has begun the filing process for its BARM technology (brain anaesthesia response monitor) in the US with the filing of an FDA 510K.
The Food and Drug Administration (FDA) is the federal agency of the United States Department of Health and Human Services which regulates the sale of medical device products (including diagnostic tests) in the US, while also monitoring the safety of all regulated medical products.
FDA approval is a necessary precursor for sales of BARM to commence in the US.
Cortical already has achieved both CE (Europe) and TGA (Australian) registration and is currently awaiting final approval of the company’s registration application to the Korean Ministry of Food and Drug Safety.
Having achieved registration in Europe and Australia, one would expect the chances of receiving FDA approval are relatively high.
The US is a large market, and this would be a significant development for Cortical, and indeed BPH given its 16% interest in the group.
Shares in BPH double on back of strong news flow
Cortical Dynamics is finishing the fiscal year in strong fashion, having announced last week that it had entered into a non-exclusive Licence and Co-operation Agreement with Philips Healthcare North America Corp.
The agreement will enable Cortical to interface its BARM into the Philips IntelliVue and Patient Information Center (PIC iX) Monitoring Systems using the IntelliBridge integration product line.
Royal Philips (NYSE:PHG; AEX:PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care.
S3 Consortium Pty Ltd (CAR No.433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information only. Any advice is general advice only. Neither your personal objectives, financial situation nor needs have been taken into consideration. Accordingly you should consider how appropriate the advice (if any) is to those objectives, financial situation and needs, before acting on the advice.
Conflict of Interest Notice
S3 Consortium Pty Ltd does and seeks to do business with companies featured in its articles. As a result, investors should be aware that the Firm may have a conflict of interest that could affect the objectivity of this article. Investors should consider this article as only a single factor in making any investment decision. The publishers of this article also wish to disclose that they may hold this stock in their portfolios and that any decision to purchase this stock should be done so after the purchaser has made their own inquires as to the validity of any information in this article.
Publishers Notice
The information contained in this article is current at the finalised date. The information contained in this article is based on sources reasonably considered to be reliable by S3 Consortium Pty Ltd, and available in the public domain. No “insider information” is ever sourced, disclosed or used by S3 Consortium.
