BPH Investee Cortical Commences US FDA Filling for BARM, Signs Licence and Co-operation Agreement with Philips

  • Jun 22, 2020 AEST
  • Team Kalkine
BPH Investee Cortical Commences US FDA Filling for BARM, Signs Licence and Co-operation Agreement with Philips

Summary

  • BPH Investee Cortical commenced US FDA filling for BARM, entered into a non-exclusive Licence and Co-operation Agreement with Philips, marking a great leap forward towards advancement of its BARM system.
  • BARM is Cortical’s next generation Brain Function Monitor, which is the only system with algorithms or methods based on model of brain’s electrical activity attained from physiological principles.
  • Backed by significant investments and highly experienced management team, Cortical appears to be well-positioned to commercialise its BARM system in the near future.
  • Initially, Cortical will focus on the TIVA (Total Intravenous Anaesthesia) market across Europe.

Cortical has now begun the FDA 510K filing process for BARM in the USA assisted by its strategic investor Intuitive X, with FDA approval being a necessary precursor for sales of BARM to commence in the USA. Notably, Cortical already has achieved TGA (Australian) and CE (Europe) registration and is currently awaiting final approval of the Company’s registration application to the Korean Ministry of Food and Drug Safety.

In a latest development, BPH Energy Ltd (ASX:BPH) notified that its investee Cortical Dynamics Limited has entered into a non-exclusive Licence and Co-operation Agreement with leading health technology company, Philips Healthcare North America Corp.

BPH Energy currently has ~16 per cent interest in Cortical.

 

 

Post the announcement, BPH shot up ~12.5 per cent higher to $0.018 on 19th June 2020.

NYSE-listed and Netherlands-headquartered, Royal Philips focusses on enhancing people’s health and allowing better outcomes across the health spectrum from prevention and healthy living to home care, diagnosis and treatment. Moreover, Philips employs deep clinical and consumer insights and advanced technology to provide integrated solutions.

The signing of Licence and Co-operation Agreement with Philips is a great leap forward towards the advancement of Cortical’s BARM system, developed to better detect the impact of anaesthetic agents on brain activities of patients, while aiding anaesthetists in keeping patients optimally medicated.

Know About Cortical’s BARM

BARM is Cortical’s next generation Brain Function Monitor, which is the only system with algorithms or methods based on model of brain’s electrical activity attained from physiological principles. In other words, BARM’s underlying algorithm generates electroencephalogram (EEG) indexes directly linked to the physiological situation of a patient’s brain.

The approach used in BARM is fundamentally different from other devices available in the market as existing monitoring systems utilise statistically based empirical approaches. In comparison to 30 second updates on competing monitoring systems, BARM produces a reading within three seconds.

Moreover, BARM offers reduced hospital costs and improved patient health outcomes, besides reliably quantifying and continuously monitoring anaesthetic state of a patient.

Initially, Cortical will focus on the TIVA (Total Intravenous Anaesthesia) market across Europe.

Two Key Investors in Cortical - IntuitiveX and Gentium Partners

In March this year, Cortical secured a considerable investment worth $250,000 from life science consulting firm and incubator based in Seattle, IntuitiveX (IX) and VC investor based in Seoul, Gentium Partners.

IntuitiveX and Gentium were issued with 12,500,00 shares representing 9.8 per cent of the increased capital base, with Intuitive X investing $186,657 (~9.3 million shares) and Gentium investing $63,433 (~3.2 million shares)

Following the investment, IntuitiveX board member Mr. Charles Chang joined Cortical board as one of the directors along with Perth based business developer, Mr. Ashley Zimpel. IntuitiveX management team brought a combined experience of over 100 years to Cortical in Prototyping, IP Strategy, Clinical, Product Development, R&D and Commercialisation.  

IntuitiveX’s team, comprising life science entrepreneurs, innovators, physicians and investors was expected to support Cortical in FDA regulatory approval process.

Moreover, investment by Gentium Partners was also a big hit for Cortical as the former prefers to invest in firms with pioneering ideas and/or technologies, particularly if they have a robust impact on healthcare, investment and lifestyle.

In a nutshell, BPH Energy’s investee Cortical seems to be advancing considerably well towards development of its core product BARM. Backed by significant investments and highly experienced management team, Cortical appears to be well positioned to commercialise its BARM system in the near future.

 


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