A Glimpse at Cortical Dynamic's Patents, Medical Trials and Regulatory approvals

4 min read | September 30, 2019 04:01 PM AEST | By Team Kalkine Media

Intellectual property is considered as one of the most important economic assets of a corporate entity, more so in today’s knowledge economy. Developing a new technology and commercialising the same is a lengthy and expensive venture and protecting the same is increasingly encouraging the businesses to opt for patent rights.

Patent signifies a legally enforceable right that prevents the commercialisation of the patented product/technology/processes by third parties for a defined number of years.

This “exclusive right” empowers the patent owner to recover development costs and obtain a return on investment in the development of the patented technology. Thus, it is not uncommon to see investors paying higher valuation premium to businesses with rich patents family.

One such player is an Australian medical device technology company, Cortical Dynamics Ltd (Cortical or Company) with 22 registered patients.

Cortical has developed a breakthrough system- Brain Anaesthesia Response Monitor (BARM), for reliable monitoring of patients’ brain responses towards the effects of anaesthetic agents, thus helping anaesthetists in maintaining an optimal anaesthesia dose.

Cortical’s innovative, proprietary, industry disruptive technology, makes BARM system, fundamentally different from its major competitors BIS from Medtronic and E-Entropy from GE, giving it a significant advantage in the competitive market.

Source: Company Reports

Cortical’s Extensive Global Patent Coverage:
  • Cortical Dynamics has a substantial patent coverage, which have been invented either by Swinburne University alone or in collaboration with the company, with each patent being allocated to Cortical.
  • The Company has a total of 22 registered patents covered under 5 patent families, all maturing to national patent applications. These patents have progressed along the international patent law treaty (Patent Corporation Treaty) pathway. The patents are registered across several countries including, Australia, USA, Europe, Japan, New Zealand and China.
  • The patents cover both CCS (Composite Cortical State) and CI (Cortical Input).
  • Additionally, the arising intellectual property will be protected as appropriate, in view of maintaining Cortical’s strong competitive position throughout the commercialization process.

Cortical’s Patent family in detail:

Clinical Trials:
  • Cortical Dynamics published 12 papers relating to the BARM system that can be retrieved from the company’s website.
  • For the validation of the two underlying model developed by Professor Liley, and the use of actual BARM system, Cortical carried out the clinical trials at Royal Melbourne Hospital in 2007, and at St Vincent’s Hospital Melbourne in 2014. The major data analysis of the previous trials was done at Ghent University Hospital, Ghent, Belgium.

Further, Dr Adrian Sultana’s clinical results using BARM highlights the importance of BARM system.

  • Dr Adrian Sultana, MD FRCP (Glasg) FANZCA, consultant anaesthetist in Sydney, implemented clinical trials using BARM on approximately 115 patients during 2018 and continues to use the BARM System on a regular basis.

Regulatory Approvals
  • It is worth noting that Cortical Dynamics has achieved both the Therapeutic Goods Administration approval (TGA) in Australia and the CE mark in early 2016, allowing BARM to be commercialised and traded in the UK, European, Asia-Pacific, and South American markets.
  • In South Korea, application for product registration is in pipeline which comes after the signing of a Distribution Agreement in 2018.

Cortical Dynamics is currently engaged in the commercialisation of this novel proprietary technology. Company’s Directors believe that the success of Cortical’s BARM system is validated by the extensive global patent coverage, clinical trials and regulatory approvals that further supports the competitive advantage, out to 2023.

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