Cortical Dynamics Limited

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Introduction

Cortical Dynamics Limited ABN 88 107 557 620 (CDS or Company) is an Australian medical device technology company, incorporated in 2004, that has developed an industry disruptive brain function monitor.

CDS has received approvals from the Australian Government Department of Health (TGA) approval and the CE mark and has now commenced its market entry, hence the need to resource the company to start commercialising the system.

CDS is addressing the current problem of no reliable objective measure of patients’ consciousness during surgery. CDL's Brain Anaesthesia Response Monitor (BARM) System was developed to better detect the effect of anaesthetic agents on patients' brain activities, aiding anaesthetists in keeping patients optimally anaesthetised. The BARM System improves on currently used electroencephalogram (EEG) technologies by incorporating the latest advances in understanding how the brain’s electrical activity is produced (EEG is a recording of the electrical activity of the brain (brain wave patterns) with the electrodes placed on the forehead). CDS’s BARM System is a fundamentally different, more accurate and reliable basis of measurement of brain electrical activity during anaesthesia.

The BARM System uniquely produces two measures:
(a) Composite Cortical State (CCS) – this measures the level of consciousness of the patient under anaesthetic; and
(b) Cortical Input (CI) – this measures analgesia (pain input received by the brain).

The BARM has significant advances over other monitoring devices currently available in the market. For example, the BARM System is sensitive to Ketamine, Nitrous Oxide and Opioids. The current global market leader depth of anaesthesia monitoring devices of BIS(Medtronic) and E-Entropy (GE) are not sensitive to these three agents. One of the most important advantages of the BARM System is that it analyses the EEG of the specific patient’s brain activity, rather than using a statistical average, which the current global market leaders of BIS(Medtronic) & E-Entropy (GE) do.

By being specific to a patient, this enables an anaesthetist to ensure that they are not administering too much or too little anaesthesia to the patient and which should result in improving a patients’ recovery time from their anaesthetic. By improving the optimal dosage of anaesthesia should result in reduced patient recovery time and ultimately optimise hospital costs.

Operating theatre costs constitute a huge investment of healthcare resources, approximating one-third of the total hospital budget. Not only do the directors believe that the BARM System delivers best in class patient care and enables anaesthetists to better deal with patient care within a risk managed environment, but the, the BARM System’s broader business case is compelling.

The BARM System enables the sale of single patient use sensors, made exclusively for the BARM System, that must be replaced for each operation. In Western Europe alone there is a market of approximately 29 million operations each year, which require anaesthesia. 20% (circa 6 million of these cases per annum, use an anaesthesia procedure called Total Intravenous Anaesthesia (TIVA), whereby the anaesthetist will induce the patient with propofol and then administer intravenously anaesthetic agents of remifentanil and fentanyl. For these TIVA cases it is highly recommended that a depth of anaesthesia monitoring device be used to monitor the patients state of anaesthesia and this has a market value opportunity to Cortical of an estimated $90million based on six million single patient use sensors @$15 per sensor cost to the distributor.

CDS directors believe the advantages of the Brain Anaesthesia Response Monitor (BARM) System include:

(a) The following direct benefits:

(i) It is the only monitor with algorithms based on a model of brain electrical activity derived from physiological principles and which are specific to a patient. Other anaesthesia monitoring systems on the market use statistically based empirical approaches;
(ii) As a result, it is sensitive to a range of sedative and anaesthetic agents including midazolam, propofol, ketamine, nitrous oxide and sevoflurane, some of which other depth of anaesthesia monitors may not be able to detect;
(iii) The monitor produces a reading within 2 seconds, compared with an average of 18 seconds to 24 seconds for a leading industry competitor thereby providing a more responsive and accurate measurement for the anaesthetist and a competitive advantage for the BARM System; and
(iv) The BARM System is believed to be the only EEG based depth of anaesthesia monitor to measure both hypnotic (level of consciousness) and analgesic (pain relief) state.

(b) Use of EEG-based depth of anaesthesia monitors have been recommended with patients receiving Total Intravenous Anaesthesia (TIVA).
(c) Distribution agreements were signed in 2018 covering South Korea and for Europe covering Belgium, Netherlands and Luxemburg. Seven hospitals are currently undertaking trials and or using the BARM System in Australia, NZ and UK
(d) LiDCO Ltd UK, a UK company whose hemodynamic monitoring products are being used by more than 50% of National Health Services Hospitals in the UK, are currently trialling the BARM System with Dr Max Jonas- intensivist at Southampton University hospital.

The Depth of Anaesthesia Monitoring market consists of between 5 – 8 core competitors in the market inclusive of CDL's BARM System.

As noted above, the CDS directors believe the BARM System differentiates itself from competitors through a disruptive technology with a clear competitive advantage in a significant global market.

Of course, there are risks in investing in CDS and the OIS outlines such risks in detail. The CDS directors believe that the funding now being sought by the company will enable the company to enter the market and either drive the commercialisation for shareholder value add or position itself to be an attractive takeover target by a major industry group again with good value outcomes for all CDS shareholders.

CDS appreciated that many of its 1,733 shareholders have been on board for some time and we appreciate their patience and the board is keen to expedite value outcomes for all shareholders.

Releases

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