Braveheart Inv Regulatory News (BRH)

Reach announcement (non-regulatory)

10 November 2020

Braveheart Investment Group plc

("Braveheart" or the "Group")

Further update re Paraytec Limited

Market

The Directors of Braveheart have been conducting a continuous review of the fast changing situation regarding possible COVID-19 vaccines and also other companies that are developing COVID-19 tests. The very positive interim trial results of a vaccine developed by Pfizer and BioNTech are hugely encouraging and welcomed by everyone. However, the Directors believe that the roll out of a vaccine will not lessen the urgent need for a fast, specific and sensitive test for COVID-19 which is what Paraytec is focusing on bringing to market as soon as possible. The Directors' expectation is that any vaccine that becomes available to protect against COVID-19 will be, initially at least, used for the protection of front line health workers and the very vulnerable. The Directors therefore believe that the best way to protect the rest of the population will be to allow mass testing. This is what Paraytec's test is focused on achieving.

Scientific

Work to ensure that Paraytec has an integrated technology proposition combining the proprietary biochemistry, hardware and software that has been developed is making good progress. Paraytec is working to optimise the speed and accuracy of the test because these are the features most important for commercial success. This work includes speeding up the capture of virus particles from a swab or saliva sample using a laser diode to make detection faster and more accurate and using a mobile phone camera to analyse the test. Paraytec is also investigating approaches for inactivation of virus particles prior to testing, so that sample handling will be safer and disposal will be made easier.

Regulatory Pathway

A key part of the pathway for the commercial launch of Paraytec's fast and sensitive COVID-19 test concerns the standards that regulators around the world require to be met prior to launch. Paraytec is focusing its efforts on meeting the requirements of major markets (and in particular the UK, EU and the US). Paraytec has engaged with the regulatory agency processes to ensure that the trials and specifications of its test will meet or exceed the requirements that the relevant regulatory agency has set out and to ensure that the regulatory approval process is fast-tracked wherever this is possible. 

Funding

Braveheart has been working through the funding requirements of this project with the management of Paraytec and ensuring that all the funding required will be in place. Braveheart's financial resources has increased following the cash raised from the recently announced exercise of warrants and the recently announced sale of a part of our holding in Remote Monitored Systems plc, which raised approximately £3.15 million. Consequently, Braveheart now expects that the forecast cash costs of this project can now be met in full by Braveheart without the requirement to raise any funding from other sources. The cash now allocated to this project is expected to be sufficient to take the project through to a point where the product is ready for commercial launch.

In addition, other non-financial support has been applied for from governmental organisations that provide assistance for the accelerated development of diagnostic devices in selected companies.

IP and Know How protection

The development of our fast and sensitive COVID-19 test project uses a combination of existing intellectual property previously developed by Paraytec and also the creation of a wide range of new intellectual property within the fields of biochemistry, equipment hardware and software. Paraytec has employed specialist patent lawyers to assist with developing a pathway for the protection of the intellectual property and know how that has been developed during the creation of our COVID-19 test and to ensure that all novel intellectual property is protected by patents. Paraytec currently has a suite of five core patents granted and a further two patent applications submitted. Paraytec expects to be filing further additional patent applications over the next few weeks as it develops the intellectual property around the COVID-19 test project. 

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