Braveheart Inv Regulatory News (BRH)

The information contained within this announcement is deemed by the Company to constitute inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.

30 September 2021

Braveheart Investment Group plc

("Braveheart" or the "Group")

Operational update on various investments

Braveheart Investment Group plc (AIM: BRH), is pleased to provide the following update on two of the companies within the Group's investment portfolio.

PhaseFocus Holdings

PhaseFocus continues to make positive progress, achieving its highest ever sales in H1 2021. In order to meet the increased demand for Livecyte™ systems, the company has opened a new manufacturing facility in Nottingham.

The company's distributors, Nakayama in Japan and Sinsi Technology in China, are now able to make onsite demonstrations of Livecyte™ to a strong pipeline of prospective buyers. CELLINK AB, recently renamed BICO Group AB, PhaseFocus's EU and US distribution partner, also has a strong pipeline and a series of Livecyte™ demonstrations is planned for those territories.

Braveheart is pleased to see the growth in sales of PhaseFocus's market leading Livecyte™ instruments to leading cell biology research institutions across the globe. The Directors believe the company has a strong future and Braveheart is working to seek an exit in the next 12 months, which, if achieved, could be at a valuation considerably in excess of the carrying value in Braveheart's accounts.

Paraytec

Paraytec's Platform Technology

Paraytec has continued to refine the platform technology that underpins its proposed fast, sensitive COVID-19 test. The platform technology (product reference "CX300") comprises a low-cost instrument that utilises intense fluorescent light to detect small specific viruses or cells in a biological sample. The biological sample is presented to the instrument via a disposable cartridge containing the reagents developed by Paraytec's team to label viruses or cells.

The CX300 platform technology is now ready for the next stage of development. Using the COVID-19 test as the lead application, it will be progressed from the current laboratory prototype into a fully functional prototype with integrated cartridge ready for testing in a clinical setting to aid development of the device to the required regulatory standards for commercial manufacture.

Paraytec plans to provide a separate update on the bladder cancer and sepsis application projects in November.

Latest results - COVID-19 test

The Paraytec team has completed testing associated with the critical design of a disposable cartridge for viral identification of the SARS-CoV-2 virus. This testing was crucial to ensure that the performance characteristics of the COVID-19 test are retained when all of the disposable components are combined in an operational device.

Key to the performance of the Paraytec test is the rapid separation of virions from other biological material present in a specimen, followed by association of fluorescent affinity molecules with surface proteins on virions. Once these have engaged, any excess unbound affinity molecules are removed, to ensure good signal-to-noise ratio and hence the analytical sensitivity of the test. The cartridge design integrates a system for selective removal of irrelevant particulate matter while retaining the biological integrity of virions, together with a "polishing" step that selectively removes excess affinity reagent.

The Paraytec test differs fundamentally from both the PCR tests, which amplify fragments of viral genes, and lateral flow tests, in which a molecular complex of SARS-CoV-2 antibodies and a specific virus protein provide a qualitative indication of the presence of viral material in a clinical specimen. The Paraytec test gives a signal when a fluorescently labelled virion passes in front of the detector. It does not respond to unassembled viral components, such as those that persist for days, or even weeks, after the illness has passed.

This is expected to be a key benefit of Paraytec's test over a PCR test: to avoid reporting a positive result for patients who are no longer infectious but whose test specimens still contain residual viral components that would be labelled positive by PCR. To validate this, the University of Sheffield team has developed an independent quantitative microscopy method for the visualisation, identification and counting of individual virions, which can then be used to compare the PCR and CX300 results for the same clinical specimen. This will be used to show regulatory authorities that, unlike PCR testing which detects the presence of viral genome only, the Paraytec test is capable of estimating viral particle load in patient specimens.

Next steps

Further to the announcement made on 13 August 2021, Braveheart has commenced its plan to accelerate the development of Paraytec's COVID-19 testing device by taking direct control of the final design and engineering packages.

To this end, Paraytec has produced several prototype versions of the instrument and is currently developing the disposable cartridges for integration within the instrument. Paraytec is working with a company who specialise in taking diagnostic instruments and disposables from laboratory prototypes through to final prototype verification, ready for transfer to the Contract Manufacturing Organisation (CMO) or commercial manufacturing partner.

During this development, Paraytec will continue to test clinical specimens and will additionally submit an application for a prospective clinical study to test subject specimens in the latest available prototypes. Once the first integrated instrument with disposable cartridge is available, the testing will be performed in a clinical setting. This study will further inform the development of the final prototype needed for the future pivotal Clinical Performance Study, which is required to confirm the performance capability of the manufactured test under point-of-care conditions and will be conducted by an independent commercial research organisation.

In parallel, Paraytec's corporate finance partner is leading discussions with over 50 companies from a wide spectrum of global markets, some of which are potential partners for licensing, some of which are potentially interested in co-development of the technology and some of which are potential acquirers of the company.

AD Scanner

Further to the announcement on 4 August 2021, Paraytec's 30-month grant funded Eurostars project with a pan-European consortium in the field of Alzheimer's disease (AD) detection ended on 31 August 2021.

As planned, a prototype instrument was tested by Vrije University Medical Centre Amsterdam (VUMC), a target user of the AD Scanner, using AD patient samples. VUMC reported that the instrument performed capillary isoelectric focusing (cIEF) in a highly stable manner and showed excellent repeatability of results. However, the analysis of test results failed to reliably discriminate between patients with Alzheimer's disease and healthy controls. The cause of this result is not known, but it is clear that commercialisation of the AD Scanner in its current form is not practical and any further work will be outside the grant funded project.

The combination, developed by Paraytec, of the cIEF analytical techniques with the ActiPix™ detection technology dramatically improves the signal to noise ratios. Paraytec is confident that this enhanced technology can be utilised in other applications, for example in the biopharmaceutical industry for quality control in manufacturing therapeutic antibodies and are seeking opportunities to explore this.

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