Braveheart Inv Regulatory News (BRH)

1 March 2021

Braveheart Investment Group plc

("Braveheart" or the "Group")

Further update re Paraytec Limited

Further to the announcements on 29 January 2021, Braveheart Investment Group plc (AIM: BRH), is pleased to provide an update concerning progress to develop a COVID-19 test that Paraytec Limited ("Paraytec" or the "Company") is working on in conjunction with the University of Sheffield.

Testing of the first 500 samples being provided by Sheffield Hospitals Trust has been a key focus of the Paraytec team's work in the last month. The clinical sample pipeline is now fully operational.

Samples are being processed and subjected to analysis using Paraytec's photonics-based detection system. The average time to acquire test results is currently less than 120 seconds, a market-leading value. The laboratory trials data confirm the performance of Paraytec's photonics-based test in identifying patients with an infectious viral load within the acceptable range specified by MHRA.

The current gold standard for estimation of viral load continues to be laboratory-based PCR tests. However, these detect viral RNA levels and not necessarily the presence of infectious virions, which means that many patients test positive, long after they are no longer infectious. Paraytec has thus adopted an additional comparator test developed by the University of Sheffield, to verify the presence of intact virus particles. This involves ultracentrifugation and high-resolution fluorescence microscopy to independently verify the presence of virions in clinical samples.

In parallel to the sample processing described above, the Paraytec team has been using isolated lab-grown virus to optimise the operational sensitivity of its instrument for the detection of pre-symptomatic and early-stage symptomatic virus levels. It believes it will be able to confirm, within a period of four weeks, a lower limit of detection of 1,000 virions per millilitre of sample, also a market-leading value.

Paraytec will complete additional analysis of samples in the clinical pipeline in order to acquire robust statistical data and prepare the detailed technical specification required by regulators and producers. The team believes that the high speed and high sensitivity of its test may enable the undertaking of multiplexed "matrix" testing. Matrix testing combines samples from multiple people for simultaneous analysis, such that 20 parallel tests can yield individual results for up to one hundred people. Such a test would be very helpful to the successful operation of large events, like sports or music festivals.

Paraytec will now progress to a prospective clinical validation with a larger number of patient samples and seek to obtain a CE mark for the test. Depending on location, the prospective clinical trial (where individual patient outcomes are monitored over time) is expected to take two months to complete and a further update is expected to be made by the end of April 2021. As previously stated, Paraytec are seeking manufacturers and licensees to take the product to the global market, with first product manufacture expected in six months, subject to regulatory approval.

Paraytec's team has demonstrated that its patented capture and detection technology platform works with a range of aptamers and proteins. With this knowledge, the platform will be developed to test for new viruses and variants of COVID-19. Importantly, the Paraytec team is also exploring its use for rapid detection and identification of bacterial and viral pathogens present in patients with sepsis, a global killer of over 11 million people per year.

Prof Carl Smythe, who leads the University of Sheffield team, commented, "We are very pleased with the performance of the system to date and we expect additional improvements in accuracy as we optimise software."

Trevor Brown, CEO of Braveheart, commented " These latest laboratory results make clear that the Paraytec technology is capable of being market leading. Our attention will now turn towards quickly commencing the final clinical trial and commercialising our product either ourselves or with a partner. We look forward to providing the next update in April."

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