Braveheart Investments Regulatory News (BRH)

21 July 2022

Braveheart Investment Group plc

("Braveheart" or the "Company")

Operational update on Paraytec

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

The clinical study at the Sheffield Teaching Hospital NHS Trust, referred to in the RNS of 16 June 2022, is in the final setup phase at the hospital, with recruitment expected to start within the next two weeks. This study will run alongside the Trust's existing NHS drive-through COVID-19 testing service for staff. In the first phase, up to 100 participants, 50 of whom are positive for COVID-19 and 50 who are negative, will provide swab specimens for analysis by Paraytec's CX300 instrument. This data will be compared to separate analyses by polymerase chain reaction (PCR) and for some samples, culture for live SARS-CoV-2 virus in the laboratory.

Culturing virus samples gives a reference standard for whether the participant is likely to be transmitting virus and will be performed by Professor Carl Smythe's team in a Containment level 3 laboratory (CAT3) at Sheffield University's Medical School. This study is expected to last around 4 weeks and, subject to its performance, will be followed by a longitudinal study to monitor the course of infection of participants over a ten-day period.

The sepsis test project continues to make progress. The target surface proteins in Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus (which represent over 50% of cases of bacteraemia in the local population) have been identified, along with suitable unique candidate antibodiess which will be used to attach fluorophore markers. The next stage will be to test these assays in the CAT3 laboratory. In parallel, the first multiwavelength CX300 instrument is being built and these will be brought together to formally demonstrate Proof of Concept.

The analysis of Virus Like Particles (VLPs) is a further application of Paraytec's technology. VLP's are a key technology used to deliver treatments in the rapidly growing market for gene therapy medicine. These VLPs are capsids (very small biological capsules) and are used to carry a modified DNA that will perform the gene therapy, into a patient's body. Critical to patient safety is the quality control of these VLPs. However, current analytical methods are not well suited to testing these materials during all the stages of VLP manufacture. Paraytec is now building a modified CX300 instrument to show that its new technology can be used to detect the ratio of full/empty capsids, a critical quality attribute to be determined both during production and following purification. Paraytec is working with FUJIFILM Diosynth Biotechnologies and the UK's Cell and Gene Therapy Catapult on a collaborative proposal for development of our instrumentation and comparing performance with current analytical methods during manufacturing runs.

Potential testing service: An initial batch of CX300 instruments is being assembled, tested and certified ready for sale. These will be offered to research partners and laboratories for use in studying a wide range of medical and industrial applications. The next step will be to explore CE marking for specific applications for the instrument, in addition to obtaining a functional CE mark for the machine only, with the aim of providing patient testing as a service. The Directors of Braveheart believe that commercialization through testing as a service and licensing to other testing providers offers an attractive alternative to monetizing Paraytec's technology as opposed to outright sale.

Trevor Brown, CEO of Braveheart, commented: "The significant investment of scientific, technological and financial resources in the CX300 program over the past two years has been against a continuously changing COVID-19 background, but we are satisfied that we have adapted continuously to remain relevant. We believe our COVID-19 test, once verified by the initial clinical study, will be amongst the most effective and most advanced in development. We will therefore explore how Paraytec can offer it as a commercially available public testing service as an alternative to monetizing it via the outright sale of the technology as previously envisaged."

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