REG - Braveheart Inv Group - Update on investments

Braveheart InvestmentAnnouncement

03/05/2023 07:00

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RNS Number : 1748Y  Braveheart Investment Group plc  03 May 2023

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3 May 2023

 

Braveheart Investment Group plc

("Braveheart" or the "Company")

 

Update on investments

 

Braveheart Investment Group (AIM: BRH), announces an update on two companies
within its investment portfolio, Paraytec Limited ("Paraytec") and Kirkstall
Limited ("Kirkstall").

 

Paraytec (Braveheart owns 100% per cent of the company)

 

Paraytec develops high performance specialist detectors for the analytical and
life sciences instrumentation markets. In addition, it has been undertaking a
programme with the University of Sheffield to develop rapid tests ("CX300")
for identifying cancer and pathogens, including viruses.

 

CX300 development programme and clinical study

 

The collection of patient specimens for the Covid-19 clinical study at
Sheffield NHS Trust Hospital has been successfully completed. Initial results
to compare performance of Paraytec's CX300 instrument with PCR tests indicate
up to 100% correlation with patients who tested positive by PCR.

 

The study identified that many patients who tested positive by PCR do not grow
the virus when their sample is cultured, suggesting they were not actually
infectious at the time of testing positive by PCR. Since PCR detects fragments
of viral DNA, which are present in patients both before and long after the
infectious phase, a person can receive a positive PCR test result for the
virus but not be infectious. The global PCR and realtime PCR testing market
size is forecast by The Business Research Company to grow to $26.12 billion by
2027 at a compound annual growth rate of 5.8%.

 

From Paraytec's initial results in the laboratory, without any of the
potential process automation, the CX300 is three times quicker than
conventional PCR tests at delivering a test result. It is expected to be able
to distinguish patients that are likely to be infectious from those who are
not, though they would test positive with a conventional PCR test.

 

The independent clinical statistical analysis and report is expected to be
completed in June, at which time a further update will be provided.

 

CE Marking

 

On 2 May 2023, the CX300 instrument passed independent testing for CE marking,
which certifies its compliance with required safety standards for a laboratory
use instrument. It will now be marketed for sale for researchers to use in a
range of applications.

 

Potential follow-on projects

 

Paraytec has been exploring potential follow-on projects and potential use
cases for the CX300. Applications already being evaluated by Professor Carl
Smythe's team at Sheffield University include:

 

·    To accelerate the diagnosis of sepsis by identifying, within 1 hour,
which of the three most common sepsis-causing pathogens is present in a blood
sample. Proof of concept is scheduled before the end of the year.

 

·    Lipid nanoparticles are used to deliver drugs and vaccines such as
the Pfizer Covid-19 vaccine into living cells. The CX300 has the potential to
reduce both the time and cost of this work, and therefore speeding up the
development of new treatments.

 

·    Extra-cellular vesicles are a natural form of Lipid nanoparticle.
Cancer cells excrete extra-cellular vesicles and researchers want to
characterise them. There is intense interest in this area with 7,500 papers
published on the subject last year. Current methods are either expensive or
difficult, the CX300 has the potential to reduce both the time and cost of
this work, which would speed up the development of new treatments.

 

·    Vaults are large intracellular objects linked to drug resistance.
Little is known about them, and currently there is no method of analysing
vaults. The CX300 has the potential to enable this analysis, enabling
researchers to study them.

 

·    Adeno-associated viruses. In gene therapy, virus-like particles such
as adeno-associated viruses are used to encapsulate the new gene and deliver
it into the body. There is potential for the CX300 to be used by gene therapy
manufacturers to assess the quality of their adeno-associated virus products
both during research, development and manufacturing.

 

·    Protein aggregation analysis. Proteins are used in the production of
many drugs and diagnostics. Medical protein producers need to know if the
material is denatured or aggregated, there are many methods to determine this,
however they typically have low sensitivity. The CX300 has the potential to
greatly increase this sensitivity and assist in the production of better drugs
and diagnostics.

 

·    Specific Immune cells in blood. There is the potential to use the
CX300 to inexpensively detect immune cells. These are used when diagnosing and
monitoring diseases, such as when studying cancer auto-immunity and
immunodeficiency.

 

·    Micro clots cause various problems including possible involvement in
long Covid. Sufferers with circulatory problems caused by micro clots need to
be diagnosed. There is currently no simple method of quantitative detection.
The CX300 has the potential to offer a simple fast quantitative method of
detection of micro clots aiding medical diagnosis.

 

 

Kirkstall (Braveheart owns 80% of the company)

 

Kirkstall operates in the market known as 'organ-on-a-chip', where it has
developed Quasi Vivo™, a system of chambers for cell and tissue culture in
laboratories. Its patented technology is used by researchers in the growing
New Approach Methodologies ("NAMs"), which enable human-relevant drug safety
decisions to be made without the need for animal testing.

Kirkstall's newly developed QV1200 product was launched in February 2023 and
has already attracted strong interest from actual and potential academic and
commercial customers. The QV1200 combines all of the most useful features of
the previous Kirkstall products: it is easy to set up; it allows single and
multi-organ experiments; its has an air-liquid interface (e.g. for use on lung
experiments) and a liquid-liquid interface (e.g. for use on blood brain
barrier experiments); and it has a standard microplate compatible with lab
equipment and uses standard wells used in cell experiments. In addition, the
QV1200 has an increased throughput, allows for cell imaging and uses improved
bio compatible materials. The QV1200 culture chambers are single use, which
will provide Kirkstall with the ability to seek repeat sales from each
customer.

Since 1999, animals have been recognised as sentient beings by the EU, and
following Brexit, this was ratified in UK law by the Animal Welfare
(Sentience) Act 2022. The United States of America recently passed the FDA
Modernization Act 2.0 which clarifies the use of alternative testing methods
by pharmaceutical companies. Testing of cosmetics on animals has been illegal
in the UK since 2013, and the Organ-on-a-Chip technology is designed to reduce
or replace the use of animals in research and testing.

 

 

Commenting on these updates, Trevor Brown, CEO of Braveheart, said:
"Shareholders have had to be patient for longer than we had anticipated but
with both Paraytec and Kirkstall now making material progress towards the
commercialisation of their technologies your directors are optimistic that
their patience will be rewarded."

 

For further information:

 

 Braveheart Investment Group plc                                Tel: 01738 587555
 Trevor Brown CEO

 Allenby Capital Limited (Nominated Adviser and Joint Broker)   Tel: 020 3328 5656
 James Reeve / George Payne

 Peterhouse Capital Limited (Joint Broker)                      Tel: 020 7469 0936
 Duncan Vasey / Lucy Williams

 

 

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