RE: Buying more than double that of sell3 Oct 2023 15:43
On 30 March 2023, following completion of a public consultation process under
their Early Value Assessment programme, NICE ratified and finalised its recommendation that the
Genedrive® MT-RNR1 ID Kit can be used by the NHS. The Directors anticipate 6-8 UK Hospitals will
be in various stages from "fully operational" to "approved and beginning implementation" by end June
2023 and anticipate 6-8 non-UK distributors will be contracted by the end of the same timeframe. The
US market represents a significant opportunity for the Group's AIHL test and an FDA "pre-submission"
process is currently underway. However additional funding would be required to progress the FDA
approval process. The Company remains engaged with the FDA in the pre-submission process and, as
such, is not at a relevant point in discussions to announce possible next steps.
The Company estimates that the total addressable UK market is up to £8.5 million per annum which is
based on approximately 100,000 NICU admissions per annum and an estimated customer price per test
of more than £80. The EU market is potentially another c. £46.8 million per annum, the U.S. market is
c. £34 million and Rest of World markets around £13.8 million. Market estimates are based on end user
pricing. The Directors believe that the UK and Europe presents an attractive market opportunity for the
Company to target. The Company expects to pursue a distributor model alongside some investment in
its own business development activities including an expanded commercial sales and marketing team
to help drive initial adoption. A geographic expansion process is underway with targeted launch (outside
the UK) expected in Spain, Saudi Arabia, Austria, France and Greece in H1 2023 with other countries
to follow. Distributors have already been appointed in 8 countries. The Company is developing materials
and undergoing activities to educate the market and drive product awareness.
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