Flying Brands Limited Update on Operations (6049K)
11 July 2017 - 4:00PM
UK Regulatory
TIDMFBDU
RNS Number : 6049K
Flying Brands Limited
11 July 2017
11 July 2017
FLYING BRANDS LIMITED
("Flying Brands" or the "Company")
Update on Operations
Flying Brands (FBDU), the medical services and software company,
is pleased to announce an update on operations, strategy and
planning.
Stone Checker
Clinical research study completed
A multi-centre investigator led study comprising data from 607
patients at two academic university hospitals; Oxford University
Hospital, Oxford, UK and Peking Union Medical College Hospital,
Beijing, China, has now been completed. Internal quality review and
expert advice from a medical statistician has concluded that the
quality of the completed 607 patient data set makes it unnecessary
to extend the data collection to the 800 patients study originally
planned and consequently the data is now being analysed ahead of
schedule.
Analysis of data
The results from the two institutions with their different
kidney stone treatment protocols have reproduced and validated the
results from the preliminary study.
Initial summary statistics and univariate analyses as part of
the first milestone provided by the external independent
statistician has confirmed expectations that CT texture parameters
are significant predictors of outcome (success/failure) from
extracorporeal shock wave lithotripsy (ESWL) treatment.
The next phase of statistical optimisation can now start ahead
of schedule and will assess the best predictive model using
multi-variate analysis. This is due to be completed by the end of
July 2017.
Software development
On the basis of the strong early results, Stone Checker has
contracted with a specialist medical imaging software development
company in North America to produce medical device quality software
in the formats of both PACS plugin and a separate
cloud-implementation. These formats are universally accepted within
medical imaging industry and will enable access to the global
market.
Regulatory
In parallel, the contracted North American software development
company will also undertake regulatory work to CE mark the software
within a medical standards quality process and then manage the
submission for approval from the UK Medicines and Healthcare
products Regulatory Agency (MHRA) and US Food and Drug
Administration (FDA) to enable the Stone Checker software to be
marketed as a clinically approved tool. Prior to regulatory
approvals, some sales from a research version of the software is
anticipated upon completion of the software implementation (see
above "software-development").
The target date for CE marking is December 2017 and for FDA
approval is Q2 2018.
Stone Prevent
Work has also progressed on the Stone Prevent product.
Development is continuing, led by a leading consultant chemical
pathologist based at a UK University Hospital.
A proof of principle phase has been completed and a unique
clinical algorithm is in development which aims to simplify the
reporting of 24-hour urine tests. These results will give doctors
and patients a convenient and clinically useful service and the
information may help to reduce the rate of kidney stone recurrence.
Crucially, the Stone Prevent algorithm will generate semi-automated
patient reports for the patient and the referring clinician via an
online platform and a mobile "App". These reports can be produced
at volume by a small team, enabling the concept to be
scaled-up.
Further work in the next weeks will identify logistic partners.
Stone Checker will be presenting the clinical algorithm at The
British Association of Urological Surgeons (BAUS) Section of
Endourology Annual Meeting in Leeds on September 8th 2017 and will
be looking for partners to help commercialise the Stone Prevent
product.
The Directors of the issuer accept responsibility for the
contents of this announcement.
**ENDS**
For further information please contact:
Flying Brands Limited
Qu Li/Trevor Brown/Vinod Kaushal
Tel: 020 7469 0930
Peterhouse Corporate Finance (Financial Advisor and Broker)
Lucy Williams/Heena Karani
Tel: 020 7220 9797
This information is provided by RNS
The company news service from the London Stock Exchange
END
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