Last checked at 11 Jul 2017 07:00
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