Flying Brands Ltd (LON:FBDU) said analysis of two studies for their Stone Checker, kidney stones treatment have reproduced and validated the results from a preliminary study, meaning the next phase of investigation can start ahead of schedule.
In an operational update, the medical services and software company said 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.
WATCH: Stone Checker's Nick Stevens 'absolutely delighted' with early completion of kidney stone studies
The group added that 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.
Flying Brands said the results from the two institutions with their different kidney stone treatment protocols have reproduced and validated the results from its preliminary study.
Next phase of statistical optimisation can now start ahead of schedule
It added, therefore, 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.
The group said, 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.
In parallel, it added, 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).
The target date for CE marking is December 2017 and for FDA approval is Q2 2018.
Stone Prevent also progressing
Flying Brands said work has also progressed on its Stone Prevent product, with development continuing, led by a leading consultant chemical pathologist based at a UK University Hospital.
They said 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.
The group said the 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, and further work in the next weeks will identify logistic partners.
Flying Brands said 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 8 2017 and will be looking for partners to help commercialise the Stone Prevent product.