Encouraged by his own experience as a GP and also by local Community Nurses to do something about the Foley - John used a Primary & Community Care Research bursary to investigate the problem and then develop a new design - here being demonstrated in a 'kitchen comparison'
John has an article accepted in the BMJ "Change the catheter!"
Initial UK Patent GB1510497 granted for the Orange catheter design
Joined by business partner Roger Holmes, former M&S CEO, engineer and investor. Set up The Flume Catheter Company Limited. Engineered development of initial prototypes with specialist developers Arrotek Medical. Secured Elizabeth Blackwell 'Proof of Concept' Award, backed by MRC and Wellcome in collaboration with Prof Marcus Drake and Dr Nicola Morris of University of Bristol/ Bristol Urological Institute (BUI)
Additional UK Patent applications made No. 1701027.3. & 1713234.1 Successful Lab Tests conducted by BUI confirm expected operation of catheter and major advantage in time to blockage, more than twice that of the market leader.
Refinement of Flume design; including selection of optimal balloon material, tapered tip design and build methods. Design frozen. Commenced process of making c.300 devices for the full range of independent tests to support the approvals required for ‘first in human clinical’ trials.
US Patent granted no 10,195,394 protecting design concept of Flume Catheter. Further UK Patent granted, GB2559883 giving protection for the method of forming the desired balloon shape. Grant funding has been secured for ‘First in human’ clinical trials that will be run in two centres, the Bristol Urological Institute (BUI) and University Hospital Southampton, under the direction of Prof. Marcus Drake and Prof. Mandy Fader. Independent testing has shown that Flume is capable of meeting the required regulatory checks, but not yet with the necessary consistency using the current manual prototype building process. The identification of the OEM manufacturer that can best support achieving scale and consistency has therefore been accelerated. These are critical steps, before seeking CE mark/ 510(k) approval and bringing the Flume Catheter to a reality for patients - Target 2021.