Design frozen and on track for 'First in human' clinical trials

We are delighted to have reached some important milestones;

  • Design freeze; After several months of intensive further development we have frozen the design that will now be taken forward to the ‘first in human’ clinical trials. Key to this was further development of the chosen balloon material, the profile of the catheter tip, the bonding adhesives and the lubricious coating, working closely with our technology partners in each area. This now clears the way for us to make up the close to 300 devices that will be sent for the full range of independent testing needed to seek the necessary approvals for the trials.

  • Grant funding for ‘first in human’ clinical trials; Grant funding has been secured for the trials that are due to commence in Q2 2019 (subject to the above approvals). They will be run in two centres, the Bristol Urological Institute (BUI)/ Southmead Hospital and University Hospital Southampton under the direction of Prof. Marcus Drake and Prof. Mandy Fader.

On Friday 9th November, we were also delighted to be a part of the BUI’s Annual Scientific Meeting when Dr. Nicola Morris made a presentation on the Flume Catheter as part of session in recognition of the legacy of Prof Roger Feneley.

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