FLUME catheter successfully raises £2.1m Angel II funding round

The Flume Catheter Company has successfully completed its second Angel funding round, that was oversubscribed at £2.1m ($2.8m). This will be used to initiate a controlled market release in the US in 2022 and to build the platform for a wider commercial launch in 2023. As a key part of this, Duke Clinical Research Institute have been commissioned to design and oversee the gathering of comparative patient data for FLUME vs Foley in the US. This is in addition to the NIHR funded ‘Research for Patient Benefit’ evaluation that is underway in Bristol in the UK.

Introducing FLUME at AUA 2022

The FLUME catheter will launch at AUA 2022 in New Orleans, the largest annual meeting of urologists globally. FLUME will be in Booth 2479 in the “Emerging Corner”, an area showcasing new innovations. Come and meet founders Dr. John Havard and Roger Holmes and have the opportunity to see and discuss the innovative FLUME catheter.

The company is conducting a controlled market release in 2022 and is keen to align with partners who have a track record of innovation in patient care. For those interested in FLUME as an option for their patients, there will be the opportunity to request sample devices to support formulary listings.

The FLUME catheter is 510(k) cleared and is manufactured in the United States.

We look forward to meeting you at AUA!

Flume II ‘design for manufacture’

The original Flume I design enabled a critical proof of concept as well as some important confirmatory testing. It proved challenging, however, to produce sufficiently consistently to meet the requirements for human clinical trials.

We decided to bring forward the task of identifying a manufacturing partner with the capabilities to develop with us a Flume II ‘design for manufacture’ - capable of being produced at the intended scale as well as meet the regulatory requirements.  Since August 2019 we have been working with Biomerics, a major specialist OEM manufacturer based in Salt Lake City, Utah.  We are delighted with the development of Flume II and have now given the go ahead for the design.  The next steps are around design qualification and validation, in advance of seeking regulatory approvals and commencing first in human clinical trials.  On the latter, we are grateful that the grant funding has been extended for the trials planned at Bristol and Southampton.

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Grant of US Patent

We are delighted to have received the grant of US Patent no 10,194,394 This builds on the earlier UK granted patent in protecting the design concept of the Flume Catheter. There is then an additional patent application in hand to protect the method of forming the critical balloon component from an inflatable element folded over the catheter tip. We understand that this will be important in securing the necessary investment in manufacturing and distribution to bring the Flume Catheter to market.

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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