We were delighted to be selected as one of just 10 Medtech startups to pitch during the McKinsey ESIC (Early Stage Investors Conference). An opportunity to present to a very relevant audience and also to a panel of experts that shared their observations and questions.
FLUME catheter on AUA TV in New Orleans
FLUME founders Dr. John Havard and Roger Holmes being interviewed by AUA TV for the Emerging Corner at AUA 22 in New Orleans.
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.
First patient - Research for Patient Benefit (RfPB) Study in UK
Tweet today by Chief Investigator Prof. Marcus Drake on first patient for NIHR funded Research for Patient Benefit (RfPB) Study. With thanks to all the Bristol team. Follow Prof. Drake below
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 receives FDA 510(k) clearance for new indwelling urinary catheter
The Flume Catheter Company Ltd. (TFCC), a medical device company dedicated to developing an improved alternative to the Foley indwelling urinary catheter, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the FLUME catheter in the United States.
FLUME catheter successfully raises £825k Angel funding round
The Flume Catheter Company has successfully completed an oversubscribed £825k Angel funding round. This will be used to take the Flume II design for manufacture, through qualification, validation and testing ahead of seeking regulatory approvals and commencing first in human clinical trials.
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.
Grant of additional UK patent
We are delighted that the UK IPO has just granted UK Patent GB2559883, giving protection for the method of forming the desired Flume balloon shape with an inflatable element folded over the tip.
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.