Trish Dromey
A simple safety valve developed by Limerick start-up Class Medical can potentially prevent over one million patient injuries a year and save hospitals from paying out millions of euros in damages.
The patented safety valve, which is set to be launched globally next year, has been designed to ensure that catheters are inserted correctly. Incorrect insertion can cause injury and in some cases even death, according to company CEO and co-founder Dr Rory Mooney noting that it was the cause of a death in the US earlier this year.
“Approximately 130m catheters are placed annually with an estimated 1.7m incidents of urethral injury due to incorrect placement,” he said.
Recently chosen as the winner of the Munster round of InterTrade Ireland’s Seedcorn Competition in the early stage category, Class Medical is, according to Dr Mooney, the first to innovate in this space in 80 years, since the invention of the now globally-used Foley urinary catheter.
Seven years after the company’s three co-founders — Dr Mooney, Dr Niall Davis and Professor Michael Walsh — came up with an idea for a safety valve for a urinary catheter, the company is preparing to start manufacturing next January and to launch into international markets by March 2019.
“Our goal is to see our valve being used in all 130m catheters worldwide,” said Dr Mooney.
Based at Annacotty Business Park, where it employs six staff, Class Medical secured €550,000 in a seed round earlier this year which included private investment as well as €250,000 from Enterprise Ireland.
To bring the product to market, it is now in the process of raising a further €500,000.
Last year the company conducted a “first in man” study of its valve and it is now carrying out a sterility shelf life study of its valves in order to secure US and EU regulatory approval, which Dr Mooney expects to get early next year.
Company co-founder Dr Niall Davis was working as a trainee urologist in 2011 when he observed a patient being injured as a result of an incorrectly inserted urinary catheter.
He suggested to Dr Mooney and Prof Walsh that this should be preventable and the three of them produced a sketch of a valve which they believed would solve the problem.
With this idea, the company’s founders won the inaugural Enterprise Ireland Cleveland Clinic Clinical Innovation award of €15,000 which got them started on a feasibility study.
They subsequently established a research team at the University of Limerick, securing commercialisation funding from Enterprise Ireland.
Setting up the spin-out company in 2014, they conducted a six-month study in two hospitals to determine the extent of the problem created by misplaced catheters.
This showed a healthcare cost of in excess of €335,000 to treat 37 urethral injuries.
- said Dr Mooney, adding that their research showed that between 1995 and 2009, £20m was paid to 493 claimants for urethral injuries in the UK.
In 2017 Class Medical carried out its “first in man” study on 100 patients in Dublin’s Beaumont Hospital. The valve activated in seven cases to prevent misplacements and prevented any injuries from occurring, said Dr Mooney.
Having secured patents in both the US and Europe and applied for FDA approval, the company is making plans to carry out a large clinical trial with 1,000 patients in the US.
Although not required for a class one medical device, Dr Mooney said that the study will effectively demonstrate the efficacy of the safety valve.
The aim is to get the results published and to secure endorsements for the mandatory use of urinary catheter safety valve technology from urology associations around the world.
Class Medical plans to manufacture the valves at its premises at Annacotty, where it expects to increase its staff size to ten next year and to 17 within three years.
The plan is to start by selling to hospitals in Ireland and the UK and then to hospitals in the US and Europe.
“Our goal within a few years is to see the valve being incorporated into every catheter kit on the market,” said Dr Mooney observing that this presents Class Medical with a multi billion euro market opportunity.
