Class Medical was spun out of the University of Limerick to commercialise the Trans-Urethral Catheter (TUC) Safety Valve, a technology that won the inaugural “Enterprise Ireland Cleveland Clinic Clinical Innovation Award”. A successful first-in-man study which was completed in 2017 (n=100) winning “Best Paper in the Trauma, Reconstruction and Diversion” session at the American Urology Association (AUA) annual conference, in Boston in 2017 and was published in Urology Gold Journal in 2018. Class Medical’s prospective study on the cost implications of misplaced urinary catheters was published in the Journal of Urology in 2016 and was selected by the journal editor as one of the top three articles in 2016. Class Medical also won Innovation of the Year at the Irish Laboratory Awards in 2018, the Intertrade Ireland Seedcorn Munster region competition 2018 and was a finalist at Medtech Rising 2019.
The US patent for the TUC Safety Valve was granted in 2016, the European Patent followed in 2018 with a patent in China granted in 2019. In addition, Class Medical’s study on the long-term outcomes of urethral catheterisation injuries was published in World Journal of Urology in 2019.
Class Medical was awarded CE and ISO 13485 under MDR in February 2021.
In 2011, Dr. Niall Davis (co-founder) was a surgical trainee in urology under the tutelage of Mr Hugh Flood in University Hospital Limerick. He observed that urinary catheter balloon injuries were occurring on a frequent basis.
Urinary catheter related injuries typically occurred in men when the catheter’s anchoring balloon was inadvertently inflated in the urethra. Risk factors for catheter related injuries are the complex anatomy of the male urethra and the blind nature of the catheterisation technique. This recurring complication led to short-term complications in patients such as pain, bleeding and acute urinary retention. Over 75% of patients with severe catheter related inflation injuries developed long-term complications such as urethral stricture disease that required complex reconstructive procedures.
Although urinary catheter related complications are well described in the medical literature, currently there are no innovative mechanisms to prevent them from occurring and they receive little attention. As this was a persistent complication caused entirely by healthcare professionals he collaborated with Dr. Rory Mooney and Professor Michael Walsh to design a safe urethral catheter system that minimises urethral trauma despite inadvertent balloon inflation in the urethra. This collaborative process led to the development of the TUC Safety Valve.