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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.

Mr. Kevin O’Shiel

Mr. O’Shiel has over 44 years experience in financial services. Last 20 of these were as Senior Vice President and Chief Financial Officer of Chubb Insurance company of Europe. Since retiring in 2012 he has served on the European insurance company’s board as a Non-Executive Director before stepping down in 2018 to focus on other projects. Mr. O’Shiel has also been active as an investor in a number of early stage start-up companies over the last ten years. Two of which have resulted is successful exits and 2 more recent ones that are now generating growing sales. He invests his time along with his funds.

Mr Hugh Flood

Mr. Hugh Flood is an academic Urologist since 1991 with a particular interest in Female and Reconstructive Urology. He was a Fellow with Professor Edward McGuire at the University of Michigan Medical Centre and has an MCh in Neuropharmaco/physiology. Previous appointments include Associate Professor of Urology at the University of Pittsburgh Medical Centre and Head of Urology at University Hospital Limerick. He was PI on an NIH RO1 grant (650k) while at UPMC. He has supervised a number of MCh/PhD medical theses at UL and UCC including an HRB grant-funded study (250k) at UL awarded to Dr. Niall Kelly. With almost 100 publications, Mr. Flood is a reviewer for a number of the major Urology journals and works as a Urology medicolegal claims expert for the State Claims Agency and the Medical Protection Society.

Mr Gavin Leonard MBA, BSc

Mr Leonard has been involved in the start phases of businesses in Mainland China, Hong Kong, Malaysia, and Ireland and has seen success across the board in these startups, two of which exited via trade sale. In 2015 Mr.Leonard completed a turn key project for the largest Dental Clinic in Ireland arranging the property, purchase, fit out and the marketing of that clinic which has achieved unparalleled success within the Dental industry. Along with the CMO Mr.Hugh Flood, Mr.Leonard presented the TUC Safety Valve in the "Intertrade Ireland Seedcorn Competition" winning the regional final and a €20,000 award. With CE certificate awarded to Class Medical, Mr.Leonard is now focusing on the Sales and Marketing of the TUC Safety Valve both in domestic and overseas markets.

Dr Niall Davis MD, PhD

Mr. Niall Davis is a graduate of University College Dublin, Ireland and undertook basic surgical training with the Royal College of Surgeons Ireland (RCSI). He completed his Higher Surgical Training in urology in 2017 and completed his fellowship in minimally invasive urological surgery in Melbourne in 2019. He is a senior lecturer for the RCSI and works as a consultant urologist in Beaumont and Connolly Hospitals. Mr Davis teamed up with researchers Dr Rory Mooney and Professor Michael Walsh of the University of Limerick to help develop the transurethral catheter safety valve for preventing traumatic transurethral catheterisation. Mr Davis has also completed a PhD in tissue-engineering in the University of Limerick and has >100 publications in indexed medical journals. Mr Davis continues to work with his biomedical engineering colleagues in Ireland to develop and commercialise his research interests.

Prof Michael Walsh PhD, BE

Prof Walsh is an experienced biomedical engineer and an expert in the field of fluid mechanics.  He is a founding member of the Centre for Applied Biomedical Engineering Research (CABER) Limerick, Ireland and responsible for raising over €5M in funding. Prof Walsh is an Associate Professor in the School of Engineering and a member of both the Bernal Institute and the Health Research Institute.  He is well published in both medical and engineering fields (75 peer-reviewed journal papers). His current research team includes 8 PhD students and 2 post-doctoral students. He has supervised to completion 17 PhD students and 22 MSc students. He holds 2 granted patents as lead inventor, 8 further patent applications, 12 Invention Disclosures, a royalty bearing license of technology to indigenous Irish company and 2 technologies selected for EI Business Partner program.

Dr Rory Mooney PhD, MSc, BE

Dr. Rory Mooney has held senior engineering roles with two large medical devices companies over the last 20 years, initially as a principal engineer with 8 years’ experience at Lake Region Medical, Integer, New Ross, Co Wexford, Ireland. In 2006 he joined Stryker Innovation, EMEA for 4 years as an Innovation Project Manager commercialising new technologies. He gained vast experience with Stryker in this role, which included key areas such as project management, patenting, OEM distribution agreements with commercial partners, CE marking and CE technical file generation, surgical liaison for innovation team and budgetary management of new product developments. During this time the Stryker Innovation team successfully launched over 100 special purpose orthopaedic instruments and Dr. Mooney finalised 4 OEM distribution agreements for the supply and manufacture of Oasys® spinal implants to the Stryker Spine division. Dr. Mooney has also worked as an academic in Mechanical and Biomedical Engineering, in both the University of Limerick and Galway Mayo Institute of Technology, specialising in Creative Design. He holds 3 granted patents as lead inventor, with 8 further patent applications. Dr. Mooney was CEO of Class Medical, leading the company through the Seed round of investment. In 2019, Dr. Mooney handed this mantle to Mr. Kevin O’Shiel, to allow himself to focus on the product directly and on the development and manufacture of the TUC Safety Valve, as the company enters the scale-up phase. Dr. Mooney is currently the Chief Technical Officer at Class Medical and is a full-time employee directing the technical programme of their TUC safety valve technology.

Mr. Ivan Cassidy

Ivan Cassidy’s roles in Class Medical focusing on the manufacture and the associated processes of the TUC Safety Valve, working closely with Ray McEvoy to bridge the Quality and Regulatory affairs with the manufacturing processes. Ivan has worked in Class Medical since 2017, in this time he has conducted design reviews, aided product development and testing, as well as undergone further training in ISO13485 and participated in NSAI audits. He has completed undergraduate studies in Limerick Institute of Technology, in Renewable and Electrical Energy Systems, as well as Galway-Mayo Institute of Technology earning a 1.1 Degree in Mechanical Engineering. He is currently pursuing a part time PhD in Biomedical Engineering evaluating the biological response of the human spine to external stimulus through computational modelling and analysis.

Mr. Ray McEvoy

Ray McEvoy (B.Eng, M.Eng.Sc, M.Sc (Mgmt))is responsible for Quality & Regulatory affairs as well as being QMS Mgmt Rep & PRRC within Class Medical. He has accumulated 40 years experience in design and manufacturing companies in the regulated industries such as Medical Devices, Pharma, Aerospace and Automotive. He has worked with Class Medical since 2017 and has implemented and developed the ISO 13485 Quality Management System, that has been certified by NSAI.  He has guided medical device organisations from start-up through initial product launch to self-certification of Class 1 medical devices per MDD 93/42 and to FDA registration. As well as a strong regulatory background, he is also a certified Lean Enterprise Expert, 6-Sigma Greenbelt and has facilitated or participated in process improvement programs in the USA, Germany, France, UK, as well as Ireland.
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