The company has developed the SteriCISION C-section Retractor, ergonomically designed to improve access and visualization during surgery, thus reducing risk factors that lead to complications. The founding team of Barry McCann, Padraig Maher and Marie-Therese Maher have over 65 years’ combined experience covering commercial, technical and design control activities. Their vision is a world where babies are born safely, women receive the best possible care, and the medical team has suitable instruments to ensure the best outcomes for mothers and their babies. The company is currently raising their Series A round to bring the technology through FDA Clearance and onto the US market in early 2025.

Recent Milestones:
· Named ‘Emerging Medtech Company of the Year’ at the prestigious Irish Medtech Awards 2023.
· Named ‘Best Indigenous Healthcare Start-up’ and ‘Best Overall Winner’ at the National HealthTech Innovation Awards 2023.
· Elizabeth Garner, MD, joins as Board Chair. Dr Garner is a global thought leader in women’s health, the President of the American Medical Women’s Association and CSO of Ferring Pharmaceuticals.
· Granted US & European Patents, plus multiple pending patents (US, China, Europe, India, Mexico, Brazil, Indonesia, Egypt, Australia) with priority date of Oct 2019.
· Established e-QMS in accordance to US and EU regulations [2023].
· Completed FDA Pre-Submission Meeting to align regulatory strategy with FDA requirements [Q4-2020]. · Completed 3 x Pre-clinical animal studies [2019-2021] & 2 x Pre-clinical cadaver studies at the Texas Medical Center [2023].
· Secured 7 x Letters of Intent from US & EU KOLs in health systems that want to trial our device once we gain regulatory clearance.
· Design for Manufacture (DFM) completed for injection moulding process [Q4-2023]

Upcoming Milestones: Establish the manufacturing line and start Design Validation & Verification Activities within the next 6 months. Submit to FDA for Class 2, 510k clearance within the next 12 months. Commence post-market studies and US commercial role out within the next 18 months.

Products: The SteriCISIONTM C-Section Retractor A lack of innovation in obstetrics has left obstetricians with inadequate surgical tools to perform C-Sections, particularly when operating on obese patients. The most common instruments used include hand-held metal retractors (such as the Doyen) and disposable O-ring retractors, but these have their limitations.
The SteriCISION C-Section Retractor is the first self-retaining surgical retractor specifically designed for this major surgery. It is a sterile, single use disposable device, providing multiple ergonomic and clinical benefits to the obstetrician, particularly when operating on high BMI patients. NUA Surgical has demonstrated functionality and efficacy of the device through bench tests and pre-clinical cadaver and animal studies. Gaining adequate access and visualization of the uterus is a constant requirement during caesarean delivery in order to safely deliver the infant, suture and crucially identify bleeds. This is significantly more challenging in obese patients and results in increased procedure time, delayed recovery and higher risk of complications. These challenging cases are becoming more prevalent, often requiring additional surgical assistants and the difficult ergonomics can lead to clinician fatigue and repetitive strain, all of which adds to higher hospital costs.

Investors: Enterprise Ireland, BlakeBrooke Ventures (US), Eabha Investments, multiple angels.

Full Company address & contact details: Nua Surgical Limited, ATU Innovation Hub, Dublin Road, Galway H91DCH9, Ireland