Meet the start-up: Making C-Sections safer

Med-Tech Innovation News spoke to Barry McCann, CEO of NUA Surgical, innovators in women’s health. Its flagship product is SteriCision, a self-retaining retractor specifically designed for C-Sections. 

Tell us about how NUA Surgical started. Where did the idea come from?

Our story began in 2017 when I was on the BioInnovate Ireland Fellowship and carrying out research in the area of women’s health. During the clinical immersion stage of the programme it became clear to me there was a major unmet need when it came to caesarean sections. 

C-Section is the most frequent surgery in the world, accounting for 29 million births each year. However, new mums are still at a higher risk of haemorrhage, infection and even death when undergoing a C-Section as opposed to a vaginal birth. 

Regardless of the size of the patient, all C-Section incisions require retraction in order to safely gain access to the uterus, deliver the baby, identify bleeds and safely repair tissue. Currently, this is achieved through hand-held metal retractors, disposable O-Ring retractors (which have been adapted from abdominal surgery), or simply additional staff members using hands in the incision. A lack of innovation has left obstetricians with tools that are not designed for the current patient demographic, particularly when operating on obese patients. This has a direct impact on the safety of the patient and new born child. 

What went into the development of SteriCISION? Can you tell us who you had to work with to bring the device to life?

Upon discovering this unmet clinical need, I got together with experienced polymer engineers to look into developing a solution. NUA Surgical co-founders Marie-Therese Maher and Padraig Maher have years of experience in polymer engineering and project management. We secured an Enterprise Ireland grant of around €500,000 to research a solution. Based in NUI Galway, we developed SteriCISION, a surgical device that aims to deliver safer C-Section outcomes through improved access and visualisation, bringing real benefits for clinicians, hospitals and patients.

How does your device meet what you described was previously an unmet need?

It is designed as a sterile, single use disposable surgical retractor device, providing multiple ergonomic and clinical benefits to the clinician, particularly when operating on high BMI patients. Crucially, it reduces hand use within the incision thus reducing the potential for bacteria entering the wound. It also enables clinicians to safely repair tissue and identify bleeds because it retracts the tissue out of the surgeon’s view. Additionally, the device aims to save valuable time in the surgery – increasing theatre throughput and enhancing patient recovery. The functionality and design of SteriCISION provides unparalleled support for obstetricians performing one of the most common major surgeries in the world.

What challenges did you face along the way?

Establishing a start-up company is certainly a long-term game. It takes persistence, patience and a tight team. Every step along the way is a learning curve, and the important thing is to learn quickly. Every meeting, presentation or pitch enables you to be more knowledgeable about your product and your market, and the tough encounters along the way have really helped us improve and bring focus to our business strategy. For example, we first entered the InterTradeIreland Seedcorn competition in 2019 and lost out at the regional final stage. We took on board the feedback and advice and entered again last year, and were thrilled to be named 2020 all-Ireland overall winner – a real stepping stone to bringing this device to market and really making a difference in women’s health. As well as a cash prize, the InterTradeIreland Seedcorn competition provides you with investment expert feedback on your business plan, and shortlisted companies get the opportunity pitch to investors and business leaders. The award win demonstrates that we are investor ready, and key to that success was learning from the challenges we faced along the way.

Which markets are you currently operating in?

We plan to bring our inaugural device to the US market by 2022. The US is the most expensive country in the world to give birth, yet it ranks amongst the worst of developed countries for maternal morbidity and mortality. As our entry market, there is established reimbursement, a clear regulatory pathway and significant pull from clinicians, patients and hospitals for improvements in this procedure. Initially, SteriCISION will be sold directly to key hospitals and growth will be achieved through strategic partnerships with specific distributors. There is a global demand for our device but strategically, we are focusing on the US for initial market release.

Any plans for further development? Or new products in the same area?

We have a strong pipeline of validated unmet clinical needs in the area of obstetrics and gynaecology, but for the time being our immediate focus is on getting SteriCISION to the market, before redeploying our resources to new R&D projects.

Anything else you would like to add?

I think it is appropriate for me to thank people and organisations in the medtech eco-system that have supported NUA Surgical to date. Enterprise Ireland, EIT Health, IntertradeIreland, Health Innovation Hub Ireland (HIHI) and NUI Galway have all provided a platform through resources and funding for us to develop an innovative start-up company. In addition to this, clinicians experienced entrepreneurs all over the world have given freely of their precious time to assist us. The next crucial step for NUA Surgical is to close our seed funding round which will enable us to gain FDA clearance and bring our innovation in women’s health to market.