About 29 million babies are delivered by Caesarean section (C-section) every year, making it the most frequently performed major surgery in the world. However, while it is common, it is not routine as the risk posed to the mother from haemorrhage or infection never goes away.
Innovation has been slower to reach obstetrics than other branches of surgery. Teams cope as best they can with the difficulties associated with C-section procedures but the field was ripe for innovation. This prompted medtech start-up Nua Surgical to design and develop SteriCision, a novel retractor device that makes C-Section surgery safer, easier and faster.
From a surgical perspective, C-sections can be challenging as there can be problems in accessing the uterus and managing the abdominal tissue around the incision. In addition, the risks and difficulties associated with C-section births become more acute in women who are overweight or have a high BMI.
Retraction is a key part of C-section surgery as it gives the surgeon access to and sight of the uterus. However, the current methodology is far from optimal as it relies on retractors adapted from abdominal surgery and/or intervention by human hands.
“A lack of innovation has left obstetricians with tools that are not designed for the current patient demographic and this has a direct impact on the safety of the patient and the newborn child,” says Barry McCann, Nua Surgical’s founder and chief executive. “In addition, surgeons often end up suffering from fatigue and repetitive strain injury during prolonged surgeries, and all these challenges become more significant with larger patients.”
SteriCision's main USP is its functionality as it gives obstetricians unparalleled support in theatre
McCann adds that existing metal handheld retractors can cause abdominal tissue trauma while the plastic retractors in use need two people. They can also pop out during the procedure and do not function well if significant adhesions, from a previous C-section for example, are present. They also lose their effectiveness when dealing with overweight patients as they can’t hold back a dense abdominal wall.
“Our innovative retractor device tackles a number of major unmet needs around Caesarean section surgery by providing obstetricians with a device that’s specifically designed for purpose and requires only one pair of hands to use it,” McCann says.
“SteriCision’s main USP is its functionality as it gives obstetricians unparalleled support in theatre, especially when dealing with overweight patients. SteriCision is a single-use device with multiple ergonomic and clinical benefits. 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. Additionally, the device aims to save valuable time in the surgery, thereby increasing theatre throughput and enhancing patient recovery. Long surgeries are in no one’s interest.”
McCann comes from a commercial background with 20 years' experience in the healthcare, professional sports and not-for-profit sectors. He has an MSc in medical device innovation and, in 2017-2018, took part in Stanford University's affiliated BioInnovate programme based at NUI Galway. The aim of this programme is to set multidisciplinary teams the task of finding solutions to unmet, under-met or under-recognised clinical needs.
McCann was assigned the obstetrics brief and, at the end of the programme, which involved talking to clinicians and observing C-sections to see the problems at first hand, McCann was convinced by the clinical and business case for what has now become the SteriCision retractor device. He set up Nua Surgical in April 2019 with a view to commercialising the technology but still needed to bridge the gap between what was essentially a concept at an early design stage and a fully fledged market-ready device.
The company has received €500,000 in backing from Enterprise Ireland's commercialisation fund
Having identified the skills and expertise required to bring the device to life, McCann tapped into his business contacts network to find them. This led to an introduction to engineering and medical device experts Marie Therese and Padraig Maher who subsequently joined his team.
Marie Therese has 15 years' experience in medical device manufacturing including bringing products from concept to commercialisation while her husband, Padraig, has spent 25 years in the medtech industry with companies such as Abbott and Johnson & Johnson. Also on the team, albeit remotely, are a clinical lead and a regulatory affairs consultant whose role is to advise the company on the path to FDA approval for the device. The company will also begin recruiting for quality and R&D positions shortly.
SteriCision has been through multiple iterations over the past two years but the device is now close to design freeze and the company is in discussion with local medical device manufacturers about making the product here.
The company has received €500,000 in backing from Enterprise Ireland’s commercialisation fund and the business, which is now investor ready, will be spun out from NUI Galway within a few weeks.
Nua Surgical will license the technology from the university and McCann’s focus now is on raising €2 million to accelerate the device’s progress to market and FDA approval. “We have already made a pre-submission with a very positive outcome and are now fine tuning the detail,” he says.
Our aim is to become the gold-standard retraction device for C-sections worldwide
McCann describes Nua Surgical as a women’s health company that intends looking at other femtech opportunities and bringing more solutions to market. But, for now, all the attention is on readying SteriCision for launch in 2022. The device will be sold directly to hospitals via distribution partnerships and the initial focus is the US market where 1.3 million C-sections are performed every year.
“The US is the most expensive country in the world to give birth, yet it ranks among the worst of developed countries for maternal morbidity and mortality,” McCann says. “There were compelling reasons for making it our entry market including established reimbursement, a clear regulatory pathway and a significant pull from clinicians, patients and hospitals for improvements in C-section procedures.”
Setting up Nua Surgical was McCann’s first foray into the entrepreneurial world and while it has not all been plain sailing, especially with Covid making travel and hospital visits impossible, McCann says the learning curve has been exciting and energising.
“I’ve had to get up to speed on a lot of things very fast and I knew from the outset that surrounding myself with experts was the way to go,” he says. “I’ve been hugely fortunate that so many people, including very busy clinicians, gave freely of their time and advice to help us to develop the best possible device. Our aim is to become the gold-standard retraction device for C-sections worldwide.”