Nua Surgical’s SteriCision device was developed following CEO Barry McCann’s immersion with obstetrics and gynaecology teams through the BioInnovate programme.
“Many people aren’t aware that C-sections are the most common major surgery in the world,” said Barry McCann, CEO and co-founder of Galway medtech start-up Nua Surgical. “And the number of women being clinically indicated for C-section is continuously increasing.”
A study published in The Lancet found that delivery by C-section had almost doubled globally from 2000 to 2015, when it reached about 29.7m births. This research was published in 2018 and the following year Nua Surgical was born.
A caesarean section requires the use of a retractor, a common tool for open abdominal surgeries. However, McCann said C-sections in particular present “unique challenges” and while there are many retractor designs out there, “existing instruments do not suffice”.
“Although this can be a life-saving procedure for both mother and infant, C-section delivery is also associated with increased risk of complications for the mother such as infection, haemorrhage and even death when compared to a vaginal birth,” said McCann.
“There is no gold standard retraction device recommended for C-sections and obstetricians rely on old inadequate tools, or extra assistants,” he added.
And so, Nua Surgical set out to lead innovation in this area with the SteriCision C-section retractor, which has been designed so that obstetricians and their assistants can gain hands-free unobstructed access to the uterus during surgery.
Reducing the need for the operating team to use their hands to retract tissue reduces the risk of surgical infection. The sterile single-use surgical retractor also has a “unique geometrical design” that allows surgeons to simultaneously retract the tissue at the point of incision and deflect any obstructive abdominal tissue, making it better suited to operating on patients of all sizes.
“The ergonomic design of the device also enables clinicians to safely deliver the infant, repair tissue, identify bleeds and prevent prolonged complications,” explained McCann. “By improving ergonomics of the surgery, the device can save valuable time in the surgery and, by doing so, it can enhance patient recovery and increase theatre throughput.”
So far, Nua Surgical has completed three pre-clinical animal trials to demonstrate the functionality and efficacy of SteriCision prototypes, as well as extensive bench testing and human factor testing at multiple hospitals. A quality management system in accordance with US and EU regulations is also underway, and these activities are led by company COO Marie-Therese Maher and CTO Padraig Maher.
‘It is clearly documented that women’s health companies secure far less investment than the sector deserves’
– BARRY MCCANN
The Mahers are both polymer engineers with more than 40 years’ combined industry experience at a line-up of headliners from Ireland’s vaunted west coast medtech scene.
Marie-Therese spent more than 15 years in R&D at medtech giant Medtronic, which involved bringing products from concept to commercialisation. Padraig has more than 25 years’ experience in medical device manufacturing at companies such as Johnson & Johnson, Goodman, Abbott and Mednova. He’s also a named inventor on more than 15 patents and previously founded a company developing bespoke machines for the medtech industry.
McCann, who himself has decades of experience in commercial and fundraising management, came to the medtech sector through the immersive BioInnovate programme where he worked as part of a multidisciplinary team to identify unmet clinical needs in obstetrics and gynaecology. He completed his fellowship in 2018 and went on to further develop his research with the Mahers at NUI Galway. They spun out in 2019 as Nua Surgical.
The start-up secured funding from Enterprise Ireland and EIT Health, an EU-funded initiative. It also took the top prize at the 2020 InterTradeIreland Seedcorn competition, which came with a €100,000 award. All of this has helped Nua Surgical to reach key milestones before needing to raise equity investment.
Relationships have been key to the company’s early development and, thankfully, strong connections had been established long before a pandemic made things more challenging.
“The lack of travel made it difficult to develop new relationships with clinicians and healthcare systems around the world, however we are fortunate that we had built very strong relationships since 2017 and we continue to work closely with hospitals in Ireland, the UK and the US,” said McCann. “We have recently secured a pilot study with a major US health system, which is a fantastic start to 2022 and will keep us engaging closely with our future end users.”
The Nua Surgical team has also grown in the past year to include external consultants in regulatory affairs, commercial strategy and clinical affairs. This includes acting chief medical officer Dr Robert Bilkovski. Based in Florida, he brings decades of experience in emergency medicine, clinical trial design, product development and risk management to the team, having worked in leadership roles at the likes of GE Healthcare and Abbott.
‘We wanted to know that the chemistry was right with investors’
– BARRY MCCANN
Meanwhile, the permanent team in Galway are operating out of office and lab units at the GMIT Innovation Hub. “We are surrounded by dozens of start-ups at various stages of their journey. It is an ideal facility for our current needs,” said McCann.
Like these start-ups, Nua Surgical faces the common challenge of raising early-stage investment – something made all the more difficult by the Covid-19 crisis.
“The pandemic has brought up a lot of the same issues for us as other medical device start-ups,” said McCann. “The limited access to testing facilities slowed technical progress for a period and the inability to meet face-to-face with investors certainly made it more challenging to raise finances.”
Nua Surgical is intent on finding a good fit with its investors. “We wanted to know that the chemistry was right and that they would bring additional expertise and contacts to the company, along with investment. It was a bonus if they understood the clinical space,” said McCann.
“Another challenge of our fundraising is that it is clearly documented that women’s health companies secure far less investment than the sector deserves,” McCann added.
A 2020 PitchBook analysis highlighted these missed opportunities in femtech as a mere 4pc of healthcare R&D investment was targeted specifically at women’s health issues.
‘I believe every woman would want her obstetrician to have access to the best possible surgical tools’
– MARIE-THERESE MAHER
Overcoming these hurdles, Nua Surgical is staying on track with suitable investors secured. “We are really excited to have such expertise and industry knowledge joining us in this first round,” said McCann as the start-up nears the close of a seed investment.
This funding round will give Nua Surgical the runway it needs to reach regulatory clearance in the US.
While McCann estimates a global market opportunity for SteriCision that exceeds €3bn, the focus for now is on the US, with plans to establish an office there in the coming year.
It’s a logical starting point as the US Centers for Disease Control and Prevention reports that almost one-third of all births there are delivered by C-section each year. One US patent for SteriCision has been granted and numerous others are pending.
The end goal is to bring a product to market that will make a difference in obstetric care. “I believe every woman would want her obstetrician to have access to the best possible surgical tools that would make the surgery faster to conduct and minimise the risks of her getting a wound infection or suffering any complications after the surgery,” said co-founder Marie-Therese.
“Our goal is to gather the data to prove the clinical and healthcare benefits of SteriCision in delivering safer outcomes for mothers and their newborns such that it becomes the gold standard retractor for all C-section surgeries all over the world.”
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