Med-Tech Innovation News spoke with Barry McCann, CEO of NUA Suzuki, a women’s health innovator. Its flagship product is the SteriCision, a self-holding retractor specifically designed for Caesarean section.
Please tell us how NUA surgery began. Where did the idea come from?
Our story began in 2017 when I participated in the BioInnovate Ireland Fellowship and was conducting research in the area of women’s health. During the clinical immersion phase of the program, it became clear that there was a major unmet need for Caesarean section.
Caesarean section is the most frequent surgery in the world, accounting for 29 million births each year. However, new mothers are at increased risk of bleeding, infection, and even death when they undergo a caesarean section, as opposed to vaginal delivery.
All Caesarean sections, regardless of patient size, require contraction to safely gain access to the uterus, give birth to a baby, identify bleeding, and safely repair tissue. Currently, this is achieved by hand-held metal retractors, disposable O-ring retractors (modified from abdominal surgery), or additional staff who simply use their hands in the incision. The lack of innovation has led obstetricians to use tools that are not designed for current patient demographics, especially when operating on obese patients. This has a direct impact on patient and newborn safety.
What went into the development of SteriCISION? Who did you have to work with to make your device a reality?
When I discovered this unmet clinical need, I considered developing a solution with an experienced polymer engineer. NUA Suzuki co-founders Marie-Therese Maher and Padraig Maher have many years of experience in polymer engineering and project management. We have secured approximately 500,000 Enterprise Ireland grants to research our solutions. Based at NUI Goalway, we are SteriCISION, a surgical instrument aimed at providing safer Caesarean section results through improved access and visualization, and delivering real benefits to clinicians, hospitals and patients. Was developed.
How does your device meet what was previously described as an unmet need?
Designed as a sterile disposable disposable surgical retractor device, it offers clinicians multiple ergonomic and clinical benefits, especially when operating on patients with high BMI. Importantly, it reduces the use of the hand in the incision, thereby reducing the chance of bacteria getting into the wound. It also pulls the tissue out of the surgeon’s field of view, allowing clinicians to safely repair the tissue and identify bleeding. In addition, the device aims to save valuable time in surgery, improve theater throughput, and accelerate patient recovery. SteriCISION’s features and design provide unmatched support. For obstetricians performing one of the most common major surgeries in the world.
What challenges did you face in the process?
Setting up a startup is certainly a long-term game. You need tenacity, patience, and a close team. Every step along the way is a learning curve, and the important thing is to learn quickly. Get to know your product and market with every meeting, presentation, or marketing. The difficult encounters in the process really helped us improve and focus our business strategy. For example, in 2019 we first entered the InterTrade Ireland Seedcorn contest and lost in the final stages of the region. We’re excited to take feedback and advice, rejoin last year, bring this device to market for all Irish overall winners in 2020, and be chosen as a true stepping stone to make a big difference in women’s health. Did. The InterTradeIreland Seedcorn Contest provides investment expert feedback on business plans as well as winnings, and finalists offer opportunities for investors and business leaders. The award shows that we are ready for investors and are the key to their success. I was learning from the challenges I faced along the way.
In what market are you currently doing business?
We plan to bring the first device to the US market by 2022. Although the United States is the most expensive country in the world to give birth, it is one of the worst developed countries in terms of maternity morbidity and mortality. Our market of entry includes established reimbursement, clear regulatory pathways, and significant attraction from clinicians, patients and hospitals to improve this procedure. Initially, SteriCISION will be sold directly to major hospitals and growth will be achieved through strategic partnerships with specific distributors. Although there is global demand for our devices, we are strategically focusing on the United States for the first market release.
Do you have any plans for further development? Or a new product in the same area?
There is a strong pipeline of unmet clinical needs that have been validated in the fields of obstetrics and gynecology, but for the time being, the focus is on bringing SteriCISION to market before relocating resources to new R & D projects. I have it.
Is there anything else you would like to add?
I think it’s appropriate to thank the people and organizations of the medtech ecosystem for supporting NUA Suzuki so far. Enterprise Ireland, EIT Health, Intertrade Ireland, Health Innovation Hub Ireland (HIHI) and NUI Galway have all provided a platform through resources and funding to develop innovative start-ups. In addition to this, experienced entrepreneurs of clinicians around the world have freed us valuable time to assist us. The next important step for NUA Surgical is to complete the seed funding round. This will enable us to obtain FDA approval and bring innovations in women’s health to market.
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