Having a sick child is a huge worry for parents, and it is even worse if getting to the bottom of what is wrong involves putting the child through a distressing procedure.
Kidney reflux is the most common urological disorder in childhood, affecting 2 per cent of young children. It is most prevalent from six months to five years of age. The condition may resolve as the child gets older, but left undiagnosed and untreated it can lead to permanent kidney damage and ultimately to kidney failure.
As of now diagnosing the condition is painful and invasive, and takes place in a hospital setting.
Sarah Loughney is a bioengineer who became familiar with difficulties surrounding the diagnosis of kidney reflux while participating in the Enterprise Ireland-backed BioInnovate Fellowship programmed in 2012. This programme encourages participants to develop medical innovations to meet identified clinical needs.
Loughney has now developed a non-invasive diagnostic solution for kidney reflux that removes the need for complicated procedures and a hospital visit.
“Diagnosing kidney reflux is traumatic and involves a lot of discomfort for the child,” Loughney says. “Our technology is based around a belt-like device the child wears. Our aim is to encourage screening for the condition, as by screening the children at risk early detection of clinically-significant cases is greatly improved.”
Loughney trained as a mechanical engineer before spending eight years in the medical devices industry working for companies such as Medtronic and Novate Medical. "I think there is an entrepreneur inside me, and the BioInnovate programme gave me the tools to pursue my idea and develop it into a start-up."
During the programme, which is affiliated to Stanford University's biodesign programme, Loughney spent time working with leading paediatric clinician Prof Prem Puri, a world authority on kidney reflux and the president of the research centre at the children's hospital in Crumlin.
“I saw the difficulties for young patients during the diagnostic procedure at first hand and believed that there was potential to greatly reduce the trauma and pain experienced,” Loughney says.
“Apart from making life easier all round, our device can increase the detection of kidney reflux and monitor follow-up care. It is also a significant cost saving as the current procedure is expensive.”
Loughney is based at NUI Galway, and will license the technology IP from the university. The project currently employs four, including signal-processing engineer Ricardo Eleuterio, who has been working with Loughney since the beginning. A new company, Kite Medical, will be set up within the next few months to commercialise the product.
"We estimate the market for the device at around $550 million based on the number of children currently referred for investigation for kidney reflux in Europe and the US," Loughney says. "Our target market is all points of presentation to the health system for children with urinary tract infections from outpatient family medicine and paediatrics to hospital-based emergency and inpatient services."
The device's development has been supported by the Enterprise Ireland commercialisation fund, and it has cost about €300,000 to reach the point where Kite Medical has a working prototype and has successfully carried out proof-of-concept pre-clinical studies.
The team is now seeking investment of €3 million to support its CE approval and accelerate the roll-out of the product for clinical use. At present there is no similar device available on the market.
Kite Medical expects to employ 10 by 2018. It is likely the device will be made in Ireland, and this will add 10 more jobs.
With the product almost market-ready the next phase will be on clinical trials and jumping through the hoops for regulatory approval in the US and Europe. The product will be launched in 2018.
