Our Start-up of the Week is Galway’s Kite Medical, which has created a novel device for detecting kidney reflux in children.
“Kite Medical is a MedTech start-up with an experienced team developing a non-invasive, child-friendly solution for detecting kidney reflux to remove the need for complicated procedures and hospital visits,” explained Kite Medical CEO Joan FitzPatrick.
The NUI Galway BioInnovate programme spin-out recently closed a €1.5m investment round.
‘The Kite device will ultimately be a wearable system that will be used to detect and monitor VUR in an outpatient setting’
– SARAH LOUGHNEY
The round comprises a mix of private investment and Enterprise Ireland high-potential start-up (HPSU) funding.
“Kidney reflux, clinically known as vesicoureteral reflux (VUR), is the most common urological condition in children, affecting up to 3pc of the population and 30pc to 40pc of children presenting with a urinary tract infection (UTI),” FitzPatrick said.
“The condition may resolve as the child develops but, left undiagnosed and untreated, it can lead to permanent kidney damage and in some cases to kidney failure. VUR is the single leading cause of chronic renal failure (CRF) in children, accounting for 25.4pc of all patients with CRF.”
She said that the current gold-standard diagnostic test (voiding cystourethrogram [VCUG]) involves catheterisation of the child, filling of the bladder and x-ray exposure.
“The Kite device will gather digital data to evaluate VUR, and encourage cost savings and a move towards outpatient care. The clinical and commercial timing is optimum for the device as it gives parents and physicians an alternative that will avoid catheterisation and radiation exposure.
“The negative aspects of the VCUG test means that it is often avoided by physicians and parents. The Kite device will be used under natural voiding conditions, in a totally non-invasive way and without radiation exposure, and so opens up the market to additional patient cohorts.
“As a result, the market size for the Kite device in selected territories is estimated to be up to $2.8bn.”
Founder and chief science officer Sarah Loughney has a mechanical engineering degree from University College Dublin and more than 14 years of experience in medical device product development, having spent time working for Medtronic, Galway-based start-up Novate Medical and Renishaw. She completed the Stanford-affiliated BioInnovate fellowship programme in 2013, and Kite Medical spun out of NUI Galway in 2016.
Chief technology officer Paul Frehill is a chartered engineer with a degree in computer engineering. He started his career in the telecommunications sector at Nortel, and later in medical devices at Respironics (on ventilator design) and Syncrophi. At the latter, he held the role of engineering manager and successfully led cross-functional engineering teams in bringing next-generation wireless patient monitoring and clinical decision support systems from concept through to market.
CEO Joan FitzPatrick is an industry pharmacist with a master’s in pharmaceutics from Trinity College Dublin. She has 25 years’ experience in drug delivery and medical devices, primarily in research and development, regulatory, and quality roles at organisations including Élan Corporation, Innocoll Technologies, GlaxoSmithKline and the HPRA. She is also the director of an investment company, Éabha Investments.
The Kite Medical device uses bioimpedance to evaluate the kidneys for changes. The system comprises adhesive sensor pads, proprietary application software and a measurement connector.
Bioimpedance is the ability of biological tissues to impede electric current due to ionic properties within tissue cells. By applying a controlled amount of alternating current into a section of tissue, the resulting voltage across that tissue generates an acquired signal that can be measured.
“The Kite device will ultimately be a wearable system that will be used to detect and monitor VUR in an outpatient setting,” Loughney explained. “Data will be collected and remote monitoring will be possible. The Kite device will significantly reduce the need for the VCUG test, thereby promoting cost savings, and enhancing patient experience and outcomes.”
Loughney said that the company is currently preparing for a pilot clinical investigation, which will be conducted later this year. “This involves significant effort preparing documentation for relevant approvals. We are also focused on clearly defining the user needs for future iterations of a commercial product and manufacturing.
“We completed a seed funding round earlier this year and have initiated discussions on our planned Series A round. This will allow us to continue design and development efforts, conduct further clinical studies, and obtain regulatory approval in Europe and the US,” said Loughney.
FitzPatrick said that product development always brings challenges. “Though, sometimes, those challenges can lead the project to a more advanced pathway to work more efficiently or expedite some aspects of the work.
“When running lean, each team member has to take on lots of different responsibilities, which is stressful and you need to know when to ask for support.”
She said that Galway is a great centre for start-ups and it is a very cooperative and integrated environment. “Enterprise Ireland has been a great support to Kite Medical from the start and they continue to facilitate us in meeting the right people. We are also greatly supported by the wealth of experienced entrepreneurs and mentors in the MedTech space and especially in Galway, who are more than willing to offer advice.”
Her advice to fellow founders? “Look for support and never rest when it comes to funding needs.”