Chris Nelson - Kite Medical
What is your idea?
We have developed a point-of-care device to non-invasively screen for urinary reflux in children.
What problem are you solving and what is innovative about your approach?
Urinary reflux, happens when a child is urinating and urine flows up to the kidneys from the bladder - it affects 1-2 percent of children. If undiagnosed and untreated, it can lead to permanent kidney scarring and in severe cases can progress to end-stage kidney disease.
Today, the current gold standard procedure for diagnosing urinary reflux is a Voiding Cystourethrogram (VCUG). A VCUG requires that the child is referred to a radiologist in the hospital, where insertion of a urethral catheter into the bladder is performed. Once the catheter is in place the medical team will fill the child’s bladder through the catheter until the child needs to urinate. Then, during urination, the clinical team can detect and diagnose urinary reflux using radiation with a real time x –ray.
The point-of-care device that we have developed is easier to use, non-invasive and is worn by the patient as a belt during urination to screen for urinary reflux. Our technology aims to encourage screening, (due to its ease of use compared to VCUG) in all children who are at a potential risk for urinary reflux and to improve the early detection rate of clinically significant cases.
What’s the backstory here and how did you get involved?
The need for a better way to diagnose VUR in children and our technology solution emerged from participation in the BioInnovate programme, which is supported by Enterprise Ireland. During the clinical immersion phase of BioInnovate, Sarah Loughney (CEO) spent time with clinicians while they worked with children with VUR. She saw the difficulties for young patients during the VCUG diagnostic procedure, who needed catheterisation and who had to remain awake, and very still, for bladder filling and voiding procedure.
Between us, Sarah and I have over 20 years of experience in the medical device industry and Ricardo Eleuterio, our signal processing engineer, strengthens the team further. We are proud to have developed the device with our customers needs at the forefront, ensuring ease of use, portability and manufacturability.
Thanks to support from the Enterprise Ireland Commercialisation Fund project at NUI Galway, we have developed the working prototype, established a manufacturer for our device and successfully carried out proof-of-concept, pre-clinical studies.
How is this idea commercially attractive?
Our device has the potential to offer patients and physicians a more straight forward flow of care, a less traumatic experience and increased detection of urinary reflux. Physicians will be able to screen and diagnose patients with urinary reflux non-invasively during an office visit, avoiding the need to refer the patient to a radiologist. Follow-up care of the patient can also be monitored through the use of our device.
Presently, there is only 40% compliance with referral for the gold standard VCUG due to the invasiveness of the procedure. As a result the condition is often missed or diagnosed late and the child is at risk for permanent kidney damage. We aim to improve detection of clinically significant urinary reflux to prevent long term kidney impairment in children.
Looking at the competitive landscape, our proprietary device is attractive and offers significant improvements over existing procedures. Positive Physician Feedback, from paediatric urologists, physicians and other experts and influencers in urinary reflux diagnosis and management has confirmed to us that there will be sufficient international adoption of the device.
What are you looking for at the Big Ideas event?
We are seeking €3 million investment to support CE approval by Q4 of 2017, so that we can get this product ready for clinical use as soon as possible.