BioPorto announced that it would be initiating a pilot study for the detection of paediatric acute kidney injury (AKI). The study will be a retrospective analysis of urine collected from paediatric ICU patients in an earlier study. We expect the results from this analysis to potentially support an additional 510(k) application for this population if The NGAL Test is approved for adults. The results are expected in H119.
The study will examine the urine from paediatric patients who were previously enrolled in a study in 2014. Urine will be used in this case (as opposed to serum in the pivotal adult AKI study) as children have much lower rates of urinary tract infection, which can interfere with test results. The samples have already been tested using the company’s NGAL ELISA test as part of the previous study (but not the turbidimetric NGAL test under current investigation), so the company has a high degree of insight into the results. Given the samples are in hand, we expect the total cost to be very low, at less than DKK4m.
In most situations, the retrospective nature of the study would limit its capacity to serve as a pivotal study. However, we believe this study could potentially support paediatric approval if The NGAL test is first approved for adults. We expect the FDA to be amenable, given the limited capacity to perform clinical studies in this small population and the agency’s mandate to address paediatric indications.
The addressable market for this new indication is significantly smaller than for the adult indication. There are many fewer admissions of paediatrics to the ICU than adults, with only 4,000 beds in the US. We estimate approximately 240,000 patients per year. However, there is a significant need: 26.9% of paediatric ICU patients have AKI, 11.6% with severe AKI, the latter of which have a 77% increased risk of death.
We have increased our valuation to DKK1,105m or DKK7.10 per basic share from DKK1,078m or DKK6.93 per basic share. We have added the paediatric ICU indication as a testing market with a valuation of DKK27.0m. We have also added the cost of the study to our model, but this does not affect our financing schedule (DKK60m in 2018).