Urinary tract infections (UTIs) are common in young children, affecting 5-7% of febrile children under 2 years. It is the most common serious bacterial infection in children.
A reliable diagnosis is particularly important in young children with recurrent urinary tract infections or in children (and eventually adults) with chronic kidney disease or bladder dysfunction, without sphincter control, who frequently need to confirm /exclude urinary tract infections.
There are more than 10.000.000 worldwide candidates for the urikit device, which is expected to overcome and largely replace the current existing methods of urine collection in small children, conquering their place in the market.
Seeking Investment
Additional financing will enable the company to continue the investment in the completion of prototypes and to advance to the production of the first units, with the future purpose of obtaining regulatory approval and to advance to clinical trials.
AAP Technical report: Urinary tract Infections in Febrile Infants & Young Children 1999
Current Development Stage
Until now we have produced several prototypes of this innovative medical device and tested their functionality in pediatric mannequins. We have also planned and agreed, with the main participants, the subsequent lab tests (microbiology tests) in order to ultimate the prototypes according to the foreseen hypotheses.
Our future purpose is to start the production of the first units and obtain regulatory approval in order to advance to the first clinical studies and dissemination of results.
Considering the TRL scale for medical device development, we are currently in the TLR4 phase.
Milestone 1 – 2018 : Pre clinical Studies (Microbiological)
Pre clinical Studies (Microbiological)
This phase intends to evaluate the final functionality of the device in the final materials through the microbiological analysis of collected fluids. It is planned to be conducted in collaboration with the Pediatric Nephrology and Microbiology Services of Centro Materno Infantil do Norte and the Department of Research and Formation from Centro Hospitalar do Porto (CHP).
Milestone 2 – 2019 : Medical Device Regulation
Medical Device Regulation
Obtain the approval for the medical device by the regulatory authorities of the main countries where it will be marketed.
Milestone 3 – 2019 : First Units Production
First Units Production
The objective of this phase is to obtain the production of the first devices and to organize their assembly, sterilization, packaging and labeling.
Milestone 4 – 2019/2020 : Clinical Studies
Clinical Studies
Elaboration of a report on the clinical trials carried out, based on the medical device (final product), and publication of an article in a scientific journal of international reference in the area of Pediatrics.
Milestone 5 – 2020 : Marketing
Marketing
Dissemination of the results of R&D activities, and the medical device, in pediatrics congresses.
