BioPorto (CPH: BIOPOR) has announced the enrollment of the first patient as part of the ProNephro AKI U.S. Adult Urine NGAL Validation Study, marking an important milestone in the company’s clinical efforts to expand ProNephro AKI (NGAL) to the adult population.
According to BioPorto, the ProNephro AKI U.S. Adult Urine NGAL Validation Study is designed to validate the clinical performance of ProNephro AKI (NGAL) for risk assessment of moderate to severe Acute Kidney Injury (AKI) in adult patients admitted to the ICU. ProNephro AKI (NGAL) is currently cleared by the FDA for patients three months through 21 years of age.
In a statement, Carsten Buhl, CEO of BioPorto, commented “Today’s first patient enrollment marks another major milestone in BioPorto’s strategy to expand ProNephro AKI into the U.S. adult market. Following the successful completion of the AKI cut-off study, we are now advancing into the validation phase with a study designed to enroll approximately 900 patients across leading U.S. hospitals. Together with ProPharma, our clinical research partner from the preceding study, we are taking the critical steps toward generating the clinical evidence needed to support an adult indication in the United States.”
