November 3, 2021
Announcement no. 19
Update on Patient Registration for Critical Study of NGAL in Pediatrics
COVID-19 continues to impact hospital surgeries and BioPorto’s enrollment of pediatric patients to be evaluated for moderate to severe acute kidney injury (AKI).
With the goal of optimizing the statistical power of the ongoing pediatric clinical trial for its upcoming filing with the U.S. Food and Drug Administration (FDA), BioPorto A/S (BioPorto) has decided to continue patient registry after the original goal of 31 December 2021, in the first half of 2022.
“Despite our strong focus on involving the participating clinics, enrollment has been slower than planned as COVID-19 continues to affect the healthcare sector. Based on actual enrollment numbers and the outlook for COVID-19, we have revised our enrollment forecast and expect to complete data collection in the first half of 2022,” said Christopher Bird, Chief Medical Officer at BioPorto.
Once enrollment is complete, BioPorto will continue to interact with the FDA to submit a De Novo classification request as the NGAL test retains its Breakthrough Designation status.
This announcement does not change BioPorto’s financial outlook for 2021, as most recently presented in the interim report for the second quarter of 2021.
For more information, please contact:
Chris Bird, Chief Medical Officer, BioPorto A/S, +1 858 868 1814
Tim Eriksen, Investor Relations, BioPorto A/S, +45 61 68 77 79
BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our expertise in antibodies and assays to turn new research tools into clinically useful biomarkers that can make a difference in patients’ lives. BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen Stock Exchange [CPH:BIOPOR].
2021 11 03 – Announcement No. 19