BioPorto A/S (“BioPorto” or the “Company”) (CPH:BIOPOR) today announced the initiation of commercialization in the US of ProNephro AKITM (NGAL) for clinical use in risk stratification for moderate-to-severe AKI for patients aged 3 months to 21 years, by receiving the first purchase order of ProNephro AKITM (NGAL) for the US market.
This purchase order is to service US hospitals through BioPorto’s distribution relationship with Roche Diagnostics. Currently, ProNephro AKITM (NGAL) has FDA 510(k) marketing clearance for Roche’s cobas® c501 analyzers, that are broadly available in standard medical laboratories and hospitals.
Peter Mørch Eriksen, BioPorto’s Group Chief Executive Officer (CEO), commented,
“As previously mentioned in the Company’s reporting and investor communications, the launch of ProNephro AKITM (NGAL) in the US is an important milestone in our journey building a commercial platform for kidney diagnostics. Today, we are pleased to announce that we have received the first purchase order from Roche. This order represents a first step and an initial commercial action toward significantly advancing adoption of ProNephro AKI in the US.”
This announcement does not alter BioPorto’s guidance for 2025 as announced on March 19, 2025 (Announcement no 5).
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