June 27, 2025
Announcement no. 18
Initiation of commercialization of ProNephro AKITM (NGAL) for diagnostic use in the US
COPENHAGEN, DENMARK and BOSTON, MA, USA, June 27, 2025 - 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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For further information
Jennifer Zonderman, BioPorto, +1 617 694 2918, jmz@bioporto.com
Hanne Søgaard Foss, +45 2636 8918, investor@bioporto.com
About BioPorto
BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers - tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company's tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem.
The Company's flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide.
BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com.
Forward looking statement disclaimer
Certain statements in this news release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the Company's expectations, intentions and projections regarding its future performance including the Company's Guidance for 2025; currency exchange rate fluctuations; anticipated events or trends and other matters that are not historical facts, including with respect to implementation of manufacturing and quality systems, commercialization of NGAL tests, and the development of future products and new indications; concerns that may arise from additional data, analysis or results obtained during clinical trials; and, the Company's ability to successfully market both new and existing products. These forward-looking statements, which may use words such as "aim", "anticipate", "believe", "intend", "estimate", "expect" and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend policy and the development of the industry in which the Company's business operates to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that may impact BioPorto's success are more fully disclosed in BioPorto's periodic financial filings, including its Annual Report for 2024 particularly under the heading "Risk Factors".
