March 31, 2026
Announcement no. 6
BioPorto Advances U.S. Adult Urine NGAL Program with FDA Pre-Submission Request After Positive EPACRA AKI Cut Off Analysis
COPENHAGEN, DENMARK, 31 March 2026 - BioPorto A/S ("BioPorto" or "Company") (CPH: BIOPOR) today announced that it has formally submitted its FDA pre-submission package to the U.S. Food and Drug Administration (FDA). This marks an important regulatory milestone for the Company and follows the positive preliminary analysis recently completed for the U.S. adult urine NGAL Cut-off Study.
On 18 March 2026, BioPorto reported that the preliminary analysis demonstrated results supporting the study's primary endpoint, providing the foundation for the next phase of the Company's regulatory strategy. Building on these findings, BioPorto has now submitted its FDA pre-submission package, seeking Agency feedback on the proposed clinical study design for the upcoming Validation Study, which is an essential step toward U.S. regulatory 510(k) clearance.
With the pre-submission meeting package now filed, BioPorto seeks FDA feedback to align with the Agency on the Validation Study protocol.
CEO Carsten Buhl commented: "The FDA pre-submission represents an important milestone for BioPorto. The positive preliminary results from the cut-off study support continued advancement of our U.S. adult Urine NGAL program. We look forward to engaging with the FDA to align on the Validation Study protocol, which supports progress toward U.S. market clearance."
This announcement does not alter BioPorto's financial guidance as recently published on 5 February 2026.
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Investor Relations contacts
Klaus Juhl Wulff, BioPorto A/S, investor@bioporto.com, C: +45 45290000
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 2026; 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 2025, particularly under the heading "Risk Factors".
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.
