September 16, 2026
News Release
First Patient In - BioPorto Initiates Patient Enrollment as part of the ProNephro AKI® U.S. Adult Urine NGAL Validation Study.
COPENHAGEN, DENMARK, September 16 , 2026 – BioPorto A/S (“BioPorto” or “Company”) (CPH: BIOPOR) today 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. 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 Intensive Care Unit (ICU). The study follows BioPorto’s recently completed adult AKI cut-off study and represents the next phase of clinical evaluation for a potential adult indication in the United States.
CEO Carsten Buhl 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.”
First patient enrollment for the ProNephro AKIU.S. Adult Urine NGAL Validation Study
The first patient in the ProNephro AKI U.S. Adult Urine NGAL Validation Study has been enrolled at Massachusetts General Hospital. The study is expected to enroll approximately 900 patients across multiple U.S. clinical sites, creating a broad and representative clinical dataset to support the expansion of ProNephro AKI (NGAL) to adult patients.
BioPorto Continues with ProPharma as Clinical Research Organization
BioPorto will continue with ProPharma as the Clinical Research Organization in the study, following its involvement in the preceding AKI cut-off study. ProPharma also assisted BioPorto as the Clinical Research Organization in the ProNephro AKI U.S. Adult Urine NGAL cut-off Study.
ProNephro AKI (NGAL) is currently cleared by the U.S. Food and Drug Administration (FDA) for patients 3 months through 21 years of age. The ProNephro AK U.S. Adult Urine NGAL Validation Study is intended to support BioPorto’s clinical and regulatory pathway toward a potential adult indication in the United States.
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Investor Relations contacts
Klaus Juhl Wulff, BioPorto A/S, investor@bioporto.com, C: +45 25 63 39 90
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.
