BioPorto Announces Submission of Response to FDA Additional Information Letter
June 29, 2023
News release
BioPorto Announces Submission of Response to FDA Additional Information Letter
COPENHAGEN, DENMARK and BOSTON, MA, June 29, 2023, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto or Company) (CPH:BIOPOR) today announced that it has responded to the Additional Information (AI) Letter the Company previously stated it received from the US Food and Drug Administration (FDA). The response relates to BioPorto’s De Novo application to the FDA for Marketing Authorization of an NGAL test to aid in identifying pediatric patients at risk of moderate to severe Acute Kidney Injury (AKI). AI requests are a standard part of the regulatory review process.
BioPorto completed additional analytical testing and statistical analysis requested by the FDA and submitted them in a comprehensive response prior to its announced goal of June 30, 2023. The Company continues to be in active dialogue with the FDA in support of its Breakthrough Designation application and the FDA’s ongoing review.
If the application is granted by the FDA, BioPorto’s NGAL test would be the first authorized pediatric AKI biomarker test commercially available in the US.
For investor inquiries, please contact:
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000, [email protected]
Ashley R. Robinson, US Investor Relations, LifeSci Advisors, +1 617 430 7577, [email protected]
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 product, The NGAL TestTM, is designed to aid in the risk assessment 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 The NGAL Test, 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 NGAL Test is CE marked and registered 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
This news release contains certain forward-looking statements. Words such as “believe”, “expect”, “may”, “plan”, “strategy”, “estimate”, “target” and similar expressions identify such forward-looking statements, and such forward looking statements include statements with respect to the U.S. regulatory approval process of BioPorto’s NGAL Test, the complete and comprehensive nature of BioPorto’s response to the request for Additional Information from the US Food and Drug Administration (FDA), the nature and extent of the Company’s dialog with the FDA, future commercialization opportunities for NGAL tests in the US and around the world, and other matters. Forward-looking statements involve risks, uncertainties and other factors, which may cause actual results, performance and achievements to differ materially from those contained in the forward-looking statements. These include numerous assumptions, risks and uncertainties, many of which are beyond BioPorto’s control. These assumptions, risks and uncertainties are described from time to time in BioPorto’s public announcements, its Interim Reports, and in its 2022 Annual Report under Risk Factors. BioPorto undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date of this presentation, except as required by applicable law.
