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BioPorto

Regulatory Filings Apr 3, 2018

3424_iss_2018-04-03_09a17fb1-a0ee-4f3f-bad9-216082888263.pdf

Regulatory Filings

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April 3, 2018 Announcement no. 7

BioPorto receives intention to grant for a divisional NGAL cutoff patent in Europe

The European Patent Office has published intention to grant BioPorto's patent no. EP3208616. The patent is part of BioPorto's IP rights in the NGAL area and relates to the use of NGAL for monitoring renal status. Specifically, the patent claims cover monitoring the onset of a renal disorder in a human being by measuring NGAL in subsequent samples obtained within 24 hours or less and detecting a rise in NGAL of 50 ng/ml or more.

Peter Mørch Eriksen, CEO of BioPorto, comments: "We are very pleased that this divisional application is now approved for issuance. Use of NGAL for monitoring AKI has been described in the literature in 2017. An article published in Kidney International Reports demonstrated the clinical impact of monitoring NGAL serially. The study showed that dynamic changes in NGAL are predictive, prognostic and theragnostic and may potentially serve as clinical support for AKI. This is a new and different application for the use of NGAL that may result in new areas of business for BioPorto in the future."

For further information, please contact:

Peter M. Eriksen, CEO Gry Husby Larsen, Investor Relations Telephone +45 4529 0000, e-mail [email protected]

The kidney biomarker NGAL

Every year about 13 million people are struck by acute kidney injury worldwide, of whom about 4 million dies. Nevertheless, there has been no real progress in methods of diagnosing kidney injury over the last half century. Existing methods, such as serum creatinine determination, only signal kidney failure 24-72 hours after the injury has taken place. In contrast, NGAL rises to diagnostic levels within a few hours of kidney injury and thus enables the physician to make vital clinical decisions before the damage progresses to potentially fatal renal shutdown. In addition to helping the patient, cost-benefit analyses show that implementing NGAL testing will contribute to reducing hospital costs in the management of kidney injury and its consequences.

About BioPorto

BioPorto Diagnostics A/S is an in-vitro diagnostics company that provides healthcare professionals in clinical and research settings a range of diagnostic tests and antibodies. Our pioneering product portfolio includes assays for underserved disease states such as NGAL for acute kidney injury. We sell our products in more than 80 countries through diverse sales channels and partners. BioPorto has its headquarters in Copenhagen, Denmark and is listed on the NASDAQ Copenhagen stock exchange.

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