BioPorto

Regulatory Filings • Sep 25, 2015

Today, BioPorto has submitted a registration application to the US Food and
Drug Administration, FDA, for approval of The NGAL Test™, cf. company
announcement no. 13 of July 3, 2015. The submission is based on finalized data
from the clinical study in the US that satisfactorily support the application’s
claim regarding the use of The NGAL Test™ in the diagnosis of acute kidney
injury. BioPorto expects to use the data commercially after FDA approval is
obtained.

Alongside the application process, BioPorto has initiated the establishment of
a business platform in the US. This will include the company’s own US sales and
support organization in charge of the commercialization of The NGAL Test™ when
FDA approval is expectedly achieved in early 2016.

The submission of the FDA application does not alter expectations for
BioPorto’s revenue and profit in 2015, as most recently expressed in the
interim report for the first half of 2015.

For further information, please contact:

Peter Mørch Eriksen, CEO

Christina Thomsen, Investor Relations Manager

Telephone +45 4529 0000, e-mail investor@bioporto.com

The kidney biomarker NGAL

Every year about 13 million people are struck by acute kidney injury worldwide,
of whom about 4 million die. 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.