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2016-02-23

Curetis AG: Curetis Starts Final Validation Study for New Unyvero Blood Culture Application Cartridge

Curetis AG / Curetis Starts Final Validation Study for New Unyvero Blood
Culture ApplicationCartridge . Processed and transmitted by NASDAQ OMX
Corporate Solutions.The issuer is solely responsible for the content of this
announcement.
- Data and CE-IVD launch expected in Q2, 2016

- Company also prepares launch of 2ndgeneration ITI Application Cartridge and
novel product for intra-abdominal infections

Amsterdam, the Netherlands and Holzgerlingen, Germany, February 23, 2016
-- Curetis N.V. (the "Company
" and, together with Curetis AG, "Curetis
"), a developer of next-level molecular diagnostic solutions, today announced
the start of a CE performance evaluation study for its third Unyvero
Application Cartridge. The BCU Blood Culture Application Cartridge is
designed to diagnose infections that are spreading through the bloodstream
and is targeting clinically most relevant microorganisms and related
antibiotic resistance markers. Curetis expects data from the study and the
subsequent launch of the CE-IVD-marked BCU Application Cartridge in Q2, 2016.

The BCU Application Cartridge features a unique and differentiated test panel
covering more than 100 diagnostic targets, including tests to identify
Gram-positive and Gram-negative bacteria, fungi and mycobacteria, as well as
tests for up to 16 antibiotic resistance markers. The Application Cartridge
is using positively flagged blood culture samples from bottles inoculated
with blood or punctate. Comprehensive results are delivered within 4 to 5
hours and require just a few minutes of hands-on time.

For the study, the BCU Application Cartridge is being validated in conjunction
with the most common commercial blood culture systems, using about 250 blood
culture samples. Previous studies testing around 200 BCU cartridges as part
of the analytical and pre-clinical performance evaluation were already
completed successfully. The data, which are to be published and presented at
upcoming conferences, are expected to support the CE-IVD-marking of the BCU
Application Cartridge. Three clinical sites in the DACH region already have
agreed to further evaluate the Unyvero BCU Application Cartridge in routine
clinical settings once it becomes available as a CE-IVD-marked product.

"With the Unyvero BCU Application Cartridge, we are entering the important
sepsis market," said Oliver Schacht, CEO of Curetis. "In Germany, sepsis is
the leading cause of death in intensive care units, with 60,000 cases per
year. In the US, sepsis has a higher incidence than common cancer types and
even heart failure. To complement the BCU cartridge with a sepsis host
response test, we have already started the partnered development program with
our Singapore-based partner Acumen announced late last year."

Curetis has also progressed with the development of a second-generation ITI
Application Cartridge for implant and tissue infections and has started the
development program towards a novel Application Cartridge targeting
intra-abdominal infections.

"The second-generation ITI Application Cartridge will be expanded from
currently 80 to up to over 100 diagnostic targets, adding further pathogens,
among them mycobacteria, and resistance markers that have become clinically
relevant in many parts of the world," Schacht added. "All in all, we expect
three product launches this year: the new cartridges for positive blood
culture, the expanded ITI cartridge and a novel application for
intra-abdominal infections. Accelerating the product pipeline development is
another key element of our post IPO equity story and in line with our
guidance to investors."

Further pipeline updates and an outlook of additional future product
opportunities will be provided in H2, 2016, including an update on the
preparation of Curetis' next US FDA trial for a second Unyvero Application
Cartridge for the US market once the ongoing LRT55 FDA trial has been
completed.

Disclaimer

CAUTION - Investigational device. Limited by Federal (or United States) law to
investigational use. The information contained in this communication does not
constitute nor imply an offer to sell or transfer any product, and no product
based on the Curetis Unyvero technology is currently available for sale in
the United States of America or Canada. The analytical and clinical
performance characteristics of any Curetis Unyvero product which may be sold
at some future point in time in the U.S. have not yet been established.

###

About Curetis

Founded in 2007, Curetis is a molecular diagnostics company which focuses on
the development and commercialization of reliable, fast and cost-effective
products for diagnosing severe infectious diseases. The diagnostic solutions
of Curetis enable rapid multi-parameter pathogen and antibiotic resistance
marker detection in only a few hours, a process that today can take up to
days or even weeks with other techniques.

To date, Curetis has raised EUR 44.3 million in an IPO on Euronext Amsterdam
and Euronext Brussels and private equity funds of over EUR 63.5 million. The
company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed
collaboration agreements with Heraeus Medical and Cempra Inc. as well as
several international distribution agreements covering many countries across
Europe, the Middle East and Asia.

On a separate note, the Company has announced for the purposes of article
2(1)(i) of Directive 2004/109/EC (as amended by Directive 2013/50/EU) and as
implemented in the Netherlands in section 5:25a of the Dutch Financial
Supervision Act (Wet financieel toezicht) that the Netherlands is the home
member state of Curetis N.V.

For further information, please visit
www.curetis.com.

Legal Disclaimer

This document constitutes neither an offer to buy nor to subscribe securities
and neither this document nor any part of it should form the basis of any
investment decision in Curetis.

The information contained in this press release has been carefully prepared.
However, Curetis bears and assumes no liability of whatever kind for the
correctness and completeness of the information provided herein. Curetis does
not assume an obligation of whatever kind to update or correct information
contained in this press release whether as a result of new information,
future events or for other reasons.

This press release includes statements that are, or may be deemed to be,
"forward-looking statements". These forward-looking statements can be
identified by the use of forward-looking terminology, including the terms
"believes", "estimates", "anticipates", "expects", "intends", "may", "will",
or "should", and include statements Curetis makes concerning the intended
results of its strategy. By their nature, forward-looking statements involve
risks and uncertainties and readers are cautioned that any such
forward-looking statements are not guarantees of future performance. Curetis'
actual results may differ materially from those predicted by the
forward-looking statements. Curetis undertakes no obligation to publicly
update or revise forward-looking statements, except as may be required by
law.

Contact details

Curetis AG
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr@curetis.comorir@curetis.com

www.curetis.com-
www.unyvero.com

International Media&Investor Inquiries

akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info(@)akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

U.S. Media&Investor Inquiries

The Ruth Group
Lee Roth
lroth@theruthgroup.com
Tel. +1 646 536 7012

20160223_Curetis_PR_EN
http://hugin.info/171382/R/1988416/730054.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Curetis AG via Globenewswire

HUG#1988416

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