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2016-10-25

Curetis: Curetis Announces Positive Top Line Data from U.S. FDA Trial

Curetis / Curetis Announces Positive Top Line Data from U.S. FDA Trial.
Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely
responsible for the content of this announcement.
-
Primary endpoint for Unyvero LRT product for lower respiratory tract
infections shows overall weighted average sensitivity of 90.2% and overall
weighted average specificity of 99.3%

- U.S. FDA submission being prepared

Amsterdam, the Netherlands, and Holzgerlingen, Germany, October 25, 2016
-- Curetis N.V. (the "Company
" and, together with Curetis GmbH, "Curetis
"), a developer of next-level molecular diagnostic solutions, today announced
top line data from its successfully completed Unyvero U.S. FDA trial. The
trial was designed to compare the performance of the Unyvero Instrument
Platform and the Unyvero LRT Lower Respiratory Tract Cartridge in detecting
lower respiratory tract infections to microbiology culture, the current
diagnostic standard of care. Additionally, the trial compared Unyvero results
to a composite of microbiology and independent PCR tests plus sequencing. The
prospective and retrospective study met its primary endpoint by demonstrating
an overall weighted average sensitivity of 90.2% and an overall average
weighted specificity of 99.3%.

The trial included a total of 2,203 prospective and retrospective samples and
has run 5,694 Unyvero Cartridges, including daily positive and negative
controls at each site as well as reproducibility tests. Tracheal aspirate and
bronchoalveolar lavage samples were collected at nine participating sites
across the U.S., namely Beaumont Health, Columbia University, Johns Hopkins,
Mayo Clinic, Northwestern University, Summa Health, UCLA, University of
Rochester, and University of Washington. Of these samples, 1,654 were
prospectively and 549 were retrospectively tested with the Unyvero LRT Lower
Respiratory Tract Cartridge, with standard of care microbiology culture and
with additional molecular diagnostic assays.

Furthermore, the study will be complemented with data from more than 400
contrived samples from well-characterized pathogen strains obtained from
several international strain providers. These strains were spiked into
negative patient samples and are currently undergoing testing with Unyvero at
several clinical trial sites in order to provide additional data points for
certain rare pathogens.

Overall, more than 1,100 samples tested positive for one or more pathogens on
the LRT panel. Data were available from Unyvero cartridges, from microbiology
culture and from independent molecular testing using PCR and sequencing,
resulting in a total of more than 350,000 data points. These data are fully
consistent and in line with the performance evaluation previously conducted
by Curetis for CE IVD marking in Europe, as well as published data from
various European KOLs and customer sites.

Based on these data, Curetis is now preparing its final package for a510(k)
submission for the Unyvero Platform and the LRT Cartridge to the U.S. FDA in
due course. The company is expecting feedback from the FDA in the first half
of 2017.

"We are truly excited about completing the study on time and as planned and
generating a strong and very comprehensive data set," said Dr. Oliver
Schacht, CEO of Curetis. "We have now started compiling the final submission
documents and are looking forward to receiving feedback from the FDA. We will
be working closely with the agency in the coming months."

"This is a very broad molecular panel for diagnosis of lower respiratory tract
infection," said Principal Investigator Dr. Robin Patel, Director of the
Clinical Bacteriology Laboratory and Infectious Diseases Research Laboratory
and Chair of the Division of Clinical Microbiology at Mayo Clinic. "It
includes numerous bacteria and resistance genes as well as one fungus. Beyond
panel breadth, the test yields faster results than those achieved using
traditional culture."

###

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.

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
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

Curetis_Logo
http://hugin.info/171382/R/2051121/767399.jpg
20161025_Curetis_PR_EN
http://hugin.info/171382/R/2051121/767398.pdf

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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 via Globenewswire

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