Curetis Announces Excellent Study Data and Multi-Region Launch of Unyvero BCU Blood Culture Application Cartridge
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Curetis AG /
Curetis Announces Excellent Study Data and Multi-Region Launch of Unyvero BCU
Blood Culture Application Cartridge
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- Interim data from prospective multicenter evaluation show 98% concordance with
conventional microbiology
- Unyvero results on average available 24 hours earlier than in conventional
microbiology, enabling rapid decision on appropriate antibiotic therapy
Amsterdam, the Netherlands, and Holzgerlingen, Germany, June 15, 2016 -- Curetis
N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of
next-level molecular diagnostic solutions, today announced the broad commercial
roll-out of its new Unyvero BCU Blood Culture Application Cartridge, which was
introduced during ECCMID in April 2016. The roll-out has been initiated in
Europe, the Middle East and Asia via Curetis' internal sales force and the
company's distribution partner network.
The market launch is supported by excellent interim data from an external,
prospective, multicenter evaluation comparing the performance of the BCU
Application Cartridge against the performance of conventional microbiology work-
up of positive blood cultures that is ongoing at three European hospitals.
The interim analysis on approximately 100 patient samples demonstrated a 98%
concordance with conventional microbiology. Additional pathogens that escaped
detection by conventional microbiology were found in several cases. On average,
Unyvero results were available 24 hours earlier and in some cases up to two days
earlier than results obtained by routine diagnostic methods. The data also
confirm compatibility with most commonly used blood culture systems, namely
BacT/ALERT® (BioMérieux) and BD BACTEC(TM) (Becton Dickinson).
Curetis expects to finalize the prospective evaluation during the third quarter
of 2016 and is planning to submit a joint publication with the clinical
investigators of the study to a peer-reviewed medical journal.
"The new Unyvero Application for blood cultures has truly proven its worth in
our microbiology laboratory, thanks to its broad coverage of pathogens, the
identification of antibiotic resistances and its easy handling," said Dr. Monika
Huber, senior physician and private lecturer of the Institute of Pathology and
Bacteriology, at SMZ Otto Wagner Spital in Vienna, Austria, one of the clinical
investigators of the study. "Even with mixed infections, excellent results are
obtained within a few hours - a very valuable time gain for bringing adequate
therapy to the patient."
"We are very pleased with these first data from the prospective evaluation of
our BCU Blood Culture Application," said Dr. Achim Plum, CCO of Curetis, "They
demonstrate the versatility and utility of our new BCU Application Cartridge in
the rapid and reliable identification of pathogens and antibiotic resistance
markers in positively flagged blood cultures. The results also indicate its
significant potential to improve the management of critically ill patients with
blood stream infections."
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.
About the BCU Application Cartridge
The BCU Application Cartridge features a unique and differentiated test panel
covering more than 100 diagnostic targets, including tests detecting Gram-
positive and Gram-negative bacteria, fungi and mycobacteria, as well as tests
for up to 16 antibiotic resistance biomarkers. The Application Cartridge is used
for samples from positively flagged blood culture samples from bottles
inoculated with blood from patients with suspected blood stream infections. The
BCU Application Cartridge delivers comprehensive results within four to five
hours and requires just a few minutes of hands-on time. The cartridge is
compatible with the most common commercial blood culture systems (e.g.
BioMérieux BacT/ALERT® and BD BACTEC(TM)). The BCU Application Cartridge was CE-
IVD marked prior to its market introduction based on a clinical CE performance
evaluation study demonstrating a sensitivity of 96% and a specificity of 99%.
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(at)curetis.com or ir(at)curetis.com
www.curetis.com - www.unyvero.com
International Media & Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info((at))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(at)theruthgroup.com
Tel. +1 646 536 7012
20160615_Curetis_PR_EN:
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Unternehmensinformation / Kurzprofil:
Datum: 15.06.2016 - 07:43 Uhr
Sprache: Deutsch
News-ID 477733
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contact information:
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