Curetis to Launch Next Generation CE-IVD Unyvero Implant and Tissue Infection Application Cartridge
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Curetis /
Curetis to Launch Next Generation CE-IVD Unyvero Implant and Tissue Infection
Application Cartridge
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- Launch follows successful completion of CE Performance Evaluation Study
- ITI now covers 102 diagnostic targets, including 85 pathogens and 17
resistance markers
Amsterdam, the Netherlands, and Holzgerlingen, Germany, September 6, 2016 --
Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a
developer of next-level molecular diagnostic solutions, today announced the
successful completion of the CE Performance Evaluation study of the next
generation of its Unyvero ITI Implant and Tissue Infection Application Cartridge
(Unyvero ITI).
The new Unyvero ITI comes with an extended panel and increased sensitivity. It
will be launched in the third quarter of 2016 as a CE-IVD-marked product in the
European direct sales and international distribution markets. Unyvero ITI is
designed for the diagnosis of many types of severe infections, including
prosthetic joint infections, surgical site infections, catheter-associated
infections and skin and soft tissue infections.
The next-generation cartridge now covers a total of 102 diagnostic targets: 85
of the most clinically relevant pathogenic microorganisms, including Gram
positive and Gram negative bacteria, several fungi, and 17 related antibiotic
resistance markers. Specifically, the next generation ITI cartridge has added a
universal bacterial primer, several Candida species, various types of
Streptococci, Klebsiella variicola, and other new diagnostic targets. In
addition, clinical sensitivity has been significantly improved for many key
pathogens. Unyvero ITI is the most comprehensive commercially available panel
for this indication area in a cartridge-based sample-to-answer format. The first
generation ITI Application Cartridge launched in 2014 covered a total of 80
diagnostic targets.
Sold as a consumable running on the Curetis Unyvero System, the product analyzes
many challenging and heterogeneous sample types such as fluids, tissues, swabs
and others. It is the second Application Cartridge for the Unyvero System
launched in 2016, following the recent launch of the BCU Blood Culture
Application Cartridge.
In the performance evaluation study, a total of 1,100 samples were tested with
the next generation ITI Cartridge. These included 700 samples positive for
microbial growth in the routine work-up of patients.
Final validation results from patient samples demonstrated
* an overall sensitivity for all pathogens of 86.9% and
* an overall specificity for all pathogens of 99.2%.
Several customer sites at renowned hospitals in Europe have already agreed to
further evaluate the second generation Unyvero ITI product in their clinical
routine.
"We are excited to start marketing the new ITI Application Cartridge for our
Unyvero Platform," said Dr. Achim Plum, Chief Commercial Officer of Curetis.
"Our development team has done a tremendous job and provided us with an
improved, next generation product with higher clinical sensitivity overall, as
well as an even broader panel. With more than 100 diagnostic targets covered by
the new Unyvero ITI cartridge, we believe we have a solution with the broadest
available panel for suspected implant and tissue infections and an unmatched
versatility allowing the use of a wide range of routine clinical patient sample
types."
Curetis' CEO Oliver Schacht, PhD, added, "A key priority for us since the IPO
has been the expansion and acceleration of our product pipeline. With the
successful validation and launch of the BCU product in Q2 and now the second
generation ITI cartridge in Q3, we continue to deliver on key milestones of our
equity story outlined at the time of our IPO."
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.
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(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
Curetis Logo:
http://hugin.info/171382/R/2039719/760435.jpg
20160906_ITI trial results_EN CLEAN_APPROVED:
http://hugin.info/171382/R/2039719/760434.pdf
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
Unternehmensinformation / Kurzprofil:
Datum: 06.09.2016 - 07:49 Uhr
Sprache: Deutsch
News-ID 492714
Anzahl Zeichen: 8940
contact information:
Town:
Holzgerlingen
Kategorie:
Business News
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