Curetis initiates U.S. FDA study for Unyvero Invasive Joint Infections Cartridge
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Curetis initiates U.S. FDA study for Unyvero Invasive Joint Infections Cartridge
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Curetis initiates U.S. FDA study for Unyvero Invasive Joint Infections Cartridge
* Initial patient samples collected for second U.S. Unyvero Product Study
* Prospective clinical trial expected to start in 2018
Amsterdam, the Netherlands, and Holzgerlingen, Germany, October 23, 2017;
published at 09:00 a.m. EDT -- Curetis N.V. (the "Company" together with Curetis
GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions,
today announced it has started collecting patient samples for a multi center FDA
study for its Unyvero IJI Cartridge for the detection of invasive joint
infections. The cartridge will be a newly developed U.S. version based on the CE
IVD marked Unyvero ITI Cartridge already marketed in Europe and other parts of
the world. The Unyvero IJI Cartridge is the second Unyvero application to
undergo a U.S. FDA study. Clearance decision by the FDA for the Unyvero LRT
(Lower Respiratory Tract) Infections Application, Curetis' first Unyvero U.S.
product, is expected by the end of 2017.
Following Institutional Review Board (IRB) approvals, the first patient samples
were collected in early October. Among the sites that have already entered the
trial for sample collection of microbiology-positive synovial fluid patient
samples are sites that previously participated in the Unyvero LRT trial (e.g.
Beaumont Hospital, Royal Oak, MI), as well as new sites (e.g. Froedtert Hospital
and the Medical College of Wisconsin, Milwaukee, WI), med fusion, (Lewisville,
TX) and a leading reference lab in the Southwest. The Company is expecting
further expansion of the network to include additional sites in the coming
months.
The overall trial design is similar to the Unyvero LRT study. Following FDA
guidance, the IJI clinical trial is expected to enroll more than 1,500
prospective test samples, complemented with archived microbiology-positive
specimens to reach significant numbers for each of the analytes in the IJI
panel, as well as a comprehensive analytical testing data package.
Development of the Unyvero IJI Application Cartridge has also advanced well. The
Company expects availability of the Cartridges and the initiation of the
prospective arm of the FDA trial to begin in 2018.
"As interactive review of the Unyvero System and the LRT cartridge application
is progressing , we decided to initiate a second U.S. FDA trial program," said
Johannes Bacher, COO of Curetis. "Upon FDA clearance, the Unyvero Invasive Joint
Infection Cartridge is expected to be yet another first-in-class application and
will expand the application options for future U.S. users of the Unyvero
Solution.
###
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.
Furthermore, Curetis has entered into a debt financing facility with EIB for up
to EUR 25 million. The company is based in Holzgerlingen near Stuttgart,
Germany. Curetis collaborates with Heraeus Medical, pharmaceutical companies,
and has entered into several international distribution agreements covering many
countries across Europe, the Middle East and Asia.
In 2017, Curetis established Ares Genetics GmbH, a wholly-owned subsidiary of
Curetis GmbH in Vienna, Austria. Ares Genetics is dedicated to maximize the R&D
and related scientific and business opportunities of the GEAR assets acquired in
2016 for the entire Curetis Group.
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 GmbH
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
20171023_Curetis_PR_EN:
http://hugin.info/171382/R/2143651/821363.pdf
Curetis_Logo:
http://hugin.info/171382/R/2143651/821365.jpg
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Source: Curetis via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 23.10.2017 - 15:02 Uhr
Sprache: Deutsch
News-ID 564755
Anzahl Zeichen: 7469
contact information:
Town:
Holzgerlingen
Kategorie:
Business News
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