Curetis initiates
U.S. FDA study for Unyvero Invasive Joint Infections
Cartridge
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@curetis.com or ir@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
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