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Curetis N.V.. (10/23/17). "Press Release: Curetis Initiates U.S. FDA Study for Unyvero Invasive Joint Infections Cartridge". Amsterdam & Holzgerlingen.

Region Region United States (USA)
Organisation Organisation FDA (US Food and Drug Administration)
  Group United States (govt)
Product Product  Unyvero molecular diagnostics platform
Persons Person Bacher, Johannes (Curetis 200812– Managing Director)
  Person 2 Weß, Ludger (akampion before 2001–2006 BioCentury Senior Editor before Financial Times Deutschland)
     


- Initial patient samples collected for second U.S. Unyvero Product Study


- Prospective clinical trial expected to start in 2018


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.


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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

   
Record changed: 2017-11-03

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