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Press Release

Curetis to Hold Investor Conference Call with Webcast on U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge today

Posted on: 04 Apr 18

Curetis to Hold Investor Conference Call with Webcast on U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge today

Amsterdam, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, April 04, 2018, 04:00 am EDT - after having obtained the De Novo clearance by the U.S. FDA for its Unyvero System and the Unyvero LRT Application Cartridge, Curetis N.V. will host a public investor conference call with webcast today at 03:00 pm CEST / 09:00 am EDT.

In this call Curetis will provide an overview on the Unyvero System and LRT Cartridge for the U.S. market, the FDA De Novo clearance decision and the underlying U.S. clinical evaluation data, and the planned U.S. launch and market development activities.

The conference call will be supplemented by a presentation, which can be accessed during the call at (participants' passcode curetis0418).

A slide presentation accompanying the investor update conference call will be accessible at using the passcode curetis0418.

To access the call, please dial the following numbers using the passcode 93120684#

BEL: +32 11500307
D: +49 69 222229043
NL: +31 1071 372 73
UK: +44 20 30092452
US: +1 855 4027766

For further international dial-in numbers, please open the following link:

The recorded webcast will be available after completion of the conference call at:


About the Unyvero System

The Unyvero System with the Unyvero LRT Cartridge is the first, most comprehensive molecular diagnostics (MDx) product for lower respiratory tract infections that has been granted clearance by the FDA. With 29 multiplexed PCR assays it can detect more than 30 Gram-positive and Gram-negative bacterial organisms known to cause lower respiratory tract infections, as well as 10 genetic markers for antibiotic resistance, including carbapenem and 3rd generation cephalosporins. Preparations for a future submission of bronchoalveolar lavage (BAL) sample types for use with the LRT Cartridge are progressing, and the Company intends to request a pre-submission meeting in due course. The Company also is already collecting patient samples for a multi-center FDA study for its Unyvero IJI Cartridge for the detection of invasive joint infections. Further Unyvero Cartridges with unique panels designed for the rapid diagnosis of microbial and viral infections are in preparation.

About Curetis

Curetis N.V. (Euronext: CURE) is a leading provider of innovative solutions for molecular microbiology designed to address the global challenge of diagnosing severe infectious diseases and identifying antibiotic resistances in hospitalized patients.

Curetis' Unyvero System is a versatile, fast and highly automated molecular diagnostic platform for easy-to-use, cartridge-based solutions for the comprehensive and rapid detection of pathogens and antimicrobial resistance markers in a range of severe infectious disease indications. Results are available within hours, a process that can take days or even weeks if performed with standard diagnostic procedures, and thereby facilitates improved patient outcomes, stringent antibiotic stewardship and health economic benefits. Unyvero in-vitro-diagnostic (IVD) products are marketed in Europe, the Middle East, Asia, and in the U.S.

Curetis' wholly-owned subsidiary Ares Genetics GmbH offers next-generation solutions for infectious disease diagnostics and therapeutics. ARES' technology platform combines the world's most comprehensive database on the genetics of antimicrobial resistances with advanced bioinformatics and artificial intelligence.

For further information, please visit and .

Legal Disclaimer

This announcement contains inside information. This is a public announcement pursuant to article 17 paragraph 1 of the European Market Abuse Regulation (596/2014).

This document constitutes neither an offer to buy nor to subscribe for 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 or

International Media & Investor Inquiries

Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

U.S. Media & Investor Inquiries

The Ruth Group
Lee Roth
Tel. +1 646 536 7012

20180404_Curetis_PR_Telco Details_EN

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

Last updated on: 05/04/2018

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