Curetis Receives U.S. FDA 510(k) Clearance of Unyvero LRT for BAL Specimens

• Broad Unyvero LRT BAL panel also includes atypical pathogens such as Pneumocystis jirovecii
• Clearance expected to substantially increase total addressable market for Unyvero System in the U.S.
• Commercial launch in the U.S. expected for Q1-2020

Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, December 20, 2019, 23:30 CET -- Curetis N.V. (the "Company" and, together with its subsidiaries, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced that the Company has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market its Unyvero LRT Lower Respiratory Tract Application Cartridge for use with bronchoalveolar lavage (BAL) samples to diagnose lower respiratory tract infections such as pneumonia. The LRT BAL panel detects a broad spectrum of clinically relevant causative agents, including atypical pathogens, as well as antibiotic resistance markers. Thereby, it provides clinicians with a valuable diagnostic tool that informs early and supports appropriate antibiotic treatment decisions in this indication.

Infections with atypical pathogens are often associated with community-acquired pneumonia (CAP), but are not considered in the context of hospital-acquired or ventilator-associated pneumonia. Therefore, hospitalized patients usually are not tested for these organisms unless there is a suspicion of infection. Further, empiric treatment of these patients does not normally cover atypical pathogens. Unyvero LRT BAL expands the diagnostic capability of clinicians to routinely identify atypical infections that might otherwise escape detection and hence can prevent prolonged inappropriate treatment of patients.

Furthermore, the Unyvero LRT BAL application is the first and only FDA cleared molecular diagnostic pneumonia panel that includes Pneumocystis jirovecii. As culture-based diagnosis of Pneumocystis jirovecii Pneumonia (PJP) is not possible, identification of this pathogen is often based on morphological detection techniques, which are labor-intensive and time-consuming and lack sensitivity. Rapid diagnosis of PJP, which causes severe and life-threatening symptoms, is crucial in patients with a weak or suppressed immune system. Initiating the appropriate therapy even one day earlier can significantly reduce mortality in this patient group.

"Pneumocystis jirovecii is a leading cause of pneumonia in immunocompromised individuals. Several features unique to Pneumocystis make its diagnosis difficult. No combination of symptoms, signs, and chest radiographic findings is diagnostic of Pneumocystis Pneumonia, the organism cannot be cultured, and its diagnosis currently relies on microscopic visualization of the characteristic cysts and/or trophic forms on stained respiratory specimens," said Richard G. Wunderink, MD, Professor of Medicine, Pulmonary Critical Care, Northwestern University Feinberg School of Medicine, and Medical Director, Medical ICU, Northwestern Memorial Hospital. "Inclusion of Pneumocystis jirovecii in a rapid comprehensive molecular panel for BAL, the preferred diagnostic procedure for Pneumocystis Pneumonia, will greatly facilitate our ability to quickly diagnose and treat these patients.”

Indiscriminate overuse and misuse of antibiotics are key drivers of dramatically spreading antibiotic resistance, a substantial global health threat. A report recently issued by the Centers for Disease Control and Prevention (CDC) revealed that drug-resistant bacteria and fungi cause almost 3 million infections and 35,000 deaths a year in the United States, meaning that antibiotic-resistant pathogens cause a serious infection every 11 seconds and a death every 15 minutes (Ref. 1).

By providing a fast and reliable solution for the rapid detection of pathogens and antibiotic resistance markers, Unyvero LRT BAL is an essential, indispensable tool for targeted antimicrobial therapy improving patient outcomes while facilitating stringent antibiotic stewardship.

"Unyvero LRT had already been cleared by the U.S. FDA for tracheal aspirate samples in April 2018,” said Johannes Bacher, COO of Curetis. "With our new Unyvero LRT BAL Application Cartridge, clinicians and hospitals can now also test bronchoalveolar lavage samples. This sample type accounts for about half of the samples obtained for the diagnosis of lower respiratory tract infections such as pneumonia. As a result, our Unyvero solution is offering the most comprehensive multiplex molecular panel for the rapid diagnosis of bacteria and fungi associated with severe pneumonia. It not only enables rapid and simultaneous detection of pathogens but also offers the broadest coverage of resistance markers.”

"We expect that the clearance of our LRT panel for BAL samples will significantly increase the total addressable market for our Unyvero System in the U.S.,” said Oliver Schacht, PhD, CEO of Curetis. "It will provide us with substantial opportunities to place Unyvero instruments for rapid testing of patients with suspected lower respiratory tract infections. Moreover, by providing laboratorians and clinicians with a powerful diagnostic tool to identify pathogens in lower respiratory tract infections earlier, faster and more reliably, Unyvero supports antibiotic stewardship efforts to avoid the unnecessary use of antibiotics.”

With commercial launch preparations underway, the Company expects to make Unyvero LRT BAL broadly available to U.S. customers in Q1-2020.

###
Reference
  1)    CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019.
        
The full 2019 AR Threats Report, including methods and appendices, is available online at www.cdc.gov/DrugResistance/Biggest-Threats.html.

About Curetis

Curetis N.V.’s (Euronext: CURE) goal is to become a leading provider of innovative solutions for molecular microbiology diagnostics designed to address the global challenge of detecting 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, thereby facilitating 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 the U.S.

Curetis’ wholly-owned subsidiary Ares Genetics GmbH offers next-generation solutions for infectious disease diagnostics and therapeutics. The ARES Technology Platform combines what the Company believes to be the most comprehensive database worldwide on the genetics of antimicrobial resistances, ARESdb, with advanced bioinformatics and artificial intelligence.

For further information, please visit www.curetis.com and www.ares-genetics.com.

Legal Disclaimer

This document constitutes neither an offer to buy nor an offer 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,” "targets,” "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’ Contact Details
Curetis N.V.
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

Attachment

• 20191220_Curetis_PR_BAL_FDA_approval_FINAL