Recent Data on Curetis' Unyvero ITI Application Demonstrate its Clinical and Health Economic Benefits

Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced the recent presentation of new data demonstrating the clinical and health economic benefits of using the Company's Unyvero ITI (Implant and Tissue Infections) Application for the diagnosis of prosthetic joint infections. Data were presented during this year's European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, April 22-25, 2017, Vienna/Austria).

Prof. Jaime Esteban-Moreno from the Department of Clinical Microbiology at IIS-Fundación Jiménez Díaz (Madrid, Spain) presented results from a health economic study demonstrating that rapid analysis of sonication fluid from explanted joint prostheses with Unyvero ITI shortened the length of hospital stays for the patients and on average saved EUR 2,040.50 per patient. The study follows a recent publication by the group investigating the diagnostic performance of Unyvero ITI in the detection of prosthetic joint infections (PJI) in sonication fluids by the group of Prof. Esteban-Moreno.*

In addition, two studies from Charité - University Medicine Berlin (Germany) and one from Helios Endoklinik, Hamburg (Germany) demonstrated that the performance of the first-generation Unyvero ITI Application in diagnosing pathogens in PJI was similar to culture-based analysis of sonication fluids or synovial fluid with the advantages of Unyvero having a much shorter processing time and being a fully automated system. One of the aforementioned studies calculated the advantage of time-to-result as 5 hours versus

6.8 days.

Further studies from major European hospitals highlighting the advantages of the Unyvero System in various other clinical indications were also featured during ECCMID at a symposium organized by Curetis.

"Three years after marketing the first Unyvero ITI Application, more and more studies demonstrate the tremendous diagnostic and health economic advantages of rapid pathogen and resistance marker identification by Unyvero ITI in diagnosing prosthetic joint infections," said Dr. Achim Plum, CCO of Curetis. "The findings are based on the analysis of synovial fluids as well as in sonication fluids after sonication of explanted joint prostheses. With our second-generation ITI Application introduced in September 2016, we further expanded the panel to over one hundred diagnostic targets while increasing sensitivity to around 90% at a specificity of about 99%. The recent enhancements significantly increase the potential benefits of this first in class product in the management of prosthetic joint infections and other implant and tissue infections."

*Prieto-Borja L, et al. Evaluation of a commercial multiplex PCR (Unyvero i60) designed for the diagnosis of bone and joint infections using prosthetic-joint sonication. Enferm Infecc Microbiol Clin. 2017;35(4):236-242. http://dx.doi.org/10.1016/j.eimc.2016.09.007 

Disclaimer

CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on the Curetis Unyvero technology is currently available for sale in the United States of America or Canada. The analytical and clinical performance characteristics of any Curetis Unyvero product which may be sold at some future point in time in the U.S. have not yet been established.

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