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Recent Data on Curetis' Unyvero ITI Application Demonstrate its Clinical and Health Economic Benefits
Several ECCMID 2017 presentations highlight advantages of rapid time to result with Unyvero ITI in Prosthetic Joint Infections
(PresseBox) (Amsterdam, the Netherlands / Holzgerlingen, Germany, )
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.
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.
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.
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.
Curetis AG
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 maximizing 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.
