Tag: Curetis
Company News: Curetis to Present Clinical Unyvero™ Data at Major Scientific Conferences
– Lower Respiratory Tract application: initial clinical evaluation data from U.S. center will be presented at ICAAC 2013 (USA)
– New application Implant and Tissue Infections: first data will be presented at DGHM/DGI meeting (Germany)
Curetis AG today announced the upcoming presentation of new clinical data on two Unyvero™ applications at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) in Denver, CO (Sept. 10-13) and at the 65th Joint Annual Meeting of the German Society for Hygiene and Microbiology and the German Society for Infectious Diseases (DGHM/DGI 2013) in Rostock, Germany (Sept. 22-25).
Curetis will introduce clinical data from a U.S. pre-FDA trial phase of its Unyvero™ LRT (Lower Respiratory Tract) infection application at the ICAAC conference. The poster ‘Evaluation of a Molecular Multiplex Test For Detection of Respiratory Microorganism and Antibiotic Resistance Genes in Clinical Specimens’[1] will present data generated at Northwestern Memorial Hospital (Chicago, IL) during the initial familiarization and training phase for the FDA trial. The FDA trial is now being conducted at four sites; all clinical data are blinded until completion of this ongoing trial which is expected for 2014. The LRT application is already marketed and branded outside the U.S. as the Unyvero™ P50 pneumonia application. During ICAAC, Curetis will also showcase its Unyvero™ Solution at booth no. 822 in the exhibition hall.
Moreover, Curetis will present data of its novel Unyvero™ i60 ITI application for the diagnosis of implant and tissue infections detecting pathogens and resistance markers at the annual DGHM/DGI meeting. The poster presentation ‘A new Multiplex PCR-Panel for the Detection of Pathogens Related to Implant and Tissue Infection’[2] will introduce the panel chosen for the diagnosis of eight indication areas and present initial validation and verification data with clinical samples. Curetis will also host the industry symposium ‘Implant and Tissue Infections – A Diagnostic Challenge’ (Sept. 24, 12:15-1:15pm, Auditorium 2) featuring talks and case studies by Prof. Petra Gastmeier (Berlin, Germany), Dr. Anne Thews (Holzgerlingen, Germany), Prof. Andrej Trampuz (Berlin, Germany), and Dr. Olivier Borens (Lausanne, Switzerland). A second poster based on data independently generated at the University Hospital in Basel, Switzerland will present a ‘Comparison of the Unyvero™ Pneumonia P50 Assay with standard culture and antimicrobial susceptibility testing’.[3]
[1] Presentation D-1655a, Session: #214 – Diagnosis and Epidemiology of Respiratory Infections, Sept. 13, 8:30-10:30am, Exhibit Hall A.
[2] Presentation DVP02, Postersession I (StAG Diagnostic Microbiology and Microbiology Procedures Quality Standards), Sept. 23, 3:00pm, Auditorium 1
[3] Presentation KMP14, Postersession II (StAG Clinical Microbiology and Infectious Diseases), Sept. 24, 3:00pm, Room HS323.
Company News: Curetis Initiates Prospective Multicenter Unyvero™ Study in Europe
– Study to demonstrate added value of Unyvero™ P50 pneumonia application in clinical routine –
Curetis AG today announced the start of an additional prospective, multicenter clinical trial of its marketed Unyvero™ P50 Pneumonia Application to demonstrate its clinical and health economic value.
The CE performance evaluation completed last year already demonstrated 81% sensitivity at 99% specificity for detecting pneumonia-causing pathogens. Following the market launch in April 2012, Curetis in 2013 presented data from more than 1,000 patient samples showing overall sensitivity of its pathogen panel of 80.6% at a specificity of 96% (ECCMID European Conference of Clinical Microbiology and Infectious Diseases, Berlin).[1]
The new multicenter study aims to establish real-world data on the health economic impact of fast, patient-near molecular testing and subsequent therapy adjustments (if necessary). It will be conducted in five leading European centers and will involve several hundred critically ill patients with pneumonia requiring mechanical ventilation. The study is designed to first evaluate the current pneumonia treatment and clinical outcome situation by detailed chart reviews comparing patients having received initial adequate, respectively inadequate treatment. Data will be used to fine tune endpoints for the interventional, randomized second part of the study, which aims to investigate the potential clinical and economic benefit of the Unyvero™ system. Parameters analyzed will be, e.g. type of antibiotic regimen and costs, length of stay in the ICU, etc.
Participating clinicians are world-renowned intensive care, pulmonology and microbiology specialists: Prof. Manfred Quintel (University of Goettingen), Prof. Tobias Welte (MHH University Clinic Hanover), Prof.s Philippe Eggimann and Gilbert Greub (CHUV University Hospital of Lausanne), Prof. Mathias Pletz (Jena University) and Prof. Antoni Torres (University Hospital Clinic Barcelona).
Preliminary results of the study are expected by the end of this year.
[1] Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.
Company News: Curetis Raises EUR 12.5 Million in Series B Round Led by New Investor HBM Partners
– Co-investment of all current institutional investors as well as several private investors and management
– Company now has access to over EUR 20 million in cash for the next phase of commercial and operational growth
Curetis AG today announced the closing of a Series B financing round totaling EUR 12.5 million. The financing was led by HBM Partners, which has taken a EUR 6.0 million equity stake in Curetis. Dr. Alexander Asam of HBM will join Curetis’ supervisory board.
In addition, the company’s existing institutional investors aeris Capital, LSP Life Sciences Partners, Forbion Capital, BioMedInvest, Roche Venture Fund, CD Venture and KfW have contributed a total of EUR 5.6 million to the round on a pro rata basis. Curetis’ management as well as several of the company’s founders, private investors and board members also co-invested.
Including the latest Series B financing, Curetis has raised a total of EUR 49.1 million in equity capital to date.
Curetis will use the proceeds for the next phase of commercial and operational growth, including a prospective, multi-center FDA registrational trial with 2,000 patients and the further expansion of the company’s commercial activities and team in Europe.
Curetis anticipates a phase of rapid market adoption in the DACH region (Germany, Austria, Switzerland) where more than 50 top tier hospitals have agreed to install Unyvero™ for local testing. The inclusion of Unyvero™ in an upcoming global Phase IIb trial by Sanofi Pasteur is expected to add further momentum to the market penetration of Unyvero™.
Moreover, the company expects to continue the rapid international expansion of its commercial distribution network across Europe and the Middle East, but also towards Asia, Latin America and, following FDA clearance, to the USA.
Further upcoming milestones include the market launch of a second Unyvero™ cartridge application (ITI) together with Heraeus Medical and clinical data from a global Phase III trial in community-acquired bacterial pneumonia conducted by Cempra Pharmaceuticals.
Company News: Curetis to Present Clinical Unyvero™ Data at ECCMID 2013 in Berlin
– Company to host medical symposium on molecular antibiotic resistance testing in standard care
Curetis AG today announced the presentation of top-line clinical data from various European cohorts and performance evaluation studies of the Unyvero™ System and the Unyvero™ P50 pneumonia cartridge at the European Conference of Clinical Microbiology and Infectious Diseases (ECCMID) 2013 in Berlin. Data from the analysis of more than 1,000 patient samples and case reports will be presented in the poster session “Molecular diagnosis of bacterial pneumonia” on Monday, April 29, from 12:30-1:30pm.*
As an ECCMID silver sponsor, Curetis will also host a medical symposium on Saturday, April 27 (1:30-3:30pm) in Hall B (P.32). The symposium entitled “Does molecular antibiotic resistance testing improve diagnostics and standard of care?” will be chaired by Professors Carl-Erik Nord and Christian G. Giske (both Stockholm/Sweden). Featured presentations will be “Genotypes and phenotypes of emerging resistance” (Prof. David Livermore, Norwich/UK) and “Correlation between genotypes and phenotypes: clinical implications” (Prof. Gian Maria Rossolini, Siena/Italy). The session will conclude with the discussion of case studies in pneumonia (Prof. Antonio Torres, Barcelona/Spain, Prof. Eiman Mokaddas, Kuwait) and implant & tissue infection (Prof. Andrej Trampuz, Berlin/Germany and Prof. Olivier Borens, Lausanne/Switzerland).
Curetis will be exhibiting its CE-marked Unyvero™ System at booth no. 323 in hall 15. Several international distribution partners of Curetis will also attend ECCMID.
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*Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.