Press Releases from Curetis AG (10 total)
Mayo Clinic’s Dr. Robin Patel Named Principal Investigator for Curetis’ Unyv …
− Curetis adds six new trial sites, significantly expanding U.S. clinical trial network for ongoing FDA study
Holzgerlingen, Germany, May 14, 2014 -- Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Robin Patel, M.D., Professor of Medicine and Microbiology at the Mayo Clinic in Rochester, Minn., has been named Lead Principal Investigator of the company’s Unyvero™ LRT Application FDA trial. The lower respiratory tract (LRT) application is…
Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance
- Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples -
Holzgerlingen, Germany, December 6, 2012 -- Curetis AG today announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014.
The prospective, multicenter trial will include samples collected from more…
Curetis and Scholz Collaborate to Industrialize and Scale-Up Production of Unyve …
- German family firm ‘Scholz-HTIK – High Tech in Kunststoff’ has been selected by Curetis based on systematic benchmarking process -
Holzgerlingen (Germany), December 4, 2012 -- Curetis AG today announced a strategic supply chain partnership with German family business Horst Scholz GmbH + Co. KG for the production of high-quality plastics parts for its Unyvero™ Cartridge.
Under the agreement, Curetis will invest more than € 2 million in multi-cavity tools for…
Curetis Completes Enrollment for its EU Trial As Planned
- Prospective multi-center trial enrolls 800 patient samples in 7 months -
Holzgerlingen (Germany), October 9, 2012 -- Curetis AG today announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.
The trial will compare the…
Curetis AG Signs Up BioLine LLC as Exclusive Distribution Partner for Russia
- Partners to start registration process and market launch in Russia -
Holzgerlingen, Germany, September 27, 2012 -- Curetis AG today announced that it has signed up BioLine LLC as an exclusive distribution partner for Russia, Ukraine, Kazakhstan and Belorus. BioLine is a major player in these markets and distributor for global companies such as Becton Dickinson, Leica Microsystems and many others.
BioLine is preparing the registration of the Unyvero™ Solution and…
Curetis AG Chooses Mediphos as Exclusive Distribution Partner for the Netherland …
- Partners prepare market launch and clinical evaluation project -
Holzgerlingen, Germany, September 26, 2012 -- Curetis AG today announced that Curetis and Mediphos have closed an exclusive distribution agreement for the Netherlands. Mediphos is an experienced independent distributor with a clear focus on molecular diagnostics and an emphasis on microbiology-based applications.
Under the agreement, both companies will prepare the market roll-out of Curetis´ Unyvero™ Solution and the Unyvero™ P50 Pneumonia…
Curetis and Heraeus Medical Collaborate on the Development of New Unyvero™ Dia …
- Joint development of cartridge for orthopaedics, wound and surgery infections -
Holzgerlingen and Wehrheim (Germany), September 20, 2012 -- Curetis AG and Heraeus Medical GmbH have signed a collaboration agreement to jointly develop a novel Unyvero™ cartridge for the detection of pathogens and antibiotic resistances in implant & tissue infections (ITI). One key application area will be in orthopaedics, e.g. to diagnose infections after knee and hip replacement surgeries.
Under…
Curetis AG Signs Distribution Deal in Middle East with ATC
- Kuwait Ministry of Health clears Unyvero™ Solution for clinical evaluation -
Holzgerlingen, Germany, July 18, 2012 -- Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that it has signed an exclusive distribution deal for its Unyvero™ solution with Advanced Technology Company K.S.C. (ATC). ATC will become the exclusive distributor of the Unyvero Solution including consumables for…
Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commerciali …
- Successful completion of performance evaluation study; CE Mark for Unyvero™ instrument system and pneumonia application -
Holzgerlingen, Germany, May 14, 2012 -- Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national…
Curetis AG to Present Its Unyvero™ System for Pneumonia Diagnostics
- Demonstration supported by symposium on bacterial pneumonia and emerging antibiotic resistance at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) -
Holzgerlingen, Germany, March 22, 2012 -- Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the presentation of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge during the European Congress of Clinical…
