Tag: Unyvero P55 pneumonia cartridge
Company News: Curetis’ Unyvero System Selected for Global Phase III Antibiotics Trial
– Unyvero to be used for pathogen identification and patient inclusion at several clinical sites across Europe
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Curetis’ Unyvero System will be used in a Phase III trial of a novel formulation of the antibiotic Amikacin. Unyvero was chosen as a platform to detect pathogens and antibiotic resistances in patients to be enrolled at intensive care units at several clinical trial sites across multiple European countries. Unyvero will be used to support patient identification and help boost enrollment rates at these sites.
Amikacin is an aminoglycoside antibiotic marketed for the treatment of severe, hospital-acquired infections with multidrug-resistant Gram-negative bacteria. The trial is evaluating the efficacy of a novel drug-device combination as an adjunctive therapy for Gram-negative pneumonia in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics. The trial is recruiting approximately 650 patients at trial sites worldwide.
Under the terms of the agreement with the sponsor of the trial, Curetis will deliver Unyvero systems and CE-IVD marked P55 cartridges to the trial sites as well as install the systems and provide training and technical support at these sites. The sponsor will fully reimburse Curetis for systems, training, services and consumables. Further financial details were not disclosed.
Company News: Curetis Expands Commercial Organization
– Augmented direct sales force, led by new Head of International Sales to broaden reach in key European markets
– New distribution partnerships in Italy and Middle East
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the strategic expansion of its sales and marketing program in Europe and the Middle East. The company appointed Klaudija Kiesinger as Head of International Sales for Western Europe and will add four new members to its broader international sales and marketing team by mid-year, bringing the total commercial team size to 14. With this sales force expansion, Curetis has added the U.K., France and the Benelux region (Belgium, the Netherlands and Luxembourg) to its direct-sales markets.
In addition, the Company announced its increased reach into Italy and the Middle East with exclusive, multi-year distribution partnerships. Curetis will distribute the Unyvero Solution through Arrow Diagnostics in Italy and Al Zahrawi Medical in the Middle East (Qatar and the United Arab Emirates).
Since 2012, Curetis has grown to an installed base of more than 60 Unyvero analyzers. The Company currently has 80 systems in the supply chain for 2015, affording customers the potential to run assays covering more than 100 analytes in two highly-multiplexed application cartridges (P55 for pneumonia and i60 for implant and tissue infections). In 2015, the Unyvero product pipeline will be expanded and enhanced by the BC70 Blood Culture Application cartridge. In the coming years, Curetis plans to add further cartridge applications in the fields of sepsis, gastrointestinal tract infections, tuberculosis, CNS infections and pediatrics, among others.
At present, there are several investigator-initiated clinical studies in pediatric applications underway. Various potential pharma projects using Unyvero in clinical trial designs for the development of novel antibiotics afford Curetis additional opportunities for commercial expansion.
In addition to these platform and product enhancements, the Company is expanding its geographic scope, with an FDA trial underway in the U.S. and pre-commercial activities in Asia and other non-European countries.