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Curetis AG has established strong relationships at a global level to expand in-house core competency by world-class partners.
Curetis signed a collaboration agreement with Sanofi Pasteur for the potential use of the Unyvero™ platform in a future global clinical trial.
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.
Cempra to use Curetis’ Unyvero™ solution in its Phase III trial of its antibiotic solithromycin (CEM-101). Under the terms of the agreement, each party may use the generated data for its own product development and for its regulatory filings. Cempra’s randomized, double-blind Phase 3 trial comparing solithromycin against a comparator drug is expected to enroll over 800 patients in more than 100 clinical sites worldwide. Sputum samples from patients will be sent to Curetis for analysis with its Unyvero™ Solution and the CE-marked Unyvero™ P50 Pneumonia Application Cartridge. Molecular diagnostic data generated from the Unyvero™ Solution will be paired with clinical and traditional microbiology data to enhance the pathogen diagnosis rate in the trial.
Curetis AG has successfully completed a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union. Principal investigator was Prof. Dr. Ingo B. Autenrieth of the University Hospital Tuebingen, Germany.
The study was conducted at the following trial sites:
An observational study with a subsequent interventional arm is currently ongoing at three trial sites (MHH Hannover, University of Goettingen, CHUV Lausanne) and is being observed by external clinical experts in Jena and Barcelona.
Scholz-HTIK, a family owned high-end injection molder, will focus on the production of the Unyvero™ cartridges components using multi cavity tools, giving the supply chain an economy of scale. Scholz has a proven expertise in the large scale production of high quality and precision plastic parts for applications in life sciences such as food, cosmetics, medical engineering and pharmaceuticals. Clean room production facilities at ISO 7 and a close monitoring of environmental conditions in compliance with GMP and CFR 21 regulations help to secure the high quality standard of Curetis products.
Contexo GmbH is a plant manufacturer responsible for the establishment of a clean-room assembly line for the automated production of the UnyveroTM Cartridges. Contexo is renowned for the design and installation of medtech manufacturing facilities compliant with GMP-standards.
Zeltwanger Automation developed the automated printing system for the arrays used in the Unyvero™ cartridges. Zeltwanger is a specialist developing assembly robotics and test systems, among others, for the medtech and biotech industry and compliant with GMP-standards.
The Natural and Medical Sciences Institute (NMI) at the University of Tuebingen is a member of the Innovation Alliance Baden-Wuerttemberg. It is involved in application-oriented research at the interface between the life sciences and material science. An interdisciplinary team of scientists is developing new technologies for companies and public research sponsors in the areas of pharma and biotechnology, biomedical technology, and surface and interface technology.
The laboratory of Applied Polymer Engineering at the University of Applied Sciences in Schmalkalden is focused on polymer analysis and polymer processing as well as product development for polymer parts and tool construction. Its biomedical expertise comprises, among others, the identification, handling and joining of bio-based and bio-compatible polymers and polymers for medical applications.
© Curetis AG 2013