News
Company News: Curetis and AKO MED Ink Distribution Agreement Covering Four Countries in CEE Region
– AKO MED to exclusively distribute Unyvero A50 portfolio in Serbia, North Macedonia, Bosnia Hercegovina, and Montenegro
– Preparing inclusion of Unyvero in several regional tender offers
Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that it has entered into two distribution agreements with the Bosnian and Serbian branches of AKO MED, a manufacturer and distributor of medical products, AKO MED d.o.o., Banja Luka, Bosnia Hercegovina, and AKO MED d.o.o., Beograd, Serbia, respectively. Read more…
Company News: Curetis to Present at Solebury Trout European Biotech Investor Day in NYC
Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that its CEO Oliver Schacht, PhD, will present at the European Biotech Investor Day in New York City, NY, USA, on Thursday, August 1, 2019, at 4pm EST. The life science-focused conference is organized by Solebury Trout and sponsored by Goodwin LLC, Deutsche Bank, H.C. Wainwright and Nasdaq and will be held at offices of Goodwin LLC in the New York Times building. Read more…
Company News: Curetis Files for U.S. FDA 510(k) Clearance of Unyvero LRT for BAL Specimens
– Final LRT BAL panel demonstrates overall weighted average sensitivity of up to 94.7% and overall weighted average specificity of up to 98.4%
– Unyvero provides results after approximately five hours, compared to an average of several days for standard-of-care methods
Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration for its Unyvero LRT Lower Respiratory Tract Cartridge for use with BAL (bronchoalveolar lavage) specimens. Read more…
Company News: BellaSeno’s Design and Manufacturing Processes Fully ISO 13485 Certified
– Company transitions from research to manufacturing stage, raises an additional EUR 1 million to conduct clinical trial
– Among the first medtech companies worldwide to offer integrated contract manufacturing of additively produced implants under ISO standards
BellaSeno GmbH, a company developing absorbable implants using additive manufacturing technology, today announced it obtained full ISO 13485 certification for its design and additive manufacturing processes, ranging from the concept and prototype to the production of novel, non-silicone-based absorbable implants. Read more…