Curetis N.V. announced that the Company has filed its formal response to the FDA’s AI (Additional Information request letter regarding the Company’s filing for 510(k) clearance of the Unyvero LRT – Lower Respiratory Tract Application Cartridge for bronchoalveolar lavage (BAL) samples. The formal response addressed all additional information requested by FDA regarding the original submission filed on July 23, 2019. The Company now expects a near-term clearance decision. Pneumonia patients are often treated empirically with broad spectrum antibiotic therapy. The Unyvero LRT Application Cartridge provides laboratorians and clinicians a powerful diagnostic tool to identify pathogens in lower respiratory tract infections quickly and reliably, and supports stewardship efforts to avoid unnecessary antibiotics. The study was complemented by an additional set of 240 contrived samples, which successfully confirmed performance of LRT BAL with negative patient samples that were spiked with rare pathogens and resistance markers at known concentrations. All in all, more than 5,500 LRT BAL cartridges were run as part of the comprehensive analytical and clinical performance evaluation.