Curetis Provides Update on Unyvero LRT FDA 510(k) Submission

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Curetis Provides Update on Unyvero LRT FDA 510(k) Submission

- Curetis reiterates that it expects FDA to provide decision on clearance of Unyvero LRT in the second half of 2017

Amsterdam, the Netherlands, and Holzgerlingen, Germany, May 24, 2017 - Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today provided an update regarding the ongoing interactive review by the U.S. Food and Drug Administration (FDA) of its 510(k) application for clearance of the Unyvero Platform and Lower Respiratory Tract Infection (LRT) Application Cartridge.

On April 21, 2017, Curetis participated in a Meeting with a team of FDA reviewers, discussing the FDA's request for additional information communicated to the Company in March 2017. Meeting minutes have been drafted and confirmed by Curetis and FDA as of May 23, 2017.

Based on the outcome of this meeting and further discussions with the reviewers, FDA is moving forward with review of the Unyvero Platform and LRT Application Cartridge for use initially with tracheal aspirate samples. Curetis believes that clearance of the Unyvero System and LRT Cartridge with one of the most relevant sample types initially could give Curetis a time advantage, being the only provider of a diagnostic solution of this kind. Following clearance of Unyvero LRT with tracheal aspirate samples, Curetis plans to submit data for clearance of the LRT Cartridge for bronchial lavage (BAL) sample types. Originally, Curetis filed for both bronchial lavage (BAL) and tracheal aspirate sample types in its De Novo submission. By making the strategic decision to move forward in this phased approach, Curetis aims to pursue the fastest and least risky regulatory pathway. This decision should render unnecessary a possible Advisory Committee Panel meeting that the FDA has brought up for moving forward with aspirate and BAL sample types at the same time.