Curetis Provides Update on Unyvero LRT FDA 510(k) Submission - Seite 2

Curetis plans to continue working closely with the FDA reviewers to identify an appropriate path to develop or augment the BAL data package, which shall be submitted as part of a proposed future label claim expansion following the potential initial clearance of Unyvero LRT for tracheal aspirates.

"In light of our ongoing discussions with the reviewers, we believe that our request to exclude the BAL sample type from the initial label claims provides the most expeditious path forward for Unyvero in the U.S., and we are pleased that the FDA might issue an initial clearance decision for tracheal aspirates. We look forward to continuing to work closely with the FDA through the interactive review while determining the optimal process through which to file a label claim extension following potential clearance," said Johannes Bacher, Chief Operating Officer of Curetis. "Apart from additional data on the BAL sample type, we are planning to generate data from the interventional use of the Unyvero LRT product in the routine clinical setting once approved, and to further assess its potential impact on antibiotic stewardship. We strongly believe in the unique, paradigm-shifting potential of Unyvero to inform better, more actionable treatment decisions and promote more efficient antibiotic use in critically ill patients."

The FDA has requested additional data (e.g. stability data of fresh vs. frozen samples, additional contrived sample testing and adding some reproducibility data) that will require Curetis to conduct incremental wet lab testing at the Company's facilities in Germany. The total number of additional Unyvero LRT Application Cartridge runs is expected to be around 500 to 1,000 (i.e. 5% to 10% of the total number of more than 10,000 cartridges already run for the LRT clinical studies) and will likely be completed in the coming 3 to 4 months.

"We are working diligently to provide this additional information to the FDA in the coming weeks and months, and still expect that a decision on the initial clearance of the Unyvero platform and LRT Application Cartridge could be issued in the second half of this year," added Dr. Oliver Schacht, CEO of Curetis.

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Disclaimer

CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on the Curetis Unyvero technology is currently available for sale in the United States of America or Canada. The analytical and clinical performance characteristics of any Curetis Unyvero product which may be sold at some future point in time in the U.S. have not yet been established.