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Curetis First-Half 2016 Revenues Fall 12 Percent

NEW YORK (GenomeWeb) – Curetis reported today a 12 percent drop in revenues for the first half of 2016 as it cut its net loss nearly in half year over year.

For the six months ended June 30, the Dutch and German molecular diagnostics firm tallied €654,682 ($741,296) in revenues compared to €742,035 in the first half of 2015.

Revenues in the first half of 2015 included €297,000 in sales of its Unyvero molecular diagnostic systems to a pharma partner, but revenues in the same period in 2016 did not include such sales. In general, the company said, revenues are expected to remain volatile quarter to quarter, as early-stage instrument sales to distribution partners are unevenly spread throughout the year.

The company said, however, that it expanded the installed base of Unyvero Analyzers to 113 as of June 30 from 70 instruments on the same date last year.

In April, Curetis completed a CE performance evaluation study and subsequently launched its Unyvero BCU Blood Culture Application Cartridge during the European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam.

The company also said that it has nearly completed a US Food and Drug Administration trial for the Unyvero LRT Application in lower respiratory tract infections. In less than a year, a total of more than 2,250 samples including approximately 1,700 prospective and more than 550 retrospective patient samples have been enrolled at nine clinical trial sites across the US, including at the Mayo Clinic, Northwestern University, Johns Hopkins Hospital, the University of California, Los Angeles, and Columbia University Medical Center.

Curetis said that it anticipates submitting a 510(k) data package to the FDA by the end of 2016 with the goal of achieving FDA clearance for Unyvero and starting commercialization in the first half of 2017.

The company cut its net loss in the first half of the year to €6.7 million from €12.4 million in the year-ago period. Its R&D expenses rose to €3.3 million from €2.9 million, whiles its distribution and administrative expenses rose to €3.5 million from €2.8 million.

Curetis finished the first half with €39.7 million in cash and cash equivalents.

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