NEW YORK (GenomeWeb) – Curetis reported today that its first quarter revenues rose 161 percent on continued demand for its Unyvero molecular diagnostic system.
For the three-month period ended March 31, Curetis' revenues increased to €347,166 ($388,393) from €132,810 a year earlier.
At the end of the first quarter, Curetis' installed base of Unyvero analyzers totaled 151 — up from 107 at the end of the same quarter last year and 142 at the end of 2016. The company also noted that more than 12 new systems were shipped in Q1, and several were brought back by customers after the completion of evaluations.
Curetis added that it continues to expect a global installed base of between 200 and 240 Unyvero systems by the end of 2017, and that it expects it will receive US Food and Drug Administration approval for the Unyvero system and a lower respiratory tract (LRT) panel in the second half of the year.
The company disclosed, however, that the FDA will only review the panel for use in tracheal aspirate samples. Although Curetis had initially sought clearance of the panel in both tracheal aspirate and bronchial lavage (BAL) samples, it has now decided to pursue separate clearance of the panel with BAL samples after securing approval with 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 US," Curetis COO Johannes Bacher said in a statement. "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."
Curetis' net loss in the first quarter widened to €4.4 million, or €.28 per share, from €3.2 million, or €.20 per share, in the same period last year.
The firm's R&D spending remained essentially flat year over year at €1.5 million as it completed development of the Unyvero intra-abdominal infection cartridge, which was launched in Europe in April, and wrapped up a clinical feasibility study of a version of the Unyvero implant and tissue infection (ITI) cartridge tailored to the US market for prosthetic joint infections. This ITI cartridge is expected to enter US clinical testing later this year.
SG&A costs, meanwhile, increased nearly 78 percent to €3.2 million from €1.8 million on higher sales and distribution expenses.
Curetis finished the first quarter with €19.3 million in cash and cash equivalents.