Curetis Publishes First Quarter 2016 Business and Financial Update

GlobeNewswire


- Worldwide commercial expansion and US FDA trial on track

- Installed base of Unyvero Analyzers increased to 107 devices

Amsterdam, the Netherlands and Holzgerlingen, Germany, May 20, 2016 -- Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today published its business update for the quarter ended March 31, 2016, and confirmed its outlook for the full year 2016.

First Quarter 2016 Operational and Business Highlights

Unyvero US FDA trial

  • The US FDA trial for the Unyvero LRT Application in lower respiratory tract infections is nearing completion, with expected enrolment targets to be reached by mid-year. At the end of March 2016, more than 1,600 patient samples had been enrolled, with over 2,000 prospective and retrospective patient samples enrolled to-date;

  • Curetis anticipates completing the contrived specimen study, molecular composite comparator testing for all samples and ancillary preclinical work packages in the second half of 2016, with top line data expected to be available upon unblinding, not before fall 2016;

  • The submission of 510(k) data package to the US FDA is expected before year-end 2016.

  • The Company also continues to prepare for the second Unyvero Application Cartridge to enter US FDA trials in the second half of 2016. Further details will be announced later this year.


Commercial Expansion

  • The Company has hired Willem Haagmans as Head of Sales EMEA. He brings a strong track record and extensive leadership experience with both large and small-to-medium sized molecular diagnostics companies. Prior to joining Curetis, he worked as General Manager Benelux at Beckman Coulter. Previously, Haagmans held international management positions at Roche, Nimblegen, and Vela Diagnostics. In addition, the Company has hired key commercial staff in the UK, France and Benelux, significantly strengthening its direct commercial footprint and positioning the Company to accelerate new Unyvero installations in these key markets.

  • Curetis has established a wholly owned sales subsidiary in the UK (Curetis UK Ltd, London, UK) at the beginning of May 2016 and anticipates to incorporate further subsidiaries in France (Curetis France SARL) and the Netherlands (Curetis Benelux BV) in the coming months.

Product Development

  • Curetis has successfully completed the CE performance evaluation study and subsequently launched its Unyvero BCU Blood Culture Application Cartridge during ECCMID 2016 in Amsterdam in April. The CE-marked BCU application is designed for diagnosing infections spreading through the blood stream in positively flagged blood cultures. The comprehensive panel covers 87 of the most relevant pathogens, including Gram negative and Gram positive bacteria, and 16 related resistance markers.

  • The Company has advanced the development of a second-generation Unyvero ITI Application Cartridge (expected European launch in mid-2016) and IAI Intra-Abdominal Infection Cartridge (expected development completion by year-end 2016). In addition, the partnered Sepsis Host Response program (anticipated completion in late 2017) is progressing according to plan.

  • Curetis has established a Medical Advisory Board with experts from the US (Robin Patel, MD, Mayo Clinic), Belgium (Jean-Louis Vincent, MD, Erasme University Hospital), Switzerland (Reno Frei, MD, University Hospital Basel), and Germany (Mathias Pletz, MD, Jena University Hospital). The advisors bring strong expertise in intensive care, clinical microbiology, sepsis and prosthetic joint infections.

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