– Review of the Unyvero System and Lower Respiratory Tract (LRT) Cartridge is nearing completion
– U.S. commercial team and operational infrastructure in place
Amsterdam, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, January 08, 2018, 01:00 am EST – Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today provided a status update on the FDA De Novo filing for the Company’s Unyvero System and LRT Cartridge for the diagnosis of lower respiratory tract infections.
The FDA and Curetis have agreed on software results screens and disclaimer language in the fourth quarter of 2017 and software implementation of the final reporting format is already underway. In December 2017, the FDA and Curetis also agreed on the format and scope of reporting of clinical and resistance marker data (incl. resistance marker statistics) as part of the labelling (package insert / handbook).
“We are in very close interaction with the FDA’s review team,” said Oliver Schacht, CEO of Curetis. “We are now expecting a near-term decision on our De Novo request for the Unyvero System and Unyvero LRT Cartridge.”
Preparations for a future submission of bronchoalveolar lavage (BAL) sample types for use with the LRT Cartridge are also progressing, and the Company intends to request a pre-submission meeting in due course.
As the FDA review is nearing completion and in anticipation of the FDA decision, the Company has continued to build its U.S. commercial organization in San Diego, CA with the recent hiring of highly experienced key regional sales and commercial support staff.
Founded in 2007, Curetis is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis enable rapid multi-parameter pathogen and antibiotic resistance marker detection in only a few hours, a process that today can take up to days or even weeks with other techniques.
To date, Curetis has raised EUR 44.3 million in an IPO on Euronext Amsterdam and Euronext Brussels and private equity funds of over EUR 63.5 million. Furthermore, Curetis has entered into a debt financing facility with EIB for up to EUR 25 million. The company is based in Holzgerlingen near Stuttgart, Germany. Curetis collaborates with Heraeus Medical, pharmaceutical companies, and has entered into several international distribution agreements covering many countries across Europe, the Middle East and Asia.
In 2017, Curetis established Ares Genetics GmbH, a wholly-owned subsidiary of Curetis GmbH in Vienna, Austria. Ares Genetics is dedicated to maximize the R&D and related scientific and business opportunities of the GEAR assets acquired in 2016 for the entire Curetis Group.
For further information, please visit www.curetis.com.
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
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