- U.S. FDA trial completed with excellent top-line data
- Leading position in genetic antimicrobial resistance biomarker testing strengthened by GEAR acquisition
Amsterdam, the Netherlands, and Holzgerlingen, Germany, November 18, 2016 - Curetis N.V. (the " Company " and, together with Curetis GmbH, " Curetis "), a developer of next-level molecular diagnostic solutions, today published a business and financial update for the first nine months ended September 30, 2016 and provided an outlook to coming months.
Recent Operational and Business Highlights
Unyvero US FDA Trial
Acquisition of NGS Database GEAR and IP from Siemens
Following the appointment of Christopher M. Bernard as President and Chief Executive Officer of Curetis USA, Inc. in La Jolla, San Diego, CA, the Company has been building its senior leadership and U.S. commercial core team for the North American market during the second half of 2016. The U.S. subsidiary has been founded to drive the future commercial development and sales of the Company's Unyvero Platform in North America. Curetis is planning direct commercialization of all Unyvero Products in the U.S. hospital market.
The Company has made excellent progress in expanding its commercial footprint in its direct sales territories. To this end, Curetis has established four new wholly owned commercial subsidiaries in Europe covering the UK, the Netherlands for the Benelux area, France and Switzerland and has hired senior market development managers and key account managers from industry leaders such as Roche, Cepheid, Abbott and others.
Financial Highlights for the First Nine Months 2016
Key non-audited financials as of September 30, 2016
|consolidated numbers in '000 Euros|
|For the nine months ended September 30, 2016||For the nine months ended September 30, 2015|
|Total comprehensive income||(10,731)||13,493|
|September 30, 2016||December 31 2015|
|Cash and cash equivalents||35,415||46,060|
Comparative figures for the nine months ended September 30, 2015, are those of Curetis GmbH (former AG).
"We are very happy with the operational development," said Dr. Oliver Schacht, CEO of Curetis. "We completed the U.S. FDA study on time and as planned. We are now using the outcome, a very strong and comprehensive data set, for compiling the final submission documents and look forward to receiving feedback from the FDA. In addition, we launched the next-generation Unyvero ITI Cartridge for Implant and Tissue Infections and submitted the pre-submission package to the FDA for a U.S. version of the Unyvero ITI Cartridge."
"Furthermore, the GEAR acquisition allows us to significantly expand the scale and scope of the Unyvero Platform and complement it with NGS-based knowledge," he added. "GEAR will allow us to stay on topof the development of cutting-edge molecular diagnostic products for critical hospital infections as it will serve as an engine for even more comprehensive and differentiated content of antibiotic resistance biomarkers in our Unyvero Products. Last but not least, the commercial expansion is also progressing in both Europe and the U.S., where we have built a senior leadershipand U.S. commercial core team for the North American market."
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.
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. The company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed collaboration agreements with Heraeus Medical and Cempra Inc. as well as several international distribution agreements covering many countries across Europe, the Middle East and Asia.
For further information, please visit www.curetis.com .
This document constitutes neither an offer to buy nor to subscribe securities and neither this document nor any part of it should form the basis of any investment decision in Curetis.
The information contained in this press release has been carefully prepared. However, Curetis bears and assumes no liability of whatever kind for the correctness and completeness of the information provided herein. Curetis does not assume an obligation of whatever kind to update or correct information contained in this press release whether as a result of new information, future events or for other reasons.
This press release includes statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes", "estimates", "anticipates", "expects", "intends", "may", "will", or "should", and include statements Curetis makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Curetis' actual results may differ materially from those predicted by the forward-looking statements. Curetis undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
International Media & Investor Inquiries
Dr. Ludger Wess / Ines-Regina Buth
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
U.S. Media & Investor Inquiries
The Ruth Group
Tel. +1 646 536 7012
Last updated on: 20/11/2016
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.