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Press Release, 8 February 2017
Kuros achieves ISO certification for surgical sealants
Kuros Biosciences (SIX:KURN) announced today that the Company has been certified as European Normative (EN) ISO 13485:2012 compliant for the design, development, manufacturing and distribution of implantable polymeric sealants for surgical application. Receiving ISO certification is an important achievement towards obtaining a CE mark approval, for which Kuros submitted Neuroseal, a novel dural sealant device, in December 2016.
Schlieren (Zurich), Switzerland, February 8, 2017
Kuros underwent a thorough evaluation process that included a quality management system review, a pre-audit, an initial assessment and a full audit in order to be certified as EN ISO 13485:2012 compliant. The certification was accredited by Dekra Certification BV and is valid until March 2019. EN ISO 13485:2012 certification is generally considered to be the first step toward obtaining a CE mark approval, the regulatory clearance recognized in the European Union and other countries that indicates that Kuros’ products consistently meet customer and regulatory requirements.
Didier Cowling, CEO of Kuros, commented: “We are very pleased to reach this important milestone for Kuros. This achievement recognizes that our policies, procedures and objectives are able to provide safe medical devices that comply with applicable statutory, regulatory and contractual requirements in the medical industry.” He continued: “The ISO certification is a mandatory prerequisite for our transition to commercial stage.”
About Kuros Biosciences Ltd
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.
Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.
For further information, please contact:
Kuros Biosciences Ltd
Harry Welten, MBA
Chief Financial Officer
Tel: +41 44 733 46 46