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Kuros Biosciences submits MagnetOs Putty for US FDA Clearance
Kuros (SIX:KURN) today announced it has filed the submission package for MagnetOs Putty seeking 510(k) clearance from the US Food and Drug Administration (FDA) for use as an autograft extender in posterolateral spine. MagnetOs is a novel synthetic bone graft substitute designed to support bone healing in the implanted site in the body. MagnetOs Putty is a moldable putty formulation of MagnetOs Granules, which is already cleared for commercialization in the United States of America and the European Union.
Schlieren (Zurich), Switzerland, June 6, 2017
Dr. Ivan Cohen-Tanugi, Chief Executive Officer of Kuros, commented: “This FDA filing is yet another important milestone for Kuros as it eventually expands our portfolio of commercial-stage products. A similar submission for MagnetOs Putty in the EU will be filed in the next months.” He continued: “MagnetOs features a unique surface science technology that supports local bone formation. To meet surgeons’ preferences, we are developing a comprehensive product line consisting of different formulations and applications of MagnetOs. Furthermore, we plan to extend the existing labels into additional indications.”
MagnetOs Putty advantage
According to Kuros estimates, there are over 3 million procedures worldwide each year that use a bone graft material or a substitute. Patient-own bone (autograft) is still considered the gold standard bone grafting material. However, harvesting healthy bone usually requires a separate surgical procedure with associated costs, risks and morbidity. Therefore, an extender that can be used in combination with local autograft, without the need for a separate autograft harvest procedure, offers significant potential benefits. Animal testing demonstrates comparable rates of bone healing for MagnetOs when used as an extender with autograft compared to autograft alone in a rabbit posterolateral fusion model.
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 news 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 79 750 15 64