Targeted & controlled bone healing
10 Dec 18
Kuros receives FDA 510(k) clearance for extending commercial indications of MagnetOs Putty in the United States

Kuros receives FDA 510(k) clearance for extending commercial indications of MagnetOs Putty in the United States

  • US Food and Drug Administration (FDA) clearance granted for extending the use of MagnetOs Putty as a stand-alone bone graft in extremities and pelvis
  • Paves way for commercial expansion into more clinical indications in orthopedic surgery

Schlieren (Zurich), Switzerland, December 10, 2018 – Kuros Biosciences (SIX: KURN) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for extending MagnetOs Putty indications to use as a stand-alone bone graft in extremities and pelvis. This is in addition to the existing clearance for use of MagnetOs Granules and MagnetOs Putty as an autograft extender in posterolateral spine.

 

Joost de Bruijn, Chief Executive Officer of Kuros, commented: “This FDA clearance is another major milestone for us as it allows Kuros to expand the commercial reach of MagnetOs into new orthopedic applications such as reconstructive surgery. It also consolidates Kuros’ strategy to expand into indications in which MagnetOs is utilized as a replacement for, rather than supplement to, autologous bone graft”.

 

Several studies have shown that MagnetOs leads to progressive bone formation comparable to the current gold standard autograft. The search for suitable alternatives to autograft could give the Company the opportunity to become a leading player in the area of total bone graft substitutes, with products that can compete in the majority of the markets growing to an estimated US $3.4 billion by 2030.,



Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 44 733 47 47   Fax: +41 44 733 47 40   Email: info@kurosbio.com

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Article
10 Dec 18
Kuros receives FDA 510(k) clearance for extending commercial indications of MagnetOs Putty in the United States

Kuros receives FDA 510(k) clearance for extending commercial indications of MagnetOs Putty in the United States

  • US Food and Drug Administration (FDA) clearance granted for extending the use of MagnetOs Putty as a stand-alone bone graft in extremities and pelvis
  • Paves way for commercial expansion into more clinical indications in orthopedic surgery

Schlieren (Zurich), Switzerland, December 10, 2018 – Kuros Biosciences (SIX: KURN) today announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for extending MagnetOs Putty indications to use as a stand-alone bone graft in extremities and pelvis. This is in addition to the existing clearance for use of MagnetOs Granules and MagnetOs Putty as an autograft extender in posterolateral spine.

 

Joost de Bruijn, Chief Executive Officer of Kuros, commented: “This FDA clearance is another major milestone for us as it allows Kuros to expand the commercial reach of MagnetOs into new orthopedic applications such as reconstructive surgery. It also consolidates Kuros’ strategy to expand into indications in which MagnetOs is utilized as a replacement for, rather than supplement to, autologous bone graft”.

 

Several studies have shown that MagnetOs leads to progressive bone formation comparable to the current gold standard autograft. The search for suitable alternatives to autograft could give the Company the opportunity to become a leading player in the area of total bone graft substitutes, with products that can compete in the majority of the markets growing to an estimated US $3.4 billion by 2030.,