Targeted & controlled bone healing
13 Mar 19
Kuros Biosciences receives US marketing clearance for intervertebral body fusion device

Kuros Biosciences receives US marketing clearance for intervertebral body fusion device

  • 510(k) clearance of the TLIF cage is an important step towards progression of Fibrin-PTH product candidate KUR-113 into clinical development
  • Kuro’s TLIF cage will be used in combination with its Fibrin-PTH product candidate in the upcoming interbody spinal fusion clinical trial

Schlieren (Zurich), Switzerland, March 13, 2019 – Kuros Biosciences (SIX: KURN) today announced that its Dutch subsidiary, Kuros Biosciences BV, has received clearance for the Kuros TLIF cage from the U.S. Food and Drug Administration (FDA).

 

The TLIF cage has been developed for the use with KUR-113, Kuros’s advanced Fibrin-PTH product candidate for spinal fusion. The combination of KUR-113 with the TLIF cage will be investigated in upcoming clinical trials.

 

The Kuros TLIF cage is intended for use in intervertebral body fusion of the spine. The cage comes in a range of sizes and includes instruments to prepare the disc space and implant the device. The cage is cleared for use in the lumbar spine (L1 to S1) in combination with autograft and/or allograft, under 510(k) number K183092

 

Joost de Bruijn, Chief Executive Officer of Kuros, said “This regulatory clearance is an important corporate milestone that allows progression towards initiation of a spinal fusion study with our lead KUR-113 product candidate in the U.S. We look forward to the next step in the development of KUR-113, a submission for approval to initiate a U.S. clinical study.”



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
13 Mar 19
Kuros Biosciences receives US marketing clearance for intervertebral body fusion device

Kuros Biosciences receives US marketing clearance for intervertebral body fusion device

  • 510(k) clearance of the TLIF cage is an important step towards progression of Fibrin-PTH product candidate KUR-113 into clinical development
  • Kuro’s TLIF cage will be used in combination with its Fibrin-PTH product candidate in the upcoming interbody spinal fusion clinical trial

Schlieren (Zurich), Switzerland, March 13, 2019 – Kuros Biosciences (SIX: KURN) today announced that its Dutch subsidiary, Kuros Biosciences BV, has received clearance for the Kuros TLIF cage from the U.S. Food and Drug Administration (FDA).

 

The TLIF cage has been developed for the use with KUR-113, Kuros’s advanced Fibrin-PTH product candidate for spinal fusion. The combination of KUR-113 with the TLIF cage will be investigated in upcoming clinical trials.

 

The Kuros TLIF cage is intended for use in intervertebral body fusion of the spine. The cage comes in a range of sizes and includes instruments to prepare the disc space and implant the device. The cage is cleared for use in the lumbar spine (L1 to S1) in combination with autograft and/or allograft, under 510(k) number K183092

 

Joost de Bruijn, Chief Executive Officer of Kuros, said “This regulatory clearance is an important corporate milestone that allows progression towards initiation of a spinal fusion study with our lead KUR-113 product candidate in the U.S. We look forward to the next step in the development of KUR-113, a submission for approval to initiate a U.S. clinical study.”