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.”