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Reimbursement / Regulatory

Safe Orthopaedics' SteriSpine PS Gains Japan Regulatory Approval -

Safe Orthopaedics gained approval from the Pharmaceuticals and Medical Devices Agency in Japan for SteriSpine™ PS. SteriSpine PS Original is a general kit comprising a preloaded pedicle screw compatible with open and minimally invasive approaches to treat spinal fractures and degenerative pathologies. The kit is also available in a SteriSpine PS Essential version with a reduced number of instruments, weighing 28% less than the Original. The Japan regulatory approval was received by KiSCO, Safe Ortho's exclusive commercialization and distribution partner in the region per an agreement signed in 2Q18. Per agreement terms, the approval initiated a milestone payment from KiSCO. The company will now commence sales of the devices in Japan. (Safe Orthopaedics, 4/23/19)