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Fibrin-PTH: In pursuit of the first drug-biologic combination for spinal fusion

Welcome to the latest candidate in our pipeline

Fibrin-PTH (KUR-113) is the latest candidate in our pipeline – and the first ever investigational drug-biologic candidate to be evaluated for spinal fusion.

It’s based on proprietary controlled-release technology that combines the well-established mechanism of the bone growth factor parathyroid hormone (PTH) with the natural healing matrix, known as fibrin.* Once implanted, Fibrin-PTH promotes spinal fusion by increasing the number and lifespan of bone-forming (osteogenic) cells in the fusion space.

Fibrin-PTH is also the first investigational drug-biologic to be compatible with narrow gauge cannulas for truly non-invasive surgical procedures – with the potential to be a true game changer once commercially available.

Current clinical trials

Fibrin-PTH is now undergoing a Phase 2 clinical trial for spinal fusion in the United States as part of a de-risked pre-market clinical program.

Are you a healthcare professional?

Review the study

Are you a patient?

Find out if you’re eligible to participate in a trial

Are you a healthcare professional?

Review the study

Are you a patient?

Find out if you’re eligible to participate in a trial

Clinical evidence

Fibrin-PTH has featured in two separate Phase 2 randomized, controlled, open-label, dose-blinded studies – each featuring 200 patients.1,2

Tibial plateau fractures: the statistical non-inferiority of Fibrin-PTH to autograft was demonstrated based on the proportion of patients who achieved radiological fracture union at 16 weeks, post-graft. Thus, the study achieved its primary efficacy endpoint.

Tibial shaft fractures: the healing rate at six months post-surgery for intend-to-treat patients was 76%, 80% & 69% for patients receiving the low, medium & high doses of Fibrin-PTH respectively – versus just 65% for those receiving Standard of Care.

Want to learn more?

Get in touch with our Medical Department.