The FDA granted Kuros Biosciences approval to evaluate Fibrin-PTH in a Phase 2a clinical trial, reports Seeking Alpha.
Three insights:
1. Kuros will determine the use of Fibrin-PTH in single level transforaminal lumbar interbody fusion procedures in patients with degenerative disc disease, with autograft as the comparator.
2. Fibrin-PTH consists of a natural fibrin-based healing matrix with an immobilized targeted bone growth factor and is designed to apply onto and around an intervertebral body fusion device as a gel.
3. The primary endpoint of the trial is radiographic interbody fusion, using CT-scans at 12 months.