Augmentation of the
The spinal disc consists of a softcore called the nucleus pulposus and an outer retaining structure called the annulus fibrosis. The nucleus pulposus and annulus fibrosis are contained between the spinal vertebrae, making intimate contact with the endplates of the vertebrae. The nucleus pulposus is thus bound laterally by the annulus fibrosis and axially by the vertebral body endplates. The nucleus pulposus, annulus fibrosis, and vertebrae are further constrained by the extra-vertebral column structures, e.g. the facet joints. In total, these structures act synergistically to allow motion and axial shock absorption in the spinal column.
The nucleus pulposus loses water content as part of the aging process and its ability to provide motion and shock absorption to the spinal column also diminishes. Furthermore, the loss of water may also cause the annulus fibrosis to change from its natural concave shape to a shape that places additional stress on the fibers of the annulus. Also, the loss of water in the nucleus pulposus causes shrinking of the spacing between vertebrae which may cause additional stress on nerve fibers that are attached to the external surface of the annulus fibrosis.
BCNP* is a novel in situ polymerizable synthetic nucleus pulposus augmentation hydrogel for the treatment of early degenerative disc disease that may result in pain.
Our intervention involves the injection of polyvinyl alcohol (PVA) based hydrogel into the existing nucleus pulposa. Starting as two radio-opaque liquid pre-polymers that cure within minutes after they come in contact with each other, creating a cohesive nucleus pulposus-like hydrogel.
BCNP Investigational Status
BioCure submitted a PRE-IDE Panel to the FDA and continues to work to complete this panel and move to the IDE phase of the program. In its PRE-IDE work, BioCure was able to demonstrate in vitro safety and efficacy, with the only deliverables remaining the completion of an extensive panel to assess mechanical strength and durability. BioCure is seeking a collaboration to complete the mechanicals testing panel, receive IDE clearance from the FDA and begin a small human clinical trial.
*BCNP not yet approved for use in any country.