An Injectable Polymer Network to Support Degraded Spinal Discs
The Intralink-Spine spinal disc stabilization product is an injectable nano-tethering polymer intended to physically secure a spinal disc to stabilize the spine. The therapeutic benefit of the GENTIS (GEnipin Nano-Tether Injectable Stabilization) treatment is derived from the inherent tensile properties of its self-forming and self-attaching polymers. The polymers attach to the degraded tissues of the spinal disc, securing (i.e., keeping together) the disc collagen matrix, inhibiting the disc from unconstrained excessive motions, thereby mechanically “stabilizing” it.
The GENTIS spinal disc stabilization product is classified as a medical device under European regulatory law. Consequently, regulatory approval and commercialization of this novel medical device is currently being pursued in Europe (CE Marking), and subsequently in the many countries outside the US that recognize the European regulatory standards.