Gentis is a developer of minimally invasive, biomaterials-based products intended to treat the early-stage degeneration of the spine. The company’s first patented product, DiscCell, is an injectable, in-situ setting, radio-opaque, non-hydrogel polymer material that augments or replaces the diseased nucleus pulposus of the spinal disc.
DiscCell has been developed and tested to demonstrate safety and efficacy in the biomechanical augmentation or replacement of the diseased nucleus. This treatment is intended to significantly delay further degradation of the diseased disc and to prevent a recurrence of sciatica at the treatment site. DiscCell has been subjected to extensive pre-clinical testing. Gentis commenced human trials on DiscCell outside the U.S. in 2007 and plans to file with the FDA in 2010 to allow for the initiation of a pivotal trial in the US.