Gentis has developed a novel and proprietary biomaterial (DiscCellÒ) that can be delivered minimally invasively or percutaneously, forming a viscoelastic implant that can be optimized for multiple orthopedic applications. Gentis is initially targeting the treatment of early stage degeneration of the spine. DiscCell was specifically designed for orthopedic applications – it can be implanted minimally invasively or percutaneously, it polymerizes in-situ, is radio-opaque, and has the demonstrated ability to reconstruct the biomechanics of the affected system. Gentis commenced human trials on DiscCell outside of the US in 2007 and is currently enrolling patients in a prospective, non-randomized, single-arm, multi-center European study for the treatment of pain in post-discectomy procedures. Gentis intends to submit for a CE Mark and US IDE during the first half of 2011.
The DiscCell biomaterial has strong patent protection, including filed and granted patents covering the material, the method of manufacturing and the method of use in the repair, regeneration or engineering of tissue at any location in the body. DiscCell’s mechanical properties can be tuned for a specific applications, such as vertebral augmentation, articular cartilage repair, bone void filling, as well as non-orthopedic applications such as aesthetics, fecal incontinence, GERD and stress urinary incontinence.