InVivo Therapeutics Holdings Corp. (OTC:NVIV) shares have been on a tear since January 2nd’s closing price of $1.75 to Friday’s close of $3.30, up just over 88% YTD. The company is a non-stem cell play on a highly unmet regenerative therapy market, most notably spinal cord injuries (SCI). InVivo’s exciting platform utilizes three different approaches to treating SCIs: (1) a biocompatible polymer scaffolding device to treat acute SCI, (2) a biocompatible hydrogel for local controlled release of methylprednisolone to treat acute SCI, and (3) a biocompatible polymer scaffolding device seeded with autologous hNSCs to treat acute and chronic SCI. In terms of near term catalysts, I believe investors should research and focus on the company’s biocompatible polymer scaffolding device. In April alone, InVivo released two significant press releases updating investors on this exciting portion of the company’s product line. The device is intended to prevent secondary damage due to immune response and inflammation after an acute SCI. This secondary damage can result in additional impairment of the damaged spinal nerve tissue including killing of neural cells and scarring, both not only impeding the healing process but also exacerbating an already critical injury. The polymer scaffolding device is designed to work as a type of “patch”, implanted and placed directly onto the damaged spinal cord. This implantation follows stabilization of the spine itself at the injury site by rigid pedicle screws. The scaffolding device is then applied directly to the cord injury and secured with a “Dura Patch” where it serves as a barrier to protect the exposed and injured spinal cord.
On April 4th, InVivo (NVIV) announced that it had received approval for its request filed with the FDA for Humanitarian Use Device (HUD) designation for its biopolymer scaffolding product. The designation is significant in that it is the medical device equivalent of an Orphan Drug