BioShape Solutions has developed novel medical devices that provide simple and effective local delivery of therapeutic agents to inhibit and treat infection around surgical implants. The Company is based in Research Triangle Park, North Carolina. Initially, BioShape will focus on devices used in fracture repair and spinal fusion for both human and animal markets. There has been no successful development of technologies to prevent or treat infections in bone fracture repair or spinal fusion surgery implants over the past 30 years. Quietly, the cost to treat these infections has risen to approximately $2 billion annually in the U.S. alone. Systemic antibiotics are not sufficiently effective in treating implant infection. Surgical exposure for irrigation and debridement coupled with a prolonged course of antibiotics is the standard of care. Despite the extreme nature of the treatment, this still results in a 30% failure rate both at initial treatment and for long-term recurrence of infection.
BioShape’s unique drug delivery devices are designed to easily and securely attach to fixation implants (metal plates or rods) during surgery. The devices enable immediate and sustained local delivery of a preventive/therapeutic medical agent. The Company’s delivery module consists of a hollow polymeric reservoir “clip” (OrthoClip™) attached to the device that is filled with an appropriate carrier/antibiotic combination. Our device will significantly lower the cost to treat implant infections by supplying a therapeutic dosage directly to the fracture or spinal implant site.
BioShape’s product design and intellectual property portfolio enable it to address a large number of therapeutic delivery opportunities in the trauma and spine surgery field. The company’s IP portfolio firmly covers the marketing space we target. Further, the intellectual capital and know-how of the development team in our target space is significant. The company considers its product system design to be a platform for surgeons to deliver a range of medical preventive and therapeutic treatments to many types of implants. The company’s initial focus will be the development and clinical evaluation of the OrthoClip device to prevent/treat infection around trauma plate implants. We believe OrthoClip represents the most significant initial market opportunity for both civilian and military applications.