Bioshape Solutions

BioShape Solutions has developed novel medical devices that provide simple and effective local delivery of therapeutic agents to treat and inhibit infection around surgical implants. Initially, BioShape will focus on devices used in fracture repair and spinal fusion for both human and animal markets.

PROBLEM
There has been no uniformly successful development of technologies to treat or prevent 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 for initial treatment and for follow-up treatment. These implant-associated infections that are not resolved by systemic medical therapy create insidious recurrent infections and cost in a range of $15,000-$300,000 per case to be cured.

SOLUTION
BioShape’s delivery module consists of a hollow polymeric reservoir “clip” that is easily and securely attached to an implanted device (plates or rods)and is filled with an appropriate carrier/antibiotic combination.This antibiotic delivery module is installed as an adjunct to standard of care during the first infection treatment surgery; therefore, requiring no additional procedures. In some configurations, the reservoir may be refilled after surgery. Our device represents a paradigm shift in treatment, significantly lowering the cost to treat these infections by supplying a sustained, high concentration therapeutic dosage directly to the fracture or spinal implant site. Direct delivery lowers systemic treatment toxicity, thus improving overall outcomes