Curis' OP-1 to be made available in USA

Curis and marketing partner Sryker Corp have been awarded HumanitarianDevice Exemption approval from the US Food and Drug Administration, allowing the latter firm to market their bone morphogenic protein OP-1 Implant for use as an alternative to autograft in recalcitrant long-bone non-unions where use of autograft is unfeasible and alternative treatments have failed. HDE approval is granted to devices with a small number of target patients, in this case numbering only around 4,000 cases a year in the USA.

OP-1 Implant is already approved and launched in the European Union and Australia as an aid to bone-healing in trauma, and Stryker has reported that it intends to launch the product in the USA later this quarter.