What measures are taken to ensure the safety of the Raptos® allograft family of products?

History of each donor and sterilization protocol.

Each donor used to produce Raptos® is thoroughly evaluated using medical/social history questions, medical records, blood tests, culture results, physical examination and autopsy reports (when performed). This process is used to ensure the donor is suitable for donation by allowing to recognize and exclude potential diseases or medical conditions that are unacceptable.

Specific lab tests are performed for Syphilis, Hepatitis B and C, HIV and other viruses.

All of the donor chart information is evaluated by individuals trained in tissue banking prior to processing the tissue. Tissue grafts are rinsed and soaked in various solutions to minimize transmission of bacteria and viruses.

Processing and packaging of the tissue are performed using an aseptic technique and occur in a clean room. As an added margin of safety, a low dose gamma irradiation after final packaging of the musculoskeletal grafts is utilized.