NovaSterilis Inc. has been issued US Patent # 7,771,652 B2 for “Combined Use of an Alkaline Earth Metal Compound and a Sterilizing Agent to Maintain Osteoinduction Properties of a Demineralized Bone Matrix”
Building on a growing platform for the sterilization of biomedical materials, NovaSterilis researchers developed a process for the sterilization of demineralized bone matrix (DBM) while introducing an entrainer composed of an alkaline earth metal compound to maintain the osteoinductive properties of this material. DBM is demineralized allograft bone with inherent osteoinductive activity, or the ability of new bone to grow on this material. It is the osteoinductive property of DBM that makes it an excellent substitute for an autograft or bone graft from the patient, reducing the need for an additional wound site and increased patient risk.
Demineralized bone matrices are prepared by acid extraction of allograft bone, resulting in the loss of most of the mineralized component, but retention of collagen and noncollagenous proteins, including growth factors. DBM products are currently not sterilized, since radiation degrades the osteoinductive properties. Moreover, gas sterilization methods may leave residual chemicals that can inhibit the healing process. The current aseptic process used to produce DBM is safe, but requires extensive precaution to maintain a clean product. The ability to terminally sterilize DBM without reducing osteoinductivity would improve patient safety and may improve the manufacturing process.
NovaSterilis currently markets a process for the sterilization of allograft tissue including soft tissue and bone. NovaSterilis identified the need for sterilized DBM, but also recognized the challenges of sterilizing DBM. Through extensive research and development NovaSterilis identified the complementary effect of adding an alkaline earth metal compound, in this case calcium carbonate, into the supercritical carbon dioxide sterilization process that maintained the osteoinductive properties. NovaSterilis is seeking parties interested in licensing this process.
NovaSterilis currently markets supercritical carbon dioxide terminal sterilization technologies, and equipment built to support applications of their supercritical carbon dioxide technology platform. The supercritical or fluid phase, of CO2 occurs at low pressure (72.9 atm) and moderate temperatures (31.1° C). Supercritical CO2 retains advantageous properties of the gas and liquid phases of carbon dioxide making it an ideal fluid for manufacturing processes. The company currently markets the Nova 2200, a 20 liter fully automated supercritical CO2 terminal sterilization chamber and is developing an 80 liter unit.