Supercritical CO2 Platform to Sterilize Human and Mammalian Tissues and Medical Equipment

Conventional tissue processing techniques rely heavily on chemical and biological agents. These agents affect the inherent structural and mechanical properties of the grafts.

Our proprietary platform using supercritical carbon dioxide (scCO2) provides a mild and efficient platform to clean tissue with limited use of chemicals. Research has shown that the use of scCO2 minimally affects the structural integrity of tissue grafts when compared to conventional processing techniques. scCO2 treatment also removes medullary tissues responsible for adverse immune response. In addition to the scCO2 treatment step, the platform includes a viral inactivation step. The combination of these two techniques has been shown to achieve a 12-fold reduction in the microbial load in the processed grafts. The successful removal of cellular and medullary materials and inactivation of viruses is the most crucial step in ensuring cleaner grafts for better patient outcomes.

By using scCO2 as the cleaning solvent, excessive incubation in detergents becomes unnecessary, thus reducing the risk of residuals of processing and extra-cellular matrix denaturation.

CO2 enters a supercritical state when both the temperature and pressure simultaneously exceed the critical point of 31^o C and 73 atm, respectively. In this state CO2 has both gas- and liquid-like properties, providing the ideal conditions for cleaning a wide variety of tissues from both human and animal origins (allografts and xenografts). scCO2 can penetrate tissue like a gas and dissolve materials like a liquid.

By regulating pressure and temperature, the solvent strength can be adjusted to simulate a wide range of organic solvents. This dissolving power can be applied to purify and sterilize different types of tissues.

The technology platform is effective on a wide variety of soft and hard musculoskeletal tissues, and has been applied to process human-derived cancellous and cortical bone, and tendons for over 10 years in Europe. The technology has also been used to develop a dental membrane, derived from porcine tissue, for applications in guided bone and tissue regeneration.

In addition, this technology can be used for a variety of tissues, to include acellular human dermis and porcine corneas, intended for use in dermal and corneal transplants, as well as on medical equipment such as endoscopy.

The platform can also be used during R&D to refine design parameters and processing techniques.

Processing of soft and hard tissues from both human and animal origins (allografts and xenografts) for dental, orthopedic, trauma, spine, cardiovascular, sports medicine.

Tissue banks, manufacturers, development projects

This technology platform encompasses several technology handles for cleaning, sterilising, and impregnating biological and synthetic grafts. These handles are generic processing protocols and production methodologies that can be combined, optimised, and then applied to a variety of tissues. We have successfully applied this technology to process human-derived cancellous and cortical bone and tendons and products have been marketed in Europe and abroad with the Human Tissue certification for over 10 years. Furthermore, this technology platform is both CE and FDA approved.

Advantages of the platform:

• Retainment of structural and mechanical properties
• Viral inactivation
• Minimal residues of harsh and hazardous materials
• Modular and adaptable
• Environmentally-friendly