Orthopedic tissue market is large and growing Technological advancements in the repair and replacement of damaged bone and soft tissue has driven the growth of the orthopedic allograft market. The market is worth an estimated $1 billion, and is growing at 15-20% annually.
Allograft procedures use tissues harvested from a living or deceased donor. The donated tissue is processed and prepared for implantation. Although allografts offer several advantages over autografts – such as a single surgical site, reduced discomfort and post operative problems, decreased recovery times, and increased availability – there are safety concerns that have impeded wider usage of allograft tissue.
While actual infections are rare, a recent study by the Centers for Disease Control and Prevention found that 70% of allografts tested revealed positive cultures for micro-organisms that exist largely due to the lack of standardized procurement and emerging pathogens.
Clearant is a developer and marketer of proprietary sterilization processes used in biomedical products. The Clearant Process is a pathogen inactivation method designed to substantially reduce all types of pathogens in biological products.
Using a combination of patented technology based on gamma irradiation, the Clearant Process tackles all types of pathogens, including viruses, bacteria, fungi and spores. The treatment inactivates all types of viruses, including HIV, and Hepatitis A and C, and achieves a level of microbial sterility that meets or exceeds the level of medical device sterility.
The company offers sterile implants for both soft tissue and cervical and spinal bone allograft surgeries. It has more than 60 issued or pending patents.
The Clearant Process not only achieves the sterility standards that FDA applied to medical devices, but it also meets the viral safety standards applied to pharmaceuticals and plasma products.