In light of the current situation surrounding COVID-19, Axogen has reviewed American Association of Tissue Banks (AATB), US Food & Drug (FDA), Centers for Disease Control and Prevention (CDC), and state health department regulations and our work practices surrounding processing of our human tissue products (Avance® Nerve Graft). Axogen takes several steps to minimise cross-contamination from the donor of human tissue to the recipient of our products. These steps start with donor eligibility screening and end with our processing practices. AATB and FDA have developed additional donor screening requirements surrounding the travel history and medical conditions of the donor due to COVID-19. Axogen is complying with all AATB and FDA recommendations. We will continue to monitor AATB, FDA and CDC communications and implement updates as needed to our donor eligibility system.
With respect to our processing practices, Axogen processing of human tissue includes controls on the environment and on processing reagents that minimise the risk of tissue contamination. Additionally, our processing solutions have some level of viricidal activity and, most importantly, the products are sterilised by gamma irradiation, which has been shown to inactivate the coronavirus family. It is our belief that the new donor screening criteria put forth by AATB and FDA and our sterilization and processing controls minimise the risk of COVID-19 transmission to a recipient from the implantation of our products.
The company has taken precautions to protect our employees and visitors and minimise the risk of any disruption to our business. We are closely monitoring the situation and, as with any public health issue, Axogen will follow all appropriate guidance and protocols issued by the CDC and state and local public health departments.
11 March, 2020