NovaSterilis Reaches 24, 000 Sterilizations

NovaSterilis Inc., which specializes in developing commercial applications for supercritical carbon dioxide (SCCO₂), has achieved a milestone for the company’s allograft tissue sterilization technology. During 2012 almost 24, 000 units of allograft tissue, including tendons and bone were terminally sterilized using their patented process.

For NovaSterilis this milestone quantifies the steady growth and market acceptance of SCCO₂ tissue sterilization. The first supercritical CO₂–sterilized tissue was introduced in the U.S. market in 2009, a significant advancement in the industry. Later that year, Australian Biotechnologies received regulatory approval to market a SCCO₂–sterilized cortical and cancellous bone product, which was launched later that year throughout Australia. In 2010 two additional U.S.–based tissue banks adopted the technology and expanded its use to multiple products including bone and tendon. NovaSterilis recently licensed the process to a European–based tissue processor and contract manufacturer for product distribution in Europe, India, China and Malaysia.

“The benefit of using supercritical CO₂ is that it has virtually no effect on collagen, which is the major structural component of all tissues, ” stated David Burns, NovaSterilis president, in the April 15, 2013 news release. “Our partners are producing the highest quality, safest tissue available, which is the proper way to honor the organ and tissue donation.”

Recent experiments with larger scale SCCO₂ units have provided important data supporting the scale–up of this technology to meet the high throughput needs of customers. NovaSterilis’s SCCO₂ process provides the medical materials industry with a safe, effective, in house, low cost terminal sterilization alternative.

Burns commented to OTW, “NovaSterilis built a machine four times larger than the current Nova2200. When testing the efficacy of the machine with the standard biologic indicator (Bacillus atropheous), the results were equivalent. We believe that scaling the process will produce linear effects.”

Asked about any surgeon comments they may have received Burns stated, “We are not in the front lines speaking with surgeons, since our process is licensed to tissue banks. But to date a few surgeons have commented on the cleanliness of the tissue and the fact that it is sterilized without gamma irradiation. The product is popular with distributers reporting demand greater than supply.”