NovaSterilis awarded NIH funding for supercritical CO2 sterilization of advanced biomaterials and absorbable sutures

NovaSterilis today received a $100,000 Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for developing a supercritical CO₂ process to sterilize absorbable sutures and advanced biomaterials. The grant funds a collaboration with Chih-Chang Chu Ph.D, a pioneer in absorbable polymer development at Cornell University.

The market for sutures, the number one wound closure device, is forecast to grow 4.4% annually to $1.2 billion by 2015. Past decades have seen few advances in medical device sterilization technologies beyond ethylene oxide (ETO) and gamma irradiation. In particular, synthetic polymers such as suture materials and hydrogels are sterilized almost exclusively by ETO, since irradiation causes undesirable chemical degradation and/or mechanical changes. Sutures can be effectively sterilized by ETO, but many governments and regulatory bodies are seeking alternatives to this process because of the short- and long-term effects of residual ETO, such as cytotoxicity and delayed healing. Moreover, ETO is a recognized carcinogen and requires precautionary measures to operate around this toxic and explosive agent.

“Suture manufacturers have been using this extremely dangerous and toxic process to sterilize sutures in the absence of a suitable alternative,” commented David Burns, President and CEO NovaSterilis. “ETO sterilization may be putting the health of employees at risk, and residual ETO may result in delayed healing. We believe that the NovaSterilis supercritical CO₂ sterilization process will sterilize these products while maintaining mechanical integrity and reduce risk to patients and process technicians.”