NovaSterilis wins grant for sterilisation of absorbable sutures
NovaSterilis, which specialises in developing applications for supercritical carbon dioxide (SCCO2), has been awarded a NIH Phase II grant to further develop a commercial process for the sterilisation of absorbable sutures using SCCO2. Sutures are the number one wound closure device with market of nearly $2 billion per annum.
The requirement to sterilise absorbable sutures (device standard SAL6*) proves particularly challenging with respect to maintaining their mechanical properties. Sterilisation technologies in wide use today such as autoclaving, hydrogen peroxide and gamma irradiation cannot achieve SAL6 without incurring significant damage to the suture. Ethylene oxide is currently the only method available for the sterilisation of absorbable sutures, but residues in the product can impair healing or cause severe reactions. These limitations have resulted in product recalls, delayed healing, suture-induced inflammation and compromised mechanical properties, says NovaSterilis.
Building on the success of a Phase I grant, which established effective SCCO2sterilisation cycles while maintaining the physical characteristics of the sutures, the Phase II grant will establish in vivo safety and efficacy of SCCO2sterilised sutures. Commercial readiness testing will be performed to establish scale-up potential and shelf-life parameters to provide regulators with a process that will pass all scrutiny and can be applied immediately to sutures and other biomaterials.
"The NovaSterilis process will improve the quality and safety of absorbable sutures by reducing patient exposure to toxic chemical residuals,” stated David Burns, President and CEO NovaSterilis. "We initially developed this technology from concept to reality for the sterilisation of allograft tissue, but there are many more delicate biomaterials that will benefit from this sterilisation technology.”
NovaSterilis technology is being utilised by US and international tissue banks to produce sterile allograft tissue in final double (terminal) packaging ready for transplantation. Recent experiments at NovaSterilis utilising larger scale SCCO2units provided important data to support the scale up of this technology to meet the high throughput needs of larger tissue processors and medical device manufacturers. NovaSterilis says its SCCO2process provides the medical materials industry with a safe, effective, in house, low cost terminal sterilisation alternative.
*(SAL6) Sterility Assurance Level 10-6 is a standard for medical devices