NovaSterilis wins grant for sterilisation of absorbable sutures
27/06/2012
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
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