NovaSterilis’ scCO2 equipment platforms are currently being utilized for a variety of functions on different biomaterials. The longest use application of the Nova Process™ has been for the cleaning and sterilization of all types of allograft tissues including skin, ligament, tendon, and bone as well as xenograft materials.
NovaSterilis’ sterilization process achieves an industry standard for sterilization of SAL6 for all allograft and xenograft materials with minimal to no impact on the tissue being processed. NovaSterilis’ process is capable of sterilization of product in final packaging (multi-layer gas-permeable sealed packaging).
Annually, doctors transplant over 1,000,000 allograft tissues. With the exception of placental tissue, allograft tissue is obtained through a donation after death. These tissues and organs provide lifesaving benefits and we believe that the selfless act of donation is best honored if the tissue maintains all of its natural characteristics yet offers no risk of infection to the recipient.
One of the fastest growing biomaterials used in regenerative medicine is xenograft tissue. These tissues originate from bovine, equine, ovine or porcine and are supplied in many different forms including powders, sheets, tubes, and gels, all of which are chosen to meet highly specific needs. Applications of xenografts include, acellular dermis, pericardium, fascia, small intestine submucosa, bladder, heart valves, and pure collagen to name a few.
Acellular dermis has a long history of abdominal wall repair but the product is also used for breast reconstruction and plastic surgery. Porcine small intestine submucosa (SIS) is widely applied in surgery and regenerative medicine with applications ranging from wound care to cardiac repair. Since many of these products are primarily used as surgical implants, sterilization is extremely important to protect patients and ensure successful surgical outcomes.
The gentle nature of the Nova Process allows tissue to be rendered sterile, in final packaging, with little or no effect on the biologic or biomechanical properties of the allograft tissue. There is growing evidence based on over eight years of commercial use that NovaSterilis sterilized grafts are not only the highest quality sterile grafts available but they also readily incorporate with less immune response. Please visit our publications page for a list of papers highlighting the benefits of NovaSterilis’ scCO2process.
In addition to sterilization, scCO2 possesses excellent solvent and cleaning capabilities. As a result, NovaSterilis has incorporated the use of non-toxic scCO2 into the tissue cleaning process to extract embedded lipids and organic material, leaving tissue cleaner than many other cleaning processes. The result of the scCO2 cleaning and sterilization treatment is an extremely clean, mechanically superior, sterile allograft tissue that surgeons prefer.
Please contact us to explore incorporating scCO2 into your allograft process.
If you are a patient who may receive an allograft tissue whether it be a tendon replacement or a bone cement filler for spinal surgery or a periodontal procedure, please ask your physician if he has access to scCO2 sterilized tissue.