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GSI's 3D bioscaffold actv-graft® guides tissue regeneration while providing tissue-like support before safely bioresorbing like a temporary suture.
actv-graft® provides biomechanical and biomolecular cues vital for functional tissue repair. It can be used in sheet form off-shelf or 3D suited to patients.
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Restoring Tissue Form & Function
Growing Tissue Repair Needs
Yearly >45M patients have reconstructive surgery for injuries, congenital defects, cancer, and disease.
Increasing sensitivity of patients and aging populations with comorbidities, infection, and revision risk is leading to growing repair needs.
Synthetic Implants
Permanent implants are preferred over biologic solutions (including bio-processed tissue, stem cell therapies, bioprinting) due to being structurally reliable, consistent, and with less contamination risks. Implants can, however, lead to poor quality fibrous tissue interfaces. In bone context, this hyper-calcifies into a crust. Long-term failure risks for implants include inflammation, infection, loosening, and immune cell mediated ROS device degradation. Even bioinert porous Ti alloy, PTFE, HDPE, PP implants release inflammatory species long term:- Ti, Al, V, TiO2, PFAS and plastic particles.
Tissue grafting
Due to implant concerns tissue grafting methods remain a key repair alternative. Unfortunately, grafting leads to patient pain, adds surgery time (0.5-2hrs), risk of contamination, and unpredictable results with settling. Processed cadaveric tissues are being used instead but are costly and can be unreliable in quality and with the same instability concerns.
A New Graft solution - "the best of both worlds"
Our surgeons have been seeking "the best of both worlds" in a tissue scaffold instead of a poor tissue substitute. The class-leading 95% interconnected space of actv-graft® rapidly fills with blood, cells, healing factors and tissue. Within 2 weeks actv-graft® is completely filled with neovascularized tissue. Tissue-like support throughout healing helps guide functional tissue repair before bioresorbing as water, carbon dioxide, nutrients.
A range of soft and hard tissues (bone, cartilage, fat, muscle, skin) have been successfully regrown in vivo using actv-graft®. This includes repair across junctions between different tissue types. Intricate repair across bone, cartilage, fat, muscle and skin is needed for facial and nasal reconstruction in particular. Unlike standard tissue grafts, selective integration and non-adherence zones can be imparted to actv-graft® to more precisely restore tissue form and function
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Bioactive Glass Mediated Cell Attachment & Tissue Regeneration
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Bioactive glass is remarkable in that supports cell and tissue attachment and guides soft and hard tissue regeneration. While bioactive glass is wholly synthetic, it adsorbs native biomolecules to enable it to act as a tissue-like substrate for cells and stimulates regeneration. We use proprietary methods to formulate an otherwise rigid bioactive glass into a highly-porous bioactive glass that presents as a supple soft tissue to cells. It can be transformed to feel and respond like skin, fat, cartilage through to bone. The bioactive glass we use to synthesize actv-graft® is also inherently angiogenic, anti-inflammatory, anti-bacterial and observable with clinical imaging (CT, X-ray, ultrasound). This makes it highly attractive for use in real-world clinical contexts.
Practical & In-surgery Adaptable
With input from leading surgeons actv-graft® has been developed for ease-of-use and in-surgery adaptability. It can be used immediately out of the packet in cuttable sheet forms without needing preparation or rehydration.
Versatile actv-graft® can be sutured, glued, tacked, or screw-fastened as per surgeon preference. In future, LED light could be used instead to nano-stitch actv-graft® in place with our proprietary bioluminos® technology.
Adjustment of shape and stiffness and the bonding of actv-graft® to itself is possible when warmed. Within minutes in surgery, a 3D printed tool can be applied to actv-graft® to adapt it suit patient need with a proprietary Industry 5.0 PSI™ method.
Our PSI™ templating method has been successfully validated in clinical trials for use with skull and spine reconstruction. A 1-3 day turn-around allows provision of a digitally rendered PSI™ implant template and position-guidance tools. These can be 3D printed at the point-of-care, adjusted in surgery, and applied to actv-graft® sheet.
Targeted therapies including factors, anti-inflammatory, or antibiotics can be added to actv-graft® in-surgery where it wicks into capillaries and adsorbs to surfaces for localized slow-delivery to support better outcomes.
actv-graft® delivers the best of both worlds by:-
-being conveniently standardized and yet 3D adaptable
-acting like a graft yet providing implant-like support and stability
-guiding natural healing yet supporting targeted therapy delivery
