Biodegradable silica gel fiber technology for wound care, hard and soft tissue regeneration, and drug delivery

Bayer Innovation

SGF is the first inorganic, biodegradable fiber with wound-healing properties. It is suitable as a platform technology for hard and soft tissue regeneration (cartilage/bone), as well as for drug delivery and tissue engineering. SGF development has demonstrated during pre-clinical phase (in-vitro and in vivo) as well as in clinical trial promising potential to improve healing with excellent tolerability, safety, and no toxicity profile. The first product is approved in Europe as CE (IIb) and can be launched immediately. A 510(k) registration is possible in the US. The technology offers a unique, bio-resorbable scaffold for several applications in regenerative medicine, with an initial focus on chronic wound management. SGF acts as a physical scaffold to aid the growth of new cells and the collagen structure that supports them. As a scaffold, it can be used to deliver drugs over a wide area to aid in healing. The material itself is inorganic, but is integrated into the tissues and resorbed by the body. Unlike collagen, the SGF scaffold stayes in the wound for 1–2 weeks before resorption SGF is progressively resorbed and replaced by new tissue during the healing process. Dimension (thickness and size) as well as degradation speed can be adjusted from some millimeters up to several hundred square centimeters, from some days up to years. A GMP (ISO 14385)-certified production plant is also available for production.

SGF provides a matrix for tissue regeneration, first final application designed for chronic wound care.

Enhances: granulation and epitheliazation of the wound; cell proliferation of keratinocytes and fibroblasts; angiogenesis; collagen structure; prophylaxis of scar and keloid formation.

SGF promotes active growth of different cell types — fibroblasts, keratinocytes, osteoblasts, chondrocytes.

Degradation speed can be adjusted in the manufacture, from some days up to months.

SGF significantly enhances endothelial VEGF synthesis and promotes vessel growth.

SGF inhibits TFG and collagen synthesis of cytokine-activated fibroblasts and differentiation to myofibroblasts.

SGF clinical post-CE mark approval trial demonstrated effective wound healing and safety in conjunction with standard of care. Good tolerability was reported during a European clinical trial of 130 patients. SGF passed all ISO 10993 and FDA standard safety tests successfully and showed no safety concerns.

SGF offers significant potential for line extensions in regenerative medicine and drug delivery:

• As a drug delivery system, SGF can act as a release system for pharmaceuticals and molecules, provide growth factors, and delivery e.g. for antiseptics and anesthetics.
• For tissue regeneration (with and without cells), SGF works with hard and soft tissues, promotes bone regeneration with the SGF matrix and cartilage regeneration on the SGF matrix, and offers a tissue scaffold for skin regeneration.

SGF preclinical studies have proven the novel, unique mechanism of action for regenerative medicine and beyond.

SGF does not contain viable or non-viable animal or human tissue or extraneous proteins.

Unlike collagen, the scaffold stays in the wound for 1–2 weeks before resorption. SGF is progressively resorbed and replaced by new tissue during the healing process.

SGF promotes skin tissue growth and enhanced wound healing by providing a new three-dimensional structure for new cell growth.

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