SYNTHAFLEECE · Creation of a synthetic, absorbable, haemostatic fleece for delivery of active agents into healing wounds

The SME Participants in the SynthaFleece project (NANOVAL, BBS, ASTERIE, STERIPACK) aim to create a new, totally synthetic medical device based on a poly-lactide (PLA) polymer platform that is capable of the sustained release of ionic silver, antibiotics and bone morphogenetic proteins (BMPs) whist stimulating haemostasis and encouraging bone growth and healing. With such a device we can target the market for healing of potentially infected wounds arising from bone and joint surgery worth in excess of €220 million in 2007. To achieve our objective we need to develop new scientific knowledge in: PLA polymer technology and in particular the creation of high density fleece materials for the release of active agents; how the variation of polymer density in a spun-bonded fleece can modify the release characteristics of silver ions, antibiotics and BMPs; the basis for physical and/or chemical induction of haemostasis; and to translate this knowledge into creation of PLA-based micro-fibres to be spun-bonded into a fleece that can bind silver ions, antibiotics and BMPs and release them over a period from seven days to two weeks. The fleece should degrade in the wound bed and be absorbed over the same time period whilst causing immediate and long-lasting haemostasis. Whilst the SMEPs form a complete supply chain for the manufacture of the ultimate fleece product we have neither the facilities nor the resources to undertake the necessary R&D. The Research for SMEs funding instrument provides the ideal solution allowing us to outsource the R&D to three RTD Performers – FhG, HERI and IMM-recherche. The Foreground Intellectual Property (FGIP) generated in the SynthaFleece project will be owned by the SMEPs and exploited in partnership with a large enterprise (BIOMET) which will provide a route to the global market for wound-healing devices. The SMEPs will benefit from sales and licensing of the FGIP to the tune of €XXX million over a ten year period.