Development and evaluation of a bio-resorbable, load bearing, tissue regenerative meniscal cartilage implant.

Orthox aims to produce an implantable device from Spidrex, a novel silk-based biomaterial, for the repair and regeneration of meniscal cartilage in the knee . Spidrex is produced through a proprietary process in which commercially sour ced silk fibres are stripped of surface componenents, and then dissolved, givn ig a fibroin solution. This immensely long chain structural protein has a simi lar tertiary structure to fibronectin, providing silk fibres with their outsta nding mechanical properties. Fibroin solutions can be cast into slowly resorba ble, 3-D scaffolds with open, micro-porous architecture. Remarkably, these com bine compressive strength and resilience comparable to human cartilage with co mplete biocompatibility and the capacity to induce tissue ingress in vivo and cell proliferation in culture, indicating great potential for use in tissue re generative surgery. These qualities should address problems in the repair of d amaged meniscal tissue unsolved by existing surgical procedures. The award wil l support five research objectives: scaffold optimisation, device design, regu latory approval, animal efficacy trials and a clinical safety trial. The goal of the project programme is to deliver a successful 'first in man trial'. This would represent a major clinical breakthrough and a value inflection point fo r Orthox, enabling a significant equity finance round to take the product to market.