Technology

StronBone™ is not currently cleared as a medical device for sale in the USA, the premarket notification (510k) is pending.

RepRegen is an emerging medical device company using patent-pending repair and regeneration technology in two platforms designed to mend and facilitate regrowth of tissue in vivo. The first platform is focused on bone void filler and the other (“hard”) tissue (non-weight bearing bone); whereas the second platform is focused on muscle and other (“soft”) tissue.

Hard Tissue Platform

The Hard Tissue platform is a family of modified bioactive ceramics used to repair and regenerate bone in surgical fields such as orthopaedic, cranio-maxillo-facial, periodontal and dental. The first product from the platform is StronBone. As a result of the incorporation of carefully controlled amounts of Strontium and other ions into the bioactive ceramic, StronBone is a Bone Graft Substitute that offers outstanding performance in regenerating non-weight bearing bones.

Strontium has a long record of safe and effective use in medicine. Strontium is found in our bodies and in our diets, it is naturally absorbed by our bodies, and it has a long history of being used in health supplements or toothpastes to strengthen bones and teeth. StronBone’s superior performance constitutes a significant competitive advantage over existing products in the market and over products known to be currently under development. StronBone is ready for product launch in Europe now.

Soft Tissue Platform

The Soft Tissue platform is a family of synthetic extracellular matrices aimed at repairing and regenerating soft tissue such as cartilage, tendon and ligament in surgical fields such as musculoskeletal and sports medicine. The first product from the Soft Tissue platform will most likely be focused on cartilage repair and regeneration.

The ability to control topography and chemistry of synthetic extracellular matrices provides exciting potential for stimulating repair and regeneration of almost any tissue type as part of the matrices’ biodegradation. All tissues are hierarchically organised down to the nanoscale and comprise nanoscaled extracellular matrix (ECM) fibres. Prof Molly Stevens, RepRegen Chief Scientific Officer and leading Imperial College London scientist, highlighted in her recent Science paper (2005) that while conventional scaffolds for tissue engineering have been designed with a microporous structure, it is likely that cells require the full context of a three-dimensional nanofibrous matrix to maintain their phenotypic shape and establish natural behaviour patterns.

RepRegen is pursuing an improved biomimetic approach to biomaterials design that involves the engineering of preferentially aligned fibres. Our aim is to produce electrospun preferentially aligned fibres that are continuous, and allow for integrated manufacturing of 3D fibre matrices as tissue scaffolds with high porosity, high spatial interconnectivity and controlled alignment of fibres to direct cell orientation and migration.

These synthetic extracellular matrices offer exciting possibilities for medical devices in the form of 3D fibre matrices as tissue scaffolds implanted with or without stem cells, growth factors or other biologics to stimulate repair and regeneration of almost any tissue type. Future proof-of-concept targets potentially include repair and regeneration in cardiac applications, pancreas (diabetes), spinal cord injury, bladder degeneration and more.

Notes:

• In the EU, StronBone Bone Graft Substitute is a medical device which has CE Marking approval.
• In the USA, StronBone Bone Graft Substitute is a medical device product which has not yet been cleared through a 510k for clinical use and is available for Research Use Only.