A new form of synthetic bone with properties mimicking natural bone has been developed in UCD. With demand for bone replacement materials expected to expand rapidly, the Irish research company MediSolve hopes to commercialise the CancellOs product and corner a significant share of a market with a $500 million potential.
Traumatic accidents and the need to remove diseased bone creates a huge demand for bone replacement materials (BRMs). With products like CancellOs, it is anticipated, for example, that it will be possible to rebuild damaged spinal bone with operations requiring short hospital stays yet resulting in accelerated natural bone growth in damaged areas within a month.
CancellOs has a porosity and matrix - a scaffold-like structure with numerous interconnecting chambers - to facilitate bone growth similar to that in natural conditions. It offers significant advantages over existing available materials.
BRMs are usually small blocks grafted into the body. Orthopaedic surgeons want them to be strong enough to bear some load yet easy to pare down. Coralbased products, which are in use, have not been as adaptable as many would like.
Calcium phosphates are well established as BRMs for use in regenerating bone not required by the body to bear heavy loads. CancellOs uses traditional materials such as hydroxyapatite and tricalcium phosphate. After implantation, it allows for optimal regeneration of natural bone and facilitates blood supply, leading to healthy sustainable new bone. As it is synthetic, risk of rejection or transmission of disease is eliminated.
Preliminary trials in Ireland on animals, using CancellOs, have been completed. More are ongoing in the US. Discussions have been initiated with 13 companies. Most are multinationals within the orthopaedic industry. "They have been impressed with the quality of the CancellOs technology and can see how it could find a niche in the bone replacement market," according to MediSolve's chief executive, Mr Sean McVeigh.
An orthopaedic surgeon, Mr James Colville, approached UCD in 1991 with a view to developing a new, more suitable synthetic BRM. Research by Dr David Tancred, Dr Alun Carr and Dr Brendan McCormack culminated in synthetic bone material with significant advantages over existing BRMs.
In 1996 MediSolve (shortly after it was set up) recognised the commercial opportunity. Forbairt supported the product's technical development.
Ideas for new devices such as a BRM come from the medical community. The Bioengineering Research Centre (a joint TCD/UCD initiative) take on such ideas, conduct applied research and build technical prototypes. MediSolve, at the Blackrock Clinic in Dublin, then supplies the expertise to develop commercial prototypes designed to attract industry.
Current BRMs facilitate new bone growth through a relatively passive process known as osteoconduction. But a more active process of inducing bone growth is believed to be the way of the future. CancellOs is effective with both.
With the latter, it provides a "scaffold" for a bone morphogenetic protein to speed up bone ingrowth. Such proteins are the focus of much research but the combination of technologies is still being developed. analysts forecast a $500 million annual market within 10 years.
In clinical practice a porous BRM is implanted into which the body's own bone will grow. Current techniques are:
Autograft: host bone is taken from the patient, typically from the pelvis.
Allograft: the use of cadaver or animal bones.
Synthetic: man-made substitutes are utilised as grafting materials.
As surgeons realise the advantages of synthetic procedures, technology such as MediSolve is using with CancellOs is predicted to grow at the expense of the autograft market. It will depend on successful transfer of osteoinductive processes to the operating theatre.
To bring this technology to market it must clear a rigorous approval process overseen by regulatory bodies in Europe and the US. "Producing commercial prototypes like CancellOs in the medical device industry is an expensive and a high-risk activity," Mr McVeigh says, "But it has the potential to deliver significant rewards."
