Bridging the gap: How calcium sulphate is used to fill bone voids

Ian Bolland caught up with Mike Harris, CEO of Biocomposites, to discuss the use of its calcium sulphate product used a bone void filler. 

Biocomposites is based in Keele, in close proximity to Stoke-on-Trent which was at the heart of the potteries industry in the UK. The intrinsic knowledge about calcium sulphate that has been developed from its past is transferring into medtech today. 

The company has five products including stimulan, an antibiotic carrier approved for use in bone and soft tissue, and genex – a synthetic bone graft that supports natural healing. 

While 2020 was transformational for many businesses, in the case of Biocomposites it was perhaps a more conventional transformation as stimulan received approval for use in the European markets with three antibiotics - gentamicin, vancomycin, tobramycin – and the company won an orthopaedic solutions tender within the NHS. Despite COVID-19, there was no need for Biocomposites to stop. 

Harris said: “I think we’ve seen a whole number of challenges, but we’ve always been able to make products. We’ve not stopped during the whole COVID crisis and we’ve always been able to supply as much product as we need to hospitals.”

Calcium sulphate is generally used in bad fractures, with Harris elaborating that an insertion of the material allows the body to recognise where bone should be and goes about addressing it. 

“It starts building bone across that calcium sulphate, but at the same time the calcium sulphate for a period – depends how much fluid is around in the area, say 12 weeks – will dissolve and leave trabeculae in a bone, which starts to form there. 

“If you have a big gap between two pieces of bone it will never heal, and that’s what they call non-unions, where there’s a gap that it doesn’t know it’s got to bridge. 

“As soon as you put calcium sulphate in the body recognises there should be a bridge there and the body recognises, ok there’s supposed to be a bridge there and it starts to put trabecula bone in place.”

The company is therefore able to have a footprint in the NHS in trauma patients, particularly those with infection. 

“We’re especially useful in infected trauma. You can imagine a really bad accident when bone breaks, but it also breaks the skin. You’re automatically infected at that stage. 

“As soon as you have an open fracture, that’s classed as infected. You’ve got to give some serious antibiotics at that stage. 

“If you imagine how you get an open fracture, you’re probably going to be doing something quite extreme, outdoors. You’re not just falling over. You’re coming off a motorbike or skidding.

“You can use it use it in open fractures which are classed as infected. Probably the biggest area is used in is when surgeons are treating infection – that may be in bone, it may be in soft tissue.”

Inevitably the treatment of infection is accompanied with certain antibiotics. With antimicrobial resistance being such a prominent issue in life sciences, Harris explains how Biocomposites products – in this case stiumlan – can help tackle it. 

“When we normally talk about antimicrobial resistance, we talk about it in a setting where there is a maximum systemic dose of the product. One of the advantages of this product is because you get higher local doses, you’re less likely to get antimicrobial resistance and when you do, you’re more able to treat it. There are higher doses of antibiotics. These things aren’t black and white, it’s about a dose you can get to that microbe.”