Diabetic foot osteomyelitis is a soft tissue infection that spreads into the bone. Credit: Alona Siniehina via Shutterstock.

UK-based medical device company Biocomposites has announced the initiation of two Phase II clinical trials of its antibiotic carrier STIMULAN VG in the US. 

STIMULAN is a pharmaceutical-grade calcium sulphate biodegradable and absorbable bone graft substitute implant. The calcium matrix, which is available in the UK, the European Union (EU), Canada, Mexico, Saudi Arabia, and South Africa, can carry antibiotics such as vancomycin, gentamicin, and tobramycin to an infection site. 

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STIMULAN VG is the calcium matrix mixed with antibiotics vancomycin and gentamicin. The two trials, BLADE-VG2 and BLADE-OPU2, will evaluate the safety and efficacy of STIMULAN VG to treat patients with diabetic foot osteomyelitis, and stage IV pressure ulcers, respectively.  

Surgeons can use STIMULAN to administer a wide spectrum of antibiotics directly into both infected and non-infected sites, supporting individualised treatment plans for each patient.  

Diabetic foot osteomyelitis is a serious infection of the bone that occurs in diabetic patients, typically as a complication of foot ulcers. It is characterised by inflammation and destruction of bone tissue, sometimes leading to amputation if not treated. Stage IV pressure ulcers, otherwise known as ‘bedsores’ are the most severe form of pressure ulcers. 

According to a market model on GlobalData, the bone grafts and substitutes market will generate $2.2bn in 2030 in the US, increasing at a compound annual growth rate (CAGR) of 3.2% from $1.6bn in 2020. 

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Biocomposites CEO Michael Harris said: “Diabetic foot osteomyelitis and stage IV pressure ulcers can severely impact a patient’s quality of life and are a burden to healthcare systems.  

“These trials aim to demonstrate the potential for STIMULAN VG to transform patient outcomes, minimise the use of antibiotics and save healthcare systems significant sums of money by reducing the incidence of recurrent infection.” 

In June 2023, Biocomposites acquired German company Artoss, adding the former’s NanoBone range to its portfolio. The bone graft company also purchased a minority stake in UK-based Renovos Biologics, for an undisclosed sum in July 2023.