Biocomposites’ STIMULAN bone infection management products have gained certification under the European Union’s Medical Device Regulation (EU MDR).
The British medtech company’s STIMULAN Rapid Cure and STIMULAN Kit are absorbable calcium sulphate antibiotic carriers that are specifically designed to support the management of dead space and surgical site infection.
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Antibiotic carriers are materials designed to deliver high local concentrations of antibiotics directly to a specific site of infection, often bypassing the need for high systemic doses.
With EU MDR certification in hand, Biocomposites’ products are permitted to be mixed with the antibiotics vancomycin, gentamicin and tobramycin, or with a combination of vancomycin with either tobramycin or gentamicin, to assist in the treatment of infection in bone and surrounding soft tissue.Research indicates that the use of antibiotics delivered at the surgical site in orthopaedic surgical procedures such as knee and hip replacement surgery is critical in reducing the need for secondary surgery.
According to Biocomposites, its Stimulan products are the only calcium matrices certified to carry a combination of antibiotics, thereby providing surgeons with the “flexibility” to apply a range of ‘off-the-shelf’ antibiotics to support patient-specific treatment plans.
Biocomposites CEO Michael Harris commented: “Gaining MDR certification, which reaffirms Stimulan as the only calcium matrix antibiotic carrier certified for mixing with a combination of Gram-positive and Gram-negative antibiotics, and also resolve infection in bone and surrounding soft tissue, is tremendous news.”
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By GlobalDataAccording to GlobalData analysis, the bone grafts and substitutes market is projected to reach a valuation of almost $1bn in Europe in 2030.
Most commonly used in orthopaedic reconstruction, trauma, diabetic foot osteomyelitis (DFO) procedures, Biocomposites Stimulan calcium matrices are also available in the UK, Canada, Mexico, and the US, the latter coming via US Food and Drug Administration (FDA) clearance in 2015.
In 2024, Biocomposites initiated two Phase II clinical trials evaluating Stimulan VG, a calcium matrix containing a premixed formulation of the antibiotics vancomycin and gentamicin.
BLADE-VG2 (NCT05539963) is evaluating Stimulan VG versus the standard of care (SoC) in DFO patients, while BLADE OPU2 (NCT06283979) is evaluating the calcium matrix alongside a course of systemic antibiotics versus SoC in DFO-associated stage IV pressure ulcer treatment.
