Biocomposites, a UK-headquartered medical devices company, has announced an expanded approval from India’s Central Drugs Standard Control Organisation (CDSCO) for its Stimulan Rapid Cure product.
The approval allows the calcium sulfate-based matrix to be mixed with a broader range of antibiotics, including combinations, and with antifungals to assist in wound healing and infection treatment within bone and soft tissue.
Stimulan Rapid Cure is already approved in over 60 countries for use in combination with an antibiotic for placement in bone and soft tissue. With this latest development, India becomes the first country globally to approve its use with antifungal agents.
Tackling Surgical Infections and Antimicrobial Resistance
Surgical site infections and the growing threat of antimicrobial resistance (AMR) are significant challenges impacting patient outcomes worldwide. Biocomposites notes that the flexibility to mix Stimulan Rapid Cure with a wider variety of antimicrobials empowers surgeons to directly target the specific pathogens causing an infection at the local site. This localized delivery method is a key strategy in the global fight against AMR, as per the company.
Michael Harris, Chief Executive Officer of Biocomposites, commented on the approval: “This will allow surgeons in India to tailor antimicrobial treatment strategies to their patients’ needs. Stimulan Rapid Cure already helps more than 150,000 patients worldwide every year, and is an important tool for surgeons as they tackle the impact of antimicrobial resistance.” Biocomposites specializes in developing calcium compounds and bone cements for surgical use. Its products are designed to regenerate bone and manage infection risk across various specialties, including orthopaedics, trauma, and
