Biocomposites launches two new phase II trials of Stimulan VG mixed with vancomycin and gentamicin in US
Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue, announces the launch of two phase II clinical trials of Stimulan VG in the US.
Both trials are part of an investigational new drug (IND) application that will evaluate the safety and efficacy of Stimulan VG (Stimulan mixed with vancomycin and gentamicin).
Biocomposites is now recruiting patients to its BLADE-VG2 trial, which will evaluate the safety and efficacy of Stimulan VG in treating diabetic foot osteomyelitis. In addition, Biocomposites will shortly be commencing its BLADE-OPU2 trial, which will investigate the safety and efficacy of Stimulan VG in treating stage IV pressure ulcers.
With over 500K diabetic foot osteomyelitis and 200K stage IV pressure ulcer cases in the US every year, the need to transform patient outcomes in these areas and minimise the use of systemic antibiotics has never been more important.
Michael Harris, chief executive officer said: “The Stimulan VG trials are an important next step in our mission to be the ‘go to’ provider for surgeons seeking products to help them in their infection management cases. 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 use of antibiotics and save healthcare systems significant sums of money by reducing the incidence of recurrent infection.”
