Single-patient expanded access (compassionate use) of Biocomposites’ products

We are leaders in the development of products for use in bone and soft tissue infection; and are actively investing in a pipeline of innovative medicinal products.

One of these products, STIMULAN VG (a local antibiotic delivery system for vancomycin and gentamicin), is at clinical trial stage with two phase II studies underway.

Treatment of Diabetic Foot Osteomyelitis
BLADE-VG2 – A Multi-center, Randomized, Controlled Feasibility Trial of STIMULAN VG and Debridement With an Abbreviated Course of Systemic Antibiotics to Debridement and a Full Course of Systemic Antibiotics for the Treatment of Diabetic Foot Osteomyelitis. Find out more

Treatment of Osteomyelitis Associated with Stage IV Pressure Ulcers
BLADE-OPU2 – A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. Find out more

Whenever possible, we encourage patients to participate in clinical trials. In rare cases, when patients don’t qualify for clinical trials and have exhausted all available medical options, we may consider providing expanded access, also called “compassionate use,” of unapproved Biocomposites’ investigational medicines.

Our Expanded Access Policy can be viewed here.

The FDA’s guidance on Expanded Access can be accessed here

If a treating physician believes Expanded Access may be the only option for a patient, the physician should contact Biocomposites to make a formal request on behalf of the patient. We will respond within 5 days.

Contact: expandedaccess@biocomposites.com