Osteal Therapeutics has developed an innovative drug therapy, VT-X7, specifically designed to address periprosthetic joint infection (PJI) affecting the hip and knee.
VT-X7, comprising vancomycin hydrochloride and tobramycin sulfate, presents a pioneering drug/device combination product. Its purpose is to administer therapeutic levels of these widely recognised broad-spectrum antibiotics—vancomycin and tobramycin—directly into the joint space and adjacent tissues. This targeted approach aims to effectively combat and treat periprosthetic joint infection (PJI).
VT-X7 is a seven-day treatment specifically developed to meet the pressing clinical demand for a swift and dependable solution in addressing these challenging infections.
During a Phase 2 clinical study involving VT-X7, all treated patients underwent a new permanent joint prosthesis within seven days, demonstrating a 93% success rate in remaining infection-free after one year.
Patients and healthcare providers need an improved treatment for PJI. This designation validates the potential of VT-X7 to revolutionise PJI treatment and fast-tracks our progress toward meeting this critical demand.
Periprosthetic joint infection (PJI), which affects over 40,000 individuals annually in the U.S., is a rare yet potentially severe complication following joint replacement surgery. This occurs when pathogenic bacteria adhere to the joint prosthesis, creating resilient structures known as biofilms that are extremely challenging to remove.
Osteal Therapeutics received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for VT-X7, its investigational drug therapy tailored to address periprosthetic joint infection (PJI) affecting the hip and knee.
