Osteal Therapeutics'® lead therapeutic candidate, VT-X7, is drug-device combination that delivers high concentrations of vancomycin and tobramycin, well-established antibiotic drugs, directly to the infected joint space. When used as part of a two-stage exchange arthroplasty procedure, VT-X7 has the potential to significantly lower treatment time and improve success rates.
VT-X7 is not approved by the FDA.
Expected Advantages of VT-X7
Antibiotic concentrations at the infection site sufficient to penetrate biofilm
Effective against gram-negative and gram-positive organisms
Low antibiotic serum concentrations
Infection is treated and patient receives new revision prothesis in 7 days
Durable results: >90% of patients are infection free at 1 year post treatment
After removing the infected joint prosthesis, bone and soft tissue, the surgeon places a VT-X7 spacer and fluid management dressing, connecting them to an irrigation pump.
Place VT-X7 spacer
Over the course of one week in the hospital, more than 150 cycles of VT-X7 antibiotics are administered to the joint space through the VT-X7 spacer, allowed to penetrate and then withdrawn prior to initiation of the next cycle.
150+ cycles of VT-X7
After 7 days of therapy, the VT-X7 spacer is removed and replaced with a permanent joint prosthesis, and the patient proceeds to post-surgical physical therapy.
days of therapy
Successful Phase 2 Results
Osteal Therapeutics conducted a Phase 2 prospective, single-arm, clinical trial for the treatment of patients with infected hip and knee prostheses at 4 U.S. centers. In the trial all subjects received new revision joint prostheses after 7 days of therapy and a clinically and statistically significant percentage of subjects were infection free at 12 weeks and 1 year.