FDA Grants Breakthrough Status to Osteal Therapeutics' VT-X7 for Hip and Knee Periprosthetic Joint Infection

The FDA has granted Breakthrough Therapy Designation to Osteal Therapeutics' VT-X7 for treating periprosthetic joint infection in the hip and knee, marking another milestone after previously receiving Orphan Drug, Qualified Infectious Disease Product, and Fast Track designations. Additionally, the company has successfully completed enrollment in the pivotal APEX-2 clinical trial for VT-X7.

David Thompson, President and CEO, commented on the Breakthrough Therapy Designation, stating, "Securing this designation from the FDA is a major milestone for the company and underscores the agency's acknowledgment of VT-X7's potential in addressing periprosthetic joint infection as a serious, life-threatening condition. With patients and providers in urgent need of improved PJI treatment options, this designation positions VT-X7 on an accelerated path to meet this critical demand."