Expanded Access Program
Osteal Therapeutics® has a program offering expanded access to its investigational drug/device combination product, VT-X7, under section 561(b) of the Federal Food, Drug, and Cosmetic Act. This program aims to provide patients with periprosthetic joint infection (PJI) of the hip or knee, who lack suitable therapeutic treatment alternatives, access to VT-X7. Eligibility for enrollment in the Expanded Access Program is dependent on several factors and criteria, including specific program requirements.
Patients or healthcare professionals seeking additional information may contact Osteal Therapeutics® at clinical@ostealtx.com. All inquiries regarding the Expanded Access Program or requests for access to the investigational drug will receive a response within five (5) business days of receipt.
To learn more about the Expanded Access Program, including information on study investigators and study locations, visit: https://clinicaltrials.gov/study/NCT06383611?term=APEX%20Osteal&rank=1.