Osteal Therapeutics provides a program that offers expanded access to its investigational drug/device combination product, VT-X7, under section 561(b) of the Federal Food, Drug, and Cosmetic Act. This expanded access program aims to provide access to VT-X7 for patients with refractory periprosthetic joint infection (PJI) of the hip or knee, who have no suitable treatment alternatives. Access may be obtained through investigator-driven individual access requests or through the APEX-Expanded Access Protocol EAP.

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Enrollment in the APEX-EAP is dependent on several factors, including meeting eligibility criteria in the treatment protocol. To learn more about the APEX-EAP, including information on participating investigators and locations, visit Study Details | Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty | ClinicalTrials.gov.

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Patients or healthcare professionals seeking additional information about individual access requests, VT-X7 treatment options, or other questions regarding the expanded access program may contact Osteal Therapeutics at clinical@ostealtx.com. We will make every effort to respond to inquiries regarding the expanded access program or requests for access to the investigational drug within five (5) business days of receiving the request.