• Gozellix, Telix's next-generation PSMA PET imaging agent, granted permanent HCPCS code by CMS
• Code enables provider billing and reimbursement, supporting clinical adoption and expanded access
• Gozellix overcomes logistical barriers, improving access to PSMA PET imaging for prostate cancer patients

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) has announced that its next-generation PSMA PET imaging agent, Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS). Effective from 1 October 2025, CMS and commercial health insurers will recognize the HCPCS Level II code A9616 assigned for reimbursement of Gozellix. The assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving Transitional Pass-Through (TPT) payment status. Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level. With its extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging. Telix believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging for prostate cancer patients across the United States.