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Abeona Therapeutics® Announces Permanent J-Code for ZEVASKYN® (prademagene zamikeracel)
CLEVELAND, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"CLEVELAND, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that the Centers for Medicare and Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, the Company’s autologous gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The new J-code for ZEVASKYN, J3389 (Topical administration, prademagene zamikeracel, per treatment) becomes effective on January 1, 2026. \"The assignment of a unique, product-specific J-code by CMS is a major step forward in ZEVASKYN’s launch,\" said Dr. Madhav Vasanthavada, Chief Commercial Officer of Abeona. \"This code will simplify claims and reimbursement processing between our qualified treatment centers and payers across public and private sectors, and further support hospital adoption and patient access for ZEVASKYN.\" J-codes are unique identifiers designed to identify non-orally administered medications in healthcare settings. A J-code plays a vital role in streamlining the medical billing and reimbursement processes related to drug administration. About ZEVASKYN® (prademagene zamikeracel) gene-modified cellular sheets ZEVASKYN is the first and only autologous cell sheet-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a severe skin disease caused by a defect in both copies of the COL7A1 gene, resulting in the inability to produce functional type VII collagen. Without functional type VII collagen and anchoring fibrils, the skin is fragile and blisters easily, leading to wounds that continually open and close, or fail to heal altogether. Patients often have large open wounds that can lead to serious life-threatening complications. ZEVASKYN gene modified cellular sheets are made by inserting the correct COL7A1 gene into a patient’s own skin cells ex vivo using a replication-incompetent retroviral vector, resulting in functional type VII collagen expression in treated wounds. ZEVASKYN has demonstrated clinically meaningful wound healing and pain reduction with a single...