CMS Grants New Technology Add-On Payment (NTAP) Status for ZEVASKYN®

About this update from Abeona Therapeutics Inc.

NTAP Designation Expected to Support Medicare Patient Access, Treatment Center Economics and Commercial Adoption CLEVELAND, Aug. 04, 2026 (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 & Medicaid Services (CMS) has granted New Technology Add-On Payment (NTAP) status for ZEVASKYN (prademagene zamikeracel) under the Fiscal Year 2027 Hospital Inpatient Prospective Payment System (IPPS) Final Rule. NTAP status provides supplemental CMS reimbursement above standard hospital payments to support access to innovative therapies like ZEVASKYN. This additional funding is awarded to technologies that meet CMS criteria, including demonstrating substantial clinical improvement over existing alternatives. "CMS's NTAP designation recognizes ZEVASKYN's meaningful clinical benefit and optimizes treatment center economics," said Madhav Vasanthavada, Chief Commercial Officer of Abeona Therapeutics®. "NTAP status further strengthens our broad payor coverage by reinforcing reimbursement for Medicare patients, including younger individuals with qualifying disabilities, complementing our permanent J-code and strong commercial foundation to ensure seamless patient access." About ZEVASKYN® (prademagene zamikeracel) gene-modified cellular sheetsZEVASKYN 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 incorporates the functional type VII collagen-producing COL7A1 gene into a patient's own skin cells, ex vivo, using a replication-incompetent retroviral vector to produce functional type VII collagen in treated wounds. ZEVASKYN has demonstrated clinically meaningful wound healing and pain reduction with a single surgical application. For more information, visit&...

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