Abeona Therapeutics Inc. (Nasdaq: ABEO) 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 Final Rule.

NTAP status provides supplemental CMS reimbursement above standard hospital payments for technologies that meet CMS criteria, including demonstrating substantial clinical improvement over existing alternatives.

ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a severe genetic skin disease that causes fragile skin and wounds that are difficult to heal. The therapy incorporates a functional copy of the COL7A1 gene into a patient's own skin cells to produce type VII collagen in treated wounds.

"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."

The company states that the NTAP designation is expected to support Medicare patient access, treatment center economics, and commercial adoption of the therapy. Abeona is based in Cleveland, Ohio, where it also operates its manufacturing facility for ZEVASKYN commercial production.