Breakthrough technology: ZEVASKYN uses patients’ own skin cells to treat RDEB wounds1

Gene-modified cellular sheets can cover multiple small and large wounds1

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1

Starting Material

Patient’s own keratinocytes are extracted from two 8 mm punch biopsies.2

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2

Gene Modification

Keratinocytes are transduced ex vivo with a retroviral vector containing full-length COL7A1, which stably integrates into the host-cell genome and leads to expression of functional type VII collagen protein in the transduced cells.1

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3

Expansion into sheets

Over the course of ~25 days, cells containing the functional COL7A1 gene are then expanded into type VII collagen protein–producing cellular sheets.1,3

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4

Application

Up to 12 credit card–sized, gene-modified sheets (each 41.25 cm2) are provided ~25 days after biopsy for surgical application.1,3 Multiple individual wounds or larger areas can be treated with ZEVASKYN in a single session.4

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Posttreatment

Treatment areas are undisturbed for 5-10 days to allow for healing.1 Patient is discharged from the ZEVASKYN Qualified Treatment Center and follow-up is at physician’s discretion.

Diagram of ZEVASKYN placement on patient
Diagram of ZEVASKYN placement on patient
Diagram of ZEVASKYN placement on patient
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Early referral to a ZEVASKYN Qualified Treatment Center is critical to confirm patient eligibility and initiate treatment*

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  • EB=epidermolysis bullosa; RDEB=recessive dystrophic epidermolysis bullosa.
  • *ZEVASKYN Qualified Treatment Centers are independently owned and operated. Abeona Therapeutics does not oversee any treatment centers or the medical care they provide.

Discover before and after images of wounds treated with ZEVASKYN

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Individual results may vary.

Example of an RDEB wound at the arm before treatment with ZEVASKYN
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References: 1. ZEVASKYN™ (prademagene zamikeracel) Prescribing Information. Cleveland, OH: Abeona Therapeutics Inc; 2025. 2. Clinical study report 14563/31095. Abeona Therapeutics Inc. 3. Eichstadt S, Barriga M, Ponakala A, et al. JCI Insight. 2019;4(19):e130554. doi:10.1172/jci.insight.130554 4. So JY, Nazaroff J, Iwummadu CV, et al. Orphanet J Rare Dis. 2022;17(1):377. doi:10.1186/s13023-022-02546-9

Indication

ZEVASKYN™ (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Important Safety Information

  • Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. Monitor for signs and symptoms of hypersensitivity reactions such as itching, swelling, hives, difficulty breathing, runny nose, watery eyes, nausea, and in severe cases, anaphylaxis and treat according to standard clinical practice.
  • Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. Monitor patients lifelong after treatment for the development of malignancies. In the event that a malignancy occurs, contact Abeona Therapeutics Inc. at 1-844-888-2236.
  • Transmission of infectious disease or agents may occur with ZEVASKYN because it is manufactured using human- and bovine-derived reagents, which are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other infectious diseases or agents.
  • The most common adverse reactions (incidence ≥5%) were procedural pain and pruritus.

Please see full Prescribing Information.

Indication

ZEVASKYN™ (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Important Safety Information

  • Severe hypersensitivity reactions to vancomycin, amikacin, or product excipients may occur with ZEVASKYN application. Monitor for signs and symptoms of hypersensitivity reactions such as itching, swelling, hives, difficulty breathing, runny nose, watery eyes, nausea, and in severe cases, anaphylaxis and treat according to standard clinical practice.
  • Retroviral vector (RVV)-mediated insertional oncogenesis may potentially occur after treatment with ZEVASKYN. Monitor patients lifelong after treatment for the development of malignancies. In the event that a malignancy occurs, contact Abeona Therapeutics Inc. at 1-844-888-2236.
  • Transmission of infectious disease or agents may occur with ZEVASKYN because it is manufactured using human- and bovine-derived reagents, which are tested for human and animal viruses, bacteria, fungi, and mycoplasma before use. These measures do not eliminate the risk of transmitting these or other infectious diseases or agents.
  • The most common adverse reactions (incidence ≥5%) were procedural pain and pruritus.

Please see full Prescribing Information.

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ZEVASKYN, Abeona Assist, and the related logos are trademarks of Abeona Therapeutics Inc. All other trademarks are the property of their respective owners.

© 2025 Abeona Therapeutics Inc. All rights reserved. US-COM-ZEV-240021  05/25