# Zevaskyn (pz-cel) by Abeona Therapeutics

Canonical page: https://technooptimist.io/biotech/zevaskyn
Frontier: [Biotech](https://technooptimist.io/biotech.md) · Field: Gene therapy · Company: [Abeona Therapeutics](https://technooptimist.io/companies/abeona-therapeutics.md)
Stage: Deploy (4 of 5: Research → Proto → Pilot → Deploy → Scaling)
Updated: last update 2026-08-13, facts checked 2026-10-11
Goal: Close the large chronic wounds of recessive dystrophic epidermolysis bullosa for years with one surgery, by grafting the patient's own skin cells after fixing the gene that anchors skin layers together.
Status: On sale; 12 patients treated by Aug 2026; Q2 2026 revenue $11.4M; manufacturing yield limits growth.
Next milestone: Expanding treatment centres and manufacturing yield, target 2026

## Milestones

| Status | Milestone | Date | Slip |
| --- | --- | --- | --- |
| Done | Phase 1/2a: grafted wounds stay closed over 5–6 years |   |   |
| Done | VIITAL phase 3: 81% of wounds half-healed vs 16% control |   |   |
| Done | FDA approval | 29 Apr 2025 |   |
| Done | Medicare add-on payment (NTAP) takes effect | 1 Oct 2026 |   |
| Current | Expanding treatment centres and manufacturing yield | 2026 |   |

## Upcoming events

- **2026**: Expanding treatment centres and manufacturing yield

## Most important updates

- **13 Aug 2026**: Abeona: Zevaskyn revenue rises 31% to $11.4M in Q2 2026; 12 patients treated since launch. Abeona reported $11.4M of Zevaskyn revenue in Q2 2026, up from $8.7M in Q1, with five patients treated in the quarter and 12 since launch. ([our story](https://technooptimist.io/stories/abeona-zevaskyn-revenue-rises-31-to-11-4m-in-q2-2026-12-patients-7afd710c.md) · [original source](https://www.1stoncology.com/blog/?p=112851))
- **29 Apr 2025**: FDA approves Zevaskyn, the first cell-based gene therapy for wounds of recessive dystrophic epidermolysis bullosa. The FDA approved Zevaskyn (prademagene zamikeracel) for wounds in adults and children with recessive dystrophic epidermolysis bullosa, a genetic disease where skin tears and blisters at the slightest friction. ([our story](https://technooptimist.io/stories/fda-approves-zevaskyn-the-first-cell-based-gene-therapy-for-wounds-of-5800a692.md) · [original source](https://www.europeanpharmaceuticalreview.com/news/254869/fda-approves-first-of-a-kind-gene-therapy-for-dystrophic-epidermolysis-bullosa))

## Current obstacles

- **Manufacturing yield**: Some batches grow too few sheets or fail release tests; two treatments so far couldn't be billed.
- **Small, slow-growing market**: RDEB is rare; uptake depends on activating specialist centres one at a time and on insurer coverage.

## Physics limits

- **Treats patches, not the whole body**: Grafts fix only the skin they cover; blistering elsewhere, including the mouth and gut, continues because the gene is not corrected body-wide.
- **Living grafts are slow to make**: Each batch is grown from one patient's cells over weeks, so cost, timing and failure rates can't scale like a vial-based drug.

## How it works

### Biopsy: Take a little skin

A small skin biopsy supplies the patient's own keratinocytes, the cells of the skin's outer layer.

### Gene fix: Add working collagen VII

The cells receive a corrected collagen VII gene; collagen VII forms the fibrils that anchor the top skin layer.

### Sheets: Grow grafts in the lab

Corrected cells are grown into up to 12 sheets, each about the size of a credit card.

### Graft: Cover the wounds once

Surgeons stitch sheets onto chronic wounds; patients keep them undisturbed 5–10 days while they take.

## Spec sheet

| Spec | Zevaskyn (pz-cel) | Provenance |
| --- | --- | --- |
| Wounds ≥50% healed at 6 months | 81% vs 16% (standard care) | reported |
| Grafts per treatment | Up to 12 credit-card-sized sheets | reported |
| Patients treated since launch | 12 (to Aug 2026) | reported |
| Q2 2026 revenue | $11.4M | reported |
| Longest follow-up (case report) | 12 years | reported |

Provenance: reported = stated by the company; estimated = our estimate; sample = a sample figure.

## About Abeona Therapeutics

US company that makes Zevaskyn: sheets of a patient's own skin cells, gene-corrected to make collagen VII, grafted onto the chronic wounds of recessive dystrophic epidermolysis bullosa.

- Zevaskyn approved by FDA April 2025, the first cell-based gene therapy for RDEB wounds.
- Q2 2026 Zevaskyn revenue $11.4M (+31% QoQ); 12 patient treatments since launch.
- Manufacturing yield is the bottleneck: two treatments so far could not be billed.

- Headquarters: US
- Status: public
- Website: https://www.abeonatherapeutics.com
- People: Vish Seshadri (Chief Executive Officer)

Company page: https://technooptimist.io/companies/abeona-therapeutics.md

## Related programs

Everything in Biotech: https://technooptimist.io/biotech.md

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