Vericel's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Vericel (VCEL).
Over the past two years, Vericel has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NexoBrid. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NexoBrid FDA Regulatory Timeline and Events
NexoBrid is a drug developed by Vericel for the following indication: Enzymatically removes nonviable burn tissue.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NexoBrid
- Announced Date:
- December 10, 2025
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid® substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries.
AI Summary
MediWound announced a peer-reviewed study showing that NexoBrid® can greatly reduce embedded particles that cause traumatic tattoos after abrasion and blast injuries. The prospective study at Sheba Medical Center treated 15 patients who first had standard scrubbing, then received NexoBrid within 24 hours. Photographs and computer analysis measured pigment before and after enzymatic debridement.
Results showed mean pigmented wound area fell from 37.5% to 2.1% after NexoBrid, a 92.5% reduction versus the post-scrub baseline. Abrasive injuries lost about 96% of visible pigment and blast injuries about 84%. Treatment was done at the bedside, was well tolerated, and no treatment-related adverse events were reported in the early post-procedure period.
Investigators say NexoBrid’s selective enzymatic action helps remove damaged tissue and reveal a clean wound bed, but note the study’s small size and short follow-up and call for larger controlled trials to confirm long-term cosmetic benefits.Read Announcement
- Drug:
- NexoBrid
- Announced Date:
- September 25, 2025
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®, the Company's innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns.
AI Summary
MediWound Ltd. announced that Australia’s Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid®, its enzymatic therapy for removing eschar in adults and children with deep partial- and full-thickness thermal burns. This marks Australia as the 45th country to approve NexoBrid, underlining its growing role as a non-surgical standard of care in burn management.
Balance Medical, MediWound’s exclusive partner in Australia, plans to launch NexoBrid in the fourth quarter of 2025. To meet rising global demand, MediWound is expanding its manufacturing capacity, with the new facility scheduled for completion by the end of 2025.
Ofer Gonen, MediWound’s CEO, said the TGA approval expands access to advanced burn treatments across Australia and opens opportunities throughout the Asia-Pacific region. Dr. Jason Brown of the Royal Brisbane and Women’s Hospital noted that NexoBrid’s rapid, selective eschar removal preserves healthy tissue and offers clinicians a valuable non-surgical option for better patient outcomes.
Read Announcement- Drug:
- NexoBrid
- Announced Date:
- February 25, 2025
- Indication:
- Enzymatically removes nonviable burn tissue
Announcement
MediWound Ltd. announced the publication of its Phase III Children Innovative Debridement Study (CIDS) in Burns, the peer-reviewed Journal of the International Society for Burn Injuries (ISBI).
AI Summary
MediWound Ltd. recently announced that its Phase III Children Innovative Debridement Study (CIDS) has been published in Burns, the peer‐reviewed journal of the International Society for Burn Injuries (ISBI). This study, conducted in multiple centers across the US, EU, Israel, and India, focused on evaluating the safety and effectiveness of NexoBrid® compared to standard care in pediatric patients with deep partial- and full-thickness thermal burns. The results demonstrated that NexoBrid provided faster removal of eschar, reduced the need for surgical intervention, and preserved healthy tissue, offering a rapid non-surgical alternative for young burn victims. These findings supported the recent label expansion for pediatric use in key regions including the U.S., E.U., and Japan and further underline NexoBrid’s clinical benefits and potential to transform burn care for children.
Read Announcement
Vericel FDA Events - Frequently Asked Questions
As of now, Vericel (VCEL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Vericel (VCEL) has reported FDA regulatory activity for NexoBrid.
The most recent FDA-related event for Vericel occurred on December 10, 2025, involving NexoBrid. The update was categorized as "Peer-reviewed publication," with the company reporting: "MediWound Ltd announced the peer-reviewed publication of new prospective clinical data showing that NexoBrid® substantially reduces embedded particles associated with traumatic tattoos following abrasion and blast injuries."
Currently, Vericel has one therapy (NexoBrid) targeting the following condition: Enzymatically removes nonviable burn tissue.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:VCEL last updated on 12/10/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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