Vericel (VCEL) FDA Approvals

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 approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Peer-reviewed publication - December 10,2025

• Drug: NexoBrid
• Announced Date: December 10, 2025
• Indication: Enzymatically removes nonviable burn tissue
• Other Companies Involved: NASDAQ:MDWD

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.

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

Marketing authorization - September 25,2025

Australian TGA Approval

• Drug: NexoBrid
• Announced Date: September 25, 2025
• Indication: Enzymatically removes nonviable burn tissue
• Other Companies Involved: NASDAQ:MDWD

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.

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.

Publication - February 25,2025

Phase 3

• Drug: NexoBrid
• Announced Date: February 25, 2025
• Indication: Enzymatically removes nonviable burn tissue
• Other Companies Involved: NASDAQ:MDWD

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).

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.

FDA Approval - August 15,2024

FDA Approved

• Drug: NexoBrid
• Announced Date: August 15, 2024
• Indication: Enzymatically removes nonviable burn tissue
• Other Companies Involved: NASDAQ:MDWD

MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns.

MediWound Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for pediatric use. This new indication allows pediatric patients from newborn through eighteen years old with deep partial- and full-thickness thermal burns to receive NexoBrid for eschar removal. The treatment helps remove the dead burn tissue without damaging healthy tissue, offering a less invasive and more effective alternative to traditional surgical methods.

This approval is based on the strong safety and efficacy data gathered from a global Phase III clinical trial, which focused on hospitalized pediatric patients. With pediatric burn victims making up a significant portion of the burn patient population, this milestone is expected to reduce trauma for both the children and their families. MediWound’s commitment to advancing burn care is highlighted by this significant step in expanding treatment options for young burn victims in the U.S.

Positive Results - August 5,2024

• Drug: NexoBrid
• Announced Date: August 5, 2024
• Indication: Enzymatically removes nonviable burn tissue
• Other Companies Involved: NASDAQ:MDWD

MediWound Ltd. announced the positive results of the NEXT—an Expanded Access Protocol. NEXT, initiated in 2019, aimed to ensure the continuous availability of NexoBrid® in burn centers until its commercialization.

MediWound Ltd. announced positive results from the NEXT Expanded Access Protocol, which was initiated in 2019 to ensure that burn centers had continuous access to NexoBrid® until its full commercialization. The NEXT program played a key role in keeping the treatment available, allowing physicians to maintain their expertise and providing burn victims with ongoing access to this life-saving therapy. By using NexoBrid®, clinicians were able to quickly remove burned tissue, reduce the need for surgical interventions, and improve patient recovery outcomes. In addition, the protocol facilitated the collection of valuable real-world safety and clinical data that supported previous trial findings. These encouraging results show that maintaining access to innovative treatments like NexoBrid® is essential for advancing burn care and improving the overall standard of treatment for severe burn injuries.