Vericel Announces FDA Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns
Vericel (NASDAQ:VCEL) has announced that the FDA has approved NexoBrid® (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness and/or full-thickness thermal burns. This approval expands NexoBrid's target customer base to include approximately 20 pediatric burn centers in the United States. The approval is based on results from the global Phase 3 CIDS trial and additional pediatric data from Phase 3 and Phase 2 studies. NexoBrid offers a non-surgical solution for managing severe burn injuries in pediatric patients, providing a less invasive alternative to traditional methods. The company expects this expansion to have a meaningful impact on overall NexoBrid uptake over time.
Vericel (NASDAQ:VCEL) ha annunciato che la FDA ha approvato NexoBrid® (anacaulase-bcdb) per la rimozione delle eschar in pazienti pediatrici con ustioni termiche di spessore parziale profondo e/o completo. Questa approvazione amplia la base di clienti di NexoBrid per includere circa 20 centri ustionati pediatrici negli Stati Uniti. L'approvazione si basa sui risultati dello studio internazionale di Fase 3 CIDS e su ulteriori dati pediatrici provenienti da studi di Fase 3 e Fase 2. NexoBrid offre una soluzione non chirurgica per la gestione di gravi ustioni nei pazienti pediatrici, fornendo un'alternativa meno invasiva ai metodi tradizionali. L'azienda si aspetta che questa espansione abbia un impatto significativo sull'adozione complessiva di NexoBrid nel tempo.
Vericel (NASDAQ:VCEL) ha anunciado que la FDA ha aprobado NexoBrid® (anacaulase-bcdb) para la extracción de escaras en pacientes pediátricos con quemaduras térmicas de espesor parcial profundo y/o de espesor total. Esta aprobación amplía la base de clientes de NexoBrid para incluir aproximadamente 20 centros de quemaduras pediátricos en los Estados Unidos. La aprobación se basa en los resultados del ensayo global de Fase 3 CIDS y datos adicionales pediátricos de estudios de Fase 3 y Fase 2. NexoBrid ofrece una solución no quirúrgica para el manejo de lesiones por quemaduras severas en pacientes pediátricos, proporcionando una alternativa menos invasiva a los métodos tradicionales. La compañía espera que esta expansión tenga un impacto significativo en la adopción general de NexoBrid a lo largo del tiempo.
Vericel (NASDAQ:VCEL)은 FDA가 심각한 부분적 및/또는 전체적인 열 화상 어린이 환자의 각질 제거를 위해 NexoBrid® (anacaulase-bcdb)를 승인했다고 발표했습니다. 이번 승인은 미국의 약 20개 어린이 화상 센터를 NexoBrid의 주요 고객군에 추가합니다. 이 승인은 글로벌 3상 CIDS 시험의 결과와 추가적으로 3상 및 2상 연구에서 얻은 소아 데이터를 기반으로 합니다. NexoBrid는 소아 환자의 심각한 화상 상처 관리를 위한 비수술적 솔루션을 제공하여 전통적인 방법에 비해 덜 침습적인 대안을 제시합니다. 이 회사는 이번 확장이 NexoBrid의 전반적인 채택에 의미 있는 영향을 미칠 것으로 기대하고 있습니다.
Vericel (NASDAQ:VCEL) a annoncé que la FDA a approuvé NexoBrid® (anacaulase-bcdb) pour l'élimination des escarres chez les patients pédiatriques souffrant de brûlures thermiques à épaisseur partielle profonde et/ou totale. Cette approbation élargit la clientèle cible de NexoBrid pour inclure environ 20 centres de traitement des brûlures pédiatriques aux États-Unis. L'approbation repose sur les résultats de l'essai mondial de phase 3 CIDS et sur des données supplémentaires pédiatriques provenant des études de phase 3 et de phase 2. NexoBrid offre une solution non chirurgicale pour la gestion des blessures graves causées par des brûlures chez les patients pédiatriques, fournissant une alternative moins invasive par rapport aux méthodes traditionnelles. L'entreprise s'attend à ce que cette expansion ait un impact significatif sur l'adoption générale de NexoBrid avec le temps.
Vericel (NASDAQ:VCEL) hat bekannt gegeben, dass die FDA NexoBrid® (anacaulase-bcdb) zur Entfernung von Schorf bei pädiatrischen Patienten mit tiefen Teil- und/oder Vollbrandverletzungen genehmigt hat. Diese Genehmigung erweitert die Zielgruppe von NexoBrid um etwa 20 pädiatrische Brandzentren in den Vereinigten Staaten. Die Genehmigung basiert auf den Ergebnissen der globalen Phase-3-Studie CIDS und zusätzlichen pädiatrischen Daten aus Phase-3- und Phase-2-Studien. NexoBrid bietet eine nicht-operative Lösung zur Behandlung schwerer Brandverletzungen bei pädiatrischen Patienten und stellt eine weniger invasive Alternative zu traditionellen Methoden dar. Das Unternehmen erwartet, dass diese Erweiterung einen bedeutenden Einfluss auf die allgemeine Akzeptanz von NexoBrid im Laufe der Zeit haben wird.
- FDA approval for pediatric use of NexoBrid, expanding the product's market
- Potential to become the new standard of care for eschar removal in burn patients
- Expansion of target customer base to include 20 pediatric burn centers in the US
- Less invasive alternative to traditional burn treatment methods for pediatric patients
- None.
Insights
The FDA approval of NexoBrid for pediatric use is a significant milestone in burn care. This enzymatic debriding agent offers a non-surgical alternative for eschar removal, which is particularly valuable for children. The approval is based on robust clinical evidence, including the global Phase 3 CIDS trial and additional Phase 2 and 3 studies.
The expansion to pediatric patients opens up a new market segment for Vericel, potentially increasing NexoBrid's adoption rate. With approximately 20 pediatric burn centers in the U.S. now accessible, this could drive substantial growth in the product's utilization. The less invasive nature of NexoBrid compared to traditional methods may lead to improved outcomes and reduced trauma for young patients, potentially establishing it as a new standard of care in pediatric burn treatment.
Vericel's expansion of NexoBrid to the pediatric market is a strategic move that could significantly impact the company's financial performance. The addition of approximately 20 pediatric burn centers to their target customer base represents a substantial market opportunity. While specific revenue projections aren't provided, this approval could drive increased adoption and sales growth.
Investors should note that becoming the "new standard of care" in both adult and pediatric burn treatment could lead to long-term revenue stability and potential market dominance. However, the actual financial impact will depend on factors such as pricing strategy, reimbursement policies and the rate of adoption among pediatric burn centers. The company's ability to execute its commercial launch strategy effectively will be important in capitalizing on this expanded market access.
The pediatric approval for NexoBrid significantly enhances Vericel's market positioning in the burn care sector. By addressing the needs of a vulnerable patient population, the company not only expands its potential customer base but also strengthens its reputation as an innovator in advanced therapies. This move aligns with the growing trend towards minimally invasive treatments and could resonate well with healthcare providers and patients alike.
The expansion into pediatric burn centers could serve as a catalyst for broader adoption of NexoBrid. Success in this sensitive patient group might accelerate acceptance in adult burn treatment as well. However, Vericel will need to navigate challenges such as specialized training for pediatric use and potential regulatory scrutiny given the sensitive nature of the patient population. The company's ability to effectively market and support the product in this new segment will be critical for capitalizing on this opportunity.
Approval Expands NexoBrid Target Customer Base to Include Approximately 20 Pediatric Burn Centers
CAMBRIDGE, Mass., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness and/or full-thickness thermal burns.
“We are pleased that the FDA approved NexoBrid for pediatric use as it provides a novel non-surgical solution for managing severe burn injuries in this vulnerable pediatric patient population,” said Nick Colangelo, President and CEO of Vericel. “We believe NexoBrid is poised to become the new standard of care for eschar removal and make a meaningful impact on the lives of adult and pediatric burn patients, and we look forward to further executing on our NexoBrid commercial launch.”
The FDA approval of the pediatric indication for NexoBrid is based on the results of a global Phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. Vericel is expanding its target customer base to include the approximately 20 pediatric burn centers in the United States, which the Company expects will have a meaningful impact on overall NexoBrid uptake over time.
“For pediatric burn patients, NexoBrid represents a less invasive alternative to traditional methods and the approval ensures that children will now have access to this innovative non-surgical option to quickly and effectively treat severe thermal burns,” said Steven Kahn, MD, Chief of Burn Surgery at MUSC, University Hospital and Shawn Jenkins Children’s Hospital.
NexoBrid was initially approved for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns by the FDA on December 28, 2022, and is commercially available in the United States.
About NexoBrid
NexoBrid (anacaulase-bcdb) is a biologic product containing proteolytic enzymes indicated for eschar removal in adults and pediatric patients with deep partial- and/or full-thickness thermal burns. To learn more about NexoBrid, please visit www.NexoBrid-US.com.
Indications for Use: NexoBrid (anacaulase-bcdb) is indicated for eschar removal in adults and pediatric patients with deep partial-thickness and/or full-thickness thermal burns.
Limitations of Use:
The safety and effectiveness of NexoBrid have not been established for treatment of:
- Chemical or electrical burns
- Burns on the face, perineum, or genitalia
- Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease
- Circumferential burns
- Burns in patients with significant cardiopulmonary disease, including inhalation injury
NexoBrid is not recommended for:
- Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance
- Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal
Important Safety Information
- Contraindications: NexoBrid is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.
- Warnings and Precautions
- Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported with post-marketing use of anacaulase-bcdb. If a hypersensitivity reaction occurs, remove NexoBrid (if applicable) and initiate appropriate therapy. Healthcare personnel should take appropriate precautions to avoid exposure when preparing and handling NexoBrid (e.g., gloves, surgical masks, other protective coverings, as needed.)
- Coagulopathy: Avoid use of NexoBrid in patients with uncontrolled disorders of coagulation. Use with caution in patients on anticoagulant therapy or other drugs affecting coagulation, and in patients with low platelet counts and increased risk of bleeding from other causes. Monitor patients for possible signs of coagulation abnormalities and signs of bleeding.
- Adverse Reactions: The most common adverse reactions (>
5% ) in adults were pruritus, pyrexia, wound complication, anemia, vomiting and insomnia. The most common adverse reactions (>5% ) in pediatric patients were pruritus, pyrexia and vomiting. - Geriatric: Clinical studies of NexoBrid did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
- To report negative side effects, contact Vericel Corporation at 888-454-BURN (888-454-2876) or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
- Please see Full Prescribing Information.
About Vericel Corporation
Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets. The Company combines innovations in biology with medical technologies, resulting in a highly differentiated portfolio of innovative cell therapies and specialty biologics that repair injuries and restore lives. Vericel markets three products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to
Epicel and MACI are registered trademarks of Vericel Corporation. NexoBrid is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2024 Vericel Corporation. All rights reserved.
Forward Looking Statements
This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel’s periodic reports on file with the Securities and Exchange Commission. Among the factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to, uncertainties associated with our expectations regarding the market penetration for NexoBrid, physician and burn center adoption of NexoBrid, and supply chain disruptions or other events or factors affecting MediWound’s ability to manufacture and supply sufficient quantities of NexoBrid to meet customer demand, including but not limited to the ongoing Israel-Hamas war. Actual results may differ materially from anticipated results.
Investor Contact:
Eric Burns
ir@vcel.com
+1 (734) 418-4411
Media Contact:
Julie Downs
media@vcel.com
FAQ
What is the new FDA approval for Vericel's NexoBrid (VCEL)?
How many pediatric burn centers could potentially use NexoBrid (VCEL) following this approval?
What clinical trials supported the FDA approval of NexoBrid (VCEL) for pediatric use?
How does NexoBrid (VCEL) differ from traditional burn treatments for pediatric patients?
