MediWound Expands Global Reach with Marketing Approval of NexoBrid® in Australia
MediWound (Nasdaq: MDWD) has received marketing authorization from Australia's Therapeutic Goods Administration (TGA) for NexoBrid®, its enzymatic therapy for eschar removal in adult and pediatric burn patients. This approval expands NexoBrid's global presence to 45 countries.
The company's exclusive partner, Balance Medical, plans to launch NexoBrid commercially in Q4 2025. MediWound's manufacturing expansion, scheduled for completion by year-end 2025, will support the Australian launch and growing global demand. The approval represents a strategic entry point into the broader Asia-Pacific market.
MediWound (Nasdaq: MDWD) ha ottenuto l'autorizzazione alla commercializzazione da parte dell'Australian Therapeutic Goods Administration (TGA) per NexoBrid®, la sua terapia enzimatica per la rimozione dell'eschar nei pazienti adulti e pediatrici ustionati. Questa approvazione amplia la presenza globale di NexoBrid a 45 Paesi.
L'unico partner dell'azienda, Balance Medical, prevede di lanciare commercialmente NexoBrid nel Q4 2025. L'espansione degli impianti di produzione di MediWound, prevista entro la fine del 2025, sosterrà il debutto in Australia e la crescente domanda globale. L'approvazione rappresenta una porta d'ingresso strategica nel più ampio mercato dell'Asia-Pacifico.
MediWound (Nasdaq: MDWD) ha obtenido la autorización de comercialización de la Australian Therapeutic Goods Administration (TGA) para NexoBrid®, su terapia enzimática para la eliminación de eschar en pacientes adultos y pediátricos quemados. Esta aprobación amplía la presencia global de NexoBrid a 45 países.
El socio exclusivo de la empresa, Balance Medical, planea comercializar NexoBrid en el cuarto trimestre de 2025. La expansión de la producción de MediWound, prevista para completarse a finales de 2025, respaldará el lanzamiento en Australia y la creciente demanda global. La aprobación representa una entrada estratégica al mercado más amplio de Asia-Pacífico.
MediWound (나스닥: MDWD)는 성인 및 소아 화상 환자를 위한 조직 제거용 효소 치료제 NexoBrid®에 대해 호주 의약광고청(TGA)으로부터 시판 허가를 받았습니다. 이 승인은 NexoBrid의 글로벌 입지를 45개국으로 확장합니다. 회사의 독점 파트너인 Balance Medical은 2025년 4분기에 NexoBrid를 상용화할 계획입니다. 2025년 말까지 완료될 MediWound의 제조 확장은 호주 출시와 증가하는 글로벌 수요를 뒷받침합니다. 이 승리는 더 넓은 아시아-태평양 시장으로의 전략적 진입점을 의미합니다.
MediWound (Nasdaq: MDWD) a obtenu l'autorisation de mise sur le marché par l'Australian Therapeutic Goods Administration (TGA) pour NexoBrid®, sa thérapie enzymatique destinée à l'élimination de l'eschar chez les patients brûlés adultes et pédiatriques. Cette approbation étend la présence mondiale de NexoBrid à 45 pays.
Le partenaire exclusif de l'entreprise, Balance Medical, prévoit de lancer commercialement NexoBrid au quatrième trimestre 2025. L'expansion de la production de MediWound, prévue pour être achevée d'ici la fin 2025, soutiendra le lancement en Australie et la demande mondiale croissante. Cette approbation constitue une porte d'entrée stratégique sur le marché plus large de la région Asie-Pacifique.
MediWound (Nasdaq: MDWD) hat von der Australian Therapeutic Goods Administration (TGA) die Marktzulassung für NexoBrid®, ihre enzymatische Therapie zur Entfernung von Eschar bei erwachsenen und pädiatrischen Brandpatienten, erhalten. Diese Zulassung erweitert die globale Präsenz von NexoBrid auf 45 Länder.
Der exklusive Partner des Unternehmens, Balance Medical, plant die kommerzielle Markteinführung von NexoBrid im vierten Quartal 2025. Die Erweiterung der Produktionskapazität von MediWound, die bis Ende 2025 abgeschlossen sein soll, wird den australischen Markteintritt und die wachsende globale Nachfrage unterstützen. Die Zulassung stellt einen strategischen Einstieg in den breiteren Asia-Pacific-Markt dar.
MediWound (تُدرج في ناسداك: MDWD) حصلت على موافقة التسويق من إدارة الأغذية والعقاقير الأسترالية (TGA) لـ NexoBrid®، علاجاته الإنزيمية لإزالة الغشاء الجلدي الميت من مرضى الحروق البالغين والأطفال. تُوسع هذه الموافقة وجود NexoBrid عالميًا ليصل إلى 45 دولة. الشريك الحصري للشركة، Balance Medical، يخطّط لإطلاق NexoBrid تجاريًا في الربع الرابع من 2025. سيساعد توسيع التصنيع لدى MediWound، المزمع الانتهاء منه بحلول نهاية 2025، في دعم الإطلاق في أستراليا والطلب العالمي المتزايد. تمثل الموافقة نقطة دخول استراتيجية إلى سوق أوسع في منطقة آسيا-المحيط الهادئ.
MediWound（纳斯达克股票代码：MDWD） 已获得澳大利亚药品管理局（TGA）对 NexoBrid® 的上市许可，这是其用于成人及儿科烧伤患者去除焦痂的酶治疗药物。此次批准将 NexoBrid 的全球覆盖扩展至 45 个国家。公司的独家合作伙伴 Balance Medical 计划在 2025 年第四季度将 NexoBrid 推向市场。MediWound 的制造扩产计划预计在 2025 年底前完成，将支持在澳大利亚的上市及日益增长的全球需求。该批准也为进入更广泛的亚太市场提供了战略性切入点。
- Regulatory approval in Australia expands NexoBrid's presence to 45 countries
- Commercial launch planned for Q4 2025 through established partnership with Balance Medical
- Manufacturing expansion on track to support growing global demand
- Strategic entry point into the broader Asia-Pacific market
- None.
Insights
TGA approval of NexoBrid in Australia expands MediWound's global footprint, creating revenue opportunities in the Asia-Pacific region with Q4 2025 launch planned.
The Australian TGA approval for NexoBrid represents a significant regulatory milestone for MediWound, extending the product's global authorization to 45 countries for both adult and pediatric burn patients. This enzymatic eschar removal therapy, which works by selectively dissolving burned tissue while preserving healthy dermis, continues to gain momentum as an alternative to surgical debridement.
The strategic importance extends beyond Australia itself. This approval serves as a potential gateway to the broader Asia-Pacific market, a region with substantial burn care needs and increasing healthcare investment. MediWound's manufacturing expansion, scheduled for completion by year-end 2025, is precisely timed to support both the Australian launch and anticipated regional growth.
Balance Medical's role as exclusive distributor will be crucial for market penetration in Australia's relatively concentrated burn care system. The planned Q4 2025 commercial launch gives the partners sufficient preparation time to engage key burn centers and secure reimbursement pathways.
The clinical endorsement from Dr. Brown, a prominent burn specialist, highlights NexoBrid's value proposition – its tissue-preserving approach allows for more targeted treatment compared to conventional surgical methods. This positions the therapy well in the evolving wound care landscape, where minimally invasive approaches with improved tissue preservation are increasingly preferred.
MediWound Expands Global Reach with Marketing Approval of NexoBrid® in Australia
TGA Approves NexoBrid® for Adults and Children; Manufacturing Readiness Positions MediWound for 2025 Launch and Asia-Pacific Expansion
YAVNE, Israel, September 25, 2025 -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today 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.
With this approval, NexoBrid is now authorized in 45 countries worldwide, reflecting its growing recognition as a new standard of care in burn management. MediWound’s exclusive partner in Australia, Balance Medical, expects to initiate commercial launch in the fourth quarter of 2025.
MediWound’s manufacturing expansion, on track for completion by year-end 2025, will support this launch and future global demand.
“The TGA approval of NexoBrid marks another important step in expanding access to innovative, non-surgical burn care,” said Ofer Gonen, Chief Executive Officer of MediWound. “Together with our partner Balance Medical, we will ensure that burn centers across Australia have access to this therapy. Importantly, this milestone also opens the door to the broader Asia-Pacific region, where we see growing demand for advanced wound and burn treatments.”
Dr. Jason Brown, Director of the Queensland Adult Burn Service at the Royal Brisbane and Women’s Hospital, commented: “The approval of NexoBrid in Australia is a welcome milestone that will improve access to innovative burn-care solutions. In our clinical experience, NexoBrid enables rapid and selective eschar removal while preserving healthy dermis, providing clinicians with a much-needed non-surgical option to optimize outcomes for burn patients.”
About NexoBrid
NexoBrid® is a topically administered, biological orphan drug for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns. It selectively removes non-viable tissue while preserving viable tissue and is approved for use in adults and pediatric patients in over 40 countries, including the United States, European Union, and Japan.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets. MediWound is also advancing EscharEx®, a late-stage investigational therapy for the debridement of chronic wounds. EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.
For more information visit www.mediwound.com and follow us on LinkedIn.
About Balance Medical Ltd.
Balance Medical Ltd. is a MedTech company focused on bringing innovative therapies to Australia, New Zealand, and Asia, with an emphasis on orphan drugs and specialized indications.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid®; the timing and success of commercial launches including the planned Q4 2025 launch in Australia; manufacturing expansion timeline and capacity increases; market size estimates and growth projections; our ability to meet global demand; and anticipated market adoption and acceptance. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with market acceptance of NexoBrid; our ability to maintain adequate protection of our intellectual property; competition risks; our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use NexoBrid in the future; regulatory delays or changes; our reliance on third-party partners for commercialization; market size and growth rate variations from projections; and macroeconomic factors affecting healthcare spending and market conditions.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
MediWound Contacts:
Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com
Daniel Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
Media Contact:
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com+1-929-588-2008
FAQ
What approval did MediWound (MDWD) receive from Australia's TGA in September 2025?
When will NexoBrid be commercially available in Australia?
How many countries has NexoBrid been approved in as of September 2025?
What is NexoBrid used for in burn treatment?
How will MediWound support the Australian launch of NexoBrid?
