MediWound Expands Global Reach with Marketing Approval of NexoBrid® in Australia
Rhea-AI Summary
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.
Positive
- 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
Negative
- None.
News Market Reaction 1 Alert
On the day this news was published, MDWD declined 1.78%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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?
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