MediWound completes commissioning of expanded GMP facility, increasing NexoBrid production capacity sixfold by late 2025.
Quiver AI Summary
MediWound Ltd. has successfully completed the commissioning of its expanded GMP manufacturing facility in Yavne, Israel, significantly increasing production capacity for its enzymatic therapeutic product, NexoBrid®. This expansion is expected to result in a sixfold increase in capacity, with full operational readiness anticipated by the end of 2025. The company aims to meet the growing global demand for NexoBrid, which is approved for the enzymatic removal of eschar in burn patients in over 40 countries. MediWound's Chief Operating and Commercial Officer, Shmulik Hess, emphasized the commitment to operational excellence and ensuring reliable supply post-regulatory review. The press release also contains cautionary notes about future projections and the inherent uncertainties related to market acceptance and regulatory processes.
Potential Positives
- MediWound's successful completion of the commissioning process for its expanded GMP manufacturing facility marks a critical step toward increasing production capacity for NexoBrid® by approximately sixfold, which positions the company to better meet growing global demand.
- The expansion of the facility enhances the company's ability to ensure a reliable and scalable global supply of NexoBrid across more than 40 approved markets, anticipating an improved market presence.
- This achievement demonstrates MediWound's commitment to operational excellence, reinforcing its reputation in the biotech industry and potentially attracting further investment and partnerships.
Potential Negatives
- Market availability of NexoBrid depends on the completion of regulatory reviews, which introduces uncertainty in the timeline for product availability.
- The expansion of the manufacturing facility is expected to achieve full operational readiness only by the end of 2025, indicating a significant wait before increased production capacity can be utilized to meet demand.
- The press release includes multiple cautionary statements about forward-looking statements, suggesting that assumptions about future operations and market acceptance may not materialize, highlighting inherent risks associated with the company's plans.
FAQ
What is the significance of MediWound's expanded GMP manufacturing facility?
The new facility will increase production capacity for NexoBrid® approximately sixfold, supporting global demand for the product.
When will the expanded facility be fully operational?
The expanded facility is expected to achieve full operational readiness by year-end 2025.
What does NexoBrid® treat?
NexoBrid® is used for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns.
In how many markets is NexoBrid® approved for use?
NexoBrid® is approved in over 40 countries, including the U.S., EU, and Japan.
What advancements are being made with EscharEx®?
EscharEx® is a late-stage investigational therapy for chronic wound debridement, showing clinical advantages over leading products.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
MediWound Successfully Completes Commissioning of Expanded GMP Manufacturing Facility for NexoBrid ®
Newly commissioned facility marks a significant development toward a sixfold production capacity increase ahead of full operational readiness by year-end 2025
YAVNE, Israel, November 3, 2025 – MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the successful completion of the commissioning process for its expanded GMP manufacturing facility in Yavne, Israel. This milestone represents an important positive development toward full operational readiness and expanding the Company’s capacity to meet rising global demand for NexoBrid ® .
“We are pleased to complete the commissioning of our expanded facility,” said Shmulik Hess, Ph.D., Chief Operating and Commercial Officer of MediWound. “Following regulatory review, we will be well positioned to ensure a reliable, scalable global supply of NexoBrid across more than 40 approved markets. This achievement reflects our team’s dedication to operational excellence and our commitment to providing physicians and patients with timely access to NexoBrid.”
The expanded facility, which is expected to achieve full operational readiness by year-end 2025, will increase production capacity for NexoBrid by approximately sixfold, enabling scalable, reliable supply to meet the product’s growing global demand. Market availability remains subject to the completion of regulatory reviews.
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 and X (formerly Twitter) .
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 operational readiness by year-end 2025, the likelihood to successfully complete the regulatory reviews and our ability to meet global demand. 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; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
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.
[email protected]
Daniel Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]
Media Contact:
Ellie Hanson
FINN Partners for MediWound
[email protected]
+1-929-588-2008