MediWound's NexoBrid Receives Marketing Authorization in Australia, Expanding Global Burn Treatment Access
核心洞察
Australia's Therapeutic Goods Administration (搜索) has granted marketing authorization for NexoBrid, an innovative enzymatic therapy for burn treatment in both adult and pediatric patients.
The approval brings NexoBrid's global authorization to 45 countries worldwide, reinforcing its recognition as a new standard of care in burn management.
Commercial launch is expected in the fourth quarter of 2025 through exclusive partner Balance Medical, supported by MediWound's manufacturing expansion completion by year-end 2025.
Israeli biotechnology company MediWound Ltd. has received marketing authorization from Australia's Therapeutic Goods Administration (搜索) (TGA) for NexoBrid, its innovative enzymatic therapy for the removal of eschar in both adult and pediatric patients with deep partial- and full-thickness thermal burns (搜索). This approval marks a significant milestone in expanding global access to non-surgical burn care solutions.
Global Expansion Milestone
With the Australian approval, NexoBrid is now authorized in 45 countries worldwide, reflecting its growing recognition as a new standard of care in burn management. The therapy is already approved for use in adults and pediatric patients in over 40 countries, including the United States, European Union, and Japan.
"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."
Clinical Advantages and Expert Endorsement
NexoBrid is a topically administered, biological orphan drug that selectively removes non-viable tissue while preserving viable tissue. This selective mechanism offers clinicians a non-surgical alternative for burn treatment.
Dr. Jason Brown, Director of the Queensland Adult Burn Service at the Royal Brisbane and Women's Hospital, highlighted the clinical significance of the approval: "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."
Commercial Launch and Manufacturing Readiness
MediWound's exclusive partner in Australia, Balance Medical, expects to initiate commercial launch in the fourth quarter of 2025. The company's manufacturing expansion, currently on track for completion by year-end 2025, will support this launch and meet future global demand.
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.
Company Profile and Pipeline
MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. Beyond NexoBrid, the company is also advancing EscharEx, a late-stage investigational therapy for the debridement of chronic wounds (搜索). EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.