MediWound Ltd. is a biopharmaceutical company, which engages in the development, manufacture, and commercialization of products to address needs in the fields of severe burns, chronic wounds, and other hard-to-heal wounds. Its product NexoBrid, is an orphan biologic for eschar removal in severe burns. The company was founded by Lior Rosenberg and Marian Gorecki in January 2000 and is headquartered in Yavne, Israel.
相关临床试验
26
21 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2001
进行中（未招募）
21
80.8%
已完成
2
7.7%
招募中
2
7.7%
暂无批准数据
- MediWound reported second-quarter 2026 revenue of $3.1 million, down 45.6% year over year, primarily reflecting the timing of BARDA-funded development revenue. - The EscharEx Phase III VALU trial in venous leg ulcers remains on track, with interim sample-size reassessment and enrollment completion expected by the end of Q1 2027. - An updated independent U.S. market assessment, expanded to include pressure ulcers, now projects $1.05 billion in annual peak sales for EscharEx. - Vericel reported NexoBrid's strongest quarter since launch, with approximately 80 U.S. burn centers ordering the product, and MediWound reaffirmed full-year 2026 revenue guidance of $24 million to $26 million.
- Multiple analysts maintain Hold ratings on Moderna with price targets around $44-45, reflecting continued uncertainty about the company's prospects near its 52-week low. - Mediwound receives Strong Buy consensus from analysts with price targets suggesting over 100% upside potential from current trading levels. - Healthcare sector coverage shows mixed analyst sentiment, with some companies like BeOne Medicines receiving strong buy recommendations while others face more cautious outlooks.
- MediWound's EscharEx VALUE Phase III trial for venous leg ulcers continues enrollment targeting 216 patients, with interim assessment and completion expected by year-end 2026. - The company plans to expand EscharEx development into diabetic foot ulcers and pressure ulcers in 2026 following positive regulatory feedback from FDA and EMA. - NexoBrid manufacturing facility expansion is now fully operational with sixfold increased production capacity, positioning the company for anticipated regulatory approvals in 2026. - MediWound reported $17 million in 2025 revenue and updated guidance projecting growth to $24-26 million in 2026, $32-35 million in 2027, and $50-55 million in 2028.
- Australia's Therapeutic Goods Administration 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. - The milestone opens opportunities for broader Asia-Pacific region expansion, where growing demand exists for advanced wound and burn treatments.
- MediWound published post hoc analysis data from 119 chronic venous leg ulcer patients demonstrating that wounds achieving wound bed preparation were 4.1 times more likely to close compared to those that did not. - The study found that wounds failing to achieve wound bed preparation had a 90% probability of not healing, providing clinical evidence for the critical role of complete debridement in wound closure. - Early achievement of wound bed preparation within 14 days was associated with significantly increased healing likelihood, supporting EscharEx's therapeutic potential in chronic wound care.
- Phase III CIDS trial demonstrates NexoBrid's effectiveness in pediatric burn patients, achieving complete eschar removal in one day compared to six days with standard care. - The enzymatic treatment significantly reduced the need for surgical intervention, with only 8.3% of NexoBrid-treated patients requiring surgical excision versus 64.4% in standard care. - Study results published in Burns journal validate NexoBrid's safety profile and long-term outcomes, supporting its recent pediatric use approval in the U.S., E.U., and Japan.
- MediWound has commenced a Phase III clinical trial (VALUE) to evaluate EscharEx for the treatment of venous leg ulcers (VLUs). - The VALUE trial is a randomized, double-blind, placebo-controlled study across 40 sites in the U.S. and Europe, enrolling 216 patients. - EscharEx has shown promise in Phase II trials, demonstrating effective and rapid debridement of chronic wounds, potentially redefining VLU treatment. - An interim analysis of the VALUE trial is expected in mid-2026, with strategic collaborations in place to ensure consistent wound management.
• MediWound has commenced a Phase II clinical trial to assess EscharEx for treating venous leg ulcers, with results expected to support a BLA submission. • The trial is a randomized, multicenter study comparing EscharEx to collagenase ointment (Santyl) and placebo across 45 patients in the U.S. and Europe. • Strategic R&D collaborations with Solventum and Mölnlycke Health Care will ensure consistency in the study through the use of advanced wound care products. • EscharEx, a bioactive debridement therapy, has shown promise in earlier trials and is also being developed for diabetic foot ulcers.
