YAVNE, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. With this FDA approval, NexoBrid is now authorized for use in the U.S. for all age g ...

财务数据和关键指标变化 - 第二季度收入为5.1百万美元,同比增长6.3% [23] - 毛利为0.4百万美元,占收入9%,同比下降15个百分点,主要由于收入结构变化和非经常性生产成本 [23] - 上半年收入为10百万美元,同比增长16.3% [26] - 上半年毛利为1.1百万美元,占收入11%,同比下降12个百分点 [26] - 上半年经营亏损为8.2百万美元,同比减亏2.4% [28] - 上半年净亏损为16百万美元,同比增加13.2百万美元,主要由于8百万美元的金融费用 [28] 各条业务线数据和关键指标变化 - NexoBrid在美国市场持续增长,医院订单和治疗患者人数大幅增加,收入增长76% [11] - 公司获得欧洲批准NexoBrid用于治疗儿童重度烧伤,将为儿童患者提供关键治疗选择 [12] - 美国NexoBrid扩展使用项目(NEXT)结果显示NexoBrid安全有效,为标准烧伤护理协议提供关键作用 [13][14] 各个市场数据和关键指标变化 - 公司正与美国政府合作开发室温稳定型NexoBrid,已获得FDA指导并获得150万美元额外资金支持 [14][15] 公司战略和发展方向及行业竞争 - 公司完成新NexoBrid生产设施建设,将在2025年实现全面投产,产能将提高6倍 [10] - 公司获得1625万欧元欧盟资金,用于将EscharEx适应症扩展至糖尿病足溃疡,大幅增加产品总可用市场 [16] - 公司与全球创可料巨头Molnlycke达成战略合作,获得2500万美元投资,双方将在临床、监管和教育资源等方面展开合作 [21][22] - 公司正在准备开展EscharEx用于静脉溃疡的III期临床试验,并计划于2024年下半年启动 [19][20] - 公司正在准备开展EscharEx用于糖尿病足溃疡的II/III期临床试验,计划于2025年启动 [36][37] 管理层对经营环境和未来前景的评论 - 公司成功完成新生产设施建设,并正在加速NexoBrid和EscharEx的临床开发,为成为全球组织修复领导者奠定基础 [8] - 公司获得战略投资和合作,显示行业对公司技术的信心,将增强公司的财务实力和战略地位 [21][22] - 公司对NexoBrid和EscharEx的未来市场需求和增长前景保持乐观 [33][34] 其他重要信息 - 公司于2024年7月完成2500万美元私募融资 [29][30] 问答环节重要的提问和回答 问题1 **Joshua Jennings 提问** 询问NexoBrid产能扩张的具体时间安排 [32] **Ofer Gonen 回答** 预计欧洲市场批准将在2025年初获得,美国市场批准将在2025年底获得,公司已做好相应的产能规划 [33][34] 问题2 **Joshua Jennings 提问** 询问EscharEx糖尿病足溃疡适应症临床试验的具体安排 [35] **Ofer Gonen 回答** 预计2025年开始进行II/III期临床试验,试验设计与静脉溃疡试验类似,公司正在与监管机构沟通具体细节 [36][37] 问题3 **Swayampakula Ramakanth 提问** 询问EscharEx糖尿病足溃疡适应症临床试验的规模和设计 [42] **Ofer Gonen 回答** 预计试验规模会略大于静脉溃疡试验,公司计划在中期评估时检查疗效,以确认与静脉溃疡适应症的一致性,具体方案还需与监管机构确认 [43][44][45][46]

MediWound (MDWD) came out with a quarterly loss of $0.68 per share versus the Zacks Consensus Estimate of a loss of $0.42. This compares to earnings of $0.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -61.90%. A quarter ago, it was expected that this developer of treatments for burns and hard-to-heal wounds would post a loss of $0.40 per share when it actually produced a loss of $0.39, delivering a surprise of 2.50%.Over ...

Wall Street expects a year-over-year decline in earnings on higher revenues when MediWound (MDWD) reports results for the quarter ended June 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on August 14, 2024, might help the stock move higher if these key numbers are better than expectat ...

YAVNE, Israel, Aug. 02, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the second quarter ended June 30, 2024 on Wednesday, August 14, 2024. Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions. Dial-in and call details ...

Research Published in THE LANCET's eClinicalMedicineEscharEx® Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy Granulation Tissue YAVNE, Israel, July 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eClin ...

Research Published in THE LANCET's eClinicalMedicineEscharEx® Outperforms Non-Surgical Standard of Care in Debridement and Promotion of Healthy Granulation Tissue YAVNE, Israel, July 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announces the peer-reviewed publication on the Phase II ChronEx study assessing the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU) in the prestigious eCli ...

Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs) Award advances MediWound's DFU program and its future revenues four years ahead of original schedule YAVNE, Israel, July 16, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today it has been selected to receive €16.25 million in blended funding from the European Innovation Council (EIC) through its accelerator program. Th ...

Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs) Award advances MediWound’s DFU program and its future revenues four years ahead of original schedule YAVNE, Israel, July 16, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today it has been selected to receive €16.25 million in blended funding from the European Innovation Council (EIC) through its accelerator program. T ...

文章核心观点 - 医疗技术公司Mölnlycke Health Care宣布投资1500万美元收购MediWound公司,后者是一家专注于非手术性创面清创的酶疗公司 [1][3][5] - 这次投资旨在为创面护理领域带来创新解决方案,提高临床结果和患者体验,减少不必要的手术 [3] - 双方还签订了合作协议,Mölnlycke将参与MediWound的研发委员会会议,并在某些情况下参与潜在的战略合作和并购 [4] 公司概况 - Mölnlycke Health Care是一家全球领先的医疗技术公司,专注于创面护理和手术解决方案 [1] - MediWound是一家专注于非手术性创面清创的酶疗公司,致力于改善现有的护理标准和患者体验,同时降低成本和不必要的手术 [1][5] 交易细节 - Mölnlycke通过私募配售(PIPE)的方式投资1500万美元收购MediWound公司 [1] - 这次投资将支持Mölnlycke"帮助患者摆脱创面负担"的创面护理使命 [3] - 这次投资将增强MediWound的战略计划,为其利益相关方创造长期价值,并有助于改善患者的护理标准 [5]