Leg Ulcer

AUCKLAND, New Zealand, May 1, 2025 /PRNewswire/ -- Soft tissue regeneration company, Aroa Biosurgery, is pleased to announce a milestone in clinical evidence. There are now over 100 peer-reviewed studies describing the efficacy of the company's proprietary AROA ECM technology. Continue Reading AROA's most recent publication was a large retrospective analysis of real-world evidence (RWE) from wound care centers in the US, assessing the efficacy of the company's Endoform NaturalTM product in treating venous leg ulcers (VLUs), in comparison to a leading reconstituted collagen dressing. VLU's are open sores that are hard-to-heal because of impaired blood flow and can be very debilitating and painful. These types of wounds are difficult for clinicians to treat successfully. For example, only ~40% of VLUs can be healed after 3 months of treatment and there is a relatively high chance that these wounds will recur[1]. The peer-reviewed study, entitled "Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidized Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real-World Evidence Study" was published in the open access journal 'International Wound Journal in April 2025. The study compared 470 VLU's that had been treated with Endoform Natural to 360 VLU's that had been treated with a reconstituted collagen product. The study used existing data from 223 wound care centers with minimal inclusion or exclusion criteria so that 'real-world' use of both products could be compared. "There is a growing awareness of RWE studies to validate clinical performance" says Chief Scientific Officer, Dr. Barnaby May. "These types of studies enable much larger patient numbers to be compared versus traditional randomized controlled trials. Given that RWE studies use data from 'real-world' use of a treatment, the results can be more meaningful, especially in wound care where there is a high degree of variability in how wounds are cared for and patient factors." The study found that VLUs treated with Endoform Natural healed up to ~ 8 weeks faster versus the comparator group, and the chances of the wound healing were significantly improved when Endoform Natural was used as part of treatment. The striking difference in the healing outcomes demonstrate the potential for considerable cost reductions and improvements in patient quality of life, due to the significant improvements seen when VLUs were treated using Endoform Natural. Dr. Gregory Bohn MD was part of the research team. "I was first introduced to Endoform in 2012 and started using the product to treat my own patients with VLUs. This new data validates what I have seen in my own practice managing VLUs with Endoform." This is the second large retrospective RWE comparing Endoform Natural to a leading reconstituted collagen dressing. A previous study included the analysis of over 2,200 diabetic foot ulcers (DFUs) and also demonstrated significantly faster healing of DFUs using Endoform Natural[2]. The study is available online here. SOURCE Aroa Biosurgery WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Presentations at WHS and SAWC to highlight EscharEx’s mechanism of action, preclinical advantages over SANTYL®, and new data in treating VLUs and DFUs Findings reinforce the ongoing Phase III study in VLUs and support the planned DFU trial strategy YAVNE, Israel, April 28, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that it will present 10 scientific abstracts—including both oral and poster presentations—at two of the world’s premier wound care conferences: the Wound Healing Society (WHS) and the Symposium on Advanced Wound Care (SAWC) Spring 2025, taking place April 30–May 3 in Grapevine, Texas. The presentations will feature new preclinical and clinical data on EscharEx®, MediWound’s investigational enzymatic therapy for chronic wounds. The findings offer important insights into EscharEx’s multitargeted and selective mechanism of action, reinforcing the ongoing VALUE Phase III study in venous leg ulcers (VLUs) and supporting the planned clinical trial in diabetic foot ulcers (DFUs). Key presentation highlights include: Wound Healing Society (WHS) New in vitro data highlighting EscharEx’ s multitargeted and selective proteolytic activity on non-viable tissueResults from a novel hard-to-heal wound model demonstrating EscharEx’s superior debridement efficacy compared to collagenase SANTYL® Symposium on Advanced Wound Care (SAWC) Overview of EscharEx’s mechanism of action, including in vitro studies and clinical findings from EscharEx and NexoBrid®Case studies highlighting EscharEx’s use in advanced DFUs (Wagner grade ≥2) and VLUsPost-hoc analyses in DFUs and preliminary strategy for the planned clinical trialUpdate on the VALUE Phase III study design and enrollment progress “These new data further validate EscharEx’s unique mechanism of action and its potential to redefine the standard of care for chronic wound management,” said Dr. Robert Snyder, Chief Medical Officer at MediWound. “We remain committed to advancing EscharEx through rigorous clinical development, with the goal of offering a meaningful, non-surgical solution for patients suffering from chronic wounds.” The VALUE Phase III study is currently enrolling patients with VLUs across multiple sites, building on positive results from three completed Phase II studies that demonstrated EscharEx’s efficacy, safety, and potential to enhance standard wound care practices. About EscharEx® EscharEx® is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily application, EscharEx has demonstrated a favorable safety profile and effective wound bed preparation in multiple Phase II trials. The therapy has shown the ability to remove non-viable tissue, promote granulation, and reduce bioburden and biofilm. A global Phase III study in venous leg ulcers (VLUs) is currently underway, with a Phase II/III study in diabetic foot ulcers (DFUs) in preparation. EscharEx has shown clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity. About MediWound Ltd. 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 the Symposium on Advanced Wound Care (SAWC) The Symposium on Advanced Wound Care (SAWC) Spring, co-hosted with the Wound Healing Society, is one of the largest multidisciplinary wound care conferences in the world. Now in its 38th year, the event convenes physicians, nurses, podiatrists, researchers, and other professionals to share the latest advances in clinical care and research. About the Wound Healing Society (WHS) The Wound Healing Society is a nonprofit organization dedicated to advancing the science and practice of wound healing. WHS promotes collaboration across clinical, academic, and industry stakeholders and publishes the peer-reviewed journal Wound Repair and Regeneration. The Society also co-hosts the SAWC Spring conference and publishes Advances in Wound Care. 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 EscharEx®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; 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 LuxenburgDaniel FerryChief Financial OfficerManaging DirectorMediWound Ltd.LifeSci Advisors, LLCir@mediwound.com daniel@lifesciadvisors.com Media Contact: Ellie Hanson FINN Partners for MediWound ellie.hanson@finnpartners.com 929-588-2008

VIRGINIA BEACH, Va., April 23, 2025 /PRNewswire/ -- More than 38 million Americans, roughly 1 in 10, are living with diabetes, with up to 95% affected by type 2 diabetes, a condition often linked to limited access to quality health care.1 This issue is especially stark in underserved communities, where barriers to care contribute to the rising prevalence and devastating complications. LifeNet Health, a global leader in regenerative medicine, is breaking down these barriers through innovative solutions that empower healthcare providers, strengthen communities, and honor the gift of donation. Advancing its mission of saving lives, restoring health, and giving hope, LifeNet Health launches Dermacell Porous, its next-generation human acellular dermal matrix processed to retain endogenous growth factors, collagen, and elastin in a biohospitable scaffold.5,6,11 Continue Reading Dermacell Porous is designed to help close chronic wounds in four or fewer applications, making it 1 of 26 skin substitute grafts and cellular or tissue-based products (CTPs) covered under Medicare's new Local Coverage Determinations (LCDs) now planned to go into effect January 1, 2026.1,3 This innovative solution expands LifeNet Health's extensive portfolio of regenerative wound solutions, reinforcing its commitment to providing clinicians with advanced, accessible options for wound care. "We applied Dermacell® Porous to a deep diabetic wound that had resisted healing. In just three weeks, it was fully closed." – Kenny Luong, DPM, FACFAS Post this Dermacell Porous stands out for its thin, durable, and naturally porous structure, enhanced by LifeNet Health's proprietary Matracell® technology for superior performance.2,12 Unlike other product alternatives, LifeNet Health's advanced technologies result in an extracellular matrix (ECM) that contains all the collagens, elastin, proteins, growth factors, matrikines, and cytokines present in the donor tissue.5,6 The advanced processing and terminal sterilization technologies also render Dermacell Porous sterile with validated viral inactivation, providing healthcare professionals and their patients with the peace of mind they deserve.4,8 Dr. Loan Lam, Medical Director of Wound Services at United Vein & Vascular Centers, was the first clinic to utilize Dermacell Porous and continues to be very impressed with the clinical outcomes. "With Dermacell Porous, not only does a thin intact dermal structure provide a good initial physical scaffold, but we see faster incorporation and better integration, and more predictable healing," said Dr Lam. Clinical studies and randomized trials show a 135% higher healing rate and 148% greater wound reduction with Dermacell AWM/Porous compared to standard dressings.9 Additionally, a Dermacell AWM/Porous study on Wagner 3 and 4 wounds demonstrated an 84% lower amputation rate.10 Dermacell Porous is yet another way LifeNet Health continues to give healing every advantage. Daniel Osborne, Chief Growth Officer at LifeNet Health, emphasized the company's broader mission, "At LifeNet Health, our goal is to transform patients' lives through innovation and compassionate care. The introduction of Dermacell Porous is testament to our commitment to addressing critical health care challenges and ensuring greater access to regenerative wound care solutions. This product reflects our dedication to honoring donors by delivering advancements that promote healing and empower both patients and health care providers." Dermacell Porous offers key benefits for wound closure, including faster full incorporation with enhanced vascularization and cell infiltration, an intact dermal structure, and easy non-sided application.5-7, 11 It's ready to use straight from the package with room-temperature shelf stability, simplifying storage and logistics for healthcare professionals.7 About LifeNet Health LifeNet Health is a global leader in regenerative medicine, providing a comprehensive range of transplant solutions from organ procurement to bio-implants and cellular therapies. LifeNet Health's mission is to improve the quality of human life by advancing medical possibilities in transplantation and research. References: Centers for Disease Control and Prevention. (n.d.). About type 2 diabetes. U.S. Department of Health & Human Services. Cazzell, S., Vayser, D., Pham H., et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair and Regeneration. 2017. Centers for Medicare & Medicaid Services. (2024). Local Coverage Determination (LCD): Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (LCD ID: 39756, Version 7). LifeNet Health, PQ-10-008, Process Qualification: Method 2B Terminal Sterilization Validation for the Devitalized Dermis Allografts Family 68-20-047, Analysis of the Acellular Matrix, Growth Factors, and Cytokines Present in Oracell. LifeNet Health, TR 0292, LifeNet Health's Decellularized Dermis, Dermacell, Comparison to the USP Monograph, Scaffold Human Dermis. Moore MA, Samsell B, Wallis G, et al. Decellularization of human dermis using non-denaturing anionic detergent and endonuclease: a review. Cell Tissue Bank. 2015; 16(2):249-2259. Moore MA. Inactivation of enveloped and non-enveloped viruses on seeded human tissues by gamma irradiation. Cell Tissue Bank. 2012 Aug;13(3):401-7. doi: 10.1007/s10561-011-9266-0. Cazzell, S., Vayser, D., Pham H., et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair and Regeneration. 2017. 25(3):483-497. Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0. PMID: 31361269; PMCID: PMC7328871. LifeNet Health, TR ED-23-0306, In vivo Assessment of Local Tissue Response and Cell Infiltration – Animal study results may not be predictive of clinical results. LifeNet Health, PQ 10-006, Process Qualification: Devitalization of Dermal Allografts For media inquiries, please contact: Doug Wilson [email protected] 757-609-4468, office SOURCE LifeNet Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED