Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis -Randomized Control Clinical Trail

The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis

Start Date01 Jul 2024

Sponsor / Collaborator

Krishnadevaraya College of Dental Sciences and Hospital

ACTRN12622000520730

/ Not yet recruitingNot ApplicableIIT

A pilot study assessing the feasibility of NexoBrid versus the current standard of care of isolated upper limb burns: A solution to the perfect crime”?

Start Date06 Mar 2023

Sponsor / Collaborator

Royal Brisbane & WomenS Hospital

JPRN-jRCT2080224058

/ CompletedPhase 3

Phase III study of KMW-1 in hospitalized patients with Deep Partial Thickness and Full Thickness thermal burns

Start Date18 Dec 2018

Sponsor / Collaborator

Kaken Pharmaceutical Co., Ltd.

100 Clinical Results associated with Anacaulase-bcdb

100 Translational Medicine associated with Anacaulase-bcdb

100 Patents (Medical) associated with Anacaulase-bcdb

106

Literatures (Medical) associated with Anacaulase-bcdb

01 Jun 2025·BURNS

Single center experience of the first 300 patients treated with bromelain-based enzymatic debridement

Article

Author: Visiedo, Maria Bayona ; Serracanta Domenech, Jordi ; Bulla, Antonio ; Baena, Jacinto ; Rivas Nicolls, Danilo Antonio ; Lopez Martinez, José Antonio ; Aguirrezabala, Jon Ander ; Barret Nerin, Juan Pedro

BACKGROUND:

This retrospective cohort study evaluates the clinical outcomes of enzymatic debridement (ED) with Nexobrid® in burn patients treated at our hospital's Burn Unit from 2015 to 2020. The primary aim was to determine whether Nexobrid® effectively reduces unnecessary surgeries and improves patient outcomes.

METHODS:

The study included 300 patients over 18 years old with deep dermal and full-thickness burns, excluding cases with chemical/electrical burns, pregnancy, and allergies to Nexobrid®. Burn depth was assessed upon admission and re-evaluated post-ED. The primary endpoint was the reliability of ED in determining surgical indications compared to traditional clinical assessments. Secondary endpoints included factors influencing healing time, complication rates, and scar hypertrophy.

RESULTS:

Among the 300 patients (76 % male, median age 41), flame burns were most common (46.7 %). Median total body surface area (TBSA) burned was 8 %, and TBSA treated with Nexobrid® was 5 %. Sequential ED was performed in 26 patients with larger burns. Post-treatment data indicated that ED improved burn depth diagnosis compared to initial assessments, often downstaging dermal burns. The "step sign" emerged as a useful predictor for graft surgery necessity in dermal burns. No significant differences were observed between scald and flame burns in ED effectiveness. ED was associated with blood loss, emphasizing caution in cases with high TBSA, and early fever was noted as a factor requiring vigilant monitoring. While scar hypertrophy was associated with surgery, this study design could not directly evaluate ED's impact on hypertrophy.

CONCLUSION:

We found ED to be a reliable method for rapid eschar removal and accurate burn depth evaluation, which often helped us avoid unnecessary surgeries-particularly important in delicate, functional areas like the upper limbs. Interestingly, the effectiveness of ED was not influenced by the burn's etiology when treating intermediate-depth injuries. While ED does not appear to rise the risk of infection, early fever should still be carefully monitored. Over time, ED has become a central tool in our burn treatment protocols. Future studies are needed to explore its impact on treating patients with extensive burns.

01 Jun 2025·BURNS

Worldwide recommendations for enzymatic debridement with bromelain-based agent (Nexobrid®) in burn care: A call for French health authorities to reconsider their position

Letter

Author: Tobalem, Benjamin ; Boccara, David ; Serror, Kevin ; Ferrero, Lauren ; Chaouat, Marc ; Mathieu, Olivier

01 Jun 2025·JOURNAL OF ETHNOPHARMACOLOGY

A study on the compatibility mechanism of Dahuang-Gancao decoction based on liquid-phase state and biopharmaceutics

Article

Author: Liu, Yi ; Ren, Xiaoliang ; Wei, Xuerou ; Liu, Liying ; Song, Yongjian ; Zhao, Xi ; Zhang, Bokai

ETHNOPHARMACOLOGICAL RELEVANCE:

Dahuang-Gancao decoction (DGD), from the Synopsis of Golden Chamber, consists of Rhubarb and Licorice. It clears heat, unblocks the bowels, and alleviates nausea. Rhubarb is potent, and clinical evidence shows that Licorice can alleviate the adverse reactions of Rhubarb, thereby enhancing its purgative action while mitigating its side effects. Nevertheless, the intricacies of the detoxification mechanism remain obscure.

AIM OF THE STUDY:

This study explores the compatibility mechanism of DGD, focusing on its liquid-phase state and biopharmaceutical properties.

MATERIAL AND METHODS:

This study validated the regulatory effect of Licorice on the toxicity of Rhubarb through a zebrafish lethality assay. Zebrafish larvae, at 72 h post-fertilization, were subjected to a gradient of Rhubarb decoction (RD) and DGD concentrations ranging from 50 to 5000 μg/mL. Mortality rates were assessed after 24 h, and the half-maximal lethal concentration (IC50) was determined. Subsequently, phase separation of DGD and RD was performed via centrifugation (8000 rpm, 10 min) to isolate the precipitate phases of DGD (DGD-P) and RD (RD-P). Further dialysis and repeated high-speed centrifugation (12000 rpm, 30 min) were employed to separate the nanoparticle phases of DGD (DGD-N) and RD (RD-N) from their true solution phases. The physicochemical properties of RD, Licorice decoction (LD), and DGD-including salinity, conductivity, particle size, polydispersity index (PDI), and zeta potential-were analyzed using a salinometer, conductivity meter, and dynamic light scattering at 20 °C, 40 °C, and 60 °C. A validated high-performance liquid chromatography (HPLC) method was employed to quantify key constituents in each phase, including sennosides A/B, rhein, emodin, and aloe-emodin. The in vitro release profiles of these compounds were evaluated using dialysis bag experiments in simulated gastric fluid (pH 1.2), intestinal fluid (pH 6.8), and colonic fluid (pH 8.3). Release kinetics were modeled using zero-order, first-order, and Higuchi equations.

RESULTS:

Licorice significantly reduced the toxicity of Rhubarb, as evidenced by a 2.5-fold increase in the zebrafish IC50 (from 938.46 μg/mL for RD to 2392.03 μg/mL for DGD). Mechanistically, Licorice altered the physicochemical properties of DGD, increasing particle size and promoting phase transition of key constituents into the precipitate phase. This redistribution diminished their stimulatory effects on the body, thereby reducing adverse reactions. In the simulated gastrointestinal environment, the precipitate phase acted as a natural slow-release matrix, while the nanoparticle phase exhibited a pattern of rapid initial release followed by sustained release. These phase-dependent release behaviors, regulated by Licorice-induced supramolecular interactions, alleviated the liver toxicity and gastrointestinal irritation caused by Rhubarb, while preserving its therapeutic efficacy.

CONCLUSION:

Licorice mitigates Rhubarb's toxicity by influencing the distribution and release of key ingredients across phases. This finding offers new insights into the efficacy and safety of traditional Chinese medicine formulations.

166

News (Medical) associated with Anacaulase-bcdb

14 Aug 2025

·www.globenewswire.com

MediWound Reports Second Quarter 2025 Financial Results and Provides Corporate Update

VALUE Phase III Trial of EscharEx® in Venous Leg Ulcers Continues to Enroll Patients NexoBrid® Manufacturing Expansion on Track; Full Operational Capacity Expected by Year-End 2025 Additional Strategic Research Collaborations Established with Essity and Convatec Second Quarter 2025 Revenue of $5.7 Million, Up 43% from Prior Quarter Conference Call Today, August 14, 2025, at 8:30am Eastern Time YAVNE, Israel, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. “We continue to execute across our clinical, commercial, and operational objectives,” said Ofer Gonen, Chief Executive Officer of MediWound. “The VALUE Phase III trial of EscharEx® is actively recruiting patients, and with the addition of Convatec and Essity to our clinical partnerships, we are now collaborating with all relevant leading global wound care companies. In the U.S., NexoBrid® is gaining commercial traction, and our manufacturing expansion remains on track to meet the anticipated growth in demand. The solid progress in the first half of 2025 reinforces our confidence in our long-term strategy and our commitment to value creation. Second Quarter 2025 Highlights, Recent Developments, and Upcoming Milestones: EscharEx® Enrollment in the global VALUE Phase III study for the treatment of venous leg ulcers (VLUs) is ongoing. The trial aims to enroll 216 patients across 40 sites in the U.S. and Europe. Interim sample size assessment is planned for mid-2026, after 65% of patients complete treatment.Established new collaborations with Essity and Convatec to support EscharEx trials. The VALUE Phase III VLU trial now includes JOBST®, a leading medical compression therapy brand, while the planned DFU trial will incorporate AQUACEL®, a market-leading wound dressing. These partnerships complement the existing ones with Solventum, Mölnlycke, Kerecis, and MIMEDX, reflecting strong industry recognition of EscharEx’s clinical value and potential.Published a post-hoc analysis of new data from the EscharEx Phase II trial in Advances in Wound Care, a peer-reviewed journal, providing clinical evidence that wound bed preparation is a key predictor of healing in venous leg ulcers. NexoBrid® U.S. adoption continues to grow. Vericel, MediWound’s exclusive U.S. commercial partner, reported 52% year-over-year revenue growth for NexoBrid in the second quarter, supported by increases in both hospital unit orders and the number of ordering centers.Commissioning of MediWound’s expanded manufacturing facility—engineered to increase NexoBrid production capacity six-fold—remains on track, with full operational readiness anticipated by year-end 2025. Regulatory review will determine commercial availability timelines.As part of a BARDA-funded initiative, planning continues for future U.S.-based manufacturing to support global demand.Received an additional $3.6 million in funding from the U.S. Department of Defense (DoD) to advance development of a room temperature-stable formulation of NexoBrid. The supplemental funding will support expanded CMC activities, enhancement of in-house manufacturing capabilities, and initial preparations for a clinical trial. Second Quarter 2025 Financial Highlights Revenue for the second quarter of 2025 increased to $5.7 million, compared to $5.1 million in the same period of 2024.Gross profit totaled $1.3 million, or 23.5% of total revenue, compared to $0.4 million, or 8.8% of total revenue, in the prior-year period. The margin improvement reflects a more favorable revenue mix.Research and development expenses were $3.5 million, compared to $1.9 million a year ago, driven by increased investment in the EscharEx VALUE Phase III trial and related clinical activities. Selling, general and administrative expenses were $3.6 million, compared to $3.0 million in the second quarter of 2024, primarily due to higher share-based compensation expenses.Operating loss was $5.7 million, compared to $4.5 million in the same period last year.Net loss was $13.3 million, or $1.23 per share, compared to $6.3 million, or $0.68 per share, in the second quarter of 2024. The year-over-year increase was primarily driven by $6.6 million in non-cash financial expenses in the second quarter of 2025, related to the revaluation of warrants.Non-GAAP Adjusted EBITDA loss was $4.5 million, compared to a loss of $3.4 million in the prior-year quarter. Year-to-Date 2025 Financial Highlights Revenue for the first half of 2025 was $9.7 million, compared to $10.0 million in the same period of 2024. The decrease primarily reflects lower BARDA-funded development services revenue as NexoBrid development nears completion.Gross profit totaled $2.1 million, or 21.5% of total revenue, compared to $1.1 million, or 10.5% of total revenue, in the first half of 2024. The margin improvement reflects a more favorable revenue mix.Research and development expenses were $6.4 million, compared to $3.4 million in the same period of 2024, reflecting increased investment in the EscharEx VALUE Phase III trial and related clinical activities.Selling, general and administrative expenses were $6.6 million, compared to $5.9 million in the first half of 2024, primarily due to higher share-based compensation expenses.Operating loss was $10.9 million, compared to $8.2 million in the same period of 2024.Net loss was $14.0 million, or $1.30 per share, compared to $16.0 million, or $1.73 per share, in the first half of 2024.Non-GAAP Adjusted EBITDA loss was $8.5 million, compared to a loss of $6.2 million in the same period of 2024. Balance Sheet Highlights As of June 30, 2025, MediWound had cash, cash equivalents, and short-term deposits of $32.9 million, compared to $43.6 million as of December 31, 2024. During the first half of 2025, the Company used $11.9 million to fund operations, including $2.3 million in capital expenditures primarily related to manufacturing scale-up. MediWound received $0.7 million in proceeds from the exercise of Series A warrants during the quarter, with an additional $1.8 million received after quarter-end. Conference Call and Webcast MediWound management will host a conference call for investors on Thursday, August 14, 2025, beginning at 8:30 a.m., Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-844-676-8833 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-634-6869 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company’s website. A replay of the call will be available on the Company’s website at www.mediwound.com Non-IFRS Financial Measures To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses. Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management. However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below. 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. 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® and NexoBrid®. 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: Media Contact:Hani LuxenburgDaniel FerryEllie HansonChief Financial OfficerManaging DirectorFINN Partners for MediWoundMediWound Ltd.LifeSci Advisors, LLCellie.hanson@finnpartners.comir@mediwound.comdaniel@lifesciadvisors.com+1-929-588-2008 MediWound, Ltd.Unaudited Condensed Consolidated Statements of Financial PositionU.S. dollars in thousands June 30, December 31, 2025 2024 2024CURRENT ASSTS: Cash and cash equivalents and short-term deposits32,436 29,215 43,161Trade and other receivable6,800 4,888 6,310Inventories3,843 3,210 2,692Total current assets43,079 37,313 52,163 NON-CURRENT ASSETS: Other receivables and long-term restricted bank deposits490 691 439Property, plant and equipment15,724 12,308 14,132Right of use assets7,642 6,852 6,663Intangible assets66 132 99Total non-current assets23,922 19,983 21,333 Total assets67,001 57,296 73,496 CURRENT LIABILITIES: Current maturities of long-term liabilities822 1,496 612Warrants18,992 14,902 17,092Trade payables and accrued expenses5,880 2,745 5,281Other payables3,377 3,468 3,556Total current liabilities29,071 22,611 26,541 NON- CURRENT LIABILITIES: Grants received in advance758 - 736Liabilities in respect of IIA grants8,504 8,009 8,149Liabilities in respect of TEVA- 1,962 -Lease liabilities8,070 6,355 6,513Severance pay liability, net479 490 404Total non-current liabilities17,811 16,816 15,802 Total liabilities46,882 39,427 42,343Shareholders' equity20,119 17,869 31,153Total liabilities and equity67,001 57,296 73,496 MediWound, Ltd.Unaudited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or LossU.S. dollars in thousands (except of share and per share data) Six months ended Three months ended Year ended June 30, June 30, December 31, 2025 2024 2025 2024 2024 Total revenues9,663 10,027 5,708 5,063 20,222 Cost of revenues7,583 8,973 4,366 4,616 17,588 Gross profit2,080 1,054 1,342 447 2,634 Research and development6,377 3,368 3,491 1,898 8,878 Selling and marketing2,749 2,403 1,462 1,224 4,936 General and administrative3,891 3,501 2,105 1,809 8,202 Other expenses4 - - - 18 Operating loss(10,941) (8,218) (5,716) (4,484) (19,400) Financing expenses, net(3,060) (7,794) (7,564) (1,823) (10,763) Taxes on income(43) (22) (38) 2 (61) Net loss(14,044) (16,034) (13,318) (6,305) (30,224) Foreign currency translation adjustments(10) 10 (11) 2 7 Total comprehensive loss(14,054) (16,024) (13,329) (6,303) (30,217) Basic and diluted net loss per share(1.30) (1.73) (1.23) (0.68) (3.03) Number of shares used in calculating basic and diluted loss per share10,816,990 9,256,862 10,835,251 9,279,370 9,959,723 MediWound Ltd.Unaudited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2025 2024 2025 2024 2024Cash flows from operating activities: Net loss (14,044) (16,034) (13,318) (6,305) (30,224)Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to profit and loss items: Depreciation and amortization 752 725 394 357 1,483 Share-based compensation 1,706 1,270 862 758 3,138 Revaluation of warrants accounted at fair value 2,377 8,007 6,647 1,927 10,704 Revaluation of liabilities in respect of IIA grants 446 470 203 237 752 Revaluation of liabilities in respect of TEVA - 206 - 99 770 Financing (income) expenses and exchange differences of lease liability 943 17 938 (11) 487 Increase (decrease) in severance pay liability, net 75 48 48 13 (30)Other expenses 4 - - - 18 Financial income, net (942) (918) (424) (405) (2,039)Unrealized foreign currency loss (gain) (21) 78 (6) 11 47 5,340 9,903 8,662 2,986 15,330 Changes in asset and liability items: Decrease (increase) in trade receivables (217) 753 (1,671) 876 (1,141)Decrease (increase) in inventories (1,151) (345) (263) 103 187 Decrease (increase) in other receivables (341) (574) 37 (459) 120 Increase (decrease) in trade payables and accrued expenses 691 (1,900) 794 (530) 406 Increase in grants received in advance - - - - 1,181 Increase (decrease) in other payables (144) (34) 3 (294) 517 (1,162) (2,100) (1,100) (304) 1,270 Net cash used in operating activities (9,866) (8,231) (5,756) (3,623) (13,624) MediWound Ltd.Unaudited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2025 2024 2025 2024 2024Cash flows from investing activities: Purchase of property and equipment(2,008) (4,275) (1,049) (3,016) (6,273)Interest received585 1,127 319 522 2,252 Proceeds from (investment in) short-term bank deposits, net2,985 4,209 5,635 5,339 (4,376)Net cash provided by (used in) investing activities1,562 1,061 4,905 2,845 (8,397) Cash flows from financing activities: Repayment of leases liabilities(537) (458) (289) (214) (928)Proceeds from exercise of warrants and share options838 610 838 111 1,210 Proceeds from issuance of shares- - - - 22,165 Repayment of IIA grants(114) (120) - - (219)Repayment of liabilities in respect of TEVA- (834) - - (2,834)Net cash provided by (used in) financing activities187 (802) 549 (103) 19,394 Exchange rate differences on cash and cash equivalent balances21 (104) 2 (15) (84)Decrease in cash and cash equivalents(8,096) (8,076) (300) (896) (2,711)Balance of cash and cash equivalents at the beginning of the period9,155 11,866 1,359 4,686 11,866 Balance of cash and cash equivalents at the end of the period1,059 3,790 1,059 3,790 9,155 MediWound Ltd.Adjusted EBITDAU.S. dollars in thousands Six months ended Three months ended Year Ended June 30, June 30, December 31, 2025 2024 2025 2024 2024Net loss(14,044) (16,034) (13,318) (6,305) (30,224)Adjustments: Financing expenses, net(3,060) (7,794) (7,564) (1,823) (10,763)Other expenses, net(4) - - - (18)Taxes on income(43) (22) (38) 2 (61)Depreciation and amortization(752) (725) (394) (357) (1,483)Share-based compensation expenses(1,706) (1,270) (862) (758) (3,138)Total adjustments(5,565) (9,811) (8,858) (2,936) (15,463)Adjusted EBITDA(8,479) (6,223) (4,460) (3,369) (14,761)

Financial StatementPhase 3Phase 2

13 Aug 2025

·www.globenewswire.com

MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers

MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers Post hoc analysis published in Advances in Wound Care, provides clinical evidence supporting wound bed preparation as a critical step in the healing process YAVNE, Israel, August 13, 2025 (GLOBE NEWSWIRE) – MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of “The Correlation Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers: A Post Hoc Analysis of the ChronEx Multicenter Randomized Controlled Trial”, in Advances in Wound Care, a leading peer-reviewed journal focused on tissue injury and repair. The publication presents data demonstrating a strong correlation between wound bed preparation (WBP) and wound closure in patients with chronic venous leg ulcers (VLUs). The analysis includes data from 119 chronic VLU patients randomized in a 3:3:2 ratio to receive up to two weeks of daily treatments with either EscharEx, a placebo gel vehicle, or non-surgical standard of care, followed by standard dressings applied weekly for 12 weeks. The incidence of wound closure was compared between patients who achieved WBP by day 14 and those who did not, as well as between those who achieved WBP at any time and those who did not. WBP was defined as complete removal of nonviable tissue and full coverage of the wound bed with healthy granulation tissue. Key Findings: Wounds that failed to achieve WBP had a 90% probability of not healing (Negative Predictive Value = 90%)Wounds that achieved WBP were 4.1 times more likely to close compared to those that did not (p = 0.0004)Early achievement of WBP (within 14 days) was associated with a significantly increased likelihood of healing (Relative Risk = 2.4, p =0.0005)Wounds that failed to reach WBP had a 12-fold higher risk of remaining unhealed throughout the study period (Hazard Ratio = 12, p < 0.0001) These findings reinforce the clinical importance of complete debridement and timely full granulation tissue coverage in facilitating wound closure. The data further validates EscharEx’s therapeutic potential to improve healing outcomes by accelerating wound bed preparation in patients with venous leg ulcers. Dr. Marissa J. Carter, a clinical trial specialist and biostatistician focused on chronic wound care research, emphasized the broader implications of the results: “While wound bed preparation has long been accepted as the conceptual foundation for managing chronic wounds, this landmark analysis provides evidence, for the first time, that there is a strong correlation between the two. Importantly, the findings indicate a high negative predictive value associated with the lack of wound bed preparation. In other words, wounds that are not adequately prepared are highly unlikely to proceed to closure, underscoring the essential role of wound bed preparation in the healing process. Without adequate wound bed preparation, chronic wounds rarely heal.” 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 tissue, and reduce bioburden and biofilm. A global Phase III study in venous leg ulcers (VLUs) is currently underway, with a clinical 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 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. 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® and NexoBrid®. 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 Luxenburg Daniel FerryChief Financial Officer Managing DirectorMediWound Ltd. LifeSci Advisors, LLCir@mediwound.com daniel@lifesciadvisors.com Media Contact: Ellie HansonFINN Partners for MediWoundellie.hanson@finnpartners.com+1-929-588-2008

Phase 2Phase 3Clinical Result

31 Jul 2025

·www.globenewswire.com

Vericel Reports Second Quarter 2025 Financial Results

Total Revenue Growth of 20% to $63.2 Million, with MACI Revenue Growth of 21% to $53.5 Million Gross Margin Increased More than 400 Basis Points to 74% Adjusted EBITDA Growth of 112% to $13.4 Million, with Adjusted EBITDA Margin Increase of More than 900 Basis Points to 21% Approximately 600 MACI Arthro Surgeons Trained to Date Received FDA IND Clearance for Phase 3 MACI Ankle Clinical Study Conference Call Today at 8:30am Eastern Time CAMBRIDGE, Mass., July 31, 2025 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the second quarter ended June 30, 2025. Second Quarter 2025 Financial Highlights Total net revenue of $63.2 millionMACI® net revenue growth of 21% to $53.5 millionBurn Care net revenue of $9.8 million, consisting of $8.6 million of Epicel® revenue and $1.2 million of NexoBrid® revenueGross margin of 74%, an increase of more than 400 basis points versus the prior yearNet loss of $0.6 million, or $0.01 per diluted shareNon-GAAP adjusted EBITDA increased 112% to $13.4 million, with adjusted EBITDA margin increase of more than 900 basis points to 21%Operating cash flow of $8.2 millionAs of June 30, 2025, the Company had approximately $164 million in cash and investments, and no debt Business Highlights and Updates Record second quarter total revenue and MACI revenueSecond highest number of MACI biopsies in a quarter since launch, with second highest number of biopsies in any month in AprilApproximately 600 MACI Arthro™ surgeons trained to dateMACI implants for the treatment of small femoral condyle defects increased more than 40% in the second quarter versus prior yearMACI sales force expansion accelerated into the second half of 2025 based on MACI Arthro launch indicators and expected MACI implant growthHighest number of Epicel biopsies in a quarter since 2023, representing 38% growth versus prior year, and the highest number of Epicel biopsies in a month in JuneNexoBrid second quarter revenue increased 52% versus the prior yearHighest number of NexoBrid hospital unit orders in any month since launch in JuneReceived FDA IND clearance for MACI Ankle™ clinical study and remain on track to initiate the study in the second half of 2025 “The Company delivered another quarter of solid financial and business results in the second quarter, with significant revenue growth and even higher profitability growth and margin expansion as well as continued strength in the key performance indicators for the MACI Arthro launch,” said Nick Colangelo, President and CEO of Vericel. “Based on the positive trends across the business to start the third quarter, we expect continued strong revenue growth and profitability for the remainder of the year and beyond.” 2025 Financial Guidance Reaffirmed MACI full-year revenue growth in the low 20% rangeUpdated Burn Care revenue guidance for the second half of 2025 to be in line with recent run rate of approximately $10 million per quarterReaffirmed full-year profitability guidance of gross margin of 74% and adjusted EBITDA margin of 26% Second Quarter 2025 ResultsTotal net revenue for the quarter ended June 30, 2025 increased to $63.2 million, compared to $52.7 million in the second quarter of 2024. Total net product revenue for the quarter included $53.5 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue, $8.6 million of Epicel (cultured epidermal autografts) net revenue, and $1.2 million of NexoBrid (anacaulase-bcdb) net revenue, compared to $44.1 million of MACI net revenue, $7.8 million of Epicel net revenue, and $0.8 million of NexoBrid net revenue, respectively, in the second quarter of 2024. Gross profit for the quarter ended June 30, 2025 was $46.6 million, or 74% of net revenue, compared to $36.6 million, or 70% of net revenue, for the second quarter of 2024. Total operating expenses for the quarter ended June 30, 2025 were $48.6 million, compared to $42.6 million for the same period in 2024. The increase in operating expenses was primarily due to increased headcount and related employee expenses and additional costs related to the Company’s new Burlington facility, including depreciation and MACI tech transfer activities. Net loss for the quarter ended June 30, 2025 was $0.6 million, or $0.01 per diluted share, compared to $4.7 million, or $0.10 per diluted share, for the second quarter of 2024. Non-GAAP adjusted EBITDA for the quarter ended June 30, 2025 was $13.4 million, or 21% of net revenue, compared to $6.3 million, or 12% of net revenue, for the second quarter of 2024. A table reconciling non-GAAP measures is included in this press release for reference. As of June 30, 2025, the Company had approximately $164 million in cash and investments, and no debt. Conference Call Information Today’s conference call will be available live at 8:30 a.m. Eastern Time. The live webcast can be accessed on the Investor Relations section of the Vericel website at http://investors.vcel.com/events-presentations. Presentation slides for the conference call will be available on the webcast and on the website. A replay of the webcast will be available until July 31, 2026. To participate by telephone, dial 855-303-0072 or +1 773-305-6837 if connecting from outside the U.S. When connected, please use passcode: 276790. About Vericel CorporationVericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets. The Company combines innovations in biology with medical technologies, resulting in a highly differentiated portfolio of innovative cell therapies and specialty biologics that repair injuries and restore lives. Vericel markets three products in the United States. MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel also holds an exclusive license for North American rights to NexoBrid (anacaulase-bcdb), a biological orphan product containing proteolytic enzymes, which is indicated for eschar removal in adults and pediatric patients with deep partial-thickness and/or full-thickness thermal burns. For more information, please visit www.vcel.com. Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2025 Vericel Corporation. All rights reserved. GAAP v. Non-GAAP MeasuresVericel’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Vericel has provided in this release certain financial information that has not been prepared in accordance with GAAP. Vericel’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Vericel’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Vericel’s industry. However, the non-GAAP financial measures that Vericel uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP. Forward-Looking StatementsVericel 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 relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Our 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. Among the factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to, uncertainties associated with our expectations regarding future revenue, growth in revenue, market penetration for MACI®, MACI Arthro™, Epicel®, and NexoBrid®, growth in profit, gross margins and operating margins, the ability to continue to scale our manufacturing operations to meet the demand for our cell therapy products, including the timely qualification of a new manufacturing facility in Burlington, Massachusetts, the ability to sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing and likelihood of the FDA’s potential approval of the use of MACI to treat cartilage defects in the ankle, the estimate of the commercial growth potential of our products and product candidates, competitive developments, changes in third-party coverage and reimbursement, including recent and future healthcare reform measures and private payor initiatives, surgeon adoption of MACI Arthro, physician and burn center adoption of NexoBrid, labor strikes, supply chain disruptions or other events or factors that might affect our ability to manufacture MACI or Epicel or affect MediWound’s ability to manufacture and supply sufficient quantities of NexoBrid to meet customer demand, including but not limited to the ongoing and evolving conflicts in the Middle East region involving Israel, negative impacts on the global economy and capital markets resulting from the conflict in Ukraine and the ongoing and evolving Middle East conflicts, including those associated with potential further involvement by the U.S., changes in trade policies and regulations, including the potential for increases or changes in duties, current and potentially new tariffs or quotas, lingering effects of adverse developments affecting financial institutions, companies in the financial services industry or the financial services industry generally, possible changes in governmental monetary and fiscal policies, including, but not limited to, Federal Reserve policies in connection with continued inflationary pressures, the impact from future regulatory, judicial and legislative changes to our industry or to the broader business landscape, including those included in the One Big Beautiful Bill Act, global geopolitical tensions and potential future impacts on our business or the economy generally stemming from a public health emergency. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, Vericel’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on July 31, 2025, and in other filings with the SEC. These forward-looking statements reflect our views as of the date hereof and Vericel does not assume and specifically disclaims any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law. Investor Contact:Eric Burnsir@vcel.com+1 (734) 418-4411 VERICEL CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share amounts - unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Product sales, net $63,240 $52,662 $115,838 $103,943 Total revenue 63,240 52,662 115,838 103,943 Cost of product sales 16,627 16,061 32,952 31,988 Gross profit 46,613 36,601 82,886 71,955 Research and development 6,731 7,363 13,992 13,781 Selling, general and administrative 41,911 35,269 83,715 69,669 Total operating expenses 48,642 42,632 97,707 83,450 Loss from operations (2,029) (6,031) (14,821) (11,495)Other income (expense): Interest income 1,657 1,510 3,314 3,272 Interest expense (157) (153) (310) (306)Other income (expense) (24) (8) 18 (15)Total other income 1,476 1,349 3,022 2,951 Net loss $(553) $(4,682) $(11,799) $(8,544)Net loss per common share: Basic and diluted $(0.01) $(0.10) $(0.24) $(0.18)Weighted-average common shares outstanding: Basic and diluted 50,368 48,686 50,138 48,413 VERICEL CORPORATIONRECONCILIATION OF REPORTED NET LOSS (GAAP)TO ADJUSTED EBITDA (NON-GAAP MEASURE)(in thousands - unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Net loss $(553) $(4,682) $(11,799) $(8,544)Stock-based compensation expense 10,140 9,520 21,645 19,354 Depreciation and amortization 2,826 1,323 5,512 2,701 Net interest income (1,500) (1,357) (3,004) (2,966)Pre-occupancy lease expense and tech transfer 2,446 1,509 4,247 2,986 Adjusted EBITDA (Non-GAAP) $13,359 $6,313 $16,601 $13,531 VERICEL CORPORATIONCONDENSED CONSOLIDATED BALANCE SHEETS(in thousands - unaudited) June 30, December 31, 2025 2024ASSETS Current assets: Cash and cash equivalents $80,532 $74,520Restricted cash — 10,529Short-term investments 36,349 41,693Accounts receivable (net of allowance for doubtful accounts of $1 and $10, respectively) 64,290 61,375Inventory 16,831 17,373Other current assets 6,575 7,287Total current assets 204,577 212,777Property and equipment, net 109,848 103,161Intangible assets, net 5,938 6,250Right-of-use assets 67,398 70,098Long-term investments 47,400 39,880Other long-term assets 447 556Total assets $435,608 $432,722LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $12,857 $23,848Accrued expenses 14,404 17,065Current portion of operating lease liabilities 13,753 9,257Other current liabilities 118 116Total current liabilities 41,132 50,286Operating lease liabilities 86,011 89,593Other long-term liabilities 1,656 876Total liabilities 128,799 140,755Total shareholders’ equity 306,809 291,967Total liabilities and shareholders’ equity $435,608 $432,722

Financial StatementLicense out/inPhase 3Cell Therapy

100 Deals associated with Anacaulase-bcdb

External Link

KEGG	Wiki	ATC	Drug Bank
-	Anacaulase-bcdb	D03BA03	DB12249

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Burns	European Union	MediWound Germany GmbH	18 Dec 2012
Burns	Iceland	MediWound Germany GmbH	18 Dec 2012
Burns	Liechtenstein	MediWound Germany GmbH	18 Dec 2012
Burns	Norway	MediWound Germany GmbH	18 Dec 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04040660 (GlobeNewswire) Manual	Not Applicable	Burns	239	NexoBrid (adults)	jylfsixtem(eobzhkdbgb) = wwtlkkqhnw fthicklrlm (nfqgkikjor ) View more	Positive	05 Aug 2024
				NexoBrid (children)	jylfsixtem(eobzhkdbgb) = aelthrvrtb fthicklrlm (nfqgkikjor ) View more
NCT02148705 (CTgov)	Phase 3	Burns	175	NexoBrid (NexoBrid Gel)	gmnvvcmofc = nyaanyxjgn nydljoznwb (pyhzexufff, zhuejfkkwp - mahnhcblhj) View more	-	27 Jun 2023
				Gel Vehicle (Gel Vehicle)	gmnvvcmofc = ebdzjalvdy nydljoznwb (pyhzexufff, rwwqevfgev - botdihhnhs) View more
NCT02278718 (GlobeNewswire) Manual	Phase 3	Burns	-	NexoBrid	jpuazvqxoq(idtxjftoxp): P-Value = <0.0001 View more	Superior	20 Jul 2021
				Standard of Care
NCT00324311 (Pubmed \| Burns)	Phase 3	Burns	182	NXB	vpjsyemzte(uwcrcijowa) = ewdybbwfyu feukmpwajr (ivyldalsnt ) View more	-	01 May 2014
				novel rapid and selective enzymatic debridement agent (SOC)	vpjsyemzte(uwcrcijowa) = gbpsrftvbg feukmpwajr (ivyldalsnt ) View more

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