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

开始日期2024-07-01

申办/合作机构

Krishnadevaraya College of Dental Sciences and Hospital

ACTRN12622000520730

/ Not yet recruitingN/AIIT

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”?

开始日期2023-03-06

申办/合作机构

Royal Brisbane & WomenS Hospital

JPRN-jRCT2080224058

/ Completed临床3期

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

开始日期2018-12-18

申办/合作机构

Kaken Pharmaceutical Co., Ltd.

100 项与 Anacaulase-bcdb 相关的临床结果

登录后查看更多信息

100 项与 Anacaulase-bcdb 相关的转化医学

登录后查看更多信息

100 项与 Anacaulase-bcdb 相关的专利（医药）

登录后查看更多信息

109

项与 Anacaulase-bcdb 相关的文献（医药）

2025-06-01·BURNS

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

Article

作者: 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.

2025-06-01·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

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

2025-06-01·JOURNAL OF ETHNOPHARMACOLOGY

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

Article

作者: 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.

176

项与 Anacaulase-bcdb 相关的新闻（医药）

2025-11-20

·GlobeNewswire-Health Care

MediWound Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Ongoing Enrollment Continues in VALUE Phase III Trial of EscharEx® in Venous Leg Ulcers Commissioning Completed for Expanded NexoBrid® Facility; Full Operational Capacity Expected by Year-End 2025 Balance Sheet Strengthened with $30 Million Equity Financing Third Quarter 2025 Revenue of $5.4 Million, Up 23% Year-over-Year Conference Call Today, November 20, 2025, at 8:30 a.m. Eastern Time YAVNE, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. “We continued to execute our growth strategy this quarter, advancing both our operational capabilities and our late-stage clinical programs,” said Ofer Gonen, Chief Executive Officer of MediWound. “Completion of commissioning for our expanded NexoBrid manufacturing facility marks a significant milestone that positions us to meet rising global demand. Enrollment in the VALUE Phase III trial of EscharEx is progressing under a robust study design aligned with endpoints where EscharEx demonstrated strong results in Phase II. With a strengthened balance sheet following our recent $30 million equity financing, we remain focused on driving revenue growth, advancing our late-stage pipeline, and delivering long-term value.” Third Quarter 2025 Highlights, Recent Developments, and Upcoming Milestones EscharEx® Enrollment continues to advance in VALUE, a global Phase III study of EscharEx in venous leg ulcers (VLUs), targeting 216 patients across approximately 40 sites in the U.S. and Europe, the majority of which are already active. The co-primary endpoints are the incidence of complete debridement and the facilitation of wound closure. A pre-specified interim sample-size assessment is planned after 65% of patients complete treatment.Following constructive FDA feedback aligning on trial design and development strategy, the Company expects to initiate its clinical trial in diabetic foot ulcers (DFU) in the second half of 2026.An updated market access and pricing assessment conducted by an independent global consulting firm estimated a peak sales opportunity of approximately $831 million for EscharEx. The estimate reflects updated clinical data and modeled health-economic considerations. NexoBrid® U.S. adoption continues to expand, with Vericel reporting NexoBrid’s highest quarterly revenue since launch, up 38% year-over-year and 26% sequentially. Vericel reported broad utilization across more than 60 burn centers and plans to pursue a permanent CPT code, which would become effective in 2027.Commissioning of the expanded NexoBrid manufacturing facility has been completed. The facility is expected to reach full operational readiness by year-end 2025, increasing production capacity sixfold to support growing global demand. Market availability remains subject to the completion of regulatory reviews.The Therapeutic Goods Administration (TGA) approved NexoBrid for use in Australia for both adult and pediatric burn patients, expanding approved markets to 45 countries worldwide. Corporate Development Raised $30 million in equity financing from healthcare-focused investors, providing capital to advance the Company’s development programs and commercialization initiatives. Third Quarter 2025 Financial Highlights Revenue for the third quarter of 2025 was $5.4 million, compared to $4.4 million for the same period in 2024. The increase was primarily driven by higher development service revenue, reflecting additional contracts with the U.S. Department of Defense (DoD).Gross profit was $0.9 million, or 16.5% of total revenue, compared to $0.7 million, or 15.5% of total revenue, in the prior-year period.Research and development expenses were $3.5 million, compared to $2.5 million in the same period of 2024, driven by increased investment in the EscharEx VALUE Phase III trial and related clinical activities.Selling, general and administrative expenses were $4.0 million, compared to $3.2 million in the same period of 2024, primarily due to increased marketing authorization holder expenses.Operating loss was $6.5 million, compared to $5.1 million for the same period in 2024.Net loss was $2.7 million, or $0.24 per share, compared to a net loss of $10.3 million, or $0.98 per share, in the third quarter of 2024. The reduction in net loss was primarily driven by non-cash financial income from the revaluation of warrants in the third quarter of 2025, compared to non-cash financial expenses from the revaluation of warrants in the same quarter last year.Non-GAAP Adjusted EBITDA loss was $5.4 million, compared to a loss of $3.7 million in the prior-year quarter. Year-to-Date 2025 Financial Highlights Revenue for the first nine months of 2025 was $15.1 million, compared to $14.4 million in the same period of 2024.Gross profit was $3.0 million, or 19.7% of total revenue, compared to $1.7 million, or 12.0% of total revenue, in the first nine months of 2024. The margin improvement primarily reflects a more favorable revenue mix.Research and development expenses were $9.8 million, compared to $5.9 million for the same period in 2024.Selling, general and administrative expenses were $10.6 million, compared to $9.1 million in the first nine months of 2024.Operating loss was $17.5 million, compared to $13.3 million for the same period in 2024.Net loss was $16.7 million, or $1.53 per share, compared to $26.3 million, or $2.72 per share, in the first nine months of 2024. The reduction in net loss was primarily driven by non-cash financial income from the revaluation of warrants in 2025, compared to non-cash financial expenses from the revaluation of warrants in the same period of 2024.Non-GAAP Adjusted EBITDA loss was $13.9 million, compared to a loss of $9.9 million in the same period of 2024. Balance Sheet Highlights As of September 30, 2025, MediWound had $60 million in cash, cash equivalents, and short-term deposits, compared to $44 million as of December 31, 2024. During the first nine months of 2025, the Company used $15.8 million in cash to fund operating activities. MediWound strengthened its balance sheet through the completion of a $30.0 million registered direct offering and $3.5 million in proceeds from Series A warrant exercises. Conference Call and Webcast MediWound management will host a conference call for investors on Thursday, November 20, 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 the 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 pioneering enzymatic, non-surgical therapies for 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 United States, European Union, Japan, and additional international markets. MediWound’s late-stage pipeline product, EscharEx®, is an investigational therapy for the debridement of chronic wounds, with potential to become a new standard of care in wound management. For more information, visit www.mediwound.com and follow us on LinkedIn and X (formerly Twitter). 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, Ltd.Unaudited Condensed Consolidated Statements of Financial PositionU.S. dollars in thousands September 30, December 31, 2025 2024 2024CURRENT ASSTS: Cash and cash equivalents and short-term deposits59,090 45,562 43,161Trade and other receivable6,038 5,304 6,310Inventories4,405 3,022 2,692Total current assets69,533 53,888 52,163 NON-CURRENT ASSETS: Other receivables and long-term restricted bank deposits465 484 439Property, plant and equipment16,715 13,453 14,132Right of use assets7,660 6,793 6,663Intangible assets50 116 99Total non-current assets24,890 20,846 21,333 Total assets94,423 74,734 73,496 CURRENT LIABILITIES: Current maturities of long-term liabilities1,057 726 612Warrants12,979 19,056 17,092Trade payables and accrued expenses8,510 3,131 5,281Other payables3,708 2,664 3,556Total current liabilities26,254 25,577 26,541 NON- CURRENT LIABILITIES: Grants received in advance758 - 736Liabilities in respect of IIA grants8,528 8,046 8,149Lease liabilities8,271 6,460 6,513Severance pay liability, net456 416 404Total non-current liabilities18,013 14,922 15,802 Total liabilities44,267 40,499 42,343Shareholders' equity*50,156 34,235 31,153Total liabilities and equity94,423 74,734 73,496 *Shareholders' equity: Issued and Outstanding Ordinary shares of NIS 0.07 par value: 12,821,433 as of September 30, 2025; 10,793,057 as of December 31, 2024 and 10,790,036 as of September 30, 2024 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) Nine months ended Three months ended Year ended September 30, September 30, December 31, 2025 2024 2025 2024 2024Total revenues15,092 14,382 5,429 4,355 20,222Cost of revenues12,116 12,651 4,533 3,678 17,588Gross profit2,976 1,731 896 677 2,634 Research and development9,842 5,892 3,465 2,524 8,878Selling and marketing4,385 3,466 1,636 1,063 4,936General and administrative6,211 5,672 2,320 2,171 8,202Other expenses4 - - - 18Operating loss(17,466) (13,299) (6,525) (5,081) (19,400) Financing income (expenses), net866 (12,974) 3,926 (5,180) (10,763)Taxes on income(96) (43) (53) (21) (61)Net loss(16,696) (26,316) (2,652) (10,282) (30,224)Foreign currency translation adjustments(19) 3 (9) (7) 7Total comprehensive loss(16,715) (26,313) (2,661) (10,289) (30,217) Basic and diluted net loss per share(1.53) (2.72) (0.24) (0.98) (3.03)Number of shares used in calculating basic and diluted loss per share10,886,487 9,679,599 11,022,459 10,511,288 9,959,723 MediWound Ltd.Unaudited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Nine months ended Three months ended Year Ended September 30, September 30, December 31, 2025 2024 2025 2024 2024Cash flows from operating activities: Net loss (16,696) (26,316) (2,652) (10,282) (30,224)Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to profit and loss items: Depreciation and amortization 1,170 1,086 418 361 1,483Share-based compensation 2,446 2,316 740 1,046 3,138Revaluation of warrants accounted at fair value (1,838) 12,668 (4,215) 4,661 10,704Revaluation of liabilities in respect of IIA grants 704 711 258 241 752Revaluation of liabilities in respect of TEVA - 770 - 564 770Financing expenses and exchange differences of lease liability 1,286 238 343 221 487Increase (decrease) in severance pay liability, net 52 (46) (23) (94) (30)Other expenses 4 - - - 18Financial income, net (1,341) (1,486) (399) (568) (2,039)Unrealized foreign currency loss (gain) (34) 74 (13) (4) 47 2,449 16,331 (2,891) 6,428 15,330Changes in asset and liability items: Decrease (increase) in trade receivables 458 285 675 (468) (1,141)Decrease (increase) in inventories (1,713) (161) (562) 184 187Decrease (increase) in other receivables (239) (283) 102 291 120Increase (decrease) in trade payables and accrued expenses 2,409 (1,948) 1,718 (48) 406Increase in grants received in advance - - - - 1,181Increase in other payables 227 105 371 139 517 1,142 (2,002) 2,304 98 1,270Net cash used in operating activities (13,105) (11,987) (3,239) (3,756) (13,624) MediWound Ltd.Unaudited Condensed Consolidated Statements of Cash FlowsU.S. dollars in thousands Nine months ended Three months ended Year Ended September 30, September 30, December 31, 2025 2024 2025 2024 2024Cash flows from investing activities: Purchase of property and equipment(3,053) (5,467) (1,045) (1,192) (6,273)Interest received1,409 1,588 824 461 2,252 Proceeds from (investment in) short-term bank deposits, net7,585 (9,346) 4,600 (13,555) (4,376)Net cash provided by (used in) investing activities5,941 (13,225) 4,379 (14,286) (8,397) Cash flows from financing activities: Repayment of leases liabilities(867) (686) (330) (228) (928)Proceeds from exercise of warrants and share options3,624 1,210 2,786 600 1,210 Proceeds from issuance of shares, net28,169 22,436 28,169 22,436 22,165 Repayment of IIA grants(214) (219) (100) (99) (219)Repayment of liabilities in respect of TEVA- (2,834) - (2,000) (2,834)Net cash provided by financing activities30,712 19,907 30,525 20,709 19,394 Exchange rate differences on cash and cash equivalent balances34 (86) 13 18 (84)Increase (Decrease) in cash and cash equivalents23,582 (5,391) 31,678 2,685 (2,711)Balance of cash and cash equivalents at the beginning of the period9,155 11,866 1,059 3,790 11,866 Balance of cash and cash equivalents at the end of the period32,737 6,475 32,737 6,475 9,155 MediWound Ltd.Adjusted EBITDAU.S. dollars in thousands Nine months ended Three months ended Year Ended September 30, September 30, December 31, 2025 2024 2025 2024 2024Net loss(16,696) (26,316) (2,652) (10,282) (30,224)Adjustments: Financial income (expenses), net866 (12,974) 3,926 (5,180) (10,763)Other expenses(4) - - - (18)Taxes on income(96) (43) (53) (21) (61)Depreciation and amortization(1,170) (1,086) (418) (361) (1,483)Share-based compensation expenses(2,446) (2,316) (740) (1,046) (3,138)Total adjustments(2,850) (16,419) 2,715 (6,608) (15,463)Adjusted EBITDA(13,846) (9,897) (5,367) (3,674) (14,761) MediWound Contacts: Hani Luxenburg Chief Financial Officer MediWound Ltd. ir@mediwound.com Daniel Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com

财报临床3期上市批准临床2期

2025-11-06

·GlobeNewswire-Health Care

Vericel Reports Third Quarter 2025 Financial Results

Record Third Quarter Total Revenue of $67.5 Million MACI Revenue Growth of 25% to $55.7 Million Net Income of $5.1 Million and Adjusted EBITDA Margin of 25% Record Third Quarter Operating Cash Flow of $22.1 Million More than 800 MACI Arthro Surgeons Trained to Date Conference Call Today at 8:30am Eastern Time CAMBRIDGE, Mass., Nov. 06, 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 third quarter ended September 30, 2025. Third Quarter 2025 Financial Highlights Total net revenue of $67.5 millionMACI® net revenue growth of 25% to $55.7 millionBurn Care net revenue of $11.8 million, consisting of $10.4 million of Epicel® revenue and $1.5 million of NexoBrid® revenueGross margin of 73.5%Net income of $5.1 millionNon-GAAP adjusted EBITDA increased 69% to $17.0 million, or 25% of revenueOperating cash flow of $22.1 million$185 million in cash and investments, and no debt Business Highlights and Updates Record third quarter total revenue and MACI revenueRecord third quarter MACI biopsies and surgeons taking biopsiesMore than 800 MACI Arthro® surgeons trained to dateRecord NexoBrid quarterly revenue, with 38% growth versus the prior year and 26% growth versus the prior quarterMACI sales force expansion on track to be completed in the fourth quarter, with all new hires to be in territories to start the year in 2026MACI Ankle™ program remains on track to initiate clinical study in the fourth quarter of 2025 “The Company delivered outstanding financial and business results in the third quarter, with strong revenue growth and even higher profitability growth, a significant inflection in operating cash flow, and continued progess across a number of key business initiatives,” said Nick Colangelo, President and CEO of Vericel. “We believe that the Company is very well-positioned for a strong close to the year and to continue to deliver a unique combination of sustained high revenue and profit growth in 2026 and beyond based on the strength of our core portfolio, the recent launch of MACI Arthro and the continued progress on our long-term growth initiatives.” 2025 Financial Guidance Total full-year revenue guidance of $272 to $276 millionReaffirmed MACI full-year revenue growth in the low 20% range, or $237.5 to $239.5 millionReaffirmed full-year profitabilty guidance of 74% gross margin and adjusted EBITDA margin of 26% Third Quarter 2025 ResultsTotal net revenue for the quarter ended September 30, 2025 increased to $67.5 million, compared to $57.9 million in the third quarter of 2024. Total net product revenue for the quarter included $55.7 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue, $10.4 million of Epicel (cultured epidermal autografts) net revenue, and $1.5 million of NexoBrid (anacaulase-bcdb) net revenue, compared to $44.7 million of MACI net revenue, $12.2 million of Epicel net revenue, and $1.1 million of NexoBrid net revenue, respectively, in the third quarter of 2024. Gross profit for the quarter ended September 30, 2025 was $49.6 million, or 73.5% of net revenue, compared to $41.7 million, or 71.9% of net revenue, for the third quarter of 2024. Total operating expenses for the quarter ended September 30, 2025 were $46.1 million, compared to $44.1 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 income for the quarter ended September 30, 2025 was $5.1 million, or $0.10 per diluted share, compared to a net loss of $0.9 million, or $0.02 per diluted share, for the third quarter of 2024. Non-GAAP adjusted EBITDA for the quarter ended September 30, 2025 was $17.0 million, or 25% of net revenue, compared to $10.0 million, or 17% of net revenue, for the third quarter of 2024. A table reconciling non-GAAP measures is included in this press release for reference. As of September 30, 2025, the Company had $185 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 November 6, 2026. To participate by telephone, dial 800-330-6730 or +1-312-471-1351 if connecting from outside the U.S. When connected, please use passcode: 476633. About Vericel Corporation Vericel 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®, MACI® and MACI Arthro® 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 Statements Vericel 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 conflicts in the Middle East region involving Israel, negative impacts on the global economy and capital markets resulting from the conflict in Ukraine and 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, a shutdown of, or gridlock within the U.S. government, 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 September 30, 2025, filed with the SEC on November 6, 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 September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Product sales, net $67,503 $57,905 $183,341 $161,848 Total revenue 67,503 57,905 183,341 161,848 Cost of product sales 17,918 16,252 50,870 48,240 Gross profit 49,585 41,653 132,471 113,608 Research and development 6,318 6,093 20,310 19,874 Selling, general and administrative 39,817 38,025 123,532 107,694 Total operating expenses 46,135 44,118 143,842 127,568 Income (loss) from operations 3,450 (2,465) (11,371) (13,960)Other income (expense): Interest income 1,808 1,578 5,122 4,850 Interest expense (158) (154) (468) (460)Other income (expense) (26) 140 (8) 125 Total other income 1,624 1,564 4,646 4,515 Net income (loss) $5,074 $(901) $(6,725) $(9,445)Net income (loss) per common share: Basic $0.10 $(0.02) $(0.13) $(0.19)Diluted $0.10 $(0.02) $(0.13) $(0.19)Weighted-average common shares outstanding: Basic 50,489 49,085 50,256 48,639 Diluted 51,908 49,085 50,256 48,639 VERICEL CORPORATIONRECONCILIATION OF REPORTED NET INCOME (LOSS) (GAAP)TO ADJUSTED EBITDA (NON-GAAP MEASURE)(in thousands - unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Net income (loss) $5,074 $(901) $(6,725) $(9,445)Stock-based compensation expense 8,699 9,224 30,344 28,578 Depreciation and amortization 2,944 1,326 8,456 4,027 Net interest income (1,654) (1,424) (4,658) (4,390)Pre-occupancy lease expense and tech transfer 1,933 1,815 6,180 4,801 Adjusted EBITDA (Non-GAAP) $16,996 $10,040 $33,597 $23,571 VERICEL CORPORATIONCONDENSED CONSOLIDATED BALANCE SHEETS(in thousands - unaudited) September 30, December 31, 2025 2024ASSETS Current assets: Cash and cash equivalents $100,403 $74,520Restricted cash — 10,529Short-term investments 34,977 41,693Accounts receivable (net of allowance for doubtful accounts of $19 and $10, respectively) 60,426 61,375Inventory 18,155 17,373Other current assets 8,006 7,287Total current assets 221,967 212,777Property and equipment, net 109,380 103,161Intangible assets, net 5,781 6,250Right-of-use assets 66,087 70,098Long-term investments 49,664 39,880Other long-term assets 395 556Total assets $453,274 $432,722LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $15,335 $23,848Accrued expenses 16,286 17,065Current portion of operating lease liabilities 13,845 9,257Other current liabilities 116 116Total current liabilities 45,582 50,286Operating lease liabilities 84,161 89,593Other long-term liabilities 1,673 876Total liabilities 131,416 140,755Total shareholders’ equity 321,858 291,967Total liabilities and shareholders’ equity $453,274 $432,722

财报引进/卖出细胞疗法

2025-09-29

·GlobeNewswire-Health Care

MediWound Announces $30 Million Registered Direct Offering of Ordinary Shares

MediWound Announces $30 Million Registered Direct Offering of Ordinary Shares YAVNE, Israel, September 29, 2025 -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that it has entered into a definitive securities purchase agreement led by a prominent U.S.-based mutual fund and other healthcare-focused investors for the sale and purchase of 1,734,105 ordinary shares of the Company, par value NIS 0.07 per share, at a purchase price of $17.30 per share, in a registered direct offering. The Company expects to close the offering on or about September 30, 2025, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to the Company from the offering are expected to be approximately $30 million, before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering primarily to support EscharEx’s pre-commercial activities, to enhance its large-scale manufacturing capabilities, and for general corporate purposes. The securities described above are being offered by means of the Company's shelf registration statement on Form F-3 (File No. 333-285908), previously filed with the Securities and Exchange Commission (the "SEC") on March 19, 2025, and declared effective by the SEC on March 27, 2025, the accompanying prospectus, dated March 27, 2025. A final prospectus supplement and accompanying prospectus relating to the securities being offered in the offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov. and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these Company securities, nor shall there be any sale of these Company securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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. 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 registered direct offering, including as to the ability to complete the registered direct offering described above, the expected gross proceeds therefrom, the intended use of proceeds and the timing of the closing of the registered direct offering. 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; market and other conditions; 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 LuxenburgChief Financial OfficerMediWound Ltd.ir@mediwound.comDaniel FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.comMedia Contact: Ellie HansonFINN Partners for MediWoundellie.hanson@finnpartners.com+1-929-588-2008

100 项与 Anacaulase-bcdb 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	Anacaulase-bcdb	D03BA03	DB12249

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
烧伤	欧盟	MediWound Germany GmbH	2012-12-18
烧伤	冰岛	MediWound Germany GmbH	2012-12-18
烧伤	列支敦士登	MediWound Germany GmbH	2012-12-18
烧伤	挪威	MediWound Germany GmbH	2012-12-18

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04040660 (GlobeNewswire) 人工标引	N/A	烧伤	239	NexoBrid (adults)	夢齋糧遞蓋壓艱淵膚衊(鹽蓋蓋鏇夢網製壓簾觸) = 遞顧鏇齋築壓淵繭築餘顧獵襯蓋鏇夢顧鬱窪積 (繭鏇範繭鹽鬱願蓋襯鏇 ) 更多	积极	2024-08-05
				NexoBrid (children)	夢齋糧遞蓋壓艱淵膚衊(鹽蓋蓋鏇夢網製壓簾觸) = 積繭淵遞繭繭顧觸鹽艱顧獵襯蓋鏇夢顧鬱窪積 (繭鏇範繭鹽鬱願蓋襯鏇 ) 更多
NCT02148705 (CTgov)	临床3期	烧伤	175	NexoBrid (NexoBrid Gel)	製糧鏇獵餘壓艱鬱鏇艱 = 遞鬱構廠蓋築鏇廠積夢遞鏇窪廠製簾夢網窪鹽 (餘遞鹹鹹繭鏇鑰廠淵糧, 蓋衊鹽鑰製醖製築衊襯 ~ 遞鏇餘壓鏇蓋憲積夢鹽) 更多	-	2023-06-27
				Gel Vehicle (Gel Vehicle)	製糧鏇獵餘壓艱鬱鏇艱 = 簾壓顧窪壓網構廠齋壓遞鏇窪廠製簾夢網窪鹽 (餘遞鹹鹹繭鏇鑰廠淵糧, 艱艱網夢鹽廠餘鏇積衊 ~ 構網鏇壓積艱簾簾積製) 更多
NCT02278718 (GlobeNewswire) 人工标引	临床3期	烧伤	-	NexoBrid	繭糧衊鹽膚觸糧選網鹹(鬱觸衊鬱夢鏇窪簾糧鏇): P-Value = <0.0001 更多	优效	2021-07-20
				Standard of Care
NCT00324311 (Pubmed \| Burns)	临床3期	烧伤	182	NXB	願醖壓壓餘衊襯襯襯淵(壓鹹膚糧製鏇鬱蓋淵鑰) = 遞鹹餘衊衊廠夢鹹衊簾積鬱衊夢膚蓋壓製鹹壓 (廠遞範積築積鑰齋鹽顧 ) 更多	-	2014-05-01
				novel rapid and selective enzymatic debridement agent (SOC)	願醖壓壓餘衊襯襯襯淵(壓鹹膚糧製鏇鬱蓋淵鑰) = 鏇觸鹹獵憲衊範選獵製積鬱衊夢膚蓋壓製鹹壓 (廠遞範積築積鑰齋鹽顧 ) 更多