Yavne

MediWound Completes Enrollment of its EscharEx U.S. Phase 2 Adaptive Design Study

Retrieved on: 
Monday, December 6, 2021
Patient, Burn, Government, Trial of the century, Review, Safety, Regeneration, Phrase, Face, Company, Debridement, Mouth ulcer, DFU, European Union, Inflammation, Contract, Incidence, Annual report, BARDA, COVID-19, Pain, Bromelain (pharmacology), Particle-size distribution, Research, Form 20-F, GLOBE, EMA, Granulation tissue, Wound healing, Development, IDMC, Union, FDA, Growth, Perseverance, Ulcer, VLU, Quality of life, Pharmaceutical industry, Medical device, Hospital

Phase 2 adaptive design clinical study evaluating the safety and efficacy of EscharEx in debridement of venous leg ulcers (VLUs) compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).

Key Points: 
  • Phase 2 adaptive design clinical study evaluating the safety and efficacy of EscharEx in debridement of venous leg ulcers (VLUs) compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).
  • We look forward to sharing topline data from this study in the first quarter of 2022.
  • The study is a multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs.
  • EscharEx is an investigational product and currently in a U.S. phase 2 adaptive design study.

EMA Provides Regulatory Path for Pediatric Label Extension for NexoBrid

Retrieved on: 
Thursday, November 18, 2021
Patient, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Burn, Government, Trial of the century, Bleeding, Review, Safety, Regeneration, Phrase, Company, Debridement, European Directive on Traditional Herbal Medicinal Products, Committee, HHS, Eschar, Contract, Cosmesis, Annual report, BARDA, COVID-19, Bromelain (pharmacology), Office of Inspector General, U.S. Department of Health and Human Services, CHMP, Research, Form 20-F, GLOBE, Adult, Incidence, EMA, Vericel, Development, Union, FDA, SOC, Committee for Medicinal Products for Human Use, Assistant, ASPR, Growth, Standard of care, Biomedical Advanced Research and Development Authority, Pharmaceutical industry, Medical imaging

Based on the feedback, the Company anticipates submitting a pediatric label extension request in the first half of 2022.

Key Points: 
  • Based on the feedback, the Company anticipates submitting a pediatric label extension request in the first half of 2022.
  • We are very pleased to have received support and positive guidance from the CHMP on the regulatory pathway towards a pediatric label extension for NexoBrid, said Sharon Malka, Chief Executive Officer of MediWound.
  • NexoBrid growth in Europe has been strong, and with the potential pediatric label extension, our commercial team and distribution partners are looking forward to expanding the market and continuing to improve on the standard of care.
  • NexoBrid demonstrated a significant reduction in time to achieve complete eschar removal and significant reduction in wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars.

MediWound Reports Third Quarter 2021 Financial Results

Retrieved on: 
Tuesday, November 16, 2021

YAVNE, Israel, Nov. 16, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the third quarter ended September 30, 2021.  

Key Points: 

MediWound to Report Third Quarter 2021 Financial Results and Host a Conference Call and Webcast on November 16, 2021

Retrieved on: 
Thursday, November 4, 2021
Safety, Development, BARDA, Burn, European, Regeneration, Debridement, Investor, Bromelain (pharmacology), Webcast, Pharmaceutical industry

An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

Key Points: 
  • An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.
  • MediWoundis a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration.
  • Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair.
  • MW005, is a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

MediWound Announces Peer-Reviewed Publication of EscharEx In-Vivo Head-to-Head Comparator Study in the Journal of Wound Care

Retrieved on: 
Monday, October 4, 2021
Debridement, Form 20-F, BLA, Annual report, Security (finance), API, U.S. Securities and Exchange Commission, FDA, Biologics license application, Patient, Bromelain (pharmacology), Development, Phrase, Travel, Company, European Union, Growth, Renaissance School of Medicine at Stony Brook University, Stony Brook University, Journal, COVID-19, Burn, Union, Eschar, Research, Collagenase, Safety, Contract, Government, Burns, SEC, Regeneration, GLOBE, Pharmaceutical industry, Electric motor

The study concluded that EscharEx was more effective than the commercially available collagenase in removing the eschar in this wound model.

Key Points: 
  • The study concluded that EscharEx was more effective than the commercially available collagenase in removing the eschar in this wound model.
  • Study results demonstrated that EscharEx treatment was more effective than the commercially available collagenase agent in debriding eschars in this novel porcine wound model.
  • The data clearly demonstrate EscharEx was superior to the commercially available enzymatic debriding agent in removing eschar, said Sharon Malka, Chief Executive Officer of MediWound.
  • Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

MediWound to Present at Upcoming Investor Conferences

Retrieved on: 
Friday, September 3, 2021
European, Regeneration, Investor, Debridement, Company, Safety, Webcast, Bromelain (pharmacology), Burn, GLOBE, Development, BARDA, Pharmaceutical industry

YAVNE, Israel, Sept. 03, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the Company), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that management will present at the following investor conferences during the month of September 2021.

Key Points: 
  • YAVNE, Israel, Sept. 03, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the Company), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that management will present at the following investor conferences during the month of September 2021.
  • A replay of each webcast will be available on the Companys website for approximately 30 days.
  • MediWoundis a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration.
  • Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

MediWound Reports Second Quarter Financial Results

Retrieved on: 
Tuesday, August 10, 2021
Debridement, FDA, European Union, Development, Thermal burn, Tax, Patient, Research, Burns, Safety, United, Government, Growth, Mission statement, Depreciation, Squamous cell carcinoma, Travel, Table, Operating cost, IFRS, Union, COVID-19, Endpoint security, Trial of the century, Investment, Particle-size distribution, Annual report, Company, Vericel, Adjustment, Finance, Form 20-F, BLA, CRL, III, Traction, EBITDA, Phrase, U.S. FDA, Biologics license application, Regeneration, Contract, Bromelain (pharmacology), GLOBE, Forecasting, Burn, Pharmaceutical industry, Fine chemical, Video game, Medical device, Ridesharing company, Lithium, Animal

YAVNE, Israel, Aug. 10, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the second quarter ended June 30, 2021.

Key Points: 
  • Revenues for the second quarter of 2021 were$6.1 million, compared with $4.0 million for the second quarter of 2020, an increase of 50%.
  • Research and development expenses for the second quarter of 2021 were$2.7 million, compared with$1.6 millionfor the second quarter of 2020.
  • Selling, general and administrative expenses for the second quarter of 2021 were $2.6 million, compared with $2.3 million in the second quarter of 2020.
  • As a percentage of revenues, selling, general and administrative expenses for the second quarter decreased from 57% in the second quarter of 2020 to 43% in the second quarter of 2021
    Operating loss for the second quarter of 2021 was $2.9 million, compared with an operating loss of $2.7 million in the second quarter of 2020.

MediWound to Report Second Quarter 2021 Financial Results and Host a Conference Call and Webcast on August 10, 2021

Retrieved on: 
Monday, August 2, 2021
Medicine, Cancer, Melanoma, Tissue engineering, Medical education, Bioactive, Skin cancer, Health

An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

Key Points: 
  • An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.
  • MediWoundis a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration.
  • Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair.
  • MW005, is a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

MediWound Announces Positive Outcome of Interim Assessment for its EscharEx U.S. Phase 2 Adaptive Design Study

Retrieved on: 
Wednesday, July 28, 2021
Design of experiments, Clinical trials, Health sciences, Science, Health, Clinical research, Medical statistics, Drugs, Clinical study design, Adaptive design, Placebo-controlled study, COVID-19 vaccine

YAVNE, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced a positive outcome from a planned interim sample size re-estimation of its ongoing EscharEx® U.S. phase 2 adaptive design study for the treatment of venous leg ulcers (VLUs), designed to assess the safety and efficacy of EscharEx compared to gel vehicle (placebo control) and non-surgical standard-of-care (either enzymatic or autolytic debridement).

Key Points: 
  • "We are very pleased with the IDMC's recommendation to continue the EscharEx study as originally planned without modifying the study sample size, said Sharon Malka, Chief Executive Officer of MediWound.
  • The multicenter, prospective, randomized, placebo-controlled, adaptive design study, evaluating the safety and efficacy of EscharEx in debridement of VLUs.
  • The study includes a pre-defined interim assessment for futility and potential sample size adjustment.
  • EscharEx is an investigational product, currently under a U.S. phase 2 adaptive design study.

MediWound Announces Initiation of U.S. Phase I/II Study of MW005 for the Treatment of Basal Cell Carcinoma

Retrieved on: 
Monday, July 26, 2021
Medicine, Cancer, Melanoma, Clinical medicine, Health, Skin cancer, Chemotherapy, Sulfonamides, MEK inhibitor, Wolfram Samlowski

YAVNE, Israel, July 26, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced initiation of its phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel. MediWound expects that data from both studies will be available by the end of 2021.

Key Points: 
  • In parallel, an investigator-initiated phase II trial of MW005 in non-melanoma skin cancers is being conducted at the Soroka Medical Center in Israel.
  • We are excited to initiate this U.S. phase I/II study of MW005, which is the first step in this important clinical development program.
  • MW005, a topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.
  • MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.