YAVNE

MediWound Reports First Quarter 2024 Financial Results and Provides Company Update

Retrieved on: 
Wednesday, May 29, 2024
Wound, Patient, GMP, Research and development, Hospital, Burn, Tax, European Wound Management Association, Eastern Time Zone, Food, Supplement, SAWC, CAPEX, HERE, Exercise, FDA, Therapy, Bank statement, Expanded access, Forecasting, EWMA, Event, WHS, Depreciation, Operating cost, Symposium, BLA, Research, Table, Adjustment, NEXT, Bromelain (pharmacology), Pharmaceutical industry

Revenue: Revenue for the first quarter of 2024 was $5.0 million, compared to $3.8 million in the first quarter of 2023.

Key Points: 
  • Revenue: Revenue for the first quarter of 2024 was $5.0 million, compared to $3.8 million in the first quarter of 2023.
  • Research and Development: R&D expenses in the first quarter of 2024 were $1.5 million, compared to $2.1 million in the first quarter of 2023.
  • Operating Results: Operating loss in the first quarter of 2024 was $3.7 million, compared to an operating loss of $4.4 million in the first quarter of 2023.
  • During the first quarter of 2024, the Company received $0.5 million from the exercise of Series A warrants.

MediWound to Report First Quarter 2024 Financial Results

Retrieved on: 
Wednesday, May 22, 2024

YAVNE, Israel, May 22, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the first quarter ended March 31, 2024 on Wednesday, May 29, 2024.

Key Points: 
  • YAVNE, Israel, May 22, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the first quarter ended March 31, 2024 on Wednesday, May 29, 2024.
  • Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions.
  • Dial-in and call details are as follows:

MediWound to Present New Data from EscharEx® Phase II Studies at Three Leading Wound Care Conferences

Retrieved on: 
Thursday, April 25, 2024
Symposium, WHS, Patient, SAWC, Wound, European Wound Management Association, Wound healing, EWMA, Nursing

YAVNE, Israel, April 25, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today that recent clinical data from EscharEx® Phase II studies will be presented throughout May 2024 at the largest, most prestigious annual meetings in the field of chronic wound care: the European Wound Management Association (EWMA), the Wound Healing Society (WHS), and the Symposium on Advanced Wound Care (SAWC).

Key Points: 
  • The oral presentations on EscharEx will include:
    Comparative data of EscharEx vs. SANTYL® that demonstrate EscharEx’s superiority over the current leading enzymatic debridement agent
    New analyses from the ChronEx phase II study, showing high correlation between wound bed preparation and wound healing
    These data indicate that EscharEx could substantially improve wound care for patients with debilitating chronic wounds, providing significant benefits over the current standard of care.
  • Additionally, the findings support the design and endpoints of the upcoming Phase III study, which is expected to begin in the second half of 2024.
  • "We are delighted to present the results of additional analyses from EscharEx Phase II studies in chronic hard-to-heal wounds, including the positive comparative data with SANTYL®, the current dominant standard of care for enzymatic debridement," said Dr. Robert J. Snyder, Chief Medical Officer of MediWound.
  • "With its robust efficacy, favorable safety profile, and multimodal mechanistic effects demonstrated in these Phase II studies, we believe that EscharEx can significantly advance wound care and has the potential to become a major player in the global wound care market."

MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, March 21, 2024
Burn, Tax, Debridement, Patient, EWMA, Bank statement, Eschar, Investment, SAWC, Therapy, Depreciation, European Commission, Phase, BCC, Research, Supplement, Wound, EMA, GMP, HERE, Safety, CMS, BLA, Eastern Time Zone, Food, Bromelain (pharmacology), WBP, Development, PMI, WHS, Adjustment, FDA, BMCI, Forecasting, Symposium, Incidence, BSV, Basal-cell carcinoma, Operating cost, European Wound Management Association, Table, Event, Medicare, Pharmaceutical industry

YAVNE, Israel, March 21, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Revenue: Revenue for the fourth quarter 2023 was $5.3 million, compared to $11.6 million in the fourth quarter of 2022.
  • Research and development expenses in the fourth quarter 2023 were $1.8 million compared to $2.7 million in the fourth quarter of 2022.
  • Selling, general, and administrative expenses in the fourth quarter 2023 were $2.8 million, compared to $3.0 million in the fourth quarter of 2022.
  • Operating Results: Operating loss in the fourth quarter of 2023 was $3.9 million, compared to an operating profit of $2.1 million in the fourth quarter of 2022.

MediWound to Report Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024

YAVNE, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the fourth quarter and full year ended December 31, 2023 on Thursday, March 21, 2024.

Key Points: 
  • YAVNE, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the fourth quarter and full year ended December 31, 2023 on Thursday, March 21, 2024.
  • Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions.
  • Dial-in and call details are as follows:

MediWound Announces Positive Results in Head-to-Head Comparison of EscharEx® vs. SANTYL® within the ChronEx Phase II Randomized Controlled Study

Retrieved on: 
Monday, February 12, 2024
Incidence, FDA, EWMA, Safety, Debridement, Wound, WBP, Patient, Symposium, WHS, Granulation tissue, Disease, SAWC, NSS, European Wound Management Association, Wound healing

SANTYL is currently the market-leading enzymatic debridement product, with more than $360 million in estimated annual sales in the United States.

Key Points: 
  • SANTYL is currently the market-leading enzymatic debridement product, with more than $360 million in estimated annual sales in the United States.
  • Ofer Gonen, CEO of MediWound said, “These head-to-head results position EscharEx to become the market leader in enzymatic agents for the treatment of chronic wounds.
  • All are achieved within a short time frame to facilitate early wound closure, a major benefit for patients suffering from chronic non-healing wounds.
  • The incidence of achieving WBP throughout the study was 78.3% (95% CI = 63.6-89.1) for EscharEx vs. 37.5% for SANTYL (95% CI=8.5-75.5); p=0.03.

MediWound to Participate in Two Upcoming Investor Conferences

Retrieved on: 
Monday, February 5, 2024
Conference

YAVNE, Israel, Feb. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced its participation in the upcoming Oppenheimer 34th Annual Life Sciences Conference, taking place virtually on February 13-14, 2024, as well as the upcoming TD Cowen 44th Annual Health Care Conference, taking place in Boston on March 4-6, 2024.

Key Points: 
  • YAVNE, Israel, Feb. 05, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced its participation in the upcoming Oppenheimer 34th Annual Life Sciences Conference, taking place virtually on February 13-14, 2024, as well as the upcoming TD Cowen 44th Annual Health Care Conference, taking place in Boston on March 4-6, 2024.

MediWound Announces that FDA has Accepted for Review the Supplement to the NexoBrid BLA to Include Pediatric Patients with Severe Thermal Burns

Retrieved on: 
Tuesday, January 9, 2024
Development, Eschar, ASPR, Patient, Burn, Administration, Food, Safety, FDA, Bromelain (pharmacology), Human services, Burns, Pharmaceutical industry

YAVNE, Israel, Jan. 09, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has completed their filing review and accepted a supplement to the NexoBrid® biologics license application (sBLA) for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns.

Key Points: 
  • NexoBrid, a topically administered biological drug that enzymatically removes nonviable burn tissue, received FDA approval in the U.S. in December 2022 for eschar removal in adult patients with deep partial-thickness and/or full-thickness thermal burns.
  • The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages.
  • “The acceptance of the NexoBrid sBLA filing by the FDA marks an important milestone for MediWound and reinforces our commitment to redefine the standard of care for the treatment of severe burns across all age groups,” said Ofer Gonen, CEO of MediWound.
  • “NexoBrid is already approved for the adult and pediatric populations in Europe and Japan, and we look forward to working with the FDA, alongside our partner Vericel, throughout the sBLA review process.”

MediWound Secures Additional U.S. Department of Defense Funding to Advance NexoBrid® Development for the U.S. Army

Retrieved on: 
Thursday, December 28, 2023
Biomedical technology, Partnership, Burn, CMC, Bromelain (pharmacology), GMP, Burns, MTEC, Pharmaceutical industry

The $14.4 million project budget will advance the development and production of a new, temperature-stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings.

Key Points: 
  • The $14.4 million project budget will advance the development and production of a new, temperature-stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings.
  • "We are delighted to further solidify our partnership with the U.S. Department of Defense.
  • The additional funding will enhance our CMC activities, expedite preclinical development, and facilitate the establishment of a GMP compliant aseptic production line for the temperature-stable formulation of NexoBrid," announced Ofer Gonen, Chief Executive Officer of MediWound.
  • In alignment with this mission, it's vital to have field solutions for severe burn treatments that are both easy-to-use and effective.

MediWound Announces Peer-Reviewed Publication of EscharEx® Mechanism of Action Study Assessing Its Effects on Biofilm and Microbial Loads

Retrieved on: 
Thursday, December 21, 2023
Phase, Mortality, Mouth ulcer, Ulcer, Debridement, Amputation, Effect, Granulation tissue

Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs.

Key Points: 
  • Results show that EscharEx not only effectively debrides wounds, but also reduces biofilm and bacterial load in both VLUs and DFUs.
  • 70% of the patients (7/10) that completed the study achieved complete debridement within a median time of 5.5 days.
  • An average reduction of 35% in wound size was achieved by the end of the 2-week follow-up period.
  • Together with the outcomes of our previous Phase II study results, this study furthers the understanding of the effects of EscharEx.