Bromelain (pharmacology)

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 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.”

Vericel Announces Preliminary Full-Year and Fourth Quarter 2023 Financial Results

Retrieved on: 
Tuesday, January 9, 2024
Total revenue, Therapy, Total, Growth, Sports medicine, Burn, MACI, P&T, Investment, Conference, Bromelain (pharmacology), Surgeon, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary, unaudited financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Full-Year Total Revenue Expected to be Approximately $197.5 Million, Representing 20% Growth, with Fourth Quarter Revenue Growth of 23% to $65 Million
    MACI Full-Year Revenue Expected to be Approximately $164.8 Million, Representing 25% Growth, with Fourth Quarter Revenue Growth of 22% to $56.7M
    CAMBRIDGE, Mass., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary, unaudited financial results for the fourth quarter and year ended December 31, 2023.
  • “We enter 2024 with a great deal of momentum and expect another year of high revenue growth and increasing profitability driven by continued strong execution with our core products, a full year of NexoBrid on the U.S. market and the anticipated launch of arthroscopic MACI later this year.”
    Vericel is scheduled to present at the 42nd Annual J.P. Morgan Healthcare Conference at 10:30 a.m.
  • ET (7:30 a.m. PT) on Wednesday, January 10, 2024.
  • A webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com .

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 Reports Third Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, November 21, 2023
Phase, Forecasting, Table, FDA, CHMP, Conference, Event, Adjustment, Journal, Tax, Depreciation, PMI, EMA, Burn, Conference call, Biologics license application, Patient, Partnership, Operating cost, Research, Eschar, Bromelain (pharmacology), Hospital, Incidence, Bank statement, Standard of care, Food and Drug Administration, GMP, Temperature, HERE, European Medicines Agency, Investment, Committee, BLA, Pharmaceutical industry

YAVNE, Israel, Nov. 21, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • Revenues: Revenues for the third quarter of 2023 were $4.8 million, compared to $5.8 million in the same quarter of the previous year.
  • Research and development expenses in the third quarter of 2023 were $1.5 million compared to $2.9 million in the third quarter of 2022.
  • Operating Results: Operating loss in the third quarter of 2023 was $3.0 million, compared to $3.5 million loss in the third quarter of 2022.
  • In the first quarter of 2023, the Company raised a gross amount of $27.5 million through a registered direct offering.

MediWound Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients

Retrieved on: 
Monday, November 13, 2023
Safety, European Medicines Agency, European Commission, Incidence, Bromelain (pharmacology), EMA, Civil service commission, Patient, Burn, Trauma, CHMP, Committee, Human services, Burns, Development, Debridement, Administration, SOC, Bleeding

The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently.

Key Points: 
  • The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently.
  • It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid.
  • “This significant milestone advances our goal to redefine the standard of care for the treatment of severe burns.
  • He added, “From a commercial perspective, pediatric burn victims comprise more than 30% of the total burn population making this new indication a significant addition to our addressable market.”

MediWound Announces a Collaboration with PolyMedics Innovations (PMI) for NexoBrid® Distribution in Europe

Retrieved on: 
Wednesday, November 8, 2023
Burns, Burn, Bromelain (pharmacology), PMI, Association of European Operational Research Societies, BTM, Surgeon, Marketing, Fine chemical, DACH

Feedback from key opinion leaders and customers indicates that NexoBrid, a non-surgical solution for eschar removal in burns, is a perfect complement to PMI's existing product line, including SUPRATHEL®, NovoSorb® BTM, and SUPRA SDRM®.

Key Points: 
  • Feedback from key opinion leaders and customers indicates that NexoBrid, a non-surgical solution for eschar removal in burns, is a perfect complement to PMI's existing product line, including SUPRATHEL®, NovoSorb® BTM, and SUPRA SDRM®.
  • Along with MediWound’s existing sales, marketing and medical teams’ infrastructure, PMI plans to leverage its extensive customer access and commercial resources to drive increased utilization of NexoBrid in the specified regions.
  • “We are thrilled to establish this collaboration with PMI, bringing NexoBrid to a broader audience of burn surgeons and improving patients’ lives.
  • “We are delighted to join forces with MediWound in this collaboration.

Vericel Reports Third Quarter 2023 Financial Results and Raises Full-Year 2023 Financial Guidance

Retrieved on: 
Wednesday, November 8, 2023
Growth, Eastern Time Zone, Bromelain, EBITDA, Telephone, Research, Marketing, Webcast, Chondrocyte, Total, Investment, MACI, Sports medicine, Video game, Pharmaceutical industry, Security (finance), Tourism, Cryptocurrency, Bromelain (pharmacology), Vericel

CAMBRIDGE, Mass., Nov. 08, 2023 (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, 2023.

Key Points: 
  • Gross profit for the quarter ended September 30, 2023 was $30.6 million, or 67% of net revenue, compared to $25.2 million, or 65% of net revenue, for the third quarter of 2022.
  • Total operating expenses for the quarter ended September 30, 2023 were $35.7 million, compared to $32.0 million for the same period in 2022.
  • Non-GAAP adjusted EBITDA for the quarter ended September 30, 2023 was $5.4 million, or 12% of net revenue, compared to $3.3 million, or 9% of net revenue, for the third quarter of 2022.
  • As of September 30, 2023, the Company had approximately $149 million in cash, restricted cash and investments, and no debt.

MediWound Deploys NexoBrid® for Emergency Supply

Retrieved on: 
Monday, October 9, 2023
Bromelain (pharmacology), Hospital, Burn, Fine chemical

YAVNE, Israel, Oct. 09, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, addresses emergency demand for NexoBrid to treat the mass of burn casualties, inflicted by the war in Israel.

Key Points: 
  • YAVNE, Israel, Oct. 09, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, addresses emergency demand for NexoBrid to treat the mass of burn casualties, inflicted by the war in Israel.
  • Hospitals and military forces have urgently requested NexoBrid supplies.
  • To address this critical need, MediWound has deployed all its available NexoBrid inventory to aid the substantial number of burn victims.
  • MediWound remains committed to fulfilling its obligations to our global markets and is implementing measures to ensure supply continuity.

Vericel Announces Publication of Positive Results from Phase 3 Debride and Protect (DETECT) Study of Thermal Burn Patients Treated with NexoBrid

Retrieved on: 
Thursday, September 28, 2023
Debridement, GV, Bromelain (pharmacology), SOC, Burn, Journal, Patient, Bromelain, Sports medicine, Safety, Dentistry

CAMBRIDGE, Mass., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the recent publication of results from the Phase 3 DETECT study assessing the safety and efficacy of NexoBrid® (anacaulase-bcdb) in the Journal of Burn Care & Research.

Key Points: 
  • “These data demonstrate the ability of NexoBrid to provide patients with severe thermal burns safe and effective enzymatic eschar removal that is superior to current debridement methods,” said Dr. Jon Hopper, Chief Medical Officer of Vericel.
  • The primary endpoint was complete eschar removal at the end of the debridement phase and secondary outcomes were the need for surgery and time to complete eschar removal.
  • Key findings include:
    Surgical excision was lower in the NexoBrid arm when compared to the SOC group (4% vs. 72%; P The estimated median time to complete eschar removal was 1.02 and 3.83 days for the NexoBrid and SOC treatment arms, respectively (P NexoBrid appeared safe and well tolerated without deleterious effects on wound closure and scarring.
  • Data from this study ultimately served as the foundation for the FDA approval of NexoBrid for commercial use in the U.S.