Eschar

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

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 Reports Third Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, November 21, 2023

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 Announces U.S. Commercial Availability of NexoBrid® for the Treatment of Severe Thermal Burns in Adults

Retrieved on: 
Thursday, September 21, 2023

Eschar removal is a critical first step in the treatment of burns as it can reduce inflammation, stop burn progression, as well as mitigate infections and sepsis.

Key Points: 
  • Eschar removal is a critical first step in the treatment of burns as it can reduce inflammation, stop burn progression, as well as mitigate infections and sepsis.
  • Surgical excision, which is the current standard of care for eschar removal, often results in the removal of viable tissue.
  • "We are thrilled to announce that NexoBrid is now commercially available in the United States through our partner, Vericel," stated Ofer Gonen, Chief Executive Officer of MediWound.
  • A first application of NexoBrid may be applied to an area of up to 15% Body Surface Area (TBSA).

Vericel Announces U.S. Commercial Availability of NexoBrid® (anacaulase-bcdb) for the Treatment of Severe Thermal Burns in Adults

Retrieved on: 
Wednesday, September 20, 2023

CAMBRIDGE, Mass., Sept. 20, 2023 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the U.S. commercial availability of NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns.

Key Points: 
  • Eschar removal is a critical first step in the treatment of burns as it can reduce inflammation, stop burn progression, as well as mitigate infections and sepsis.
  • Surgical excision, which is the current standard of care for eschar removal, often results in the removal of viable tissue.
  • “We are very pleased to announce the U.S. commercial availability of NexoBrid, as it significantly expands our Burn Care franchise and represents an important paradigm shift in the treatment of severe thermal burns,” said Nick Colangelo, President and CEO of Vericel.
  • A first application of NexoBrid may be applied to an area of up to 15% body surface area.

MediWound Announces Commercial Launch of NexoBrid® in Japan

Retrieved on: 
Tuesday, August 1, 2023

Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan.

Key Points: 
  • Kaken Pharmaceutical, a top ranked Japanese pharmaceutical company, has the exclusive marketing and distribution rights for NexoBrid in Japan.
  • NexoBrid is indicated for the removal of eschar in deep partial and full thickness thermal burns.
  • “As one of the top healthcare markets worldwide, Japan holds special strategic importance.
  • Over 6,000 patients are treated for severe burns in Japan every year, with a majority of these patients undergoing eschar removal as a critical first step.

MediWound Reports Fourth Quarter and Full Year 2022 Financial Results and Company Update

Retrieved on: 
Thursday, March 16, 2023

Total revenues for the fourth quarter of 2022 were $11.6 million, compared to $5.5 million for the fourth quarter of 2021.

Key Points: 
  • Total revenues for the fourth quarter of 2022 were $11.6 million, compared to $5.5 million for the fourth quarter of 2021.
  • Research and development expenses for the fourth quarter of 2022 were $2.7 million, compared to $2.5 million in the fourth quarter of 2021.
  • Selling, general and administrative expenses for the fourth quarter of 2022 were $3.0 million, compared to $2.6 million in the fourth quarter of 2021.
  • Operating profit for the fourth quarter of 2022 was $2.1 million compared to a loss of $3.5 million in the fourth quarter of 2021.

Vericel Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Full-Year 2023 Financial Guidance

Retrieved on: 
Thursday, February 23, 2023

CAMBRIDGE, Mass., Feb. 23, 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 fourth quarter and year ended December 31, 2022, and provided full-year 2023 financial guidance.

Key Points: 
  • Gross profit for the quarter ended December 31, 2022 was $38.2 million, or 73% of net revenue, compared to $34.0 million, or 72% of net revenue, for the fourth quarter of 2021.
  • Total operating expenses for the quarter ended December 31, 2022 were $32.2 million, compared to $29.9 million for the same period in 2021.
  • Non-GAAP adjusted EBITDA for the quarter ended December 31, 2022 was $14.9 million, or 28% of net revenue, compared to $12.8 million, or 27% of net revenue, for the fourth quarter of 2021.
  • Total net revenue for the year ended December 31, 2022 was $164.4 million, compared to $156.2 million in 2021.

Vericel Announces Preliminary Fourth-Quarter and Full-Year 2022 Financial Results and Accelerated Launch Timeline for MACI Arthroscopic Program

Retrieved on: 
Tuesday, January 10, 2023

CAMBRIDGE, Mass., Jan. 10, 2023 (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, 2022 and an accelerated launch timeline for MACI® arthroscopic delivery, which is now anticipated to be launched in 2024.

Key Points: 
  • MACI Full-Year Revenue Expected to be at the High End of Guidance Range, with Fourth Quarter Revenue Growth of Approximately 24%
    CAMBRIDGE, Mass., Jan. 10, 2023 (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, 2022 and an accelerated launch timeline for MACI® arthroscopic delivery, which is now anticipated to be launched in 2024.
  • “We also had very strong MACI performance to close the year and we look forward to building on this momentum in 2023 across both of our franchises, as we expect accelerating total revenue growth this year and further acceleration in 2024 driven by a full year of NexoBrid on the market and the planned launch of arthroscopic MACI.”
    Vericel is scheduled to present at the 41st Annual J.P. Morgan Healthcare Conference at 10:30 a.m.
  • ET (7:30 a.m. PT) on Wednesday, January 11, 2023.
  • A webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com .

MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults

Retrieved on: 
Thursday, December 29, 2022

YAVNE, Israel, Dec. 29, 2022 (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 the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

Key Points: 
  • “We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries,” said Ofer Gonen, Chief Executive Officer of MediWound.
  • We also thank our partner, BARDA, for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the U.S.
  • This U.S. FDA approval of NexoBrid validates our enzymatic technology platform.
  • MediWound will receive a $7.5 million milestone payment from Vericel Corporation, triggered by the FDA approval of NexoBrid.

Vericel Announces FDA Approval of NexoBrid for the Treatment of Severe Thermal Burns in Adults

Retrieved on: 
Thursday, December 29, 2022

CAMBRIDGE, Mass., Dec. 29, 2022 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

Key Points: 
  • “There is a considerable unmet need for non-surgical eschar removal for patients with severe thermal burns, and the FDA’s approval of NexoBrid marks an important advancement in the treatment paradigm for these patients,” said Nick Colangelo, President and CEO of Vericel.
  • A key safety endpoint, non-inferiority in time to >95% wound closure compared with patients treated with SOC, was also achieved.
  • A first application of NexoBrid may be applied to an area of up to 15% body surface area.
  • A second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.