Vericel

MediWound Announces Additional $9 Million in Funding from BARDA to Support NexoBrid BLA Resubmission and the Expanded Access Treatment Protocol

Retrieved on: 
Thursday, February 10, 2022
United States Department of Health and Human Services, Office of Inspector General, U.S. Department of Health and Human Services, GLOBE, BARDA, Phrase, Government, Contract, Growth, Office of the Assistant Secretary for Preparedness and Response, Burn, Assistant, Research, Biomedical Advanced Research and Development Authority, Bromelain (pharmacology), Annual report, Marketing, NEXT, Union, Debridement, FDA, Patient, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Form 20-F, Human services, Regeneration, Safety, Review, BLA, Population, HHS, CEO, Burns (surname), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ASPR, Food, Development, USG, Vericel, COVID-19, Pharmaceutical industry

We are greatly appreciative that BARDA is providing additional funds to develop NexoBrid, and support NexoBrids potential approval to enhance U.S. preparedness," said Sharon Malka, CEO of MediWound.

Key Points: 
  • We are greatly appreciative that BARDA is providing additional funds to develop NexoBrid, and support NexoBrids potential approval to enhance U.S. preparedness," said Sharon Malka, CEO of MediWound.
  • Under that first BARDA contract, BARDA provided technical assistance and a total of up to $91 million for NexoBrid development activities needed to request U.S. marketing approval from the FDA.
  • These activities include the NexoBrid Phase 3 (DETECT) study and subsequent requirements for BLA resubmission, the ongoing Phase 3 pediatric (CIDS) study and the NexoBrid expanded access treatment protocol (NEXT).
  • Contract number HHSO100201500035C provides funding and technical support including the expanded access treatment protocol (NEXT), the pivotal U.S.

Vericel Announces Plans for a New State-of-the-Art Cell Therapy Manufacturing Facility to Support Long-Term Growth

Retrieved on: 
Wednesday, February 2, 2022
Growth, LEED, Northwest Park (Windsor), Patient, Forward-looking statement, NASDAQ, Gold, MACI, Windows Server, Thermal burn, Knee, Company, GLOBE, Chondrocyte, Sports medicine, Leadership in Energy and Environmental Design, Debridement, Securities & Exchange Commission of Pakistan, Pharmaceutical industry, Vericel

The new facility, which will include approximately 125,000 square feet of manufacturing, laboratory, and office space, will significantly increase the Companys cell therapy manufacturing capacity to support the long-term growth of MACI (autologous cultured chondrocytes on porcine collagen membrane) and Epicel (cultured epidermal autografts).

Key Points: 
  • The new facility, which will include approximately 125,000 square feet of manufacturing, laboratory, and office space, will significantly increase the Companys cell therapy manufacturing capacity to support the long-term growth of MACI (autologous cultured chondrocytes on porcine collagen membrane) and Epicel (cultured epidermal autografts).
  • The Network Drive facility is expected to be completed in 2024, with commercial manufacturing expected to begin in 2025.
  • The Network Drive Campus is designed and operated in accordance with existing LEED Gold and Fitwel Level 2 certifications and the new facility will be included in those certifications.
  • This important manufacturing expansion plan represents another major milestone for the Company and demonstrates our confidence in the continued growth trajectory of MACI and Epicel in the years ahead.

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.

Vericel to Report Third-Quarter 2021 Financial Results on November 9, 2021

Retrieved on: 
Thursday, October 21, 2021
Thermal burn, Patient, NASDAQ, Telephone, Vericel, ID, Chondrocyte, Webcast, EDT, Investor relations, Sports medicine, Debridement, GLOBE, Knee, Pharmaceutical industry

CAMBRIDGE, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the following webcast and conference call to discuss its third-quarter 2021 financial results and business highlights.

Key Points: 
  • CAMBRIDGE, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the following webcast and conference call to discuss its third-quarter 2021 financial results and business highlights.
  • The conference call will be available live in 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 in the Investor Relations section of the Vericel website.
  • To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation third-quarter 2021 earnings call.

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.

Vericel Corporation Investors: Company Investigated by the Portnoy Law Firm

Retrieved on: 
Thursday, July 22, 2021
Finance, Money, Economy, Vericel, Securities fraud, Investor

LOS ANGELES, July 22, 2021 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Vericel Corporation ("Vericel" or the "Company") (NASDAQ: VCEL) investors that the firm has initiated an investigation into possible securities fraud, and may file a class action on behalf of investors.

Key Points: 
  • LOS ANGELES, July 22, 2021 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Vericel Corporation ("Vericel" or the "Company") (NASDAQ: VCEL) investors that the firm has initiated an investigation into possible securities fraud, and may file a class action on behalf of investors.
  • The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors options for pursuing claims to recover their losses.
  • Vericel announced on May 7, 2019 that the company would enter into an exclusive license agreement in North America with MediWound Ltd. to commercialize NexoBrid, a product under development by MediWound for debridement of severe thermal burns.
  • The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing.

Vericel to Report Second-Quarter 2021 Financial Results on August 4, 2021

Retrieved on: 
Wednesday, July 21, 2021
Corporate finance, Vericel, Earnings call, Conference call, GlobeNewswire, Financial markets, Finance, Financial economics

CAMBRIDGE, Mass., July 21, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the following webcast and conference call to discuss its second-quarter 2021 financial results and business highlights.

Key Points: 
  • CAMBRIDGE, Mass., July 21, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the following webcast and conference call to discuss its second-quarter 2021 financial results and business highlights.
  • The conference call will be available live in the Investors 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 in the Investor Relations section of the Vericel website.
  • To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation second-quarter 2021 earnings call.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vericel Corporation - VCEL

Retrieved on: 
Sunday, July 18, 2021
Abraham Pomerantz, Pomerantz, Securities fraud, Vericel

NEW YORK, July 18, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors ofVericel Corporation ("Vericel" or the "Company")(NASDAQ:VCEL).

Key Points: 
  • NEW YORK, July 18, 2021 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors ofVericel Corporation ("Vericel" or the "Company")(NASDAQ:VCEL).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Vericel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vericel Corporation - VCEL

Retrieved on: 
Friday, July 16, 2021
Abraham Pomerantz, Pomerantz, Securities fraud, Vericel

NEW YORK, July 15, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors ofVericel Corporation (Vericel or the Company) (NASDAQ:VCEL).

Key Points: 
  • NEW YORK, July 15, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors ofVericel Corporation (Vericel or the Company) (NASDAQ:VCEL).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Vericel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vericel Corporation - VCEL

Retrieved on: 
Thursday, July 8, 2021
Abraham Pomerantz, Pomerantz, Securities fraud, Vericel

NEW YORK, July 07, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors ofVericel Corporation (Vericel or the Company) (NASDAQ:VCEL).

Key Points: 
  • NEW YORK, July 07, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors ofVericel Corporation (Vericel or the Company) (NASDAQ:VCEL).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Vericel and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.