VCEL Vericel Corporation

18.53
+0.34  (+2%)
Previous Close 18.19
Open 18.28
52 Week Low 6.78
52 Week High 19.64
Market Cap $838,489,949
Shares 45,250,402
Float 44,866,934
Enterprise Value $763,922,268
Volume 313,954
Av. Daily Volume 507,808
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Upcoming Catalysts

Drug Stage Catalyst Date
NexoBrid
Severe burns
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
ixmyelocel-T
Stem cells - Dilated Cardiomyopathy
Phase 2b
Phase 2b
Phase 2b topline data released March 2016. Full data released April 2016
MACI
Focal chondral cartilage defects in the knee.
Approved
Approved
FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.

Latest News

  1. CAMBRIDGE, Mass., Sept. 16, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the recently submitted Biologics License Application (BLA) for NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application. 

    "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of…

    CAMBRIDGE, Mass., Sept. 16, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the recently submitted Biologics License Application (BLA) for NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application. 

    "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns," said Nick Colangelo, President and CEO of Vericel. "We look forward, together with MediWound, to working with the FDA during the BLA review process as we seek marketing approval for NexoBrid in the United States."

    Sharon Malka, CEO of MediWound added, "The acceptance of the NexoBrid BLA is a major milestone for MediWound and it is gratifying to know NexoBrid is one step closer to being available to help burn victims in the United States. We thank all of the investigators, their teams, our employees and all our partners, especially BARDA and Vericel, for their commitment to the program."

    Vericel will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus on NexoBrid. In addition to a general corporate update, Vericel executives will facilitate discussions with burn surgeon thought leaders on current burn debridement practices and how NexoBrid, upon approval, could change the current treatment paradigm for debridement of severe thermal burns.

    About Vericel Corporation

    Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full-thickness burns greater than or equal to 30% of total body surface area. The company also holds an exclusive license from MediWound Ltd. for North American rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns. Funding and technical support to MediWound Ltd. for development of NexoBrid is provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA). For more information, please visit the company's website at www.vcel.com.

    Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2020 Vericel Corporation. All rights reserved.

    Cautionary Note Regarding Forward-Looking Statements

    Vericel cautions you that all statements other than statements of historical fact included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations and commercial potential of NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; competitive developments; whether FDA will provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of our NEXT Study; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability to sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in Vericel's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Vericel's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 5, 2020, and in other filings with the SEC. These forward-looking statements reflect our views as of the date hereof and Vericel does not assume and specifically disclaims any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

    Investor Contact:

    Lee Stern

    Solebury Trout



    +1 (646) 378-2922

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  2. YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance…

    YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance of the NexoBrid BLA submission for review is a major milestone for MediWound, and it is gratifying to know NexoBrid is one step closer to being available to help burn victims in the United States," said Sharon Malka, CEO of MediWound. "We thank all our partners for their commitment to this important program, and we look forward, together with BARDA and Vericel, to working with the FDA during the regulatory review process as we seek marketing approval for NexoBrid in the United States."

    Nick Colangelo, President and CEO of Vericel, added, "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns and brings us one step closer to providing NexoBrid as a treatment option for the thousands of patients each year who suffer deep-partial and full-thickness burns that require debridement."

    The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets. NexoBrid is currently an investigational product in the United States. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    Vericel, our U.S. commercial partner, will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus on NexoBrid, which will include discussions with burn surgeon thought leaders on current burn debridement practices and how NexoBrid, upon approval, could change the current treatment paradigm for debridement of severe thermal burns.

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment.

    About MediWound

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid®, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA.

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; the timing of the NexoBrid delivery to BARDA, expected payments under the license agreement with Vericel; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.



                           

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

       

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  3. CAMBRIDGE, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced presentations at multiple upcoming investor conferences.

    • The H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15th at 10am EST
    • The 2020 Cantor Global Healthcare Conference on Wednesday, September 16th at 4:00pm EST
    • The Oppenheimer Fall Healthcare Summit on Monday, September 21st at 3:20pm EST

    A live webcast of the presentations will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com.

    About Vericel Corporation
    Vericel is a leader in advanced therapies for the sports medicine…

    CAMBRIDGE, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced presentations at multiple upcoming investor conferences.

    • The H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15th at 10am EST
    • The 2020 Cantor Global Healthcare Conference on Wednesday, September 16th at 4:00pm EST
    • The Oppenheimer Fall Healthcare Summit on Monday, September 21st at 3:20pm EST

    A live webcast of the presentations will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com.

    About Vericel Corporation

    Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. The company also holds an exclusive license for North American rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns. For more information, please visit the company's website at www.vcel.com.

    Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2020 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Lee Stern

    Solebury Trout



    +1 646-378-2922

    Primary Logo

    View Full Article Hide Full Article
  4. CAMBRIDGE, Mass., Sept. 04, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present the latest company overview at the 18th Annual Morgan Stanley Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, September 17, 2020 at 2:45 p.m. Eastern Time.

    A live webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com.

    About Vericel Corporation
    Vericel is a leader in advanced therapies for the sports medicine and severe burn care…

    CAMBRIDGE, Mass., Sept. 04, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present the latest company overview at the 18th Annual Morgan Stanley Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, September 17, 2020 at 2:45 p.m. Eastern Time.

    A live webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com.

    About Vericel Corporation

    Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. The company also holds an exclusive license for North American rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns. For more information, please visit the company's website at www.vcel.com.

    Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2020 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Lee Stern

    Solebury Trout



    +1 646-378-2922

    Primary Logo

    View Full Article Hide Full Article
  5. YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds…

    YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million. 

    "This first shipment of NexoBrid is another major milestone in our longstanding partnership with BARDA, and we look forward to delivering the full procurement by the end of 2021," said MediWound Chief Executive Officer Sharon Malka. "The acceptance of the first delivery by BARDA during the ongoing COVID-19 pandemic underscores the importance of NexoBrid to U.S. national preparedness for the potential emergency treatment of large numbers of patients with severe thermal burns injuries."

    "The procurement of NexoBrid for our nation's response preparedness is one of many key NexoBrid activities occurring in 2020," said Nick Colangelo, President and Chief Executive Officer of Vericel. "This shipment, combined with the recent BLA submission and growing number of burn centers enrolled in the NexoBrid expanded access treatment protocol, bring us a step closer to ensuring that healthcare providers have both the supply and training needed to enzymatically debride burn patients, whether the need is due to individual accidents or a burn mass casualty event."

    On June 30, 2020, a Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. While the BLA is being reviewed by the FDA, burn centers across the U.S. are treating burn patients under the NexoBrid expanded access (NEXT) protocol.

    The procurement is a key milestone of the Project BioShield (PBS) contract between MediWound and BARDA which was signed in September 2015 with procurement initiated in January 2020. Under the PBS contract, BARDA provides funds and support for the advancement of the development and manufacturing of NexoBrid, as well as the procurement of NexoBrid as a medical countermeasure for mass casualty emergencies involving thermal burns. In May 2019, Vericel entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. As part of the license agreement, Vericel and MediWound will equally split gross profits generated by BARDA's initial $16.5 million procurement.

    In October 2019, MediWound initiated the NEXT protocol, which is supported and funded by BARDA and enables the continued clinical use of NexoBrid for U.S. patients during the preparation and review of the NexoBrid BLA. NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns up to 30 percent of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers are anticipated to participate. MediWound received FDA concurrence that patients can be treated under the NEXT protocol in a burn mass casualty incident that is not a declared national emergency.  Therefore, this provides a mechanism for U.S. burn centers to treat patients and gain valuable experience using Nexobrid prior to FDA approval as well as making the product readily available for response to mass burn emergencies.

    BARDA submitted a Pre-Emergency Use Authorization (PEUA) to FDA for the intended use of NexoBrid under an Emergency Use Authorization (EUA) during a declared emergency involving burn injuries. The availability of medical countermeasures (MCMs), such as Nexobrid, which mitigate preparedness gaps (like debridement and excision steps of burn care) will add to the United States Government's armamentarium for treatment of mass burn casualties. The EUA is a mechanism by which the FDA can allow an unapproved medical product that qualifies as a mass casualty medical countermeasure to be used in a public health emergency.

    About NexoBrid

    NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue.  NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets.  Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area.  The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal.  Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved.  In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed.  On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment. NexoBrid is currently an investigational product in the United States.

    About Vericel Corporation

    Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full-thickness burns greater than or equal to 30% of total body surface area.  The company also holds an exclusive license for North American commercial rights to NexoBrid, a registration-stage biological orphan product for debridement of severe thermal burns.  For more information, please visit the company's website at www.vcel.com.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    This document contains forward-looking statements, including statements concerning the anticipated progress, development, objectives, expectations and commercial potential of NexoBrid. This release also includes forward-looking statements concerning the objectives and expectations regarding MediWound Ltd. and Vericel Corporation described herein, all of which involve certain risks and uncertainty. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements.

    Among the factors that may result in differences are the inherent uncertainties associated with: the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of our NEXT; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, Quarterly Reports on Form 6-K and other filings with the Securities and Exchange Commission ("SEC"), as well as information contained in Vericel's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 25, 2020, Quarterly Reports on Form 10-Q and other documents filed by the Company with the SEC from time-to-time.

    These forward-looking statements reflect Vericel's and MediWound's current views and neither Vericel nor MediWound undertakes any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

    Vericel Contacts:  
    Lee Stern  
    Solebury Trout  
      
    +1 (646) 378-2922  
       
    MediWound Contacts:  
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial Officer Managing Director, LifeSci Advisors
    MediWound Ltd. 212-915-2568
                                                                 

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