Vericel Announces Submission of Biologics License Application to the FDA for NexoBrid for the Treatment of Severe Thermal Burns

Announces Submission of Biologics License Application to the FDA for NexoBrid for the Treatment of Severe Thermal Burns

CAMBRIDGE, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- Vericel

Corporation (NASDAQ: VCEL) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration

(FDA) seeking the approval of NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) for eschar removal

(debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. NexoBrid is approved in the European Union

and other international markets and has been designated as an orphan biologic in the United States, European Union and other international

markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support to

MediWound Ltd. for development of NexoBrid is provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

The BLA submission for NexoBrid is based on multiple preclinical

and clinical studies including the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-thickness

and full-thickness thermal burns up to 30% of total body surface area. The study met its primary endpoint of complete eschar removal

as well as all secondary endpoints, including shorter time to eschar removal, a lower incidence of surgical eschar removal, and

lower blood loss during eschar removal compared to standard of care (SOC), including both surgical and non-surgical debridement

methods. A key safety endpoint, non-inferiority in time to complete wound closure compared with patients treated with SOC, was

also achieved. Long-term follow-up data to assess cosmesis, function, and quality of life, including 12-month results from the

DETECT study, were also included in the submission.

"The BLA submission for NexoBrid marks an important

milestone in our partnership with MediWound, bringing us one step closer to providing NexoBrid as an innovative treatment for

the thousands of patients admitted to burn units each year with deep partial-thickness and full-thickness burns who would

benefit from rapid and selective eschar removal," said Nick Colangelo, President and CEO of Vericel. "We look

forward, together with MediWound, to working with the FDA during the BLA filing and review process as we seek marketing

approval for NexoBrid in the United States." Sharon Malka, CEO of MediWound added, "Submitting the NexoBrid BLA

has been a team effort and we thank all of the investigators, their teams, our employees and all our partners, especially

BARDA and Vericel, for their commitment to the program. This 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 U.S."

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. 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.

Epicel and MACI are registered

trademarks of Vericel Corporation. NexoBrid is a registered trademark of MediWound Ltd. and is used under license

Cautionary Note Regarding Forward-Looking

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.

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

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; 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 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, 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 management's current views

as of the date hereof and Vericel does not undertake, and specifically disclaims, any obligation to update any of these forward-looking

statements to reflect a change in our views or events or circumstances that occur after the date of this release except as required