Full Press Release Details
Announces U.S. Commercial Availability of NexoBrid (anacaulase-bcdb) for the Treatment of Severe Thermal Burns in Adults
Full commercial launch
of NexoBrid marks important first step to becoming the new standard of care for eschar removal in patients with deep partial- and/or full-
thickness thermal burns
NexoBrid launch significantly
expands the total addressable market for Vericel Burn Care
CAMBRIDGE, Mass., September 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
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. NexoBrid selectively targets eschar while preserving
viable tissue, enabling more rapid and precise eschar removal, which may reduce the need for subsequent skin grafting and lessen patient
"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. "In addition to providing burn surgeons with an important
new tool to manage these severely injured patients, NexoBrid will also diversify our revenue stream and enhance our topline earnings."
Each year, approximately 40,000 people are hospitalized in the U.S.
for burn-related injuries, and of those patients, more than 30,000 of them require some level of eschar removal, representing a $300 million
addressable market for NexoBrid. NexoBrid can be applied in up to two applications of four hours each. 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% Total Body Surface Area (TBSA).
NexoBrid (anacaulase-bcdb) is a botanical
drug product containing proteolytic enzymes indicated for the removal of eschar in adults with deep partial- and/or full-thickness thermal
burns. To learn more about NexoBrid, please visit www.NexoBrid-US.com.
Indication: NexoBrid
(anacaulase-bcdb) is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns.
The safety and effectiveness of NexoBrid have not been established for treatment of:
NexoBrid is not recommended for wounds contaminated with radioactive
and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.
Important Safety Information
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 and one specialty biologic product
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 (anacaulase-bcdb), a biological orphan product containing
proteolytic enzymes, which is indicated for the removal of eschar in adults with deep partial- and/or full-thickness burns. For more
information, please visit www.vcel.com.
are registered trademarks of Vericel Corporation. NexoBrid is a registered trademark of MediWound Ltd. and is used
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 relating to our operations and business environment, all of which are difficult to predict and many of which
are beyond our control. Our 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.
Among the factors that could cause actual results to differ materially
from those set forth in the forward-looking statements include, but are not limited to, uncertainties associated with our expectations
regarding future revenue, growth in revenue, market penetration for MACI, Epicel, and NexoBrid, growth in profit, gross margins and operating
margins, the ability to continue to scale our manufacturing operations to meet the demand for our cell therapy products, including the
timely completion of a new headquarters and manufacturing facility in Burlington, Massachusetts, the ability to achieve or sustain profitability,
contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of
operations over the course of the year, timing and conduct of clinical trial and product development activities, timing and likelihood
of the FDA's potential approval of the arthroscopic delivery of MACI to the knee or the use of MACI to treat cartilage defects in
the ankle, the estimate of the commercial growth potential of our products and product candidates, competitive developments, changes in
third-party coverage and reimbursement, physician and burn center adoption of NexoBrid, supply chain disruptions or other events affecting
MediWound Ltd.'s ability to manufacture and supply NexoBrid to meet customer demand, negative impacts on the global economy and
capital markets resulting from the conflict in Ukraine, global geopolitical tensions or record inflation and potential future impacts
of the COVID-19 pandemic on our business or the economy generally.
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, 2022, filed with
the Securities and Exchange Commission (SEC) on February 23, 2023, Vericel's Quarterly Report on Form 10-Q
for the quarter ended June 30, 2023, filed with the SEC on August 2, 2023, 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.