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.
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 trauma.
“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).
About NexoBridNexoBrid (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.Limitations of UseThe safety
and effectiveness of NexoBrid have not been established for
treatment of:
- Chemical or electrical burns
- Burns on the face, perineum, or genitalia
- Burns on the feet of patients with diabetes mellitus or on the
feet of patients with occlusive vascular disease
- Circumferential burns
- Burns in patients with significant cardiopulmonary disease,
including inhalation injury
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
- Contraindications: NexoBrid is contraindicated
in patients with: known hypersensitivity to anacaulase-bcdb,
bromelain, pineapples, or to any other components; known
hypersensitivity to papayas or papain because of the risk of
cross-sensitivity.
- Warnings and Precautions:
- Hypersensitivity Reactions: Serious
hypersensitivity reactions, including anaphylaxis, have been
reported with postmarketing use of anacaulase-bcdb.
- Pain Management: Manage pain as
appropriate for an extensive dressing change of burn wounds. At
least 15 minutes prior to NexoBrid-related procedures ensure
adequate pain control measures are in place.
- Proteolytic Injury to Non-Target
Tissues: NexoBrid is not recommended for treatment of
burn wounds where medical devices or vital structures could become
exposed during eschar removal.
- Coagulopathy: Avoid use of NexoBrid in
patients with uncontrolled disorders of coagulation. Use with
caution in patients on anticoagulant therapy or other drugs
affecting coagulation, and in patients with low platelet counts and
increased risk of bleeding from other causes. Monitor patients for
possible signs of coagulation abnormalities and signs of
bleeding.
- Adverse Reactions: The most common
adverse reactions (>10%) were pruritus and pyrexia.
- Geriatric: Clinical studies of NexoBrid
did not include sufficient numbers of subjects 65 years of age and
older to determine whether they respond differently from younger
adult subjects.
- To report negative side-effects, contact the FDA at
1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
- For complete risk information, please see the Full
Prescribing 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.
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. © 2023 Vericel
Corporation. All rights reserved.
Forward Looking StatementsVericel 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.
Investor Contact:
Eric Burns
ir@vcel.com
+1 (734) 418-4411
Media Contact:
Julie Downs
media@vcel.com
Grafico Azioni Vericel (NASDAQ:VCEL)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Vericel (NASDAQ:VCEL)
Storico
Da Giu 2023 a Giu 2024