Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
announced that the U.S. Food and Drug Administration (FDA) has
approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in
adults with deep partial-thickness and/or full-thickness thermal
burns.
“There is a considerable unmet need for non-surgical eschar
removal for patients with severe thermal burns, and the FDA’s
approval of NexoBrid marks an important advancement in the
treatment paradigm for these patients,” said Nick Colangelo,
President and CEO of Vericel. “The addition of NexoBrid to our
commercial portfolio significantly expands our target addressable
market, and we look forward to executing on our NexoBrid commercial
launch plans and establishing NexoBrid as the new standard of care
for eschar removal.”
The FDA approval of NexoBrid is based on multiple preclinical
and clinical studies, including the pivotal Phase 3 U.S. clinical
study (DETECT) which evaluated NexoBrid in adult patients with deep
partial-thickness and full-thickness thermal burns of 3%-30% of
total body surface area (TBSA). The study met its primary endpoint
of complete eschar removal as well as all secondary endpoints,
including shorter time to eschar removal and a lower incidence of
surgical eschar removal compared to standard of care (SOC),
including both surgical and non-surgical eschar removal methods. A
key safety endpoint, non-inferiority in time to >95% wound
closure compared with patients treated with SOC, was also
achieved.
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% TBSA.
“When treating partial- and full-thickness burns, a critical
first step is the rapid removal of eschar and I believe the
approval of NexoBrid provides us with an important non-surgical
option to quickly and effectively treat severe thermal burns,” said
Jeremy Goverman, MD, Massachusetts General Hospital. “As a
principal investigator in the Phase 3 DETECT clinical trial, I look
forward to further incorporating NexoBrid into my practice, as I
believe it will lead to improved outcomes for my patients.”
NexoBrid is anticipated to be commercially available in the U.S.
in the second quarter of 2023. To learn more about NexoBrid, please
visit www.NexoBrid-US.com.
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.
Indications for Use: 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 sports medicine and severe burn care. The
Company develops, manufactures and 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. Vericel
also holds an exclusive license for North American rights to
NexoBrid, a biological orphan product containing proteolytic
enzymes, which is approved for eschar removal in adults with deep
partial-thickness 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. © 2022 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, the ultimate timing of the
commercial launch of NexoBrid in the United States, physician and
burn center adoption and market penetration for NexoBrid, the
estimate of the future commercial growth potential of NexoBrid,
competitive developments, changes in third-party coverage and
reimbursement, supply chain disruptions or other events affecting
MediWound’s ability to manufacture and supply sufficient quantities
of 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 the ongoing or
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, 2021, filed with the Securities and Exchange
Commission (SEC) on February 24, 2022, Vericel’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2022, filed with
the SEC on November 9, 2022, 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 Burnsir@vcel.com+1 (734)
418-4411
Media Contact:Julie Downsmedia@vcel.com
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