Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded
autologous cell therapies for the treatment of patients with
serious diseases and conditions, today announced the presentation
of Epicel® (cultured epidermal autografts [CEA]) data at the 49th
Annual Meeting of the American Burn Association (ABA) on Thursday,
March 23, 2017 during Scientific Sessions on Reconstruction.
The presentation, entitled “Cultured Epidermal Autografts (CEA)
for Coverage of Large Burn Wounds in Pediatric and Adult Patients,
1989-2015”, was based on the clinical database used to support the
original Epicel Humanitarian Device Exemption application in 2007
and the Epicel Medical Device Tracker, a post-approval patient
registry. Combined, the outcomes data included 953 patients
between 1989 and 2015. The mean total body surface area
(TBSA) burned of patients in the databases was 67.3% (SD 17.48),
with median graft take at discharge of 75%, and an overall survival
to discharge rate of 84% (804/953). The databases included
325 pediatric patients with survival rates being similar for
pediatric and adult patients (88.8% vs 81.7%, respectively).
These results are consistent with earlier analyses of the Epicel
clinical experience databases and a controlled, physician-sponsored
study comparing outcomes in patients with severe burns treated with
Epicel and standard care compared to standard care alone.
“According to a data set reported in the 2016 ABA National Burn
Repository, burns greater than 65 to 70% TBSA are associated with a
50% case mortality rate1” said Dr. Dave Recker, chief medical
officer of Vericel. “The reported 84% survival rate from the Epicel
clinical experience databases in over 950 patients with a mean TBSA
of 67% continues to support a probable survival benefit of Epicel
in severe burn patients.”
The full abstract is available on the ABA website
at: http://www.abstractsonline.com/pp8/#!/4303/presentation/88
About Epicel® Epicel® (cultured epidermal
autografts) is a permanent skin replacement indicated for use in
adult and pediatric patients who have deep dermal or full thickness
burns comprising a total body surface area greater than or equal to
30%. Epicel may be used in conjunction with split-thickness
autografts or alone in patients for whom split-thickness autografts
may not be an option due to the severity and extent of their
burns. The probable benefit of Epicel, mainly related to
survival, was demonstrated in two Epicel databases and one
physician-sponsored study. Epicel has been used to treat
severely burned patients in the U.S. and internationally since
1988, and was approved in the United States in 2007 as a
Humanitarian Use Device (HUD) under a Humanitarian Device Exemption
(HDE).
Important Safety Information Epicel is
contraindicated in patients with known hypersensitivity to
vancomycin, amikacin, or amphotericin. Epicel should not be
used in patients with sensitivities to materials of bovine or
murine origin. Epicel is contraindicated for use on
clinically infected wounds. Because Epicel is manufactured
with and contains residual amounts of murine cells, the FDA
considers it a xenotransplantation product. Therefore,
recipients should not donate whole blood, blood components, source
plasma, source leukocytes, tissue, breast milk, ova, sperm or other
body parts for use in humans because there is a potential risk of
carrying an infection that is transmitted from mouse cells to
humans. In addition, the risk of disease transmission from
Epicel is unknown.
Squamous cell carcinoma (SCC) has been reported in patients with
burn injury after being grafted with Epicel. The most common
adverse reactions, occurring in ≥ 2% of patients were infection,
graft shear, blister, drainage, sepsis, graft detachment and renal
failure. Patient information supplied by treating physicians and
attending burn teams from 1989 to 1996 included 552 patients, 205
children (age 21 years and younger) and 347 adults reported death
(13%) and the adverse reactions of highest incidence as: infection
(13.8%), graft shear (7.8%), blister (4.2%) and drainage (3.3%).
From June 1998 through September, 2015, over 1,662 patients,
including 589 children (age 21 and younger) and 1,073 adults were
tracked through spontaneous reports via medical device reports,
reports from burn sites and published literature. Adverse reactions
were similar to the previously identified adverse reactions. Events
that were reported in ≥ 2% of patients included death (8.8%), and
adverse reactions of multi-organ failure, sepsis, infection and
graft procedure complications. Because of the potential
underreporting of adverse reactions from these sources, the
percentages of adverse reactions should be interpreted with
caution. Epicel is intended solely for autologous use.
The effectiveness of Epicel has not been proven in clinical
studies. The long-term safety of Epicel is unknown. The
safety of Epicel has not been studied in pregnant and nursing
women.
Vericel develops, manufactures, and markets expanded autologous
cell therapies for the treatment of patients with serious diseases
and conditions. The company markets three cell therapy
products in the United States. Vericel is
marketing MACI® (autologous cultured chondrocytes on porcine
collagen membrane), 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. Carticel® (autologous cultured
chondrocytes) is an autologous chondrocyte implant for the
treatment of cartilage defects in the knee in patients who have had
an inadequate response to a prior arthroscopic or other surgical
repair procedure. 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 is also developing
ixmyelocel‑T, an autologous multicellular therapy intended to treat
advanced heart failure due to ischemic dilated cardiomyopathy
(DCM). For more information, please visit the company's
website at www.vcel.com.
Epicel®, Carticel®, and MACI® are registered trademarks of
Vericel Corporation. © 2017 Vericel Corporation. All
rights reserved.
This document contains forward-looking statements, including,
without limitation, statements concerning anticipated progress,
objectives and expectations regarding the commercial potential of
our products and growth in revenues, intended product development,
clinical activity timing, regulatory progress, and objectives and
expectations regarding our company described herein, all of which
involve certain risks and uncertainties. These statements are
often, but are not always, made through the use of words or phrases
such as "anticipates," "intends," "estimates," "plans," "expects,"
"we believe," "we intend," and similar words or phrases, or future
or conditional verbs such as "will," "would," "should,"
"potential," "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
competitive developments, clinical trial and product development
activities, regulatory approval requirements, estimating the
commercial growth potential of our products and product candidates
and growth in revenues and improvement in costs, market demand for
our products, and our ability to supply or meet customer demand for
our products. 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, 2016, filed with the Securities and Exchange
Commission ("SEC") on March 13, 2017, Quarterly Reports on Form
10-Q and other filings with the SEC. These forward-looking
statements reflect management's current views and Vericel does not
undertake 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.
References
1 American Burn Association National Burn Repository 2016
Report. Version 12.0:10.
CONTACT:
Chad Rubin
The Trout Group crubin@troutgroup.com
(646) 378-2947
or
Lee Stern
The Trout Group lstern@troutgroup.com
(646) 378-2922
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