Vericel Submits HDE Supplement to the FDA to Revise the Labeled Indications for Use and Add Pediatric Labeling for Epicel
December 08 2015 - 8:00AM
Vericel Corporation (NASDAQ:VCEL), a leading developer of
patient-specific expanded cellular therapies for the treatment of
severe diseases and conditions, today announced that it has
submitted a Humanitarian Device Exemption (HDE) supplement to the
U.S. Food and Drug Administration to revise the labeled indications
for use of Epicel® (cultured epidermal autografts) to specifically
include use in pediatric patients and add pediatric labeling for
Epicel.
Epicel is a permanent skin replacement for the treatment of
patients with deep dermal or full thickness burns comprising
greater than or equal to 30 percent of total body surface
area. Epicel has been used in the United States and
internationally to treat severely burned patients since
1988. Epicel was approved by the FDA in 2007 as Humanitarian
Use Device (HUD) under the HDE regulations.
"We believe that the revised label will provide valuable
information describing the safety and clinical use of Epicel for
pediatric patients and will better inform physicians regarding the
safety of Epicel in this patient population," said David Recker,
MD, chief medical officer of Vericel.
About Humanitarian Use Devices and the Humanitarian
Device Exemption
HUDs are medical devices intended to benefit patients in the
treatment or diagnosis of diseases or conditions that affect fewer
than 4,000 individuals in the United States per year. Devices
that receive HUD designation from the Office of Orphan Products
Development of the FDA may be eligible for marketing approval under
an HDE application. FDA approval of an HDE application
authorizes the applicant to market the device, subject to certain
profit and use restrictions.
Except in certain circumstances, HUDs approved under an HDE
cannot be sold for an amount that exceeds the costs of research and
development, fabrication, and distribution of the device (i.e., for
profit). A HUD is eligible to be sold for profit after
receiving HDE approval if the device meets certain eligibility
criteria, including where the device is intended for the treatment
of a disease or condition that occurs in pediatric patients and
such device is labeled for use in pediatric patients in which the
disease or condition occurs. If the FDA determines that a HUD
meets the eligibility criteria, the HUD may be sold for profit as
long as the number of devices distributed in any calendar year does
not exceed the annual distribution number (ADN). The ADN is
defined as the number of devices reasonably needed to treat a
population of 4,000 individuals per year in the United States.
About Vericel Corporation
Vericel Corporation (formerly Aastrom Biosciences, Inc.) is a
leader in developing patient-specific expanded cellular therapies
for use in the treatment of patients with severe diseases and
conditions. The company markets two autologous cell therapy
products in the U.S.: Carticel® (autologous cultured chondrocytes),
an autologous chondrocyte implant for the treatment of cartilage
defects in the knee, and Epicel® (cultured epidermal autografts), a
permanent skin replacement for the treatment of patients with
deep-dermal or full-thickness burns comprising greater than or
equal to 30% of total body surface area. Vericel is also
developing MACI™, a third-generation autologous chondrocyte implant
for the treatment of cartilage defects in the knee, and
ixmyelocel-T, a patient-specific multicellular therapy for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy. For more information, please visit the
company's website at www.vcel.com.
Epicel®and Carticel®are registered trademarks and MACI™ is a
trademark of Vericel Corporation. © 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 revenue trends and gross margin improvements,
intended product development, clinical activity timing and
regulatory pathway and timing, integration of the acquired
business, 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," "can
continue," "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, integration of the acquired business,
clinical trial and product development activities, regulatory
approval requirements, the availability and allocation of resources
among different potential uses, estimating the commercial 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, 2014, filed with the Securities and Exchange
Commission ("SEC") on March 25, 2015, 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.
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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