Vericel Provides Business Updates at 2017 Cell & Gene Meeting on the Mesa
October 05 2017 - 7:00AM
Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded
autologous cell therapies for the treatment of patients with
serious diseases and conditions, today provided a general business
update during a previously announced webcast presentation at the
2017 Cell & Gene Meeting on the Mesa.
As part of the update the Company announced that, effective
October 1, 2017, UnitedHealthcare updated its medical policy for
autologous chondrocyte implantation in the knee to include MACI®
(autologous cultured chondrocytes on porcine collagen
membrane). At this time, the number of covered lives for
commercial plans providing access to MACI is approximately
equivalent to the number of covered lives for commercial plans that
previously covered Carticel® (autologous cultured chondrocytes),
the Company’s first generation autologous chondrocyte implant
product. Based on the expanded medical policy coverage for
MACI and the continued momentum of MACI uptake following launch,
the Company announced plans for a further expansion of the MACI
sales force in 2018. The Company will provide additional
updates on its commercial business during its upcoming
third-quarter 2017 earnings webcast and conference call.
During the presentation the Company also announced that it had
met with the U.S. Food and Drug Administration (FDA) on September
29, 2017 for a scheduled Type B meeting to discuss the potential
for an accelerated approval pathway for ixmyelocel-T for the
treatment of patients with advanced heart failure due to ischemic
dilated cardiomyopathy (DCM) utilizing existing Phase 2 clinical
trial data. Ixmyelocel-T has received orphan drug, fast track
development and regenerative medicine advanced therapy designation
from the FDA in this indication. The FDA indicated that the
Company should plan to conduct at least one additional adequate and
well-controlled clinical study to support a Biologics License
Application for ixmyelocel-T. Consistent with its previously
disclosed strategy to focus investments on its high-growth
commercial business, the Company does not plan to conduct any
additional clinical studies for ixmyelocel-T unless fully funded by
a partner.
About MACI MACI® (autologous cultured
chondrocytes on porcine collagen membrane) is an autologous
cellular scaffold product that is indicated for the repair of
symptomatic single or multiple full-thickness cartilage defects of
the knee with or without bone involvement in adults. The MACI
implant consists of autologous cultured chondrocytes seeded onto a
resorbable Type I/III collagen membrane. Autologous cultured
chondrocytes are human-derived cells which are obtained from the
patient's own cartilage for the manufacture of MACI.
About Ixmyelocel‑T Ixmyelocel‑T is an
investigational autologous expanded multicellular therapy
manufactured from the patient's own bone marrow using Vericel's
proprietary, highly automated, fully closed cell-processing system.
This process selectively expands the population of mesenchymal
stromal cells and alternatively activated macrophages, which are
responsible for production of anti-inflammatory and pro-angiogenic
factors known to be important for repair of damaged tissue.
Ixmyelocel-T has received orphan drug, fast track development, and
regenerative medicine advanced therapy (RMAT) designation by the
U.S. Food and Drug Administration for use in the treatment of
advanced heart failure due to DCM.
About Vericel CorporationVericel develops,
manufactures, and markets expanded autologous cell therapies for
the treatment of patients with serious diseases and conditions. The
company markets two 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. Vericel is also marketing Epicel® (cultured
epidermal autografts), 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. 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, sales force expansion, payer access and our ability
to secure consistent reimbursement 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.
Global Media Contacts:David SchullRusso
Partners LLC+1 212-845-4271 (office)+1 858-717-2310
(mobile)David.schull@russopartnersllc.com
Karen ChaseRusso Partners LLC+1 646-942-5627 (office)+1
917-547-0434 (mobile)Karen.chase@russopartnersllc.com
Investor Contacts: Chad RubinThe Trout
Groupcrubin@troutgroup.com+1 (646) 378-2947
Lee SternThe Trout Grouplstern@troutgroup.com+1 (646)
378-2922
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