Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded
autologous cell therapies for the treatment of patients with
serious diseases and conditions, announced today that the company
is hosting a symposium on the MACI® (autologous cultured
chondrocytes on porcine collagen membrane) implant for treating
articular cartilage defects in the knee at the American Orthopedic
Society for Sports Medicine’s 2017 Annual Meeting.
Symposium topics will include a review of MACI published
clinical studies, patient case profiles, and a discussion of the
regulatory approval process for MACI. Featured speakers
include Daniël Saris, MD, PhD, Professor of Orthopedics at
University Medical Center in Utrecht, Netherlands; Alison Toth, MD,
Associate Professor of Orthopaedic Surgery at Duke University in
Durham, North Carolina; Eric Strauss, MD, Assistant Professor of
Orthopaedic Surgery at the NYU Hospital for Joint Diseases in New
York; Seth Sherman, MD, Assistant Professor of Orthopaedic Surgery
at the University of Missouri in Columbia; and David Recker, MD,
Vericel’s chief medical officer.
The symposium, entitled “The MACI Implant for Treating
Articular Cartilage Defects in the Knee,” is being held on
Thursday, July 20, 2017 from 12:30 – 2:00 pm at the Metro Toronto
Convention Center, 700 Level, Room 205.
To register for the symposium and for more information, go to:
http://BIT.LY/AOSSM-MACI
Editor’s Note: Vericel will have MACI
information at Booth #619 at the AOSSM 2017 Annual Meeting.
About MACIMACI® (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.
Important Safety Information
- MACI is contraindicated in patients with a known history of
hypersensitivity to gentamicin, other aminoglycosides, or products
of porcine or bovine origin. MACI is also contraindicated for
patients with severe osteoarthritis of the knee, inflammatory
arthritis, inflammatory joint disease, or uncorrected congenital
blood coagulation disorders. MACI is also not indicated for
use in patients who have undergone prior knee surgery in the past
six months, excluding surgery to procure a biopsy or a concomitant
procedure to prepare the knee for a MACI implant.
- MACI is contraindicated in patients who are unable to follow a
physician-prescribed post-surgical rehabilitation program. The
safety of MACI in patients with malignancy in the area of cartilage
biopsy or implant is unknown. Expansion of present malignant
or dysplastic cells during the culturing process or implantation is
possible.
- Patients undergoing procedures associated with MACI are not
routinely tested for transmissible infectious diseases. A
cartilage biopsy and MACI implant may carry the risk of
transmitting infectious diseases to healthcare providers handling
the tissue. Universal precautions should be employed when
handling the biopsy samples and the MACI product.
About Articular Cartilage Defects of the Knee
Articular cartilage is a highly organized avascular tissue composed
of chondrocytes embedded within an extracellular matrix of
collagens, proteoglycans and noncollagenous proteins. Its
primary function is to enable the smooth articulation of joint
surfaces, and to cushion compressive, tensile and shearing forces.
Articular cartilage damage is caused by both acute and
repetitive trauma resulting in knee pain, effusion or mechanical
symptoms such as catching and locking, and swelling. Since
articular cartilage is avascular it has little capacity to repair
itself or regenerate. Articular cartilage lesions that are
left untreated may progress to debilitating joint pain,
dysfunction, and osteoarthritis.1 The prevalence rate for
cartilage lesions in the knee has been reported to be 63% in
patients undergoing investigational arthroscopies.2
About Vericel Corporation Vericel develops,
manufactures, and markets autologous expanded 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. 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. 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. Vericel is
developing ixmyelocel-T, an autologous multicellular therapy
intended to treat advanced heart failure due to ischemic dilated
cardiomyopathy. 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
Vericel products, intended product development, clinical activity
timing, regulatory process, 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, clinical trial and product development
activities, regulatory approval requirements, estimating the
commercial potential of our products and product candidates, market
demand for our products, product performance, ability of ICT to
obtain approval to transfer funds to the U.S., 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
1Bedi A, Feeley BT, Williams RJ. Management of articular
cartilage defects of the knee. J Bone Joint Surg Am.
2010;92(4):994‑1009.
2Curl WW, Krome J, Gordon ES, Rushing J, Smith BP, Poehling GG.
Cartilage injuries: a review of 31,516 knee arthroscopies.
Arthroscopy. 1997;13(4):456-60.
Global Media Contacts:
David Schull
Russo Partners LLC
+1 212-845-4271 (office)
+1 858-717-2310 (mobile)
David.schull@russopartnersllc.com
Karen Chase
Russo Partners LLC
+1 646-942-5627 (office)
+1 917-547-0434 (mobile)
Karen.chase@russopartnersllc.com
Investor Contacts:
Chad Rubin
The Trout Group
crubin@troutgroup.com
+1 (646) 378-2947
Lee Stern
The Trout Group
lstern@troutgroup.com
+1 (646) 378-2922
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