Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell
therapies for the sports medicine and severe burn care markets,
today announced that world champion swimmer, best-selling author,
five time Olympian and recent MACI® (autologous cultured
chondrocytes on porcine collagen membrane) patient Dara Torres is
teaming up with Vericel for the “It’s Your Move” campaign.
The “It’s Your Move” campaign is aimed at active individuals who
are sidelined from their favorite activities due to knee pain
possibly caused by cartilage injury, and will seek to help these
individuals better understand their medical condition and seek
treatment.
As a former competitive athlete and world-record holder, Torres
is no stranger to injury. Throughout her long career, she has
sought innovative treatments to assist her to get back into
competition. In fact, she is the first and only female
swimmer to represent the United States in five Olympic Games and,
as a 41-year-old mother, she was the oldest swimmer to medal at an
Olympic Games.
Following the 2009 world championships, Torres began
experiencing chronic pain in her left knee. “The pain was so
bad, I had to use a ladder to get out of the pool,” Torres
recalled. She was diagnosed with a cartilage defect and,
after researching treatment options and consulting with several top
U.S. sports medicine surgeons, chose to be treated with Carticel®
(autologous cultured chondrocytes), Vericel’s earlier generation
autologous chondrocyte implant. In 2016, she was diagnosed
with a similar cartilage injury in her right knee and, based on the
positive outcome of the earlier treatment of her left knee, chose
to be treated with MACI, Vericel’s latest generation autologous
chondrocyte implant approved by the FDA in December, 2016.
MACI is a procedure that repairs cartilage using the patient’s
own cells. MACI is used for the repair of symptomatic, deep
cartilage damage of the adult knee that may or may not affect the
bone. Please see Important Safety Information for MACI
below.
“When discussing treatment options with active patients, their
primary concern is choosing a treatment that increases their
chances of returning to an active lifestyle,” said James Carey, MD,
MPH who is an Assistant Professor of Orthopaedic Surgery at the
Perelman School of Medicine at the University of
Pennsylvania. “MACI is unique in that it uses a patient’s own
cells to regenerate tissue, and it is a proven method of cartilage
repair backed by numerous clinical studies and substantial outcomes
data.”
“When it comes to training, I use the latest proven methods and
I wanted to do the same for the treatment of my cartilage injury,”
said Torres. “My biggest fear before learning about MACI was
the fact that I couldn't do the things I love to do, whether it's
running, biking, playing with my daughter, just everyday things
that are part of my life. Within nine months of my MACI
procedure, I was able to return to my active lifestyle. I
want to encourage others to speak with a healthcare professional
and not let the pain stop them from living their fullest life.”
"Through the ‘It’s Your Move’ campaign, Vericel hopes to help
raise awareness of treatment options for knee pain due to cartilage
damage, while simultaneously celebrating the achievements made by
patients such as Dara Torres,” said Nick Colangelo, president and
CEO of Vericel. “We are thrilled by Dara’s recovery and
thankful for her willingness to work with us to motivate and
educate patients.”
To learn more about the “It’s Your Move” campaign, knee pain,
Dara’s personal story, and to find a MACI specialist, visit
www.maci.com.
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.
Limitations of Use
- Effectiveness of MACI in joints other than the knee has not
been established.
- Safety and effectiveness of MACI in patients over the age of 55
years have not been established.
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.
- Local inflammation or active infection in the bone, joint, and
surrounding soft tissue, meniscal pathology, cruciate ligament
instability, and misalignment should be assessed and treated prior
to or concurrent with MACI implantation.
- Final sterility test results are not available at the time of
shipping.
- The most frequently occurring adverse reactions (≥5%) reported
for MACI were arthralgia, tendonitis, back pain, joint swelling,
and joint effusion.
- Serious adverse reactions reported for MACI were arthralgia,
cartilage injury, meniscus injury, treatment failure, and
osteoarthritis.
- Because MACI implantation requires invasive surgical
procedures, use in pregnancy is not recommended.
About Articular Cartilage Defects of the
KneeArticular 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 CorporationVericel is a leader in
advanced cell therapies for the sports medicine and severe burn
care markets. The company markets two cell therapy products
in the United States. Vericel markets 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
also markets 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.
MACI®, Carticel® and Epicel® are registered trademarks of
Vericel Corporation. © 2018 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, clinical benefit and return to active
lifestyle, 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, 2017, filed with the Securities and
Exchange Commission ("SEC") on March 5, 2018, 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.
1 Bedi A, Feeley BT, Williams RJ. Management of
articular cartilage defects of the knee. J Bone Joint
Surg Am. 2010;92(4):994‑1009.
2 Curl 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.
vcel-corp
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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