Replies to post #5637 on Vericel Corp. (VCEL)

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Vericel Announces First MACI Implant in the United States for the Treatment of Symptomatic Cartilage Defects of the Knee

2/1/17, 5:00 AM
CAMBRIDGE, Mass., Feb. 01, 2017 (GLOBE NEWSWIRE) -- 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
first implant of MACI® (autologous cultured chondrocytes on porcine collagen
membrane) in the United States for the repair of symptomatic single or multiple
full-thickness cartilage defects of the knee with or without bone involvement in
adults.

“While surgeons have long understood that autologous chondrocyte implantation
can repair cartilage tissue, the previous surgical procedure was more invasive,
technically demanding, time consuming and could result in an uneven distribution
of cells,” said Dr. David Recker, chief medical officer of Vericel. "With the
introduction of MACI, surgeons now have an FDA-approved product in which the
patient’s own cells can be reproducibly delivered using less invasive
techniques. The MACI implant not only ensures more uniform distribution of the
cells in the cartilage defect, but also greatly simplifies the implantation
procedure.”

“Treating the first patient with MACI this soon following FDA approval is
incredibly rewarding for everyone at Vericel,” said Nick Colangelo, president
and CEO of Vericel. "We believe that the simplified MACI surgical technique,
together with the MACI Phase 3 clinical data demonstrating statistically
significantly greater improvement in pain and function scores compared to
microfracture, will drive significant growth for our cartilage repair
franchise. We are now focused on realizing this growth potential by providing
training to expand the number of implanting surgeons and working with payers to
ensure reimbursement for MACI."

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.

The FDA approval of MACI was supported by the results of SUMMIT trial1, a Phase
3 two-year, prospective, multicenter, randomized, open-label, parallel-group
study that enrolled a total of 144 patients, ages 18 to 54 years, with at least
one symptomatic Outerbridge Grade III or IV focal cartilage defect on the medial
femoral condyle, lateral femoral condyle, and/or the trochlea. The co-primary
efficacy endpoint was change from baseline to Week 104 for the subject’s Knee
injury and Osteoarthritis Outcome Score (KOOS) in 2 subscales: Pain and Function
(Sports and Recreational Activities [SRA]).2 At Week 104, KOOS pain and
function (SRA) had improved from baseline in both treatment groups, but the
improvement was statistically significantly (p<0.001) greater in the MACI group
compared with the microfracture group. In a responder analysis, the proportion
of subjects with at least a 10-point improvement in both KOOS pain and function
(SRA) was greater in the MACI group (63/72 = 87.5%; 95% CI [77.6%, 94.6%])
compared with the microfracture group (49/72 = 68.1%; 95% CI [56.0%, 78.6%]).

The most frequently occurring adverse reactions (≥5%) reported for MACI in the
2-year randomized, controlled clinical trial 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.

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.Final sterility test results are not available at the time of shipping. In the case of positive sterility results, health care provider(s) will be contacted.To create a favorable environment for healing, concomitant pathologies that include meniscal pathology, cruciate ligament instability and joint misalignment, must be addressed prior to or concurrent with the implantation of MACI. Local treatment guidelines regarding the use of thromboprophylaxis and antibiotic prophylaxis around orthopaedic surgery should be followed. Use in patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.The MACI implant is not recommended during pregnancy. For implantations post-pregnancy, the safety of breast feeding to infant has not been determined.Use of MACI in pediatric patients or patients over 55 years of age has not been assessed.The most frequently occurring adverse reactions reported for MACI (≥5%) 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.


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.3 The prevalence rate for cartilage lesions in the knee has been
reported to be 63% in patients undergoing investigational arthroscopies.4

About Vericel CorporationVericel develops, manufactures, and markets expanded
autologous cell therapies for the treatment of patients with serious diseases
and conditions. The company currently markets two cell therapy products in the
United States. 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 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, which has just been
approved by the FDA. 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 MACI® and our other products,
and timing, 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 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, 2015, filed with the
Securities and Exchange Commission ("SEC") on March 14, 2016, 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
1Saris D, Price A, Widuchowski W, Bertrand-Marchand M, Caron J, Drogset JO, et
al. Matrix-applied characterized autologous cultured chondrocytes versus
microfracture: two-year follow-up of a prospective randomized trial. Am J Sports
Med. 2014 Jun;42(6):1384-94.

2Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64.

3Bedi A, Feeley BT, Williams RJ. Management of articular cartilage defects of the knee. J Bone Joint Surg Am. 2010;92(4):994-1009.

4Curl 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.



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Chad Rubin
The Trout Group [e-mail]
[phone]
or
Lee Stern
The Trout Group [e-mail]
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