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Advanced therapies for the sports medicine and severe burn care markets

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World Champion Swimmer and Twelve-Time Medalist Dara Torres Partners with Vericel for the ‘It’s Your Move’ Campaign

March 5, 2018 at 7:00 AM EST
Campaign Aims to Empower Patients with Knee Pain to Seek Treatment

CAMBRIDGE, Mass., March 05, 2018 (GLOBE NEWSWIRE) -- 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 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.

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 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 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.

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

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

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Russo Partners LLC
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David.schull@russopartnersllc.com

Karen Chase
Russo Partners LLC
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Karen.chase@russopartnersllc.com

Investor Contacts: 
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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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