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Vericel Reports Publication of Results from the Phase 3 SUMMIT Extension Study Demonstrating Sustained Clinical Benefit of MACI Out to Five YearsCAMBRIDGE, Mass., March 23, 2018 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced the publication of results from the MACI® (autologous cultured chondrocytes on porcine collagen membrane) Phase 3 SUMMIT Extension Study in the American Journal of Sports Medicine. The results demonstrated that the significantly greater improvements in Knee injury and Osteoarthritis Outcome Score (KOOS)1 pain and function scores for MACI versus microfracture shown in the two-year Phase 3 SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) study were maintained over the additional three-year follow-up in the SUMMIT Extension Study. MACI is an autologous cellular 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. MACI is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue. The FDA approval of MACI was based on the results of the SUMMIT study, a Phase 3, prospective, multicenter, randomized, controlled study that enrolled a total of 144 patients. The co-primary efficacy endpoint was the change from baseline to two years in the KOOS2 pain and function scores. The SUMMIT study is the only Phase 3 clinical trial of a cartilage repair product to date to demonstrate statistically significant improvement over microfracture at both one and two years.2 The SUMMIT Extension Study was a three-year follow-up of the SUMMIT clinical trial, entailing up to five years of observation after surgery. Of the 144 patients randomized in the SUMMIT study, 128 (89%) continued observation out to five years in the SUMMIT Extension Study. Evaluation of these patients post treatment showed that there was sustained improvement in both KOOS pain and function for the study period. A post-hoc evaluation showed that the significantly greater improvement of MACI versus microfracture observed at the two-year endpoint was maintained at the five-year follow-up. The frequency of adverse events and subsequent surgical procedures were similar in both the MACI and microfracture treatment groups. The Extension Study is the first study in the field of cartilage repair to provide long-term, five-year follow-up results from a successful multicenter, superiority study in comparison to microfracture. “MACI is the only FDA-approved cartilage repair product that has demonstrated significantly greater improvement versus microfracture in a Phase 3 controlled clinical trial,” said Nick Colangelo, Vericel’s president and chief executive officer. “It is important to both clinicians and patients that MACI, in addition to demonstrating significant improvements compared to microfracture as early as one year, maintains improvements over microfracture out to at least five years.” The publication is entitled “Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfacture: Five-Year Follow-up of a Prospective Randomized Trial” and the full abstract is available on pubmed: http://journals.sagepub.com/doi/full/10.1177/0363546518756976 About MACI Limitations of Use
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About Articular Cartilage Defects of the Knee About Vericel Corporation MACI® 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 including maintenance of clinical benefit, 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. References 1Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003;1:64. 2Saris 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. 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. (vcel-Corp) Global Media Contacts: Karen Chase Investor Contacts: Lee Stern |