Vericel Wins on Key FDA Approval

Vericel Corp. (NASDAQ: VCEL) saw its shares jump sharply early Wednesday after it reported a key U.S. Food and Drug Administration (FDA) approval. Essentially, the company announced that the FDA has approved its treatment of symptomatic cartilage defects of the knee in adults, or MACI (autologous cultured chondrocytes on porcine collagen membrane).

The approval of MACI is based on the SUMMIT study (Superiority of MACI implant versus Microfracture Treatment in patients with symptomatic articular cartilage defects in the knee), which demonstrated a statistically significantly greater improvement in KOOS pain and function scores in the MACI group compared to the microfracture group at two years.

A majority of the patients who completed the SUMMIT study also participated in the extension study, a three-year followup. Overall, efficacy data support a long-term clinical benefit from the use of MACI in patients with cartilage defects of the knee.

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Note that MACI is the first FDA-approved cellularized scaffold product that applies tissue engineering processes to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.

David Recker, M.D., chief medical officer of Vericel, commented:

The treatment of articular cartilage defects in the knee is challenging because articular cartilage in adults has minimal capacity to repair itself. While orthopedic surgeons have long understood that autologous chondrocyte implantation can regenerate cartilage tissue, the previous surgical procedure was technically complex and time consuming, and the indicated patient population was limited. MACI is the first product to show a statistically significantly greater improvement in KOOS pain and function scores compared to microfracture, a commonly performed alternative surgical treatment for cartilage repair, in a well-controlled Phase 3 clinical study. With the introduction of MACI, orthopedic surgeons will have a simplified treatment option available for a broader patient population supported by solid clinical evidence.

Shares of Vericel closed Tuesday at $2.60, with a consensus analyst price target of $10.30 and a 52-week trading range of $1.76 to $6.69. After the release, the stock was up about 67% at $4.35 in early trading indications on Wednesday.

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