FDA Approves Paragon 28 R3ACT Stabilization System; Shares Gain

Shares of Paragon 28, Inc. (NYSE: FNA) rose 1.3% to close at $16.66 on Wednesday after the medical device company revealed that the U.S. Food and Drug Administration (FDA) has given 501(k) marketing clearance to its R3ACT Stabilization System.

The Stabilization System, which is expected to be commercially available in early 2022, will complement Paragon 28’s ankle fracture and soft tissue portfolio. Furthermore, it will expand the company’s product offering in the foot and ankle orthopedic market.

Markedly, the company’s comprehensive portfolio will provide clients with numerous innovative solutions for fracture repair and soft tissue stabilization.

CEO Comments

Paragon 28 CEO Albert DaCosta commented, “Syndesmotic stabilization has been a journey to understand and more importantly to replicate. We are excited to have developed a product that we believe addresses the complex needs of this indication and mimics not only the dynamic environment of the syndesmosis but also transitions the function of stabilization to best match the healing phases of the soft tissues.”

Wall Street’s Take

Last month, JMP Securities analyst David Turkaly reiterated a Buy rating and a price target of $30 (80.07% upside potential) on the stock.

Consensus among analysts is a Strong Buy based on 4 unanimous Buys. The average Paragon 28 price target of $29.75 implies 78.57% upside potential from current levels. However, shares have fallen almost 11% since its IPO in October.

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