Paragon 28, Inc. R3ACT™ Stabilization System Cleared by FDA

Rhea-AI Summary

Paragon 28, Inc. (NYSE: FNA) announced FDA 501(k) marketing clearance for its R3ACT™ Stabilization System, set for commercial launch in early 2022. This product enhances Paragon 28's existing portfolio aimed at ankle fractures and soft tissue stabilization. CEO Albert DaCosta highlighted the product's innovative design, which meets complex needs in syndesmotic stabilization and adapts to healing phases of soft tissues. This new addition complements current offerings, including the Gorilla® and Mini-Monster® systems, strengthening the company's position in the orthopedic market.

Positive

• FDA 501(k) marketing clearance for R3ACT™ Stabilization System.
• Expected commercial launch in early 2022.
• Enhances comprehensive portfolio in ankle fracture and soft tissue solutions.

Negative

• None.

ENGLEWOOD, Colo.--(BUSINESS WIRE)-- Paragon 28, Inc. (NYSE: FNA) (“PARAGON”), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced that the U.S. Food and Drug Administration (FDA) has given 501(k) marketing clearance to its R3ACT™ Stabilization System. The R3ACT™ Stabilization System, expected to commercially launch in early 2022, will complement Paragon 28’s comprehensive ankle fracture and soft tissue portfolio and further expands Paragon 28’s product offering in the foot and ankle space.

Paragon 28 Chief Executive Officer and Co-Founder 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.”

The addition of the R3ACT™ Stabilization System bolsters Paragon 28's ankle fracture and syndesmotic product offering, which includes the Gorilla® Ankle Fracture Plating System, Gorilla® Pilon Plating System, Mini-Monster® Screw System, and R3LEASE™ Stabilization System. With this comprehensive portfolio, Paragon 28 provides its customers a broad array of innovative solutions for fracture fixation and soft tissue stabilization.

About Paragon 28, Inc.

Based in Englewood, Colo., Paragon 28®, is a leading medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that cover a wide range of foot and ankle ailments including fracture fixation, hallux valgus (bunions), hammertoe, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot foot and orthobiologics. The company designs products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedures simpler, consistent, and reproducible.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211229005080/en/

Investor Contact:

Gilmartin Group

Matt Bacso, CFA

Matt.bacso@gilmartinir.com

Source: Paragon 28, Inc.

FAQ

What is the significance of the FDA clearance for FNA?

The FDA clearance allows Paragon 28 to market its R3ACT™ Stabilization System, which will enhance its product offerings in the orthopedic market.

When is the R3ACT™ Stabilization System expected to launch?

The R3ACT™ Stabilization System is expected to launch commercially in early 2022.

How does the R3ACT™ Stabilization System relate to other FNA products?

The R3ACT™ Stabilization System complements Paragon 28's existing products aimed at ankle fractures and soft tissue stabilization.

What markets does Paragon 28, Inc. focus on?

Paragon 28 focuses exclusively on the foot and ankle orthopedic market.