FDA clears Atreon Orthopedics' regenerative rotator cuff product — 4 insights


The FDA cleared Atreon Orthopedics' Rotium Bioresorbable Wick for healing rotator cuff injuries.

What you should know:

1. The Rotium is a bioresorbable scaffold that sits between the repaired tendon and bone to enhance healing.

2. Fort Collins-based Colorado State University researchers tested the product on sheep models. The sheep demonstrated, "tremendous improvement" in tendon strength when treated with the Rotium.

3. This is Atreon's second regenerative product to earn FDA clearance. The first was the Phoenix Wound Matrix, an absorbable synthetic graft that mimics a patient's extracellular matrix.

4. "To receive the second FDA clearance in a year, in two different clinical areas, tells us we are on the right track in developing our regeneration technology platform," said Atreon CEO Ross Kayuha.

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