Atreon Orthopedics reported on Tuesday the receipt of US Food and Drug Administration (FDA) clearance for its proprietary product, the Rotium Bioresorbable Wick that supports the regeneration of healthy tendon in the healing of rotator cuff injuries.
Following the US FDA clearance, the Rotium is expected to be available on 1 April 2019, revealed the company.
The company added that the Rotium is a synthetic bioresorbable scaffold that is positioned between the repaired tendon and the bone and acts to facilitate and enhance the healing of the tendon to the bone. The results from both an acute and chronic sheep model performed at Colorado State University showed a tremendous improvement in the strength of the repaired tendon with the Rotium Bioresorbable Wick over the tendons repaired without Rotium.
In 2018, ParaGen received its first US FDA clearance for the Phoenix Wound Matrix, a product from ParaGen subsidiary RenovoDerm.
Additionally, Atreon Orthopedics is a subsidiary company of ParaGen Technologies, a joint venture between Nanofiber Solutions, which aids in developing the core technology and Ikove Venture Partners, which provides full operational support, market strategy and access to funding via a global network of investors.
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