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Atreon Orthopedics Receives FDA Clearance for Rotator Cuff Regeneration Device

Atreon Orthopedics received FDA 510(k) clearance to market the Rotium™ Bioresorbable Wick for use in rotator cuff repair. Product launch will begin in 2Q19.

Rotium is a synthetic bioresorbable scaffold. Inserted between a repaired tendon and bone, it acts as a facilitator to enhance tendon healing. Animal study of acute and chronic models has demonstrated an improvement in tendon strength from repairs using Rotium vs. without the device. Histological evaluation supported the results seen by showing the development of Sharpey's Fibers between the tendon and the bone.

Atreon Orthopedics is a subsidiary company of ParaGen Technologies, which is itself a joint venture between Nanofiber Solutions, the technology developer, 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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