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Reimbursement / Regulatory

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. 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 in repairs using Rotium vs. without the device. 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. (Atreon Orthopedics LLC, 3/19/19)