FDA approves IND for living tissue graft product from ISTO, Zimmer Holdings

By Lisa Kerner

Charlotte, N.C., June 21 - The Food and Drug Administration has approved ISTO Technologies, Inc.'s Investigational New Drug application for Neocartilage, a living tissue graft to repair cartilage defects, restore joint function and relieve pain in the knee.

With the FDA approval, ISTO and its collaboration partner Zimmer Holdings, Inc. can move forward with human clinical trials of the novel cartilage regeneration treatment. Final approvals from clinical sites are expected in the second half of the year.

Zimmer has exclusive worldwide commercial distribution rights to Neocartilage, developed by ISTO, which it plans to market as DeNovo ET Live Chondral Engineered Tissue Graft.

Located in Warsaw, Ind., Zimmer develops and markets reconstructive and spinal implants and related orthopedic surgical products.

ISTO is a clinical-stage orthobiologic company based in St. Louis.

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