OCC 1.32% 38.5¢ orthocell limited

Ann: Appendix 4C - Quarterly, page-7

  1. 2,028 Posts.
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    Database lock was dated 15th Nov....analysis done.
    2 big points:
    • There are currently no proven long-term, non-surgical solutions to repair chronic shoulder tendon
    injuries
    • Ortho-ATI® is well positioned to become the first FDA approved injectable cell therapy in orthopaedics
    for the treatment of chronic tendon injuries
    Remembering its only the result from Rotator cuff trial, still recruiting for Tennis elbow 92% completed last 4c, pending full recruitment CY2021.
    "The Company remains on track to complete data analysis for the RC Study with data expected to be
    available in Q4, 2021. The Company will provide further updates in relation to the market opportunity
    for Ortho-ATI®, the regulatory strategy to be pursued to enable rapid approval by FDA and also the
    study design to facilitate the first global approval of a cell therapy for tendon injuries. Plans for the
    development of a US commercial and development team are well advanced and are pending
    successful outcomes from this important study".....going it alone in US??
    Huge prospects for Nerve repair unmet need.....
    The Company continues to work closely with the Experien Group, headquartered in Silicon Valley as
    the Company’s US regulatory advisers to evaluate opportunities for expedited approval of Remplir
    for nerve regeneration. The team is now finalising the US FDA submission to confirm the most
    appropriate US regulatory pathway, potential for inclusion in expedited programs and what this will
    mean for reimbursement value for the product.
    End the year with a BANG...yep sure. gltah cept Lopez
 
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