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    Orthocell Receives Approval for Human Nerve Regeneration Study Using CelGro®

    Chelsea Pratt
    Oct. 18, 2016 01:34AM PST
    Biotech Investing

    Regenerative medicine company Orthocell has been granted ethics approval for a human study examining the effectiveness of its CelGro® collagen medical device, to guide and promote nerve regeneration in severed peripheral nerves of the hand and upper limb.

    Regenerative medicine company Orthocell has been granted ethics approval for a human study examining the effectiveness of its CelGro® collagen medical device, to guide and promote nerve regeneration in severed peripheral nerves of the hand and upper limb.
    The primary objective of this study is to demonstrate the safety,
    tolerability and effectiveness of CelGro® when used as a conduit in the
    surgical repair of peripheral nerve injuries. The study will involve 20
    patients who have suffered injury to one or more peripheral nerves and
    will be undertaken at St John of God Hospital beginning in the fourth
    quarter of calendar 2016.
    Peripheral nerve injury is most commonly caused by accidents or other
    trauma and in the US alone, over 20 million people are affected each
    year, at a cost of approximately $150 billion in annual health care
    dollars.
    Principal investigator, orthopaedic surgeon Dr Alex O’Beirne said: “This
    is an exciting development that has the potential to improve patient
    outcomes by allowing for a suture-less repair to the damaged nerve, to
    guide nerve regeneration and accelerate the healing process.”
    CelGro® is a biological medical device used as a scaffold for a variety
    of orthopaedic and general reconstructive surgical applications.
    Orthocell is also undertaking clinical studies using CelGro® to augment
    repair of the rotator cuff tendon within the shoulder, as an augment to
    guide and promote bone regeneration, as well as an augment to cartilage
    repair within the hip joint.
    Orthocell Managing Director Paul Anderson said, “This is an exciting new
    phase in the development of CelGro® and its use as an augment to improve
    nerve repair. It further validates CelGro as a unique platform
    technology for soft tissue repair.”
    Orthocell has submitted CelGro® for first regulatory approval in Europe
    and expects to receive notice of approval of its CE Mark application in
    2016. Receipt of this approval will enable sales of CelGro® to commence
    in Europe, and trigger applications for other regulatory approvals in
    the United States, Australia and Japan in 2017.
    About Orthocell Limited
    Orthocell is a commercial-stage, regenerative medicine company focused
    on regenerating mobility for patients and our ageing population by
    developing products for a variety of tendon, cartilage and soft tissue
    injuries. Orthocell’s portfolio of products include TGA-approved stem
    cell therapies Autologous Tenocyte Implantation (Ortho-ATI™) and
    Autologous Chondrocyte Implantation (Ortho-ACI™), which aim to
    regenerate damaged tendon and cartilage tissue. The Company’s other
    major product is CelGro™, a collagen medical device which facilitates
    tissue repair and healing in a variety of orthopaedic, reconstructive
    and surgical applications and is being readied for first regulatory
    approvals.

    australiaclinical studieseuroperegenerative medicineunited states
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