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    Avita Medical
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    28159 Avenue Stanford, Suite 220 Valencia, CA 91355
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    AVITA Medical Announces Achievement of Co-Primary Endpoints in Updated Analysis of Pivotal Trial of RECELL® System for Soft Tissue Repair

    Details:

    The RECELL® System technology platform, approved by the FDA for the treatment of acute thermal burns in both adults and children, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells.


    Lead Product(s): Regenerative Epidermal Cell

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: RECELL

    Highest Development Status: UndisclosedProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 09, 2022

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    AVITA Medical Completes Enrollment in Pivotal Trial Evaluating the RECELL® System for Soft-Tissue Reconstruction

    Details:

    Enrollment of Pivotal trial for Recell (Regenerative Epidermal Suspension) is completed and topline result are expecting in the second half of 2022 for treatment of soft-tissue reconstruction.


    Lead Product(s): Regenerative Epidermal Suspension

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Recell

    Highest Development Status: ApprovedProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 06, 2022

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    FDA Approves IDE Amendment to a Single-Arm Design for AVITA Medical’s Pivotal Study of the RECELL® System for Vitiligo Treatment

    Details:

    The primary effectiveness evaluation is based on a comparison of the incidence of successful repigmentation with RECELL versus that of a standard of care control. Long-term durability data (assessing sustained repigmentation over 52 weeks) will be collected.


    Lead Product(s): Regenerative Epidermal Suspension

    Therapeutic Area: Dermatology Product Name: Recell

    Highest Development Status: ApprovedProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 16, 2021

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    First Patient Enrolled in AVITA Medical’s Pivotal Study Evaluating RECELL® System for Pediatric Scald Injuries

    Details:

    This study seeks to demonstrate that treatment with the RECELL System of partial-thickness burn injuries within 72-hours can safely increase the healing at day 10.


    Lead Product(s): Autologous regenerative epidermal cells

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Undisclosed

    Highest Development Status: UndisclosedProduct Type: Cell and Gene therapy

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 04, 2020

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