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[{"orgOrder":0,"company":"Avita Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"First Patient Enrolled in AVITA Medical\u2019s Pivotal Study Evaluating RECELL\u00ae System for Pediatric Scald Injuries","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Undisclosed","date":"March 2020","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Undisclosed"},{"orgOrder":0,"company":"Avita Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves IDE Amendment to a Single-Arm Design for AVITA Medical\u2019s Pivotal Study of the RECELL\u00ae System for Vitiligo Treatment","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"August 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Avita Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AVITA Medical Completes Enrollment in Pivotal Trial Evaluating the RECELL\u00ae System for Soft-Tissue Reconstruction","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Approved"},{"orgOrder":0,"company":"Avita Medical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AVITA Medical Announces Achievement of Co-Primary Endpoints in Updated Analysis of Pivotal Trial of RECELL\u00ae System for Soft Tissue Repair","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Undisclosed"}]

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            Development Status

            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: Undisclosed Product 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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            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: Approved Product 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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            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: Approved Product 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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            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: Undisclosed Product 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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