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    AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction

    “FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our RECELL System technology platform. We are pleased with the strong interest expressed by the clinical community in participating in this study and we look forward to working with physicians and their patients upon study commencement,” said Dr. Michael Perry, Chief Executive Officer of AVITA Medical.

    RECELL® System Feasibility Study Results

    The 26-week, single-arm, observational study included 16 patients treated at three hospitals in the United Kingdom, including Manchester Royal Infirmary, Kings College Hospital and Northwick Park Hospital.

    AVITA Medical Announces U.S. National Market Launch of RECELL® System

    1/8/19: The U.S. sales team of Regenerative Tissue Specialists and Clinical Training Specialists that joined AVITA Medical in November 2018 has been trained and fully deployed across the U.S. in support of the nationwide launch of the RECELL System.

    AVITA Medical Announces Commencement of Randomized Controlled Clinical Study of RECELL® System in Treatment of Children with Burn Injuries

    10/25/18: Avita Medical reports the clinical study is being conducted in Brisbane, Australia in collaboration with the Queensland University of Technology and Lady Cilento Children’s Hospital.

    AVITA Medical Announces Acquisition of Manufacturing Facility to Support Planned U.S. Launch of RECELL® Device

    6/28/18: “Having direct control over the manufacturing of RECELL will ensure that we have the capacity to meet commercial demand, including the planned U.S. launch and the BARDA procurement, and provide us further control over our production processes and timelines,” said Dr. Michael Perry, Chief Executive Officer. “Acquiring this facility that has a track record of producing RECELL allows us to realize the benefits of inhouse production while maintaining the continuity of proven manufacturing and quality processes and systems.”

    AVITA Medical Announces Presentation of RECELL® Device Clinical Trial Results at Changhai Academic Week for Burns Treatment Conference in China

    6/27/18: Also announces that Plastic Surgery Department of Peking Union Medical College Hospital (PUMCH) completes first national training session in treatment of vitiligo and scars.

    AVITA Medical Announces Institutional Placement of A$16 Million to Support U.S. Commercialization of the RECELL® Device

    6/6/18: “We appreciate the support of our shareholder group and the investors in this institutional placement as we proceed toward a transformative series of events for AVITA, including the U.S. market launch of the RECELL Device,“ said Dr. Michael Perry, Chief Executive Officer. “Proceeds from this placement will ensure that we are positioned to take full advantage of the expected upcoming PMA approval of the RECELL Device in the U.S., including establishment of our marketing and sales team, scale-up of manufacturing capabilities and expansion of clinical development. The extensive series of clinical data presented at the recent ABA and ISPOR conferences strongly supports the value of RECELL in the treatment of severe burns, and we have an exceptional commercial opportunity resulting from the unique combination of improved patient outcomes and substantial health economic benefits.”

    AVITA Medical Announces Presentation at ISPOR Meeting Validating Acute Burn Health Economic Model

    5/22/18: “This first landmark economic model examines the continuum of definitive care in burns and can bring value to the burn community by estimating the likely economic impact of new treatments for burns,” said Pinar Bilir, IQVIA.

    RECELL® Pivotal Trial in Third-Degree Burns Meets Co-Primary Endpoints and Shows Statistically Significant Reduction in Donor Skin Requirements

    4/16/18: Presentation at American Burn Association Meeting highlighted potential of RECELL to improve patient care in severe burns.

    RECELL® Study in Facial Burns Shows Excellent Cosmetic Outcomes

    4/13/18: Two presentations at the American Burn Association Meeting highlight potential of RECELL to improve patient care in difficult-to-treat burns.

    RECELL® Data Demonstrating Statistically Significant Reduction in Donor Skin Requirements and Pain, Increased Patient Satisfaction and Improved Donor Scar Outcomes for Second-Degree Burn Patients

    4/12/18: RECELL Device presentations include data from pivotal trial and health economic results showing 44 percent reduction in total treatment costs compared to standard of care.

    Avita Medical Announces Submission of U.S. FDA Premarket Approval Application for the ReCell® Device for Treatment of Burn Injuries

    Avita Medical (ASX: AVH) (OTCQX: AVMXY), (a regenerative medicine company specializing in the treatment of wounds and skin defects), announced today that it has...

    Avita Medical and BARDA Execute a US $24.3m Contract Option

    Australia & LONDON--(BUSINESS WIRE)--Avita Medical (ASX: AVH) (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, today announced...

    Avita Medical: New Randomized Trial Shows ReCell® Heals Donor Sites Faster

    Deploying a suspension of cells generated from a ReCell® medical device onto a skin donor site can speed up healing by 30.7% and deliver...

    Avita Medical Announces Positive Results from Pivotal Trial Highlights

    These data will be submitted to the U.S. Food and Drug Administration as part of an application to support Premarket Approval (PMA) for the ReCell® Autologous Cell Harvesting device.

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