AVH 0.41% $2.42 avita medical inc.

Ann: AVH Quarterly Cash Flow Report and Company Update, page-5

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    Extract from quarterly:


    "The importance of our approval cannot be overstated, not only for AVITA Medical but for the burn community. The RECELL System was the first Premarket Approval (PMA) application for the treatment of burns approved by the FDA in over 20 years," said Dr. Michael Perry, Chief Executive Officer. "We believe that the approval will allow us to significantly advance the standard of care for the treatment of severe burns and greatly improve outcomes for patients." Less than a month after FDA approval the Company received the first commercial sales orders from multiple U.S. burn centers for the RECELL System and commenced commercial shipment of the product. The national commercial launch of the RECELL System is not scheduled to occur until after the completion of hiring and training of the Company’s field sales force, which is currently underway. Of the 134 burn centers in the U.S., 24 already have experience using the RECELL System through participation in clinical trials and the Compassionate Use and Continued Access programs. Notably, these 24 burn centers are estimated to treat more than 30 percent of the U.S. burn patients annually. A number of the larger burn centers experienced with the RECELL System have commenced incorporating the product into their practices in advance of AVITA Medical’s market launch. RECELL System"

 
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