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AVITA Medical Announces FDA Approval of New RECELL® System with Improved Ease of Use
System enhanced in response to clinician workflow and usability feedback; new system simplifies process United States product launch planned for Q2 2022
About this update from Avita Medical, Inc.
[{"type":"text","content":"System enhanced in response to clinician workflow and usability feedback; new system simplifies process United States product launch planned for Q2 2022 VALENCIA, Calif. and MELBOURNE, Australia, Feb. 17, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that the United States Food and Drug Administration (FDA) has reviewed and approved the premarket approval application (PMA) supplement for RECELL® Autologous Cell Harvesting Device, an enhanced RECELL System aimed at providing clinicians a more efficient user experience and simplified workflow. The RECELL® System is a device that enables healthcare professionals to produce a suspension of Spray-On Skin™ Cells using a small sample of the patient’s own skin for the treatment of acute thermal burns. “To ensure RECELL continues to meet the needs of our customers, we initiated a program to explore how we could improve the device, and then addressed those matters with this new system,” said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. “Based upon research and human factors testing, we are confident that the new RECELL System will be positively received by the burn community. The enhancements will provide a range of benefits to clinicians using the device and in turn, patients will benefit as the procedure becomes more efficient.” Until now, the RECELL System – which launched in the United States nearly two years ago – consisted of multiple individually packaged sterile components requiring transfer into the sterile field and required clinicians to rely on multiple people to assist during the process. AVITA Medical researchers spoke with surgeons, physician assistants and registered nurses – both experienced and new users of the device – to study how procedures with the RECELL System are being conducted in real-world scenarios and how they can be improved. While the intended use of the device as a whole remains unchanged, the RECELL System has been modified to reduce set-up steps by approximately one-third and to enable use of the device with reduced support personnel. In a survey, 94% of users believe that the new RECELL System will allow them to prepare for a pro...