The first controlled trial compared treatment with the RECELL System versus treatment with conventional split-thickness autografts in patients with deep partial-thickness (second-degree) burn injuries. Additionally, the potential reduction in mortality is extremely promising.” FDA Approval Supported by the Results from Two Randomized, Controlled Clinical TrialsįDA approval was based on the results of two randomized, controlled clinical trials comparing the treatment of burn patients with the RECELL System against the standard of care. “Dramatically reducing the amount of donor skin needed to treat second- and third-degree burns has important implications for pain, scarring and costs of care, while still providing comparable healing to the current standard of care. “Today’s approval of the RECELL System is a significant advancement in how we treat patients with burns,” said James H Holmes IV, MD, FACS, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina. The RECELL System can be used to prepare enough RES™ to treat a wound up to 80 times the size of the donor skin sample, so a skin sample approximately the size of a credit card can be used to treat a wound that covers a patient’s entire back. The suspension is then sprayed directly onto the prepared burn wound, providing a broad and even distribution of live cells across the entire wound bed. The resultant Regenerative Epidermal Suspension™ (RES™) includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. A small skin sample is collected and immersed in the Company’s proprietary Enzyme solution in the RECELL System to separate the skin cells to produce Spray-On Skin Cells. The RECELL System can be used alone in the treatment of partial- thickness burns, or in combination with autografting for the treatment of full-thickness burns. The RECELL System is approved to be used at the point of care by trained healthcare professionals to treat adult patients with severe thermal burns. We also greatly appreciate our collaboration with BARDA and the support that they have provided to us throughout the development of the RECELL System.” We are grateful to those patients who participated in clinical trials of the RECELL System and to the clinical trial investigator teams whose dedication and scientific rigor made this approval possible. “Today’s approval of the RECELL System marks an important milestone for us and provides a new way to treat burns for the thousands of patients with significant unmet medical needs. “Patients are at the center of everything we do at AVITA Medical and we are pleased to be able to provide an innovative solution for the treatment of severe burn injuries,” said Dr. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment. The two randomized, controlled clinical trials supporting the FDA approval demonstrated that treatment of acute burn wounds with the RECELL System required substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin™ Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. Food and Drug Administration (FDA) approved the Company’s Premarket Approval (PMA) application to market the RECELL® Autologous Cell Harvesting Device (RECELL® System) to treat severe thermal burns in patients 18 years and older. Valencia, Calif., USA, and Melbourne, Australia, 21 September 2018 - AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that the U.S. Target market for burns approximates USD $200 million market launch planned for 4 th calendar quarter 2018. Point-of-care regenerative medicine technology approved to treat second- and third-degree burns using Spray-On Skin™ Cells product
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