$AVMXY ---> AVITA Medical Announces FDA Approval o

$AVMXY ---> AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S. #pharma #bigpharma #stocks #market #investor #business

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VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--

Point-of-care regenerative medicine technology approved to treat second- and third-degree burns using Spray-On Skin™ Cells product

U.S. market launch planned for 4th calendar quarter 2018. Target market for burns approximates USD $200 million

AVITA Medical (ASX: AVH) (OTCQX: AVMXY), a global regenerative medicine company, today announced that the U.S. 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. 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. 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. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.

“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. Michael Perry, Chief Executive Officer. “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. 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. We also greatly appreciate our collaboration with BARDA and the support that they have provided to us throughout the development of the RECELL System.”

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. 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. 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 resultant Regenerative Epidermal Suspension™ (RES™) includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. 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 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.

“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. “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. Additionally, the potential reduction in mortality is extremely promising.”

FDA Approval Supported by the Results from Two Randomized, Controlled Clinical Trials

FDA 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. 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. During the pivotal trial, the patient donor skin required to be harvested to treat burn sites with the RECELL System was 97.5% less than the amount harvested to treat burn sites using standard of care resulting in a statistically significant reduction in patient-reported pain, increased patient satisfaction and improved donor scar outcomes. Despite the statistically significant reduction in donor skin required to treat with the RECELL System, burn sites treated with RECELL achieved definitive closure comparable to the burn sites treated with standard of care. Results from the second-degree burn pivotal trial were published online on May 24, 2018 in the Journal of Burn Care & Research (JBCR), followed by publication in the September/October 2018 issue (Volume 39, Issue 5) of JBCR. The results have also been presented at multiple scientific conferences, including the Top Five Abstract plenary session of the American Burn Association (ABA) 50th Annual Meeting held in April 2018.