AVITA Medical Announces Medical Education Symposium and Presentation of RECELL® System Pivotal Trial Results at U.S. Midwest Region Burn Conference
VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--Avita Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that a medical education symposium on the use of the RECELL® Autologous Cell Harvesting Device (RECELL® System) was held at the U.S. Midwest Region Burn Conference in Minneapolis. The symposium was led by Jeffrey Carter, MD, FACS, Medical Director of University Medical Center New Orleans Burn Center and Associate Professor of Surgery at LSU Health New Orleans School of Medicine. Dr. Carter also presented at the conference the results from two U.S. pivotal clinical trials demonstrating the effectiveness and clinical benefits of the RECELL System.
The U.S. Food and Drug Administration (FDA) recently approved the RECELL System to treat acute thermal burns in patients 18 years and older. The medical symposium was organized as the first step in training U.S. physicians who had not previously treated patients with the RECELL System in advance of FDA approval in clinical trials or in the Compassionate Use program. The Midwest Region Burn Conference is one of the series of conferences sponsored by the American Burn Association each year.
“The RECELL System allows us to navigate a new course of recovery for people suffering acute burn injuries. The clinical trials using the RECELL System have demonstrated a substantial reduction in the burden of burn care where patients have dramatically reduced donor sites and improved scarring,” said Dr. Carter. “In my own experience at two active burn centers using the RECELL System, patients have also demonstrated significantly reduced length of stays and inspiring outcomes. These kinds of results are exciting, and I am pleased to have the opportunity to share with my peers this innovative product that has enabled us to bring regenerative medicine out of the lab and to the bedside.”
The RECELL System is approved by the FDA to be used at the point of care by licensed healthcare professionals to treat adult patients with acute thermal 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.
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 enzymatically and mechanically processed in the RECELL System at the point of care to isolate the skin cells to produce a suspension of Spray-On Skin Cells. The regenerative cell suspension includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. The suspension can be sprayed directly on a second degree burn or with an expanded skin graft on a third-degree burn, allowing for broad and even distribution of live cells across the entire wound bed. The RECELL System can be used to prepare enough suspension 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 two randomized, controlled clinical trials presented by Dr. Carter at the conference were used to support the FDA approval and 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.
Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device for a full description of important safety information including contraindications, warnings and precautions.
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™), an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
AVITA Medical’s first FDA approved product, the RECELL® System, produces Spray-On Skin™ Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 7,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings.
In international markets outside of Europe, our portfolio is marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia, and CFDA-cleared in China.
In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. The RECELL Autologous Cell Harvesting Device is designed for the treatment of burns and plastic reconstructive procedures; REGENERCELL™ Autologous Cell Harvesting Device has been formulated for chronic wounds including leg and foot ulcers; and RENOVACELL™ Autologous Cell Harvesting Device is tailored for aesthetic applications including the restoration of pigmentation.
To learn more, visit www.avitamedical.com.
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among other things, our ongoing clinical trials and product development activities, regulatory approval of our products, the potential for future growth in our business, and our ability to achieve our key strategic, operational and financial goal. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward- looking statement contained in this letter is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the timing of regulatory approvals of our products; physician acceptance, endorsement, and use of our products; failure to achieve the anticipated benefits from approval of our products; the effect of regulatory actions; product liability claims; risks associated with international operations and expansion; and other business effects, including the effects of industry, economic or political conditions outside of the company’s control. Investors should not place considerable reliance on the forward-looking statements contained in this letter. Investors are encouraged to read our publicly available filings for a discussion of these and other risks and uncertainties. The forward-looking statements in this letter speak only as of the date of this release, and we undertake no obligation to update or revise any of these statements.
Syneos Health Public Relations
Christian Pflaumer, +1-212-229-8412
Nicole Beckstrand, +1-858-431-9611
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Caroline Corner, +1-415-202-5678
AVITA Medical Ltd
Dale A. Sander, +1-661-367-9178
Chief Financial Officer Phone
Source: AVITA Medical