Valencia, Calif., USA, and Melbourne, Australia, 16 November 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that it has completed hiring of the U.S. sales team to support the U.S. market launch of the RECELL® System for the treatment of acute thermal burns. The full direct sales team of 20 healthcare professionals has joined AVITA and are in the process of completing a rigorous training program, including on-site training within burn centers, in preparation for the market launch of the RECELL System. The Company also announced that in advance of the market launch a total of 32 U.S. burns centers are in active review of the RECELL System or have commenced ordering and are taking deliveries of the product. The U.S. sales team includes Regenerative Tissue Specialists (RTS) who are based throughout the U.S. and will lead the qualification, account management, and relationship development within each burn center. Each RTS is highly experienced in the burn care market and well versed in the clinical aspects of patient care. Also incorporated in the sales team are Clinical Training Specialists (CTS) who will train surgeons and nurses and assist burn centers in their use of the RECELL System. Each CTS is a Registered Nurse and joins AVITA with an accomplished background in burn care and institutional relationships. The efforts of the RTS and CTS teams to train and certify doctors and nurses will be augmented by AVITA’s Medical Affairs team, a group that is highly experienced in the burn space and were responsible for training the 24 burn centers who participated in the clinical trials and Compassionate Use program for the RECELL System. “We are quite pleased with how quickly we were able to recruit a highly experienced, specialized field force,” said Erin Liberto, Chief Commercial Officer. “Industry awareness and credibility resulting from the strong clinical results and economic benefits of the RECELL System led to the fast recruitment and enables us to proceed quickly to the U.S. national sales launch during the first week of January 2019. In general, we expect most U.S. burn centers will follow a fairly standard process of evaluating the RECELL System and then taking it through their hospital’s Value Analysis Committees prior to purchasing the product. This process can sometimes be a lengthy one taking six months to complete, although we are already seeing a number of burn centers move more rapidly.” In advance of the national sales launch of the RECELL System a large number of burn centers have proactively initiated the process with AVITA to enable them to commence purchasing the product. Of the 134 burn centers in the U.S., 32 have already commenced an evaluation of RECELL or have proceeded to the formal purchasing approval process required to order the product. Seven of these burn centers have completed their internal processes, ordered the RECELL System, and have received commercial shipments. “We are excited about the market response to date considering that prior to our sales launch we have purely been reacting to the market interest and meeting the demand driven by our clinical results and key opinion leader support as opposed to creating demand,” said Dr. Michael Perry, Chief Executive Officer. “We are in a unique position as many large burn centers already have significant experience with the product through our clinical trials and Compassionate Use program, and we are pleased that a good number of burn centers have adopted the product in advance of the formal market launch.” Key commercial achievements subsequent to the FDA approval on 20 September 2018 include:
• Customer Service Line went live within two days of approval
• Commercial Product availability within two weeks of approval
• First commercial sale within two days of product availability
• Entire U.S. field force in place within eight weeks of approval
ABOUT THE RECELL SYSTEM
The U.S. Food and Drug Administration (FDA) approved the RECELL System in September 2018 to treat acute 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. 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 thirddegree 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 an adult patient’s entire back. Randomized, controlled trials have demonstrated that treatment of acute burn wounds with the RECELL System requires 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. Funding for the development of the RECELL System was provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C. Programs discussed above which were funded under the BARDA contract include the two randomized, controlled clinical trials, the Compassionate Use program, and development of the health economic model demonstrating the cost savings associated with the RECELL System.
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 U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns in patients 18 years and older. 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. 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. 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, CFDA-cleared in China, and received CE-mark approval in Europe.
To learn more, visit www.avitamedical.com.
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