Valencia, Calif., USA, and Melbourne, Australia, 20 December 2018 — AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that PM360, a leading trade magazine for marketing decision makers in the pharmaceutical, biotech, medical device, and diagnostics industries, has named AVITA as one of the most innovative companies of 2018.
AVITA Medical’s RECELL® Autologous Cell Harvesting System (RECELL System) was selected as part of PM360’s 7th Annual Innovations Issue which is published in December each year. The RECELL System was approved by the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of acute thermal burns in patients 18 years and older. The RECELL System is used to prepare 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. PM 360 selected the RECELL System as the product is expected to make an immediate impact within a market that has not seen major innovation in decades.
“Our selections represent the companies, offerings, and strategies that demonstrated what we believe is unique in its ability to impact the industry,” says Anna Stashower, CEO/Publisher of PM360. “We hope others in the industry are able to work with these innovators or use these innovations to better serve patients, physicians, and other healthcare stakeholders.”
PM360 received hundreds of submissions from across the healthcare and life sciences industries. The editorial staff of PM360 evaluated each submission and selected their picks for the most innovative, regardless of category. All of this year’s selections can be found at: www.pm360online.com/pm360- presents-the-2018-innovators.
PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, medical device, and diagnostics industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharmaceutical marketing professionals to succeed in the complex and highly regulated healthcare environment.
The journal’s targeted and insightful editorial focuses on issues that directly impact critical decision making, including: Planning and implementation of cutting-edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the “360” in the title signifies the span of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read.
By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.
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 is used to prepare 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 products are 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.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this letter include, but are not limited to, statements concerning, 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 forwardlooking 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