Valencia, Calif., USA, and Melbourne, Australia, 15 May 2019 — AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, announced today that Dale A. Sander is resigning as Chief Financial Officer (CFO) to spend more time with his family on the east coast, effective immediately. Tim Rooney, AVITA’s Chief Administrative Officer, will assume the role of interim CFO until a comprehensive search can be completed. Tim previously served as CFO for AVITA from 2012 to 2017 before assuming his current role.
“We thank Dale for his service and contributions to AVITA over the past eighteen months and wish him all the best,” said Dr. Mike Perry, Chief Executive Officer. “This year has proven to be transformational for AVITA as we continue the launch of our first product for the treatment of burns in the United States. Tim is well suited to assume the interim role of CFO. In addition to his deep financial expertise and previous experience as AVITA’s CFO, Tim is instrumental in our ongoing operational and strategic growth.”
Mr. Rooney joined AVITA Medical as CFO and Chief Operating Officer in 2012, leading various key executive roles including interim CEO from 2013 to 2015. Prior to AVITA, Mr. Rooney was an executive at PDI Enterprises, Inc., a pharmaceutical wholesale distributor, where he served as CFO/COO, and managed their revenue growth from $5 million to $430 million. Mr. Rooney holds degrees in Business Administration with an emphasis in Finance and Economics and has over 25 years of experience in C-level financial and operational management in the healthcare industry.
AVITA has retained an executive recruiting firm to commence a formal search for a permanent Chief Financial Officer.
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 (https://recellsystem.com/) for a full description of indications for use and 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 and CFDA-cleared in China.
To learn more, visit www.avitamedical.com.
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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 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.
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