VALENCIA, Calif. & PERTH, Australia & LONDON--(BUSINESS WIRE)--Avita Medical (ASX:AVH) (OTCQX:AVMXY), a regenerative medicine company with a technology platform positioned to address opportunities and unmet medical needs in burns, chronic wounds, and aesthetics indications, announced that Dale A. Sander has been appointed Avita’s new Chief Financial Officer (CFO) effective today. Dale will be responsible for overseeing the global finance and investor relations functions, and aligning them with the company’s commercialization strategy. Current CFO, Tim Rooney, has been appointed Avita’s Chief Administrative Officer (CAO), responsible for global operations and supply chain management, human resources, and information technology. Both executives will be based in Valencia, CA.
“These executive changes come at a pivotal time in the transformation of our company,” said Dr. Mike Perry, CEO, Avita Medical. “Dale has more than 20 years of experience, including serving as CFO of four medical device and pharmaceutical companies as well as eleven years of leading public companies in the CFO role. Dale brings extensive experience in leading both public and private equity offerings, including multiple IPOs in the U.S. and Europe. He also has a strong track record of managing investor relations in these markets as well as in Asia. Dale’s expertise will be critical in supporting our commercialization strategy in advance of our anticipated approval of ReCell® in the United States.”
Tim Rooney, who has been with Avita Medical since 2012 in various key executive roles, will now lead a variety of critical operational and strategic functions. “I’m thrilled to continue my work with Avita as part of our senior executive team,” said Tim Rooney, CAO, Avita Medical. “In my new role, I look forward to continuing my contributions to critical elements in Avita’s growth, especially as we prepare for the anticipated approval of ReCell®.”
A premarket approval (PMA) application for the ReCell® device was filed on September 28, 2017, and is currently under review by the U.S. Food and Drug Administration (FDA). ReCell® is a regenerative medicine platform with the potential to offer patients benefits across a broad range of applications, including burns, chronic wounds, and aesthetics.
ABOUT AVITA MEDICAL LIMITED
Avita’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. Our medical devices work by preparing a Regenerative Epithelial Suspension (RES™), an autologous suspension comprised of the patients’ own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This is then applied to the area to be treated.
In all countries outside of Europe, our portfolio is marketed under the ReCell® brand to promote skin healing in a wide range of applications, including burns, chronic wounds, and aesthetics.
ReCell® is TGA-registered in Australia, and CFDA-cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational use.
In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. ReCell® is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell™ has been formulated for chronic wounds, including leg and foot ulcers; and ReNovaCell™ is tailored for aesthetic applications, including the restoration of pigmentation.
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 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.