Today, the CEO of Avita Medical Limited
(ASX:AVH) (OTCQX:AVMXY) issued the following letter to
shareholders:
Dear Shareholder,
It is with great pleasure that I write to you as the new CEO of
Avita Medical as we move into an exciting new era of
commercialization and clinical trials. Avita’s proprietary
technology that generates our “spray-on skin” or RES (Regenerative
Epithelial Suspension) delivers to the patient an innovative
regenerative medicine solution applicable to a broad array of
challenging skin conditions. These include, but are not limited to,
acute and/or chronic skin injuries such as burns and chronic wounds
as well as various skin defects such as depigmentation, for example
in patients with vitiligo. Our technology platform is one that I
contend to be unique in the marketplace with a plethora of
opportunities.
I have been involved with Avita as a non-executive director
since early 2013 and bring with me extensive experience and
expertise across the value chain in cellular therapies.
Additionally, I bring to the company notable experience in product
development, regulatory affairs, business development, and general
management — all of which I trust will be of material value to
Avita’s future success.
My motivation to undertake the CEO role for the company was in
part inspired because 2017 and 2018 are transformational years for
Avita that include multiple value-creating milestones including a
US PMA (Premarket Approval Application) submission, initial BARDA
procurement, potential for an advisory panel as part of the FDA
review process, and an opportunity to focus on augmenting our
supply chain while eagerly preparing for our US launch in 2018.
Many of you may be asking yourselves, what is different today as
compared to prior years for Avita Medical? Well, let me begin by
stating some important facts that will shape and indeed transform
Avita’s future trajectory. Firstly, the US represents the largest
healthcare market in the world, and this accounts for our
increasing US focus. Secondly, in 2015, a five-year contract was
signed with the Biomedical Advanced Research and Development
Authority (BARDA) allocating US$61.9 million to Avita. Of key
importance is the fact that BARDA is supporting not only our PMA
process, but is also substantially motivated to ensure that Avita
is market-ready by supporting ongoing exposure and training of
clinicians and surgeons to our product via Compassionate Use and
Continued Access. Thirdly, BARDA intends to purchase, prior to US
FDA approval, US$7.5 million of ReCell® devices to be stockpiled
with an option to buy up to an additional US$23.5 million in
support of surge capacity. Moreover, BARDA has also allotted US$6.9
million in support of a burns trial in pediatric patients.
In a nutshell, BARDA funds are being purposefully directed to
broadly strengthen Avita’s operations, to de-risk our FDA review
and approval process, and to build awareness of ReCell® in the
burns community ahead of our US launch. So, to answer the question
directly, this is remarkably different from our prior approach
because the US launch of our technology platform will this time be based upon well controlled clinical
trials inextricably intertwined with robust health-economic and
cost-effectiveness data. These data will demonstrate to regulators
and physicians alike, that ReCell® works precisely as we claim it
does and will justify why it should be embraced as the new standard
of care.
As you are aware from our mid-May announcement, we have
completed our US pivotal trial which demonstrated positive results
in our US burns study.
As I mentioned above, in the near-term, Avita intends to submit
a PMA to the US FDA seeking approval of ReCell® for use in patients
with severe burns. We also plan to review whether the US should
become Avita’s main operational hub while still maintaining key
strategic R&D efforts in Australia and other influential
geographies. To this end, Avita will be conducting a strategic
review to assess the long-term positioning of the company and its
operations as it increasingly looks to the US markets for growth of
product sales. Within this framework, we also intend to review the
best location for Avita’s administration and head office and to
concurrently evaluate future capital requirements as we grow the
company. This strategic review may include a proposal for moving
our administration and head office functions to the US in context
of a re-domicile of the group.
I look forward to keeping you updated as we progress in
achieving our goals and objectives.
Sincerely,
Mike
Dr. Michael S. PerryChief Executive OfficerAvita Medical
Ltd.
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 and compassionate
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170712006389/en/
AustraliaMonsoon CommunicationsSarah KemterPhone:
+61 (0)3 9620 3333Mobile: +61 (0)407 162
530sarahk@monsoon.com.auorUSAWestwicke PartnersJamar
IsmailPhone: +1 (415) 513-1282jamar.ismail@westwicke.com
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