AVITA Medical Announces Receipt of $1 Million Research and Development Tax Credit
September 25 2018 - 7:54PM
Business Wire
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, today announced that it has received a Research
and Development Tax Incentive cash rebate from the Australian Tax
Office in the amount of A$1.0 million for the year ending 30 June
2017. The R&D Tax Credit incentive program provides a cash
rebate to support companies in Australia in undertaking research
and development projects. Qualifying projects undertaken by AVITA
Medical qualifying for the rebate included the development of its
RECELL® Autologous Cell Harvesting Device (RECELL® System), which
was approved by the U.S. Food and Drug Administration (FDA) last
week to treat severe thermal burns in the U.S.
“We appreciate the support of the Australian government in the
development of our regenerative medicine platform, including the
RECELL System,” said Dr. Michael Perry, Chief Executive Officer.
“Last week’s FDA approval of the RECELL System was a major
undertaking and resulted from the contributions by patients,
clinical trial investigator teams and our dedicated employees. The
non-dilutive funding provided by the R&D Credit over the past
several years helped make this success possible.”
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 FDA approved product, the RECELL® System,
produces Spray-On Skin™ Cells using a small amount of a patient’s
own skin, providing a new way to treat acute burns wounds in
patients 18 years of age and older, 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, and
CFDA-cleared in China.
In Europe, our portfolio of medical device products received
CE-mark approval as three tailored product presentations, with
three individual brand names. The RECELL Autologous Cell Harvesting
Device is designed for the treatment of burns and plastic
reconstructive procedures; REGENERCELL™ Autologous Cell Harvesting
Device has been formulated for chronic wounds including leg and
foot ulcers; and RENOVACELL™ Autologous Cell Harvesting Device 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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US MediaSyneos Health Public RelationsChristian
PflaumerPhone +1-212-229-8412Nicole BeckstrandPhone
+1-858-431-9611AVITAMedicalTeam@syneoshealth.comorOUS
MediaMonsoon CommunicationsSarah KemterPhone +61 (0)3
9620 3333Mobile +61 (0)407 162
530sarahk@monsoon.com.auorInvestors:Westwicke
PartnersCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.comorAVITA
Medical LtdDale A. SanderChief Financial OfficerPhone
+1-661-367-9178dsander@avitamedical.com
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