AVITA Medical Announces Receipt of A$1.4 Million Research and Development Tax Credit
December 17 2018 - 10:49PM
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$1,421,000 for the year ending 30 June
2018. The R&D Tax Credit Incentive program provides a cash
rebate to support companies in Australia conducting research and
development projects. Projects undertaken by AVITA Medical
qualifying for the rebate include the development of its RECELL®
Autologous Cell Harvesting Device (RECELL® System), as well as
expanded research and development related to the RECELL System and
the Company’s broader regenerative medicine platform.
“The non-dilutive financing provided by the R&D tax credit
has greatly assisted our development of the RECELL System and we
appreciate the ongoing support of the Australian government,” said
Dr. Michael Perry, Chief Executive Officer. “As we close out 2018,
we look forward to the next major milestone in AVITA’s progression,
the early January 2019 U.S. market launch of RECELL for the
treatment of thermal burns.”
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 produces 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
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: https://www.businesswire.com/news/home/20181217005902/en/
Media:Monsoon CommunicationsSarah KemterPhone: +61
(0)3 9620 3333Mobile: +61 (0)407 162 530sarahk@monsoon.com.au
Investors:Westwicke PartnersCaroline CornerPhone:
+1-415-202-5678caroline.corner@westwicke.com
AVITA Medical LtdDale A. SanderChief Financial
OfficerPhone: +1-661-367-9178dsander@avitamedical.com
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