Avita Medical (ASX: AVH) (OTCQX: AVMXY), a regenerative medicine
company specializing in the treatment of wounds and skin defects,
today announced the execution of an expanded contract option valued
at approximately US$24.3 million. This newly executed contract
option establishes funding for key clinical and health economics
research in U.S. pediatric burn care and extends Avita’s Project
Bioshield contract through to September 2022.
The option execution relates to an original contract between
Avita Medical and the Biomedical Advanced Research and Development
Authority (BARDA), a division of the U.S. Department of Health and
Human Services, Office of the Assistant Secretary for Preparedness
and Response (ASPR).
Avita Medical has had a strong relationship with BARDA since the
execution of a five-year contract in September 2015. Under the base
contract BARDA made an initial investment of US$16.9 million to
support Avita’s ongoing U.S. clinical regulatory program towards
FDA Premarket Approval (PMA), and to procure 5,000-plus ReCell®
devices. The contract also allowed BARDA to exercise future options
to support additional clinical trials, and provide surge capacity
for up to another 20,000 ReCell® devices. Supplemental funding
worth up to US$7.96 million was also provided to Avita under the
contract in June of 2016, to provide further operational support to
Avita’s PMA preparation and Compassionate Use program. Both
objectives support BARDA's overarching goal of building burn care
preparedness, by securing effective medical countermeasures for
burn injuries for use in case of a mass casualty.
The base contract between BARDA and Avita Medical has provided
substantial support to the shared primary goals of achieving U.S.
regulatory approval for the Company’s ReCell® Autologous Cell
Harvesting Device thus establishing preparedness for a potential
U.S. mass casualty event involving thermal burn injuries.
Pediatric burn care is of particular concern to BARDA and Avita,
as the primary modality for treatment continues to involve
harvesting the patient’s own skin for autografts. Thirty percent of
burns in the U.S. occur in patients under 16 years of age.i In the
pediatric population, donor skin comes at a high premium due to
limited availability and distinct increases in morbidity associated
with harvesting skin for conventional autografts. Pediatric use is
of interest to BARDA because MCM development must include at-risk,
vulnerable populations such as children.
Two randomized control trials (RCTs), powered to demonstrate
statistical significance, have been presented to the FDA via the
pre-submission process. One trial focuses on characterizing benefit
derived from use of Regenerative Epithelial Suspension prepared
using the ReCell® device to treat donor sites in patients aged 1 to
16 years. The other trial, planned to run in parallel, will aim to
show decreases both in time to healing and in the frequency of
conventional autografting in patients of the same age range who
have suffered second-degree burn injuries. Second-degree burns
often result from scald injuries, accounting for approximately 60%
of burns in the U.S. in the study population. i The two-cohort
study design, planned to include collection of costing data in
addition to clinical data, will further inform both clinical and
health economic benefits of using ReCell®. Both studies will
compare treatment using the ReCell® device versus current standard
approaches. Up to twenty U.S. burn centers may be involved in
recruiting patients into these studies.
“Continued development of the foundation of evidence supporting
the use of ReCell® is essential for elevating the standard of care
in pediatric burns. These studies will contribute substantially
toward rounding out the story and enabling changes to burn care in
everyday clinical practice,” said Andrew Quick, Sr. VP of Clinical
Development.
i 2016 National Burn Repository Report of Data from 2006-2015,
The American Burn Association
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.
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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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