Highlights
- Co-primary endpoints achieved in
pivotal trial deploying ReCell® in patients with severe burns
- Positive results also seen in another
supportive trial
- Company on track to file a PMA with the
U.S. Food & Drug Administration in mid-2017
- Avita primed to execute on U.S.
commercialization strategy as early as Q2 2018
Avita Medical Limited (ASX:AVH; OTCQX:AVMXY), a regenerative
medicine company focused on the treatment of wounds and skin
defects, today said it achieved both co-primary endpoints in its
pivotal clinical trial which will soon be submitted for U.S. market
approval of its ReCell® device to treat severe burns. The company
also released supportive results from a previous burns trial in a
dual data release.
These data will be submitted to the U.S. Food and Drug
Administration as part of an application to support Premarket
Approval (PMA) for the ReCell® Autologous Cell Harvesting device.
The Company is now focused on fulfilling requirements for remaining
non-clinical data needed for the PMA submission, which is on track
for mid-2017. Based on expected timelines, approval could occur by
Q2 2018, the Company said.
“The positive results from both clinical trials clearly
demonstrate the efficacy of ReCell® for treating burn injuries,”
said Dr James Holmes, from Wake Forest Medical Center, North
Carolina, who led the pivotal trial. “Submission of the PMA, and
FDA approval, will be the final steps on a long road to improve
burn care. The addition of ReCell® to the U.S. burn surgeon's
armamentarium is eagerly awaited and will undoubtedly advance burn
care in the U.S.”
The 30-patient trial was conducted at seven leading U.S. burn
centers between 2015 and early 2017. Co-primary endpoints were
designed to demonstrate the effectiveness of ReCell® when combined
with widely meshed (expanded) skin grafting in the closure of
deep-partial and full-thickness burn injuries. Within the trial
design, treatment was randomly allocated to two separate parts of
each patient’s burn wound such that a controlled comparison of
outcomes could be made for conventional skin grafting versus the
combination of ReCell® with a more expanded skin graft. Independent
analyses of the study data showed that the co-primary endpoints
have both been met.
The first co-primary effectiveness endpoint gauged superiority
of donor skin expansion, to resolve whether using ReCell® could
lead to less donor skin being needed. This difference in donor skin
expansion with ReCell® was found to be significant (p<0.001) and
resulted in use of an average of just over 30% less donor skin than
the Control and a commensurate reduction in donor site size.
The second co-primary effectiveness endpoint explored the
incidence of healing within 8 weeks, which was similar in wounds
that received ReCell® compared to those that received control
treatment. Healing with ReCell® was found to be statistically
non-inferior relative to conventional treatment.
Three secondary endpoints evaluated (1) patient preference of
scar outcomes along with (2) patient- and (3) blinded-observer
overall opinion ratings using a standardized scar assessment scale
and no statistical difference was observed between ReCell® and
Control on these measures. The Company said it was encouraged by
the equivalent secondary endpoint data because more expanded meshed
skin grafts are expected to result in a worse long-term scar
outcome, but this was not the case with the adjunctive use of
ReCell® with these autografts.
The results of the co-primary endpoints suggest the use of
ReCell®, relative to conventional autografting, can result in use
of over 30% less donor skin to achieve comparable short-term
healing and long-term scar outcomes. This is important for patients
dealing with burn injuries, because the harvesting of donor skin
adds discomfort and increases the effective size of their
injury.
The Biomedical Advanced Research and Development Authority
(BARDA) has supported Avita’s late-stage clinical development of
ReCell® through a USD 61.9m contract. The successful completion of
this trial is a major Avita milestone under the BARDA contract,
supporting the Department of Health and Human Services mission
toward burn care preparedness in the response to a mass casualty
event.
The other U.S. trial was conducted between 2010 and 2014, and
involved 101 burns patients treated under the same Investigational
Device Exemption (IDE) as used for the PMA pivotal trial.
Participants in this trial were treated under a different protocol
that compared the effectiveness of the cell suspension alone to
that of conventional meshed autografting on partial-thickness
injuries. These data showed superiority in healing of donor sites
used for ReCell®. It also showed superiority of scar outcomes in
terms of scar height, in the straight comparison between ReCell®
and autografting. The data did not show statistical non-inferiority
of burn injury healing using ReCell® compared to standard
treatment, although analysis of the group concluded this outcome
was due to post-operative care rather than treatment. The Company
said this earlier work could support Avita’s PMA submission by
providing additional safety and effectiveness information. Avita
received support for this trial from the Armed Forces Institute of
Regenerative Medicine (AFIRM), a six-way partnership among the U.S.
Army, Navy, Air Force, Veterans Administration, the Defense Health
Program and the National Institutes of Health.
“Both studies validate our broader view that this unique
regenerative approach will transform the way burns are treated in
the U.S., a sector that has been starved of innovation for many
years,” said Andy Quick, Avita’s Senior VP of Clinical Development.
“The successful trial data represent years of hard work and
commitment from patients and physicians across the U.S., all of
whom we would like to thank for their participation. We look
forward to publication of the complete data set in a peer-reviewed
journal.”
Avita CEO Adam Kelliher agreed, saying: “This significant data
readout, from a total of 131 burns patients evaluated under
randomized controlled settings, takes us one step further along the
approval pathway. The Avita team will now push ahead with
completing and submitting the PMA, our next big milestone as we
work towards launching ReCell® into the U.S. burns market.”
To learn more, visit www.avitamedical.com.
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.
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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Avita Medical LtdAdam KelliherChief Executive
OfficerPhone: +44 020 8947 9804akelliher@avitamedical.comorTim
RooneyChief Financial OfficerPhone: + 1 (661)
367-9170trooney@avitamedical.comorAustraliaMonsoon
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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