Highlights
- Skin donor sites heal just over 30%
faster with ReCell® in 106-patient randomized controlled trial
- Superior wound healing and aesthetic
appearance in ReCell®-group
- The 3rd positive clinical trial
recently announced by Avita Medical
Deploying a suspension of cells generated from a ReCell® medical
device onto a skin donor site can speed up healing by 30.7% and
deliver a superior final outcome, according to the results of a
randomized controlled trial involving 106 patients who received
skin grafts, Avita Medical (ASX:AVH) (OTCQX:AVMXY), said today.
Avita, a regenerative medicine company focused on the treatment
of wounds and skin defects, said the findings reported in the
British Journal of Surgery (BJS) further supported its growing data
package around its ReCell® autologous cell harvesting device. This
is the 3rd randomized controlled trial announced in recent weeks:
last month, the Company presented data from two trials conducted at
leading burns centers across the US, including successful results
from its pivotal trial needed for PMA approval with the Food and
Drug Administration.
“We are excited about these results, as together, the data show
that ReCell® can be deployed both to reduce patient trauma, and to
help patients heal faster,” said Avita’s CEO Mike Perry. “Our
pivotal trial in the US, announced last month, showed how ReCell®
allowed doctors to successfully treat burns using about 30% less
donor skin. Now, in China, surgeons have shown that the donor site
itself can heal some 30% faster when treated with Regenerative
Epithelial Suspension™ made using the ReCell® device. Demonstration
of clinical benefit for treatment of burn injuries and treatment of
donor sites further substantiates the key, versatile role for
ReCell® in burn care.”
The BJS paper — Randomized clinical trial of autologous skin
cell suspension for accelerating re-epithelialization of
split-thickness donor sites — was based on work by a team of burns
and plastic surgeons at the Sun Yat Sen University Hospital, in
Guangzhou, China, led by Prof. J. Zhu. The Chinese investigators
wished to explore whether donor sites for skin grafts healed faster
and better if ReCell® was deployed alongside the main standard of
care, which was a hydrocolloid dressing. Over a period of some 18
months, a total of 106 patients were recruited, with 53 in either
the Control or ReCell®-treated groups, amongst patients who
presented at the hospital requiring split-thickness skin
grafts.
The researchers evaluated how long it took for the epithelial
layer of skin to restore on donor sites, with and without ReCell®,
a device that allows surgeons to deliver a suspension of skin cells
to aid tissue repair and skin regeneration. They reported that the
median time to complete re-epithelialization was 9.0 days in the
ReCell®-treated group, compared with 13.0 days in the control
group, a 30.7% difference that was a statistically significant (p
< 0.001).
The authors said both patients and independent observers
evaluated that the donor sites treated with autologous skin cell
suspension displayed better physical attributes and patients were
more satisfied with healing quality. Early and rapid
re-epithelialization is thought to enhance wound healing, improve
long-term aesthetic appearance, and deliver ‘appropriate
pigmentation,’ they said.
“The autologous skin cell suspension is produced quickly and is
available immediately for wound application,” the investigators
said. “This study suggests that its use [on] skin graft donor
[sites] should promote healing and improve long-term aesthetic
results.”
Avita said the positive data reflected the growing interest
about ReCell® amongst burns surgeons in China. In an earlier trial,
Zhu’s team in Guangzhou showed successful healing of chronic wounds
with the ReCell® device.
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 patient’s
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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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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