Research Definitively Confirms Superiority of ReCell® for Treatment of Burn Injuries
September 11 2017 - 8:36PM
Business Wire
US Study results presented at European Burns
Association (EBA) Annual Meeting
The ReCell® Autologous Cell Harvesting Device effectively
reduces the amount of skin harvesting required relative to
conventional treatment of burn injuries, which has important
benefits from both clinical and economic perspectives, according to
burn surgeons presenting at a major burns conference this past
week.
Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative
medicine company specializing in the treatment of wounds and skin
defects, reports that key findings were presented by U.S. surgeons,
alongside German and British surgeons who presented on their
routine use of ReCell® this week at the 17th European Burns
Association Congress, held September 6-8, 2017 in Barcelona.
In reporting on the largest prospective study of the ReCell®
device in treatment of second-degree burn injuries, Dr William
Hickerson (Firefighters Regional Burn Center, Memphis, Tenn.)
reviewed outcomes from 101 subjects studied in the U.S., showing a
97.5% reduction in donor skin harvested for treatment of
second-degree burn injuries, which yielded a 4.4 times greater
likelihood of donor site healing after one week.
Dr James H Holmes IV (Wake Forest Baptist Medical Center,
Winston-Salem, North Carolina) highlighted the successful
co-primary endpoint outcomes in the U.S. confirmatory trial for the
Company’s premarket approval (PMA) study for the U.S. FDA. Dr
Holmes reported on treatment of 30 patients who sustained
third-degree burn injuries and concluded that relative to
conventional skin grafting treatment, use of the ReCell® device
achieved comparable short-term healing and long-term scar and
satisfaction outcomes using less donor skin, with no safety
concerns. On average, in this randomized control trial, a 32%
reduction in use of donor skin was observed. Dr Holmes further
presented a clinical case conducted under Compassionate Use,
highlighting how autograft-sparing with ReCell® translates into
life-saving treatment of an extensive burn injury.
Ms Isabel Jones (Chelsea and Westminster Hospital, London)
reviewed the algorithm established for treatment of acute facial
burns at the burn center she directs, and Dr Simon Kuepper
(Unfallkrankenhaus, Berlin) reviewed the integration of the ReCell®
device into the burn care pathway at his burn center in Berlin.
“Presentations of positive outcomes for treatment of burn
injuries of both second- and third-degree, ranging from the face to
massive total body surface area injuries, validates the broad
implications for application of ReCell® in elevating the standard
of care in burns, and we eagerly anticipate the opportunity to
launch the ReCell® device in the United States,” said Erin Liberto,
Chief Commercial Officer.
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.
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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
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and financial goal. Forward-looking statements by their nature
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forward-looking statement contained in this letter is subject to
risks and uncertainties that could cause actual results to differ
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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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