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Research Definitively Confirms Superiority of ReCell® for Treatment of Burn Injuries

2017年09月12日 AM09:36
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VALENCIA, Calif. & PERTH, Australia & LONDON

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.

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170911006350/en/

CONTACT

Australia
Monsoon Communications
Sarah Kemter
Phone:
+61 (0)3 9620 3333
Mobile: +61 (0)407 162 530
sarahk@monsoon.com.au
or
USA
Westwicke
Partners

Jamar Ismail
Phone +1 (415) 513-1282
jamar.ismail@westwicke.com

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