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Avita Medical Announces Five RECELL® Abstracts Accepted for Presentation at American Burn Association (ABA) 50th Annual Meeting

2018年01月30日 AM11:15
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VALENCIA, Calif. & MELBOURNE, Australia

Avita Medical (ASX – AVH, OTCQX: AVMXY) announced that five abstracts highlighting the compelling clinical data and health economic benefits of RECELL® in the treatment of burns have been accepted for presentation at the American Burn Association 50th Annual Meeting to be held from April 10 through 13, 2018 in Chicago, Illinois. Avita Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications.

The ABA meeting will be the first venue in which clinical investigators present the full effectiveness and safety data from the two pivotal trials used to support Avita’s United States PreMarket Approval (PMA) application for the treatment of burn injuries. One of the RECELL pivotal studies has been selected as a top five abstract for presentation during a plenary session at the ABA conference. Researchers will also present the positive results from other clinical studies as well as the conclusions from a model showing the health economic benefits of RECELL. Lastly, RECELL will be featured in a pre-conference Provider Course accredited by the Accreditation Council for Continuing Medical Education (ACCME).

“These abstracts highlight the depth of the positive clinical data supporting the medical and economic benefits of RECELL in the treatment of burn injuries,” said Dr. Michael Perry, Avita Medical’s Chief Executive Officer. “The burn community has taken great interest in RECELL as evidenced by the prominent featuring of this product candidate at the ABA conference and the strong support we have received from the leading medical professionals participating in the studies being presented.”

Presentation of RECELL Pivotal Trials and Other Clinical Study Results

Both of the pivotal clinical trials of RECELL supporting the PMA application have been selected for presentation during the ABA conference. These two presentations will highlight the favorable data supporting the use of RECELL in the treatment of burns, including but not limited to the significant reduction in the amount of donor skin required to treat burn patients:

Abstract #1: A Comparative Study of Autologous Skin Cell Suspension to Split-Thickness Autografting in the Treatment of Acute Burns

Abstract #2: Demonstration of the Safety and Effectiveness of Autologous Skin Cell Suspension Combined with Meshed Skin Grafts for the Reduction of Donor Area in the Treatment of Acute Burns

Notably, Abstract #1 has been selected for presentation during the ABA Meeting’s Plenary for Top 5 Abstracts session and was selected for this special honor from over 500 abstracts submitted. This RECELL presentation will be made Wednesday, April 11, 2018, from 4:15 p.m. to 5:30 p.m. CT.

In addition to the pivotal studies, the large body of scientific evidence supporting the potential applications and benefits of RECELL continue to grow as evidenced by the following abstracts accepted for presentation. These abstracts relate to work performed under the extensive Compassionate Use Investigational Device program for RECELL allowing treatment of patients in the United States in advance of PMA approval:

Abstract #3: Initial Experience with Autologous Cell Suspension for Treatment of Partial Thickness Facial Burns

Abstract #4: A Prospective Evaluation of RECELL in Compassionate Use: Experience with the Use of RECELL to Treat Large TBSA Injuries

Presentation of Health Economic Data

Complementing the positive clinical results and expanding scientific awareness of RECELL, data will be presented at the conference highlighting the cost effectiveness and economic value of RECELL:

Abstract #5: Cost-Effectiveness (CE) of an Autologous Regenerative Epithelial Suspension (RES) Versus Standard of Care (SOC) for Treatment of Severe Burns in the United States

Burns require costly care, due to the need for complex and individualized treatment. A cost-effectiveness model was developed by a major health care information and technology provider to quantify the economic value of RECELL versus standard of care for the treatment of severe burns. This health economic data will demonstrate how using RECELL alone or in combination with standard of care has the potential to reduce hospital costs and length of hospital stay in the United States in the treatment of severe burns.

About the ABA Annual Meeting

The American Burn Association and its members dedicate their efforts and resources to promoting and supporting burn-related research, education, care, rehabilitation, and prevention. The ABA has more than 2,000 members in the United States, Canada, Europe, Asia, and Latin America. The goal of the ABA is to help improve the lives of everyone affected by burn injury. The ABA Annual Meeting attracts more than 1,700 physicians, nurses, occupational and physical therapists, researchers, firefighters, and hospitals with burn centers.

About RECELL

In September 2017, Avita submitted to the United States Food & Drug Administration (FDA) a PMA application for RECELL for the treatment of burn injuries. RECELL is an Autologous Cell Harvesting Device designed to facilitate skin regeneration while reducing the amount of skin harvested at the time of surgery. This reduction in donor site skin requirements has important benefits from both clinical and health economic perspectives. The annual cost of treating burns in the United States is estimated to total US$5.7 billion. The pivotal data and other upcoming presentations described above build on a large body of supportive evidence for RECELL that includes over 50 peer-reviewed journal publications.

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 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/20180129006273/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

Caroline Corner
Phone +1 (415) 202-5678
caroline.corner@westwicke.com
or
Avita
Medical Ltd

Dale A. Sander
Chief Financial Officer
Phone
+1 (858) 663-6993
dsander@avitamedical.com

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