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AVITA Medical Announces MIHS Burn Center Press Conference Regarding RECELL® Treatment of Patient with Necrotizing Fasciitis (Flesh Eating Bacteria)

2018年03月22日 PM01:53
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VALENCIA, Calif. & MELBOURNE, Australia

AVITA Medical (ASX – AVH, OTCQX: AVMXY) announced that Maricopa Integrated Health System (MIHS) Burn Center will hold a press conference today to highlight the recent treatment with RECELL® of a woman with necrotizing fasciitis, or flesh eating bacteria. The woman was treated with the RECELL Autologous Cell Harvesting Device under a U.S. Food and Drug Administration (FDA) approved Compassionate Use Investigational Device Exemption (IDE) program.

RECELL is a medical device designed to facilitate skin regeneration. In the United States, RECELL is an investigational device limited by federal law to investigational use. In September 2017, Avita submitted to the U.S. Food and Drug Administration (FDA) a PreMarket Approval (PMA) application for RECELL for the treatment of severe burn injuries, and that application is currently under review.

An announcement from MIHS about the press conference is included below.

MARICOPA INTEGRATED HEALTH SYSTEM (MIHS)
Maricopa County Special Health Care District

NEWS
March 21, 2018

Flesh eating bacteria survivor to tell her story of survival; Burn surgeon to discuss groundbreaking use of “skin spray” to treat wounds from the disease

A Peoria woman who contracted flesh eating bacteria in January will appear at a news conference Thursday to discuss her fight for survival against the rare disease.

Christin Lipinski, still a patient at MIHS’s Arizona Burn Center, will appear with Burn Center Director Dr. Kevin Foster, who has pioneered use of the investigational RECELL® “skin spray” to treat burn victims.

Dr. Foster obtained FDA approval for “compassionate use” of Avita Medical’s RECELL treatment on Mrs. Lipinski. This is the first time in the United States that RECELL has been used to treat a victim of necrotizing fasciitis, or flesh eating bacteria.

When: 10 a.m., Thursday, March 22, 2018

Where: Maricopa Medical Center Administration Building, 2601 E. Roosevelt Street (just east of the hospital)

Who: Christin Lipinski, a mother and Peoria school teacher who contracted flesh eating bacteria in January. She will talk about her experience, her treatment, and outlook for recovery.

Contact: Michael Murphy (602) 568-0010

About Maricopa Integrated Health System (MIHS)
Located in Phoenix, Ariz., Maricopa Integrated Health System has a proud tradition of being both the community safety net health care system, with a mission and commitment to serving the underserved and Arizona’s only public teaching hospital. MIHS consists of Maricopa Medical, the only Level I Trauma Center in Arizona verified by the American College of Surgeons to care for both adults and children, Arizona’s only nationally verified Burn Center serving the entire Southwestern United States, MIHS’s McDowell Healthcare Center, which is the largest provider of HIV primary care in Arizona, the Refugee Women’s Health Clinic, the Arizona Children’s Center, two behavioral health centers, and 13 neighborhood Family Health Centers. To learn more about MIHS, please visit www.mihs.org.

© 2015 MIHS Contact Privacy Policy

ABOUT AVITA MEDICAL LIMITED

AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. 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 autologous suspension is then sprayed onto the areas of the patient 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 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: https://www.businesswire.com/news/home/20180321006305/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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