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
NEWSMarch 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180321006305/en/
Australia:Monsoon CommunicationsSarah KemterPhone:
+61 (0)3 9620 3333Mobile: +61 (0)407 162
530sarahk@monsoon.com.auorUSA:Westwicke
PartnersCaroline CornerPhone: +1 (415)
202-5678caroline.corner@westwicke.comorAVITA Medical LtdDale
A. SanderChief Financial OfficerPhone: +1 (858)
663-6993dsander@avitamedical.com
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