AVITA Medical (ASX: AVH) (OTCQX: AVMXY) today announced that it
expanded its management team in the commercial, legal and medical
affairs functions to support the planned U.S. launch of the RECELL®
Autologous Cell Harvesting Device in the treatment of burns.
Joining AVITA Medical are Donna Shiroma, General Counsel; Terry
Bromley, Vice President, Commercial Operations; and Debbie Garner,
Vice President, Global Marketing. The Company also announced that
Katie Bush, PhD, has been promoted to Vice President, Medical
Affairs.
As General Counsel, Ms. Shiroma is responsible for all legal
operations of AVITA. With over 20 years of legal and compliance
experience in the pharmaceutical and medical device industries, she
has played an instrumental role in transitioning companies from
clinical to commercial entities. Prior to joining AVITA Medical,
Ms. Shiroma served in roles of increasing responsibility as
corporate counsel, general counsel, vice president of legal, chief
privacy and compliance officer, and chief commercial officer for
Ascend Therapeutics, PDL BioPharma, and several Johnson &
Johnson companies.
Mr. Bromley, Vice President, Commercial Operations, has broad
commercial responsibility for the planned U.S. launch of the RECELL
device including management of the Commercial Field Team, Sales
Training, Sales Operations and Customer Service. Mr. Bromley led
sales and marketing operations for a number of medical products,
including wound healing and skin care, with Crawford Healthcare,
Emergent BioSolutions, Convatech and Bristol-Myers Squibb.
As Vice President, Global Marketing, Ms. Garner is responsible
for leading the long-term commercial plan for AVITA Medical,
focusing initially on the RECELL Device. Ms. Garner joins AVITA
Medical from Allergan, where she served as Executive Marketing
Director for the Medical Dermatology Franchise. While at Allergan
she also led global pipeline and business development for aesthetic
and therapeutic dermatology products including BOTOX® Cosmetic and
Juvederm®. Previously, Ms. Garner held various marketing roles at
Takeda Abbott Pharmaceuticals (TAP).
As a result of her promotion to Vice President, Medical Affairs,
Dr. Katie Bush has responsibility for the development and
implementation of educational programs, medical-scientific
communications, and supporting company-sponsored scientific
research and clinical studies. Dr. Bush will also oversee AVITA’s
Medical Science Liaison and Medical Education teams. Through her
career Dr. Bush has contributed to the development and
commercialization of products for soft tissue regenerative
applications, including multiple product lines focused on skin
regeneration. She holds a doctorate in Biomedical Engineering &
Medical Physics from The University of Massachusetts &
Worcester Polytechnic Institute, Worcester, MA, completing a thesis
on the development of a novel collagen-based skin substitute to
enhance re-epithelialization.
“These leaders and their respective teams join AVITA Medical at
an exciting time as we take the steps to prepare for a successful
launch of the RECELL Device in the U.S.,” said Dr. Michael Perry,
Chief Executive Officer. “We are pleased to have such a strong
group of professionals join us and look forward to benefiting from
their experience in the commercialization of products in the
regenerative medicine and skin care space.”
The RECELL Device is an investigational medical device in the
U.S. that is designed to enable medical professionals to produce,
at the point-of-care, a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™)
using a small sample of the patient’s own skin. The autologous
suspension contains cells necessary to regenerate epidermis and
provides a new way to achieve permanent closure in burns and other
wounds while reducing the amount of skin harvested at the time of
surgery. Reduction in donor-site skin requirements has important
benefits from both clinical and health economic perspectives.
A U.S. Premarket Approval (PMA) application for the treatment of
burn injuries is currently under review by the U.S. Food and Drug
Administration (FDA). The Company expects completion of the FDA
review of the PMA during the third quarter of calendar 2018,
followed by U.S. approval and market launch. In April 2018
researchers from major burn centers throughout the U.S. made six
presentations of data describing the clinical and cost-savings
advantages of the RECELL Device in the treatment of severe burns at
the 50th Annual Meeting of the American Burn Association (ABA), in
Chicago.
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 Medical’s
patented and proprietary collection and application technology
provides innovative treatment solutions derived from the
regenerative properties of a patient’s own skin. The medical
devices work by preparing a REGENERATIVE EPITHELIAL SUSPENSION™, an
autologous suspension comprised of the patient’s skin cells and
wound healing factors necessary to regenerate natural healthy
epidermis. This autologous suspension is then sprayed onto the
areas of the patient requiring treatment.
In the United States, the RECELL Device is an investigational
device limited by federal law to investigational use. In September
2017, AVITA Medical submitted to the U.S. Food and Drug
Administration (FDA) a Premarket Approval (PMA) application for the
RECELL Device for the treatment of burn injuries.
In all countries outside of Europe, our portfolio is marketed
under the RECELL Device brand to promote skin healing in a wide
range of applications including burns, chronic wounds and
aesthetics. The RECELL Device 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. The RECELL Autologous Cell Harvesting
Device is designed for the treatment of burns and plastic
reconstructive procedures; REGENERCELL™ Autologous Cell Harvesting
Device has been formulated for chronic wounds including leg and
foot ulcers; and RENOVACELL™ Autologous Cell Harvesting Device 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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OUS MediaMonsoon CommunicationsSarah KemterPhone:
+61 (0)3 9620 3333Mobile: +61 (0)407 162
530sarahk@monsoon.com.auorUS MediaSyneos Health Public
RelationsDavid PolkPhone: +1 (310) 309 1029Mobile +1 (805) 428
5775david.polk@syneoshealth.comorInvestors: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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