Market Overview

AVITA Medical Announces Expansion of Management Team to Support Planned U.S. Launch of RECELL® Device


AVITA Medical (ASX: AVH)
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

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.


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


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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