AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a
regenerative medicine company that is developing and
commercializing a technology platform that enables point-of-care
autologous skin restoration for multiple unmet needs, announced
today that a discussion on the RECELL System will be held during
the Symposium for Cosmetic Advances & Laser Education (SCALE)
multidisciplinary dermatology meeting taking place May 11-15 in
Nashville, TN. SCALE is the premier multidisciplinary meeting for
aesthetic medicine, plastic surgery and medical dermatology.
The presentation will feature Dr. Jeffrey Carter, FACS,
Associate Professor of Surgery and Medical Director, UMCNO Burn
Center at LSU Health in New Orleans, who will discuss the use of
the RECELL System for treatment of burn injuries. Additionally, Dr.
Seemal Desai, FAAD, Diplomate of the American Board of Dermatology,
and a Board-Certified Dermatologist, will review the clinical trial
protocol aimed at establishing safety and effectiveness for
repigmentation of stable vitiligo lesions utilizing the RECELL
System. The discussion, “RECELL: A Novel Treatment Strategy for
Regenerative & Restorative Skin Conditions” will take place
Thursday, May 12 from 2:30-2:40 pm CDT.
“It is important for us to share clinical evidence and peer
insights related to the RECELL System with leaders of the
dermatology community to help physicians make educated treatment
decisions for their patients,” said Dr. Mike Perry, Chief Executive
Officer of AVITA Medical. “As we pursue the vitiligo indication,
our vision is to offer the community an innovative solution to
better serve the millions of people who suffer with this
disease.”
Vitiligo is a disease that attacks pigment-producing cells,
called melanocytes, resulting in their destruction or malfunction.
The result is a loss of pigmentation in patches of skin. Vitiligo
affects up to 2% of the population worldwide,i including an
estimated 3-6.5 million Americans.ii Vitiligo has a comparable
market size and psychosocial impact to other major dermatology
diseases including psoriasis (thick, scaly skin) and atopic
dermatitis (red, cracked skin).iii iv v Like these diseases, those
living with vitiligo may suffer from poor body image along with low
self-esteem, leading to an impaired quality of life.vi
AVITA Medical is currently completing a pivotal trial for the
use of the RECELL System for treatment of stable vitiligo.
Currently, the RECELL System is indicated in the U.S. for treatment
of acute thermal burns. Our vitiligo clinical trial aims to
demonstrate safe and effective repigmentation when using the RECELL
System in combination with phototherapy. Topline data from the
trial will be shared later this year.
ABOUT AVITA MEDICAL, INC.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 RES® REGENERATIVE
EPIDERMAL SUSPENSION, an autologous suspension comprised of the
patient’s skin cells necessary to regenerate natural healthy
epidermis. This autologous suspension is then sprayed onto the
areas of the patient requiring treatment.
AVITA Medical’s first U.S. product, the RECELL® System, was
approved by the U.S. Food and Drug Administration (FDA) in
September 2018. The RECELL System is indicated for use in the
treatment of acute thermal burns. The RECELL System is used to
prepare Spray-On Skin™ Cells using a small amount of a patient’s
own skin, providing a new way to treat severe burns, while
significantly reducing the amount of donor skin required. The
RECELL System is designed to be used at the point of care alone or
in combination with autografts depending on the depth of the burn
injury. Compelling data from randomized, controlled clinical trials
conducted at major U.S. burn centers and real-world use in more
than 10,000 patients globally reinforce that the RECELL System is a
significant advancement over the current standard of care for burn
patients and offers benefits in clinical outcomes and cost savings.
Healthcare professionals should read the INSTRUCTIONS FOR USE -
RECELL® Autologous Cell Harvesting Device
(https://recellsystem.com/) for a full description of indications
for use and important safety information including
contraindications, warnings, and precautions.
In international markets, our products are marketed under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, chronic wounds, and aesthetics. The
RECELL System is TGA-registered in Australia and received CE-mark
approval in Europe. To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This press release 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 press release 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 press release 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 press release.
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 press release speak only as of
the date of this release, and we undertake no obligation to update
or revise any of these statements.
This press release was authorized by the review committee of
AVITA Medical, Inc.
FOR FURTHER INFORMATION:
U.S. MediaSam Brown, Inc.Christy CurranPhone
+1-615-414-8668christycurran@sambrown.comO.U.S.
MediaRudi MichelsonPhone +61 (0)3 9620 3333Mobile +61
(0)411 402 737rudim@monsoon.com.au |
InvestorsICR WestwickeCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.com |
_______________________________________i Picardo et al.
Vitiligo. Nature Reviews Disease Primers. 2015.ii John Harris, MD,
PhD – Presentation as part of Incyte Corporate presentation.
(Harris, UMass, is a global leader in Vitiligo; AVITA
collaborator).
https://investor.incyte.com/static-files/01f77a1c-6351-4348-adc2-597e2bc1f42eSERTiii
National Psoriasis Foundation – Statistics,
https://www.psoriasis.org/psoriasis-statistics/ Accessed
10/5/2020iv The burden of vitiligo: Patient characteristics
associated with quality of life. Homan, et al. JAAD. 2009v
Comparison of the Psychological Impacts of Asymptomatic and
Symptomatic Cutaneous Diseases: Vitiligo and Atopic Dermatitis.Noh,
et al. Annals of Derm. 2013vi Willingness-to-pay and quality of
life in patients with vitiligo. Radtke, et al. BJD. 2009
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