AVITA Medical Completes Enrollment in Pivotal Trial Evaluating the RECELL® System for Repigmentation of Stable Vitiligo
16 December 2021 - 8:01AM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), 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 it has
completed enrollment into its pivotal trial for the use of the
RECELL® System for repigmentation of stable vitiligo.
Currently, the RECELL System is indicated in the U.S. for use in
the treatment of acute thermal burns.
“Recruitment of the last patient in this blinded, randomized
pivotal trial is a significant milestone and lays the groundwork
for the regulatory approval and commercialization of the RECELL
System in 2023 for use in patients with stable vitiligo,” said Dr.
Mike Perry, Chief Executive Officer of AVITA Medical. “We look
forward to sharing the topline data from this trial next year.”
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
“There is currently no cure for vitiligo and no FDA-approved
treatment options, so this is a very exciting clinical trial,” said
Dr. Anand Ganesan, professor of dermatology and biological
chemistry in the University of California Irvine School of
Medicine. “We believe the RECELL System has the potential to become
an important new treatment option for the millions of people with
stable vitiligo.”
For more information about the RECELL System, please visit
www.RECELLSystem.com.
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
STATEMENTSThis 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 Michelson Phone +61 (0)3 9620 3333 Mobile +61
(0)411 402 737 rudim@monsoon.com.au |
InvestorsICR WestwickeCaroline CornerPhone
+1-415-202-5678 caroline.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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