AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative
medicine company leading the development and commercialization of
first-in-class devices and autologous cellular therapies for skin
restoration, today announced that the U.S. Food and Drug
Administration (FDA) has approved its application for premarket
approval (PMA) of its RECELL® System for the treatment of vitiligo.
RECELL for repigmentation of stable depigmented vitiligo lesions
is the first FDA-approved therapeutic device offering a one-time
treatment at the point-of-care. Using the device, a clinician
prepares and delivers autologous skin cells from pigmented skin to
stable depigmented areas, offering a safe and effective treatment
for vitiligo.
“RECELL represents first-in-class treatment for repigmentation
through the delivery of normal, healthy skin cells,” said Jim
Corbett, Chief Executive Officer of AVITA Medical. “This is a
breakthrough approval for AVITA Medical, significantly expanding
the clinical applications for RECELL, and demonstrates our
continued commitment to patient care. We look forward to offering a
meaningful one-time treatment option for patients with stable
vitiligo across the U.S.”
PMA approval was based upon results from the company’s pivotal
trial evaluating the safety and effectiveness of the RECELL System
for repigmentation of stable vitiligo lesions. The study compared
repigmentation success rates with RECELL treatment in areas of skin
resurfaced using ablative laser, versus standard of care (control)
treatment in another area. Repigmentation was evaluated by an
expert central review committee (CRC) at 6 and 12 months after
treatment. The CRC reported 36% of RECELL treatments (versus 0% of
control treatments) resulted in repigmentation of at least 80% of
the treated area at 6 months, establishing super-superiority for
the primary endpoint (p<0.025), with 100% durability of
repigmentation at 12 months. At the same 6-month point, treating
physicians reported RECELL treatment as a success for 68% of
patients, and 80% of patients self-reported RECELL treatment as a
success.
The RECELL System is an autologous cell harvesting device that
is used to prepare and deliver a regenerative cell suspension,
Spray-On Skin™ Cells, using a small amount of a patient’s own skin.
The Spray-On Skin Cells contain a combination of single living
cells that stimulate healing and repigmentation throughout the
wound bed. The preservation of melanocytes is important for
restoring natural pigmentation to the recipient area. The
suspension of Spray-On Skin Cells is suitable for application to
skin resurfaced by an ablative laser. A portion of the suspension
of Spray-On Skin Cells may also be applied to the donor site.
The PMA received prioritized review through the FDA’s
Breakthrough Device program. The FDA grants the Breakthrough Device
designation to medical devices that provide more effective
treatment of life-threatening or irreversibly debilitating diseases
or conditions.
Authorized for release by the Chief Executive Officer of AVITA
Medical, Inc.
ABOUT VITILIGOVitiligo 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 up to 6.5 million Americans,ii
with an estimated 1.3 million suffering from stable vitiligo.
Vitiligo has a comparable 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
ABOUT AVITA MEDICAL, INC.AVITA Medical® is
a regenerative medicine company leading the development and
commercialization of devices and autologous cellular therapies for
skin restoration. The RECELL® System technology platform, approved
by the FDA for the treatment of thermal burn wounds and
full-thickness skin defects and for repigmentation of stable
depigmented vitiligo lesions, harnesses the regenerative
properties of a patient’s own skin to create Spray-On Skin™ cells.
Delivered at the point-of-care, RECELL enables improved clinical
outcomes. RECELL is the catalyst of a new treatment paradigm and
AVITA Medical is leveraging its proven and differentiated
capabilities to develop first-in-class cellular therapies for
multiple indications.
In international markets, AVITA Medical products are approved
under the RECELL System brand to promote skin healing in a wide
range of applications including burns, soft tissue repair,
vitiligo, and aesthetics. The RECELL System is TGA-registered in
Australia, received CE-mark approval in Europe and has PMDA
approval in Japan.
To learn more, visit www.avitamedical.com.
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 statements. Applicable risks and uncertainties
include, among others, the timing and realization 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.
FOR FURTHER INFORMATION:
|
Investors & MediaAVITA Medical,
Inc.Jessica EkebergPhone +1-661-904-9269
investor@avitamedical.commedia@avitamedical.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/f72257b8-ea0a-484e-8644-9bdcc9694fe5iii
National Psoriasis Foundation – Statistics,
https://www.psoriasis.org/psoriasis-statistics/ Accessed
10/5/2020.iv The burden of vitiligo: Patient characteristics
associated with quality of life. Homan, et al. JAAD. 2009.v
Comparison of the Psychological Impacts of Asymptomatic and
Symptomatic Cutaneous Diseases: Vitiligo and Atopic Dermatitis.Noh,
et al. Annals of Derm. 2013.vi Willingness-to-pay and quality of
life in patients with vitiligo. Radtke, et al. BJD. 2009.
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