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, today announced that
preclinical data successfully established proof of concept in two
key areas of cell-based gene therapy – skin rejuvenation and
epidermolysis bullosa.
“We are very pleased to partner with leading scientists to
explore opportunities for utilizing Spray-On Skin™ Cells in new and
broad applications such as skin rejuvenation and genetic skin
defects,” said Dr. Mike Perry, Chief Executive Officer of AVITA
Medical. “These data, while early, demonstrate promise for skin
regeneration from modified Spray-On Skin™ Cells, for treatment
of aging skin with reverse-aged skin cells and for treatment of
epidermolysis bullosa with gene-corrected skin cells.”
A Novel RNA-Based Approach for RejuvenationIn
partnership with researchers at the Houston Methodist Research
Institute (HMRI), preclinical data show successful regeneration of
the skin by pairing AVITA Medical’s proprietary Spray-On Skin Cells
with HMRI’s patented RNA technologies to reverse cellular aging.
Personalized, cellular-level skin rejuvenation is an area of
significant interest for consumers, with a total addressable market
of $15 billion. More than three million aesthetic procedures are
performed annually in the U.S., with approximately one million
people undergoing facial lifting and tightening procedures. i
ii
“We are encouraged by these early results and look forward to
continuing to work with AVITA Medical to explore technologies for
reversing aging of skin cells,” said Dr. John Cooke, Chair of the
Department of Cardiovascular Sciences, and Medical Director of the
RNA Therapeutics department at Houston Methodist Research
Institute. “Skin is the body’s largest organ, and molecular
signaling from aged cells can have a significant impact on the rest
of the body. Therefore, reversing aging of skin could have
significant implications for other systems in the body.”
Epidermolysis BullosaIn partnership with
scientists at the Gates Center for Regenerative Medicine at the
University of Colorado School of Medicine, preclinical data show
successful regeneration of skin from gene-modified skin cells to
correct the mutation associated with recessive dystrophic
epidermolysis bullosa, a rare and incurable skin disorder caused by
mutations in the gene encoding structural proteins, resulting in
skin fragility and blistering.
“These initial results are a meaningful step forward in the
advancement of our epidermolysis bullosa program,” said director of
the Gates Center for Regenerative Medicine Dr. Dennis Roop. “We’re
looking forward to continuing to work with AVITA Medical on this
novel approach to delivering gene-edited skin cells to
patients.”
Epidermolysis bullosa can lead to chronic wounds and, in some
sub-types, an increased risk of squamous cell carcinoma or death.
There are no approved curative therapies, and current treatment is
palliative, focused primarily on pain and nutritional management,
itching relief, wound care and bandaging. As an orphan indication
with 25,000-50,000 patients in the U.S., it is estimated that the
current cost of palliative care ranges between $200K-$500K per year
per patient. The total addressable U.S. market is estimated at $850
million.
For more information about the RECELL System, please visit
www.RECELLSystem.com.
ABOUT HOUSTON METHODISTHouston Methodist is one
of the nation’s leading health systems and academic medical
centers. The health system consists of eight hospitals: Houston
Methodist Hospital, its flagship academic hospital in the Texas
Medical Center, six community hospitals and one long-term acute
care hospital throughout the Greater Houston metropolitan area.
Houston Methodist also includes a research institute; a
comprehensive residency program; international patient services;
freestanding comprehensive care, emergency care and imaging
centers; and outpatient facilities. Houston Methodist employs
approximately 27,000 people.
ABOUT THE UNIVERSITY OF COLORADO SCHOOL OF
MEDICINEFaculty at the University of Colorado School of
Medicine work to advance science and improve care. These faculty
members include physicians, educators, and scientists at UC Health
University of Colorado Hospital, Children’s Hospital Colorado,
Denver Health, National Jewish Health, and the Veterans Affairs
Eastern Colorado Health Care System. The school is located on
the Anschutz Medical Campus, one of four campuses in the
University of Colorado system.
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 Estimates and data based on information on file at Avita
Medical Limitedii 2020 Plastic Surgery Statistics Report (Defined
as Facelifts, Ablative Laser, Dermabrasion, Non-Surgical Skin
Tightening)
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