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, today
announced topline results from its pivotal randomized, controlled
trial evaluating the safety and effectiveness of the RECELL System
combined with meshed autograft for reduction of donor skin
harvesting in soft tissue reconstruction. Injuries
considered for the clinical trial included any full-thickness acute
skin defect, such as degloving or peeled back skin injuries, road
rash, surgical wounds, and flesh-eating disease.
“Soft-tissue injuries can be challenging to treat and I am very
pleased with the outcomes using RECELL – especially the use of less
donor skin when treating a variety of injuries,” said Dr. Steven E.
Mapula, Assistant Professor of Surgery TCU and Division Chief of
Plastic Surgery at John Peter Smith Hospital. “Following FDA
approval, I look forward to utilizing RECELL broadly to help
patients with a wide variety of soft-tissue injuries.”
The study design included co-primary endpoints, based on
pairwise comparisons where each subject received both RECELL used
in combination with widely-meshed skin grafting and the Control
treatment of conventional skin grafting; one endpoint had a
hypothesis of superiority for donor skin sparing and the other
co-primary endpoint had a hypothesis of non-inferiority for
healing. Preliminary review of adverse events shows consistency
with our years of prior RECELL experience, reinforcing the
product’s compelling safety profile. The primary study outcomes are
as follows:
- The donor sparing endpoint was met, showing a superior ratio of
treated injury area to donor site area (p<0.001) with RECELL
versus Control
- The healing endpoint did not reach pre-specified statistical
non-inferiority, however, observed values for healing with RECELL
were the same or slightly better than Control
“Our study has shown statistically superior donor sparing and
comparable healing rates for RECELL treatment of soft tissue
injuries and we are confident in moving forward with our plan for a
PMA submission later this year,” said Dr. Mike Perry, Chief
Executive Officer of AVITA Medical. “The RECELL System has been
used to effectively treat serious burn injuries and we anticipate
that the RECELL System will be well-positioned to treat patients
with soft-tissue injuries, pending FDA review and
approval.”
The Company also plans to submit detailed results from the trial
for peer-reviewed publication.
Skin grafting is the standard of care for soft tissue
reconstruction, including post-trauma and post-surgical skin
reconstruction. Skin grafting requires the harvesting of donor
skin, resulting in an additional wound to the patient. Significant
pain, delayed healing, risk of infection, the need for multiple
procedures, discoloration and scarring are associated with donor
site wounds.i The total addressable market (“TAM”) for soft tissue
repair is approximately $1 billion and more than twice as large as
the TAM for burns. Further, if FDA approved, the existing
reimbursement codes utilized for burn treatment with the RECELL
System will apply to this indication.
ABOUT AVITA MEDICAL, INC.AVITA Medical, Inc. is
a regenerative medicine company with a technology platform
positioned to address unmet medical needs in burns, chronic wounds,
and aesthetics indications. AVITA Medical Inc.’s patented, and
proprietary collection and application technology provides
innovative treatment solutions derived from the regenerative
properties of a patient’s own skin. The Company’s lead product is
the RECELL® System, a device that enables healthcare professionals
to Spray-On Skin™ Cells using a small sample of the patient’s own
skin to create an autologous suspension. The RES® Regenerative
Epidermal Suspension™ is then sprayed onto the areas of the patient
requiring treatment to regenerate natural healthy epidermis.
AVITA Medicals’ 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 approved for acute
partial-thickness thermal burn wounds in patients 18 years of age
and older or application in combination with meshed autografting
for acute full-thickness thermal burn wounds in pediatric and adult
patients. In February 2022, the FDA reviewed and approved the PMA
supplement for RECELL Autologous Cell Harvesting Device, an
enhanced RECELL System aimed at providing clinicians a more
efficient user experience and simplified workflow.
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 15,000 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 approved 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, received CE-mark
approval in Europe, and received Japan’s Pharmaceuticals and
Medical Devices Act (PMDA) approval for burns in Japan.
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 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.
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 |
InvestorsWestwicke PartnersCaroline CornerPhone
+1-415-202-5678 caroline.corner@westwicke.com |
_________________________i Ter Horst B, Chouhan G, Moiemen NS,
Grover LM. Advances in keratinocyte delivery in burn wound care.
Advanced drug delivery reviews. 2018 Jan 1; 123:18-32.
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