Study to enroll a minimum of 65 patients across
the United States to evaluate safety and effectiveness of treatment
of acute, non-burn skin injuries
AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative
medicine company with a technology platform positioned to address
unmet medical needs in therapeutic skin restoration, announced
today the initiation of the pivotal study for soft tissue
reconstruction with the enrollment of the first patient at the
Arizona Burn Center at Valleywise Medical Health Center in Phoenix,
AZ. This study will evaluate the safety and effectiveness of the
RECELL® System when used as an adjunct to meshed autografts in
patients undergoing reconstruction of skin defects not associated
with a burn injury.
“The commencement of this pivotal trial is an important
milestone for AVITA and a critical step toward making the RECELL
System broadly available to help patients heal from traumatic or
soft tissue wounds with the use of less donor skin than the
standard of care,” said Dr. Mike Perry, AVITA Medical Chief
Executive Officer. “We are pleased to have initiated this
registration trial and to have enrolled the first patient in this
study.”
Skin grafting is the standard of care for full-thickness, 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 all associated with
donor site wounds. While skin grafting is commonly associated with
burn treatment, in 2017 approximately 80% of acute wounds that
required skin grafting were non-burn related injuries accounting
for more than 200,000 procedures in the U.S.i
“We routinely treat acute non-burn wounds using conventional
skin grafting, but that approach results in a donor site wound that
adds to the patient’s pain and to the cost of their care,” said Dr.
Kevin Foster, Director of the Arizona Burn Center at Valleywise
Health Medical Center. “We are eager to evaluate use of the RECELL
System as a way to reduce the amount of donor skin required. In
burn care, where RECELL is currently FDA-approved, clinical and
health economic benefits have been demonstrated. Relative to burn
treatment, autografting for non-burn injuries occurs far more
frequently, so this has the potential to be a significant treatment
advancement for a large number of patients.”
The prospective multi-center trial of at least 65 patients will
compare the clinical performance of conventional skin grafting to
the use of the RECELL System in combination with more widely meshed
autografts on acute full-thickness non-burn skin defects. The
study’s two primary effectiveness endpoints are:
- Superior donor skin sparing, evaluated by comparing the actual
expansion ratios of donor skin used to treat the wounds
- Non-inferior incidence of healing by eight weeks post
treatment
Healing will be evaluated by a qualified clinician blinded to
the treatment allocation. Additional long-term safety and
effectiveness data collected over the course of the 52-week study
will include blinded evaluation of scar outcomes and patient
treatment preference.
Of note: Use of the RECELL System in patients undergoing
reconstruction of skin defects not associated with a burn injury is
limited by Federal law to investigational use.
The pivotal studies leading to the RECELL System’s FDA premarket
approval for the treatment of acute thermal burns demonstrated that
the RECELL System treated burns using 97.5ii percent less donor
skin when used alone in second-degree burns, and 32 percent less
donor skin when used with autograft for third-degree burns.iii
Despite the statistically significant reduction in donor skin
required to treat burn patients with the RECELL System, burn wounds
treated with the RECELL System achieved healing comparable to the
burn wounds treated with standard of care.ii
Authorized for release by the Chief Executive Officer of AVITA
Medical Limited.
ABOUT AVITA MEDICAL LIMITED
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 REGENERATIVE EPIDERMAL SUSPENSION™
(RES™), 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 in patients 18 years and older.
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 8,000 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 letter 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 letter 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 letter 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 letter. 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 letter 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 Limited.
i © Procedural Data 2017 Millennium Research Group, transmission
or publication is prohibited. Reprinted with permission. ii Holmes
JH, Molnar JA, Carter JE, et al. A comparative study of the RECELL®
device and autologous split-thickness meshed skin graft in the
treatment of acute burn injuries. J Burn Care Res. 2018 iii Holmes
JH, Molnar JA, Shupp JW, et al. Demonstration of the safety and
effectiveness of the RECELL System combined with split-thickness
meshed autografts for the reduction of donor skin to treat
mixed-depth burn injuries. Burns. 2019;45:772-782
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