First RECELL System clinical trial in the U.S.
focused on acute soft tissue injuries, defects, and reconstruction;
study expected to commence within next 6 months
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine
company focused on the development and commercialization of
innovative therapies leveraging the healing properties of a
patient’s own skin, announced today that the U.S. Food and Drug
Administration (FDA) has approved the company’s Investigational
Device Exemption (IDE) application to conduct a pivotal trial
evaluating the safety and effectiveness of the RECELL® Autologous
Cell Harvesting Device (RECELL® System) in combination with meshed
autografting for the treatment of acute full-thickness skin
defects, such as degloving (a type of injury where the skin is
ripped from the underlying tissue), crush wounds (a break in the
external surface of the body), abrasions, lacerations, and surgical
wounds.
“FDA approval of our IDE for a soft tissue reconstruction
pivotal clinical trial is an important next step in expanding the
potential indications of our RECELL System technology platform. We
are pleased with the strong interest expressed by the clinical
community in participating in this study and we look forward to
working with physicians and their patients upon study
commencement,” said Dr. Michael Perry, Chief Executive Officer of
AVITA Medical. “Many burn specialists who have experience treating
burn patients with the RECELL System also treat patients with
trauma injuries in their clinics. The treatment protocols for burns
and trauma are well-aligned and as such, we anticipate a positive
transfer of clinical experience to benefit this patient population
during the clinical trial.”
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. 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
“Based on the compelling safety and effectiveness of the RECELL
System in treating burn wounds, we believe our innovative
technology is ideally positioned to be evaluated as a treatment to
heal trauma- and surgery-related wounds,” said Andy Quick, Chief
Technology Officer of AVITA Medical. “With a clear opportunity to
improve the standard-of-care, we look forward to sharing results
upon completion of this pivotal trial.”
AVITA Medical will initiate a prospective, multi-center,
randomized controlled study to compare the clinical performance of
conventional skin grafting with and without the use of the RECELL
System on acute non-burn full-thickness skin defects. Each patient
will have a control wound treated with conventional skin grafting
and a wound treated with expanded skin grafting in combination with
the RECELL System. The study’s two primary effectiveness endpoints
are:
- Incidence of healing by eight weeks post treatment
- Donor skin sparing, evaluated by comparing the ratios of donor
skin required to treat the wounds
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.
The pivotal studies leading to the RECELL System’s FDA premarket
approval (PMA) 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. Donor site outcomes from the clinical trial for second-degree
burns also revealed a statistically significant reduction in
patient-reported pain, increased patient satisfaction and improved
scar outcomes.ii
ABOUT AVITA MEDICAL
ABOUT AVITA MEDICAL LIMITED
AVITA Medical is a regenerative medicine company focused on the
development and commercialization of innovative therapies
leveraging the healing properties of a patient’s own skin. With its
novel technology platform, AVITA Medical is advancing the
standard-of-care for burn patients and is poised to address unmet
medical needs across a range of dermatological indications,
including vitiligo, wounds and aesthetic rejuvenation. The
company’s patented and proprietary collection and application
technology prepares a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™)
comprising the patient’s skin cells necessary to regenerate a
natural healthy epidermis that can then be sprayed onto the areas
of the patient’s skin requiring treatment. More information about
AVITA Medical is available at www.AvitaMedical.com.
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, acute wounds, scars and vitiligo. The
RECELL System is TGA-registered in Australia, CFDA-cleared in
China, and has 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.
i 2017 Procedural Data. © 2019 DR/Decision Resources, LLC 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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U.S. Media Sam Brown, Inc. Christy Curran Phone
+1-615.414.8668 christycurran@sambrown.com
O.U.S. Media Monsoon Communications Sarah Kemter Phone
+61 (0)3 9620 3333 Mobile +61 (0)407 162 530
sarahk@monsoon.com.au
Investors Westwicke Partners Caroline Corner Phone
+1-415-202-5678 caroline.corner@westwicke.com
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