Recent journal publications investigate the
potential use of the RECELL System to treat multiple dermatological
conditions
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 data published in Aesthetic
Plastic Surgery by the Department of Plastic Surgery at Peking
Union Medical College Hospital exploring the use of the RECELL®
Autologous Cell Harvesting Device (RECELL® System) in combination
with dermabrasion to treat facial acne scars.1
The retrospective study analyzes the healing time and rate of
postoperative complications of 78 patients with acne scars treated
using dermabrasion with and without the RECELL System, revealing a
statistically significant difference in healing time (P 0.001)
between the two treatment regimens. Acne scars treated using
dermabrasion healed more quickly on average with RECELL (5.27 ±
1.086 days) than without RECELL (average healing time of 12.30 ±
1.725 days). In addition, there were no postoperative
complications, such as pigmentation and scar hyperplasia, and
higher patient satisfaction rates (P< 0.001) for those patients
treated with RECELL.
“It’s exciting to see physicians worldwide interested in
studying the possible application of the RECELL System to advance
patient care across a broad range of treatments,” said Andrew
Quick, AVITA Medical’s Chief Technology Officer. “We look forward
to continued collaboration within the global medical community as
we explore the full potential of this regenerative technology
platform to address unmet medical needs.”
Other recent publications investigating the use of the RECELL
System in the treatment of dermatological conditions, include:
- “The use of noncultured regenerative epithelial suspension for
improving skin color and scars: A report of 8 cases and review of
the literature” by Jie Ren, PhD, M.D., and Jianlan Liu, PhD,
Department of Dermatology, Huashan Hospital, Fudan University,
Shanghai, China, et al. published in the Journal of Cosmetic
Dermatology2
- “The clinical efficacy of treatment using the autologous
non-cultured epidermal cell suspension technique for stable
vitiligo in 41 patients” by Bin Liu and Zhong-Hai Liu, Guangzhou
New Centre Institute of Vitiligo, Guangzhou, PR China, and Hui-Heng
Chen, Dongguan Eighth People’s Hospital & Dongguan Children’s
Hospital, Dongguan, PR China, et al. published online in the
Journal of Dermatological Treatment3
The RECELL® System, which uses a small amount of a patient’s own
skin to prepare Spray-On Skin™ Cells at the point of care, is
currently approved by the U.S. Food and Drug Administration (FDA)
for the treatment of acute thermal burns in patients 18 years and
older. In international markets, the RECELL® System is approved to
promote skin healing in a wide range of applications including
burns, acute and chronic wounds, scars, and vitiligo.
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.
1 Chen, Q., Yu, N., Liu, Z. et al. Aesth Plast Surg (2019).
https://doi.org/10.1007/s00266-019-01481-8
2 Ren J, Liu J, Yu N, et al. The use of noncultured regenerative
epithelial suspension for improving skin color and scars: A report
of 8 cases and review of the literature. J Cosmet Dermatol.
2019;00:1–8. https://doi. org/10.1111/jocd.13071
3 Bin Liu, Hui-Heng Chen, Zhong-Hai Liu, Jing-Feng Liang, Ru-Jun
Xue, Ping-Jiao Chen, Chang-Xing Li, Xiao-Dong Liang, Jie Deng,
Rui-Xian Ye, Xi-Bao Zhang & Jing-Yao Liang (2019) The clinical
efficacy of treatment using the autologous non-cultured epidermal
cell suspension technique for stable vitiligo in 41 patients,
Journal of Dermatological Treatment, DOI:
10.1080/09546634.2019.1619657
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