RECELL® System Data Presented at American Burn Association Fall Regional Burn Conferences
December 15 2020 - 8:00AM
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, announced today the
presentation of RECELL® System data recently presented at the
Northeast Regional Burn Conference and Southern Regional Burn
Conference of the American Burn Association.
“Since the U.S. Food and Drug Administration approval of the
RECELL System in September 2018, 93 U.S. burn centers have ordered
the RECELL System, with more than 80% of burn surgeons throughout
the United States certified on the use of the system. There have
now been more than 10,000 patients treated globally, with U.S.
RECELL System sales topping $27 million in the two years since FDA
approval,” said Dr. Mike Perry, AVITA Medical’s Chief Executive
Officer. “As burn surgeons continue to gain experience with the
RECELL System and increasingly use it across a range of burn sizes,
we are encouraged to see the utility, positive clinical outcomes,
and health economic benefits of the RECELL System highlighted at
medical conferences. We remain committed to advancing burn care in
collaboration with burn surgeons and look forward to expanding the
benefit of the RECELL System to additional indications, including
soft tissue defects and vitiligo, amongst others.”
Recent RECELL® System
Data Abstracts:
- Carney. A Pilot Study of Negative Pressure Therapy with
Autologous Skin Cell Suspensions in a Porcine Model. Presented
at Northeast Region Burn Conference; 2020 November 6; Virtual.
- Chihade. Autologous Epidermal Skin
Cell Suspension: A Cost-Effective Treatment for Burns >20% TBSA
in a County Hospital with Limited Resources. Southern Region
Burn Conference; 2020 December 6; Virtual.
- Desai. Aesthetic superiority of
autologous cell suspension device in treating deep partial and full
thickness burn compared to skin graft in a single case. Southern
Region Burn Conference; 2020 December 6; Virtual.
The RECELL System is FDA-approved for the treatment of acute
thermal burns in patients 18 years and older. Used by a trained
healthcare professional at the point of care, the RECELL System is
used to prepare Spray-On Skin™ Cells to be sprayed directly on
second-degree burn injuries or applied in combination with meshed
autografts for third-degree burn injuries. 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 97.5i 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.ii This
statistically significant reduction in donor skin required to treat
burn patients with the RECELL System produced healing comparable to
the standard of care while providing a significant reduction in
donor site pain and improved donor site healing.i
For more information about the RECELL System, please visit
www.RECELLSystem.com.
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 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 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
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.
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 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. 2018ii 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
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Sep 2023 to Sep 2024