AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative
medicine company leading the development and commercialization of
first-in-class devices and autologous cellular therapies for skin
restoration, today announced that the U.S. Food and Drug
Administration (FDA) has approved its premarket approval (PMA)
supplement for the use of its RECELL® System to treat
full-thickness skin defects.
“This is a landmark approval representing an inflection point
for AVITA Medical,” said Jim Corbett, AVITA Medical Chief Executive
Officer. “The FDA approval now offers surgeons a best-in-class
treatment option for a multitude of severe wounds within inpatient
and outpatient settings.”
The expanded indication represents a broad label of
full-thickness skin defects, such as wound injuries after traumatic
avulsion (e.g., degloving), surgical excision (e.g., necrotizing
soft tissue infection), or resection (e.g., skin cancer), thereby
dramatically expanding the company’s market opportunity at least
five times.
“We had a high level of confidence in the FDA’s approval
timeline of RECELL for the treatment of skin defects,” continued
Mr. Corbett. “In anticipation of the expanded indication, we more
than doubled our field sales organization in the first few months
of the year. Our sales team is now ready, trained, and fully
prepared for the commercial launch, which will commence July 1,
2023. On behalf of AVITA Medical, I’d like to express my utmost
appreciation to the many patients and healthcare providers who
partnered with us to help bring our innovative technology to more
patients across the U.S.”
The RECELL System was first approved in the U.S. for the
treatment of severe burns in 2018. The system is an autologous cell
harvesting device that prepares, produces, and delivers a
regenerative cell suspension, Spray-On Skin™ Cells, using a small
amount of a patient’s own skin. The Spray-On Skin Cells contain a
combination of single living cells that stimulate healing and
repigmentation throughout the wound bed.
Currently, skin grafting is the standard of care for
full-thickness skin defects, including post-trauma and
post-surgical skin reconstruction. However, 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. Based on results from the
company’s pivotal trial for soft tissue repair and reconstruction,
RECELL demonstrated statistically non-inferior healing rates with
statistically significant donor sparing, meaning less skin from the
patient is required to repair and close the wound without
compromising the healing outcomes relative to convention
autografting.
The PMA supplement received prioritized review through the FDA’s
Breakthrough Device program. The FDA grants the Breakthrough Device
designation to medical devices that provide more effective
treatment of life-threatening or irreversibly debilitating diseases
or conditions. The PMA supplement approval follows the original PMA
approval of the RECELL System for the treatment of severe burns in
September 2018.
AVITA Medical’s clinical trial in soft tissue repair has been
funded in part with Federal funds from the U.S. Biomedical Advanced
Research and Development Authority (BARDA), Administration for
Strategic Preparedness and Response (ASPR), within the U.S.
Department of Health and Human Services (HHS), under ongoing USG
Contract number HHSO100201500028C.
Authorized for release by the Chief Executive Officer of AVITA
Medical, Inc.
ABOUT AVITA MEDICAL, INC.AVITA Medical® is a
regenerative medicine company leading the development and
commercialization of devices and autologous cellular therapies for
skin restoration. The RECELL® System technology platform, approved
by the FDA for the treatment of thermal burn wounds and
full-thickness skin defects, harnesses the regenerative properties
of a patient’s own skin to create Spray-On Skin™ cells. Delivered
at the point-of-care, RECELL enables improved clinical outcomes and
validated cost savings. RECELL is the catalyst of a new treatment
paradigm and AVITA Medical is leveraging its proven and
differentiated capabilities to develop first-in-class cellular
therapies for multiple indications, including repigmentation of
stable vitiligo lesions.
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 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 and full-thickness skin defects after traumatic avulsion
(e.g. degloving) or surgical excision (excision (e.g., necrotizing
soft tissue infection) or resection (e.g., skin cancer), in
patients 15 years of age and older. 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 wounds, 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 or in combination with meshed
autographs for full-thickness skin defects. 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, soft tissue repair, vitiligo, and
aesthetics. The RECELL System is TGA-registered in Australia,
received CE-mark approval in Europe and has PMDA approval in
Japan.
To learn more, visit www.avitamedical.com.
FORWARD-LOOKING STATEMENTS
This 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 statements. 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.
FOR FURTHER INFORMATION:
Investors & MediaAVITA Medical,
Inc.Jessica EkebergPhone +1-661-904-9269
investor@avitamedical.commedia@avitamedical.com |
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