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, announced today that COSMOTEC, an M3 Group Company,
received insurance coverage in Japan for the RECELL® System for the
treatment of acute burns.
“We are very pleased that the Japanese MHLW (Ministry of Health,
Labour and Welfare) has granted the RECELL System marketing
approval with favorable reimbursement that will be aligned with
pricing in the United States,” said Dr. Mike Perry, Chief Executive
Officer of AVITA Medical. “We look forward to continuing to work
with our partner, COSMOTEC, as they launch and promote RECELL in
the Japanese market.”
The RECELL System is used to prepare Spray-On Skin™ Cells using
a small amount of a patient’s own skin, 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.
“We will utilize the capabilities of our robust team to support
the successful launch of RECELL in Japan,” said Mr. Tatsuro
Tsutsumi, CEO of COSMOTEC. “With this product in market, we look
forward to contributing to the treatment of burn patients with the
goal of returning them to their daily lives as soon as
possible.”
About M3M3 Inc. is a publicly traded company on
the Tokyo Stock Exchange (TYO:2413) with subsidiaries in major
markets including USA, UK, Japan, South Korea, and China. M3 Inc.
provides services to healthcare and the life science industry. In
addition to market research, these services include medical
education, ethical drug promotion, clinical development, job
recruitment, and clinic appointment services. M3 Inc. operates in
the US, Asia, and Europe with over 4.5 million physician members
globally via its portals including MDLinx.com, m3.com,
Doctors.net.uk, medigate.net and medlive.cn. M3 has offices in
Tokyo, Washington D.C., Fort Washington, PA, Oxford, London,
Beijing, and Seoul. Please visit https://corporate.m3.com/en/ for
more information.
About COSMOTECCOSMOTEC Co., Ltd., established
in 1992 specialises in sales and consulting of medical devices
focusing on cardiac surgery, general surgery and endovascular
treatment. COSMOTEC has 98% market share of the institutions
conducting cardiovascular surgery in Japan. COSMOTEC has offices in
Tokyo, Sapporo, Sendai, Nagoya, Osaka, Okayama and Fukuoka across
Japan. COSMOTEC is an M3, Inc., group company. Please visit
http://cosmotec.com/english/ for more information.
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 acute thermal burns in both adults
and children, 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 acute traumatic
wounds and 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. 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 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 15,000 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 approved under the
RECELL System brand to promote skin healing in a wide range of
applications including burns, acute traumatic wounds, 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.
CAUTIONARY NOTE REGARDING 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 statement. 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.
This press release was authorized by the review committee of
AVITA Medical, Inc.
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 |
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