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 that it has
received approval from Japan’s Pharmaceuticals and Medical Devices
Agency (PMDA) to market the RECELL® System in Japan. COSMOTEC, an
M3 Group Company, championed the approval and is AVITA Medical’s
distribution partner.
“We are excited about the opportunity this approval provides in
enabling the RECELL® System to be made available
to Japanese medical institutions to treat patients with
burns requiring skin grafting,” said Dr. Mike Perry, Chief
Executive Officer of AVITA Medical. “Japan is the second largest
healthcare market in the world and represents a valuable
opportunity for our Company with more than 6,000
patients treated for severe burns annually
who will now have access to this innovative treatment
option.”
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 are very pleased to bring this landmark treatment to
patients in Japan and believe we are in an excellent position to
ensure the RECELL System is available to physicians through our
established distribution network and salesforce,” said Mr. Tatsuro
Tsutsumi, President of COSMOTEC. “We’re looking forward to working
with AVITA Medical to swiftly bring this treatment to patients in
need.”
For more information about the RECELL System, please visit
www.RECELLSystem.com.
About M3
M3 Inc. is a publicly traded company on the Tokyo Stock Exchange
(TYO:2413) with subsidiaries and affiliates 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 approximately 6 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 business reach or access to 98% 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 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 and a new ease-of-use design was approved in 2022.
The RECELL System is indicated for use in the treatment of acute
thermal burns. 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
STATEMENTSThis 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 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 |
InvestorsICR WestwickeCaroline CornerPhone
+1-415-202-5678 caroline.corner@westwicke.com |
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Apr 2023 to Apr 2024