COSMOTEC has filed a JPMDA application for
approval to market the RECELL System in Japan
AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative
medicine company, announced that it has collaborated with COSMOTEC,
an M3 Group company, to market and distribute the RECELL®
Autologous Cell Harvesting Device (RECELL® System) for the
treatment of burns and other wounds in Japan. In addition, COSMOTEC
filed on 25 February 2019 a Japan’s Pharmaceuticals and Medical
Devices Act (“JPMDA”) application for approval to market the RECELL
System in Japan. The JPMDA has accepted the application and review
is expected to take nine months to a year.
“The number of patients suffering from chronic wounds and
decubitus ulcers is increasing in Japan due to aging. Japan is also
planning for the Tokyo Olympic Games in 2020 and must be prepared
for major disasters such as a large earthquake. We are very proud
to add the RECELL System to our product lineup,” said Mr. Kiyoshi
Takei, President of COSMOTEC. “With over 30 years since our
foundation, COSMOTEC has been doing business in 90-100% of high
acute care hospitals in Japan in the fields of cardiac surgery,
vascular surgery, and wound care. As a member of the M3 Group, we
can deliver the RECELL System's benefits to at least 90% of
Japanese plastic surgeons and dermatologists through the portal
site 'm3.com.' With this opportunity, we would like to contribute
to the advancement of burn injury and wound care in Japan.”
“We are very excited to partner with COSMOTEC on the
commercialization of the RECELL System in Japan, a key global
market,” said Dr. Michael Perry, AVITA Medical Chief Executive
Officer. “COSMOTEC’s experience marketing medical devices and other
products into hospitals and surgical suites throughout Japan,
including specialties requiring a high level of training such as
cardiovascular treatment, make them an ideal partner for us. We are
also pleased that they are backed by the M3 Group, a major
healthcare company with great physician access in Japan and other
markets. The filing of the JPMDA application is a major milestone,
and we look forward to making the RECELL System available to
patients in Japan.“
Japan is the second largest healthcare market in the world and
represents a valuable market for the RECELL System with more than
6,000 patients with severe burns treated in hospitals each year.
Over two million people in Japan are estimated to have vitiligo, a
disease that causes the loss of skin color in blotches and can
affect the skin on any part of a patient’s body. Financial terms of
the collaboration were not disclosed.
About M3
M3 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 COSMOTEC
COSMOTEC 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 LIMITED
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 REGENERATIVE EPIDERMAL SUSPENSION™
(RES™), 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 7,000 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 and CFDA-cleared in
China.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190303005047/en/
U.S. MediaSam Brown, Inc.Christy CurranPhone
+1-615.414.8668chrristycurran@sambrown.com
OUS MediaMonsoon CommunicationsSarah KemterPhone
+61 (0)3 9620 3333Mobile +61 (0)407 162
530sarahk@monsoon.com.au
Investors: Westwicke PartnersCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.com
AVITA Medical LtdDale A. SanderChief Financial
OfficerPhone +1-661-367-9178dsander@avitamedical.com
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