AVITA Medical Announces Government Funded Clinical Trial of RECELL® in China
March 19 2018 - 3:42PM
Business Wire
Also Announces that Major Hospital Will Host
New Training Center for RECELL in Beijing
AVITA Medical (ASX: AVH) (OTCQX: AVMXY) today announced the
commencement of a randomized, controlled clinical trial of RECELL®
in the treatment of deep partial-thickness (second-degree) burns in
China. RECELL is a medical device designed to facilitate skin
regeneration while reducing the amount of skin harvested at the
time of surgery. Reduction in donor site skin requirements has
important benefits from both clinical and health economic
perspectives.
The clinical trial entitled “Key Technique and Clinical Pathway
for Burn Treatment” is being funded by the China National Health
and Family Planning Commission. In the controlled clinical trial,
burn patients will be randomized to be treated with either standard
of care, RECELL or one of two other treatments. The study is being
led by Dr. Dahai Hu of The First Affiliated Hospital of the Fourth
Military Medical University (Xijing Hospital).
AVITA Medical also announced that it is collaborating with the
Plastic Surgery Department of Peking Union Medical College Hospital
(PUMCH), one of the most renowned hospitals in China, to establish
a RECELL training center based in Beijing. The training center will
help standardize protocol for the use of RECELL, train RECELL
surgeons country wide, and encourage the expansion of the use of
this innovative treatment to hospitals across China. RECELL is
being distributed in China by China Pharmaceutical Group Shanghai
Medical Instrument Co., Ltd., a wholly owned subsidiary of
Sinopharm, the state-owned healthcare conglomerate.
“We are pleased to be working with such prestigious
organizations as the China National Health and Planning Commission,
PUMCH and Sinopharm,” said Dr. Michael Perry, AVITA Medical’s Chief
Executive Officer. “Our initiatives within China are consistent
with our evolving strategy of using data from controlled clinical
trials and health economic studies to ensure that RECELL is
effectively promoted and priced in all major markets.”
AVITA Medical has completed two U.S. pivotal clinical trials in
patients with severe burns which will be used to support the
planned launch of RECELL in the U.S. and in other markets
internationally. In addition, the Company expects the commencement
of additional clinical trials in burn patients in Australia and the
United Kingdom this year, as well as two controlled clinical trials
in the U.S. in pediatric patients. Support from organizations such
as China National Health and Planning Commission in China and
Biomedical Advanced Research and Development Authority (BARDA,
under Contract No. HHSO100201500028C), under the Assistant
Secretary for Preparedness and Response, within the US Department
of Health and Human Services in the U.S., allows these trials and
other RECELL initiatives to be accelerated while maintaining
resource requirements at a reasonable level.
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’s patented and proprietary collection
and application technology provides innovative treatment solutions
derived from the regenerative properties of a patient’s own skin.
Our medical devices work by preparing a REGENERATIVE EPITHELIAL
SUSPENSION™, an autologous suspension comprised of the patient’s
own skin cells and wound healing factors that are necessary to
regenerate natural healthy skin. This autologous suspension is then
sprayed onto the areas of the patient to be treated.
In all countries outside of Europe in which our devices are
registered for sale, our portfolio is marketed under the RECELL
brand to promote skin healing in a wide range of applications
including burns, chronic wounds and aesthetics. RECELL is
TGA-registered in Australia, and CFDA-cleared in China. In Europe,
our portfolio of medical device products received CE-mark approval
as three tailored product presentations, with three individual
brand names. RECELL is designed for the treatment of burns and
plastic reconstructive procedures; REGENERCELL™ has been formulated
for chronic wounds including leg and foot ulcers; and RENOVACELL™
is tailored for aesthetic applications including the restoration of
pigmentation. In the United States, RECELL is an investigational
device limited by federal law to investigational use.
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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For Further Information:AustraliaMonsoon
CommunicationsSarah KemterPhone: +61 (0)3 9620 3333Mobile: +61
(0)407 162 530sarahk@monsoon.com.auorUSAWestwicke
PartnersCaroline CornerPhone +1 (415)
202-5678caroline.corner@westwicke.comorAVITA Medical LtdDale
A. SanderChief Financial OfficerPhone +1 (661)
367-9178dsander@avitamedical.com
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