Now allows up to 68 patients to be treated at
18 US burns centers
The U.S. Food and Drug Administration has approved a further
increase in the number of patients who can be treated in the United
States with the ReCell® regenerative medical device under a
compassionate use protocol, Avita Medical Ltd. (ASX: AVH),
(OTCQX: AVMXY) said today.
The regenerative medicine company, which specializes in the
treatment of wounds and skin defects, said the FDA had approved its
fourth and largest expansion of its Compassionate Use
Investigational Device Exemption (IDE) program for ReCell®, now
allowing treatment of up to 68 patients who have insufficient
healthy skin available for standard skin grafting treatment of
their injury. The FDA also approved an increase to the total number
of hospitals that could deploy the protocol from 15 to 18, enabling
other hospitals not already involved in the ongoing Continued
Access protocol to be introduced to Avita’s autologous cell
harvesting approach in cases where the patients’ treating
physicians believe there to be no suitable alternative
treatment.
“We are pleased to receive this compassionate use expansion,
which we think underscores both the necessity of our product for
treating life-threatening burns, and the growing interest within
the U.S. burns community,” said Avita CEO Adam Kelliher. “We look
forward to submitting for premarket approval (PMA) of ReCell in
coming weeks with the goal of launching the product, if approved,
into the broader burns market in 2018.”
The FDA first approved the IDE for up to 12 subjects in
life-threatening circumstances in April 2014. Since then, requests
have increased from surgeons to access the exemption and treat
their patients. In September 2015, the FDA allowed a doubling of
the number of patients permitted under the IDE, from 12 to 24
patients. In February of 2016 the FDA approved an increase to the
number of patients to 36 and another increase approval was granted
again in October 2016 to 48 patients.
To date, 49 compassionate use cases using ReCell® have been
conducted at several leading institutions, including Wake Forest
Baptist Medical Center, the Arizona Burn Center at Maricopa Medical
Center, Walter Reed National Military Medical Center, MedStar
Washington Hospital Center, University of California San Diego
Health System, Regional Medical Center / University of Tennessee,
the U.S. Army Institute for Surgical Research (San Antonio),
University of South Alabama, Baton Rouge General Hospital, Riley
Hospital for Children (Indianapolis), and Massachusetts General
Hospital.
“We are thrilled that the FDA is allowing us to continue to
serve severely burned patients through the Compassionate Use
program,” said Andrew Quick, Avita’s Senior VP Clinical
Development. “This also allows us to further build our
collaborations with U.S. surgeons as we develop best practices for
treatment of burn injuries in front of our planned launch of ReCell
next year.”
Avita is seeking a Pre-Market Approval (PMA) for its ReCell®
device, and its fully enrolled clinical trial has involved seven
leading US burns centers. The Company expects to submit its
clinical and non-clinical data package in mid-2017, with an
anticipated FDA approval in the second calendar quarter of
2018.
ABOUT AVITA MEDICAL LIMITED
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
(RES™), an autologous suspension comprised of the patients’
own skin cells and wound healing factors that are necessary to
regenerate natural healthy skin. This is then applied to the area
to be treated.
In all countries outside of Europe, 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 the United States, ReCell® is an investigational
device limited by federal law to investigational and compassionate
use.
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.
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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Avita Medical LtdAdam KelliherChief Executive Officer+44
020 8947 9804akelliher@avitamedical.comorTim RooneyChief Financial
Officer+ 1 (661)
367-9170trooney@avitamedical.comorAustraliaMonsoon
CommunicationsSarah Kemter+61 (0)3 9620 3333Mobile: +61 (0)407
162 530sarahk@monsoon.com.auorUSAWestwicke
PartnersJamar Ismail+1 (415)
513-1282jamar.ismail@westwicke.com
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