AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine
company with a technology platform positioned to address unmet
medical needs in burns, chronic wounds, and aesthetics indications,
today announced an institutional placement of A$16.0 million to
prepare for the planned U.S. launch of the RECELL® Device in the
treatment of severe burns.
Avita has received commitments from international and Australian
institutional and sophisticated investors for a placement of A$16.0
million at an issue price of A$0.050 per share, with the placement
to occur in two tranches. Tranche 1 of the institutional placement,
totaling A$12.77 million, is expected to settle on 12 June 2018.
Settlement of Tranche 2 totaling A$3.25 million is subject to
shareholder approval at an Extraordinary General Meeting to be held
in July 2018.
“We appreciate the support of our shareholder group and the
investors in this institutional placement as we proceed toward a
transformative series of events for AVITA, including the U.S.
market launch of the RECELL Device,“ said Dr. Michael Perry, Chief
Executive Officer. “Proceeds from this placement will ensure that
we are positioned to take full advantage of the expected upcoming
PMA approval of the RECELL Device in the U.S., including
establishment of our marketing and sales team, scale-up of
manufacturing capabilities and expansion of research and
development in areas such as pediatric burns, aesthetics and
chronic wounds. The extensive series of clinical data presented at
the recent ABA and ISPOR conferences strongly supports the value of
RECELL in the treatment of severe burns, and we have an exceptional
commercial opportunity resulting from the unique combination of
improved patient outcomes and substantial health economic
benefits.”
The RECELL Device is an investigational medical device in the
U.S. that is designed to enable medical professionals to produce,
at the point-of-care, a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™)
using a small sample of the patient’s own skin. The autologous
suspension contains cells necessary to regenerate epidermis and
provides a new way to achieve permanent closure in burns and other
wounds 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 (reduction in cost
of treatment) perspectives.
A U.S. PreMarket Approval (PMA) application for the treatment of
burn injuries is currently under review by the U.S. Food and Drug
Administration (FDA). The Company expects completion of the FDA
review of the PMA during the third quarter of calendar 2018,
followed by U.S. approval and market launch. In April 2018
researchers from major burn centers throughout the U.S. made six
presentations at the American Burn Association (ABA) 50th Annual
Meeting in Chicago describing the clinical and cost-savings
advantages of the RECELL Device in the treatment of severe
burns.
Institutional Placement
The institutional placement was managed by Bell Potter as sole
lead manager and the Company has received commitments for A$16.0
million at an issue price of A$0.050 per fully paid ordinary share.
Upon completion of the placement, the Company will issue up to
320,475,665 shares to international and Australian institutional
and sophisticated investors to whom disclosure was not required
pursuant to Chapter 6D of the Corporations Act 2001. The issue
price of $0.050 per share represents a 3.8 percent discount to the
last closing price on 1 June 2018, and a 6.3 percent discount to
the 30-day VWAP of the Avita share price prior to the Company
seeking a trading halt. The new Avita shares to be issued under the
institutional placement will rank equally with existing Avita
shares on issue.
“We are pleased to move toward the completion of this
institutional placement to ensure that resources are in hand to
strengthen our position and ensure that we are fully enabled to
take advantage of opportunities facing us, including the upcoming
U.S. launch of the RECELL Device,” said Dale Sander, Chief
Financial Officer. “We note that the issue price of this
institutional placement is higher than that of our last financing
round, and is within the range at which our shares have traded for
the past 30 days.”
Tranche 1 of the institutional placement totals A$12,773,783 of
proceeds and the issuance of 255,475,665 shares. For Tranche 1 the
Company will issue 153,285,399 shares under its 15 percent
placement capacity (under ASX Listing Rule 7.1) and 102,190,266
shares under its 10 percent placement capacity (under ASX Listing
Rule 7.1A). Tranche 2 totals A$3,250,000 of proceeds and the
issuance of 65,000,000 shares, and settlement is contingent upon
shareholder approval at Extraordinary General Meeting to be held in
July 2018.
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. Our medical
devices work by preparing a REGENERATIVE EPITHELIAL SUSPENSIONTM,
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 the United States, the RECELL Device is an investigational
device limited by federal law to investigational use. In September
2017, AVITA Medical submitted to the U.S. Food and Drug
Administration (FDA) a PreMarket Approval (PMA) application for
RECELL for the treatment of burn injuries.
In all countries outside of Europe, our portfolio is marketed
under the RECELL Device brand to promote skin healing in a wide
range of applications including burns, chronic wounds and
aesthetics. RECELL Device 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 Device is designed for the
treatment of burns and plastic reconstructive procedures;
REGENERCELL™ Autologous Cell Harvesting Device has been formulated
for chronic wounds including leg and foot ulcers; and RENOVACELL™
Autologous Cell Harvesting Device 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180605006898/en/
OUS MediaMonsoon CommunicationsSarah KemterPhone:
+61 (0)3 9620 3333Mobile: +61 (0)407 162
530sarahk@monsoon.com.auorUS MediaSyneos Health Public
RelationsDavid PolkPhone: +1 (310) 309 1029Mobile +1 (805) 428
5775david.polk@syneoshealth.comorInvestors:Westwicke
PartnersCaroline CornerPhone +1 (415)
202-5678caroline.corner@westwicke.comorAVITA
Medical LtdDale A. SanderChief Financial OfficerPhone +1 (858)
663-6993dsander@avitamedical.com
AVITA Medical (ASX:AVH)
Historical Stock Chart
From Mar 2024 to Apr 2024
AVITA Medical (ASX:AVH)
Historical Stock Chart
From Apr 2023 to Apr 2024