AVITA Therapeutics Provides Company Update and Revised Corporate Presentation
AVITA Therapeutics, 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, today
provided an update on corporate developments.
- U.S. RECELL® System Sales:
- July represented the highest monthly sales for RECELL Systems
in the United States since launch in January 2019.
- Unaudited sales for the RECELL System in July were U.S.$1.83
- July also witnessed very broad utilization of the RECELL System
with 57 unique account orders, and more than 90 physicians using
the RECELL System.
- AVITA expects quarterly revenue in the September quarter to
resume growth, and for sales to exceed the U.S.$3.9 million
previously reported for the three (3) months ended June 30, 2020.
- Recall that in the quarter ended June 30, 2020 revenue was
deeply impacted by COVID in the United States with sales in the
month of April down approximately 25% (versus the previous
- Revenue then recovered in both May and June to deliver a flat
sequential quarterly revenue result from the March quarter to the
- Clinical Studies:
- As previously advised, the U.S. Food & Drug Administration
(FDA) granted an investigational device exemption (IDE) to support
a vitiligo pivotal study on July 2nd, 2020.
- Since receipt of the IDE, the Company has worked aggressively
to obtain investigational review board approval (IRB) to support
initiation of this study, together with commencing contracting
discussions with potential clinical sites.
- AVITA expects to treat our first vitiligo patient during
- There is a very high degree of both patient and clinical site
enthusiasm in participating in our vitiligo pivotal study. Further,
the Company continues to believe that the RECELL System is uniquely
positioned to offer vitiligo patients a single curative therapy
given that the RECELL System has been used to treat over 1,000
vitiligo patients internationally, and has been shown to provide
patient benefits to vitiligo patients in eight (8) peer-reviewed
- AVITA is also actively endeavoring to increase the number of
clinical studies participating in each of our clinical studies.
Additional clinical study sites have recently been added to both
the pediatric scald and the soft tissue pivotal studies, and more
sites are expected to be onboarded over the next few months.
- The Company expects to release its Annual Report for the twelve
(12) months ended June 30, 2020 on August 28th.
- The Company will participate both in the Morgan Stanley Virtual
18th Annual Global Healthcare Conference and the Cantor Global
Healthcare Conference, which are both scheduled to take place in
- A copy of the Company’s revised corporate presentation is
available on the Company’s website.
For more detailed information on the Company’s recent
developments, please see our press release dated July 10, 2020
(which is available on both the Company’s and ASX’s website).
Authorized for release by the Chief Executive Officer of AVITA
ABOUT AVITA THERAPEUTICS, INC.
AVITA Therapeutics is a regenerative medicine company with a
technology platform positioned to address unmet medical needs in
burns, chronic wounds, and aesthetics indications. AVITA
Therapeutics’ 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
AVITA Therapeutics’ 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 8,000 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 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
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