AVITA Medical Announces Preliminary Unaudited Results for the Quarter ended December 31, 2021
January 10 2022 - 8:00AM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX:AVH) (the
“
Company”), 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 announced preliminary unaudited estimates of its
top line results for the three months ended December 31, 2021.
Preliminary Results for the Quarter ended December 31
and Recent Updates:
- Total revenue increased 35% to $6.9 million in the quarter
ended December 31, 2021, compared to $5.1 million over the same
quarter in the prior year
- As of December 31, 2021, the Company had approximately $55.5
million in cash and cash equivalents and $49.3 million in
short-term and long-term marketable securities, and no debt
- Effective December 2021, the Company changed its fiscal
year-end to December 31
- Completed enrollment in two clinical trials with the goal of
submitting premarket approval (PMA) supplements in 2022
- In December 2021, completed enrollment of pivotal clinical
trial evaluating the safety and effectiveness of the RECELL® System
for the repigmentation of stable vitiligo lesions
- In January 2022, completed enrollment of pivotal study of
RECELL System for soft tissue reconstruction (trauma)
- Successfully established proof of concept with preclinical data
in two key areas of cell-based gene therapy – skin rejuvenation and
epidermolysis bullosa.
“Our recent successes in getting two pivotal clinical trials
fully enrolled, and also demonstrating proof of concept in two
other potential indications, underscore our commitment to further
growing the market opportunities for the RECELL system,” said Dr.
Mike Perry, AVITA Medical Chief Executive Officer. “Looking ahead,
we will be preparing our vitiligo and soft tissue dossiers to
submit PMA supplement applications to the FDA in late 2022 for
commercial launches for those indications in 2023.”
Authorized for release by the Chief Financial
Officer of AVITA Medical, Inc.
ABOUT AVITA Medical, Inc.AVITA Medical, Inc. is
a regenerative medicine company with a technology platform
positioned to address unmet medical needs in burns, chronic wounds,
and aesthetics indications. AVITA Medical Inc. 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 treatment.
AVITA Medicals’ 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 approved for acute
partial-thickness thermal burn wounds in patients 18 years of age
and older or application in combination with meshed autografting
for acute full-thickness thermal burn wounds in pediatric and adult
patients. 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
STATEMENTSThis press release 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 press
release 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 goals.
Forward-looking statements by their nature address matters that
are, to different degrees, uncertain. Each forward- looking
statement contained in this press release 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 including,
but not limited to the ongoing COVID-19 pandemic which are outside
of the company’s control. Investors should not place considerable
reliance on the forward-looking statements contained in this press
release. 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 press release
speak only as of the date of this release, and we undertake no
obligation to update or revise any of these statements.
FOR FURTHER INFORMATION:
U.S. MediaSam Brown,
Inc.Christy CurranPhone +1 615 414
8668christycurran@sambrown.com |
InvestorsICR WestwickeCaroline CornerPhone
+1 415 202 5678caroline.corner@westwicke.com |
O.U.S MediaMonsoon
CommunicationsRudi MichelsonPhone +61 (0)3 9620 3333Mobile
+61 (0)411 402 737rudim@monsoon.com.au |
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