RECELL® System Data to be Presented at the Controversies and Conversations in Laser & Cosmetic Surgery Annual Meeting
August 17 2022 - 4:50PM
AVITA Medical, 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, announced today that a poster
presentation on cell characterization and potential clinical
benefits of the RECELL® Autologous Cell Suspension System (RECELL®
System) for the treatment of stable vitiligo will be shared at the
Controversies and Conversations in Laser & Cosmetic Surgery
Annual Meeting. The conference will be held in Santa Barbara, CA,
on August 19-21 bringing experts together to discuss controversial
issues in cutaneous and aesethetic surgery or challenging
therapeutic problems within dermatology.
“Given the unique format of this meeting, we look forward to the
presentation of RECELL and, more importantly, the conversation
amongst dermatology experts as they discuss the unique attributes
of this platform, including the potential for in-office
point-of-care treatment in about 30 minutes,” said Dr. Mike Perry,
Chief Executive Officer of AVITA Medical. “Following review by the
FDA, we believe the RECELL System may well offer a welcome
treatment option for patients seeking repigmentation for stable
vitiligo lesions.”
RECELL® System Presentations
- Autologous Melanocyte Transfer for Repigmentation and Scar
Healing – Girish Munavalli, MD, MHS
- Characterization of Autologous Skin Cell Suspension
prepared using RECELL® Autologous Cell Suspension System and
Evidence of Melanocyte Transfer – G. Kashgari, et
al
In the U.S., the RECELL® System is indicated for the
treatment of acute 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. Physician-initiated research beyond the FDA approved
indication is not sponsored by AVITA Medical and contains
independent data.
AVITA Medical is currently completing a pivotal trial for the
use of the RECELL System for treatment of stable vitiligo. The
vitiligo clinical trial aims to demonstrate safe and effective
repigmentation when using the RECELL System in combination with
phototherapy. AVITA anticipates FDA approval in 2023.
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.’s patented, and proprietary collection and application
technology provides innovative treatment solutions derived from the
regenerative properties of a patient’s own skin. The Company’s lead
product is the RECELL® System, a device that enables healthcare
professionals to Spray-On Skin™ Cells using a small sample of the
patient’s own skin to create an autologous suspension. The RES®
Regenerative Epidermal Suspension™ is then sprayed onto the areas
of the patient requiring treatment to regenerate natural healthy
epidermis.
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. In February 2022, the FDA reviewed and approved the PMA
supplement for RECELL Autologous Cell Harvesting Device, an
enhanced RECELL System aimed at providing clinicians a more
efficient user experience and simplified workflow.
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 15,000 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 approved 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, received CE-mark
approval in Europe, and received Japan’s Pharmaceuticals and
Medical Devices Act (PMDA) approval for burns in Japan.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This 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 goal. 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 and realization 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 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.
This press release was authorized by the review committee of
AVITA Medical, Inc.
FOR FURTHER INFORMATION:
U.S. MediaSam Brown, Inc.Christy CurranPhone
+1-615-414-8668christycurran@sambrown.comO.U.S.
MediaRudi MichelsonPhone +61 (0)3 9620 3333Mobile +61
(0)411 402 737rudim@monsoon.com.au |
InvestorsICR WestwickeCaroline CornerPhone
+1-415-202-5678caroline.corner@westwicke.com |
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