FDA Approves IDE Amendment to a Single-Arm Design for AVITA Medical’s Pivotal Study of the RECELL® System for Vitiligo Treatment
August 16 2021 - 8:00AM
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 the U.S.
Food and Drug Administration (FDA) has approved the company’s
request to amend its pivotal clinical trial evaluating the safety
and effectiveness of the RECELL® System for the repigmentation of
stable vitiligo lesions to a streamlined single-arm trial design.
The Company’s strategic decision to pursue a single cell suspension
formulation (1:20 expansion ratio) is based on data from other
research efforts that suggest the improbability of meaningful
clinical performance differences amongst the three cell suspensions
in the initial pivotal clinical trial design.
“The simplified study design and reduced number of study
subjects reflects confidence both in the exceptional safety profile
of RECELL and in the anticipated high incidence of repigmentation
with RECELL treatment, as we have seen in 11 peer-reviewed
publications and in the treatment of more than 1,000 patients
outside the U.S.,” said Dr. Mike Perry, Chief Executive Officer of
AVITA Medical. “The design change allows this program to progress
in a timely and cost-effective manner toward bringing a novel
therapeutic option to an underserved population. Our ongoing
multi-media outreach and clinical and advocacy group referral
programs are generating significant interest in the trial. The
program is on track, and we continue to believe we could be in a
position to enter the U.S. market with the vitiligo indication,
following successful completion of the clinical trial, as early as
the second half of calendar year 2023.”
Pivotal Trial DesignThe multi-center pivotal
study includes 15 clinical sites to assess the safety and
effectiveness of the RECELL System in treatment of depigmented
vitiligo lesions in patients whose vitiligo is stable, meaning they
have not had new vitiligo lesions or lesions that have expanded for
at least one year. The primary effectiveness evaluation is based on
a comparison of the incidence of successful repigmentation with
RECELL versus that of a standard of care control. Long-term
durability data (assessing sustained repigmentation over 52 weeks)
will be collected.
Each site is required to complete a run-in treatment as part of
study initiation. Subjects treated in the earlier version of the
pivotal clinical trial will be counted as part of the run-in
cohort. After run-in, 23 subjects will be treated and evaluated in
the final pivotal cohort. As with the previous design, an interim
analysis will be conducted on 24-week data for approximately half
of the subjects to evaluate sufficiency of the sample size, with a
possible increase to sample size as needed (up to 46 subjects).
About VitiligoVitiligo is a disease resulting
in loss of color, or pigmentation, in patches of skin, negatively
impacting the quality of life for those living with the
condition.(i) Vitiligo affects approximately 6.5 million people in
the United States(ii), rivalling the prevalence of psoriasis.(iiii)
There is currently no cure for vitiligo, nor a universally accepted
method for limiting the spread of the disease. Although many
treatments are being used for the management of vitiligo, they are
often temporary with a high rate of recurrence.(iv)
Authorized for release by the Chief Financial Officer of AVITA
Medical, Inc.
ABOUT AVITA MEDICAL, INC.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. 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 Medical’s 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. 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 10,000 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
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
MediaMonsoon CommunicationsRudi
MichelsonPhone +61 (0)3 9620 3333Mobile +61 (0)411 402
737rudim@monsoon.com.au |
Investors:Westwicke
PartnersCaroline CornerPhone +1 415 202
5678caroline.corner@westwicke.com |
(i) Willingness-to-pay and quality of life in
patients with vitiligo. Radtke, et al. BJD. 2009(ii) Advances in
Vitiligo: An Update on Medical and Surgical Treatments. A. Dillon,
et al. J Clin Aesth Derm. 2017 (iii) National Psoriasis Foundation
– Statistics, https://www.psoriasis.org/content/statistics Accessed
12/28/19 (iv) Vitiligo Research Foundation – Treatment Guidelines.
https://vrfoundation.org/treatment_guidelines Accessed 12/28/19
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