AVITA Medical Announces Achievement of Co-Primary Endpoints in Updated Analysis of Pivotal Trial of RECELL® System for Soft Tissue Repair
November 09 2022 - 6:45PM
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative
medicine company leading the development and commercialization of
first-in-class devices and autologous cellular therapies for skin
restoration, today announced achievement of co-primary endpoints as
a result of updated analysis of data from its clinical trial
evaluating the safety and effectiveness of the RECELL® System for
soft tissue repair.
The study design included two co-primary endpoints based on
pairwise comparisons where each subject received both RECELL
treatment and standard of care treatment (Control): one endpoint
had a hypothesis of superiority for donor skin sparing and the
other co-primary endpoint had a hypothesis of non-inferiority for
healing.
Both co-primary endpoints have been met:
- RECELL achieved statistically
significant donor sparing over Control (p<0.001).
- RECELL achieved statistical non-inferiority for healing versus
Control (p<0.025).
“These results reinforce the potential for RECELL to become a
new standard of care for soft tissue repair,” said Jim Corbett,
AVITA Medical Chief Executive Officer. “We look forward to sharing
the soft tissue repair outcomes with the FDA via our PMA submission
expected in December 2022.”
Previously, the company announced that the donor sparing
endpoint had achieved superiority and that the healing endpoint had
just missed non-inferiority. Subsequently, further re-verification
resulted in corrections to the healing data, ultimately leading to
a conclusion of non-inferiority for healing.
AVITA Medical’s clinical trial in soft tissue repair has been
funded in part with Federal funds from the Office of the Assistant
Secretary for Preparedness and Response, Biomedical Advanced
Research and Development Authority, under Contract No.
HHSO100201500028C.
Authorized for release by the Chief Financial Officer of AVITA
Medical, Inc.
ABOUT AVITA MEDICAL, INC.AVITA Medical is a
regenerative medicine company leading the development and
commercialization of devices and autologous cellular therapies for
skin restoration. The RECELL® System technology platform, approved
by the FDA for the treatment of acute thermal burns in both adults
and children, harnesses the regenerative properties of a patient’s
own skin to create Spray-On Skin™ cells. Delivered at the
point-of-care, RECELL enables improved clinical outcomes and
validated cost savings. RECELL is the catalyst of a new treatment
paradigm and AVITA Medical is leveraging its proven and
differentiated capabilities to develop first-in-class cellular
therapies for multiple indications, including soft tissue repair
and repigmentation of stable vitiligo lesions.
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 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, soft tissue repair, vitiligo, and
aesthetics. The RECELL System is TGA-registered in Australia,
received CE-mark approval in Europe and has PMDA approval in Japan.
To learn more, visit www.avitamedical.com.
FOR FURTHER INFORMATION:
Investors & MediaAVITA Medical,
Inc.Jessica EkebergPhone +1-661-904-9269
investor@avitamedical.commedia@avitamedical.com |
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Aug 2024 to Sep 2024
Avita Medical (NASDAQ:RCEL)
Historical Stock Chart
From Sep 2023 to Sep 2024