Avita Medical Completes Patient Recruitment for its FDA Approval Study Evaluating Use of ReCell® in Acute Burns
Jan 10, 2016
OTC Disclosure News Service
Northridge, CA and Cambridge, UK
Represents a major Company
milestone toward US approval and commercialisation
Solidifies timeline for collection
of pivotal clinical data required for FDA PreMarket Approval (PMA)
Company on track for readout
on primary effectiveness data by end of calendar Q1
Northridge, CA, USA and
Cambridge, United Kingdom, 10 January
2016 — Avita Medical Ltd. (ASX:
AVH), (OTCQX: AVMXY), a regenerative medicine Company specializing
in the treatment of wounds and
skin defects, today announced
that patient recruitment is complete for its U.S. Food and Drug
Administration (FDA) approval study evaluating the use of ReCell® in combination with meshed autografting for the
treatment of partial-thickness and full-thickness acute burns.
The recruitment of the
last patient in this pivotal trial is a significant milestone and follows the
announcement in December that the FDA granted
the ReCell® Autologous Cell Harvesting Device an Expedited
Access Pathway (EAP) designation. The Company anticipates that the priority
review afforded by the EAP designation will have a positive effect on the
approval timeline for ReCell®.
objective of the trial is to demonstrate the safe and effective use of ReCell® to
achieve definitive wound closure (healing) with a reduced requirement for donor
skin harvesting. The trial’s secondary objective is to show improved functional
and aesthetic outcomes. Using less donor skin allows surgeons to achieve definitive
closure in fewer surgical procedures, corresponding with a decreased length of
hospital stay and less pain management, particularly for extensive burns.
Better long-term functional and aesthetic outcomes result in a reduced need for
follow-on procedures to address issues associated with scarring.
completion means the Company is fully on track to collect the more challenging effectiveness
data required for this 30-patient trial. Once treated, each patient follows a
prescribed schedule of follow-up evaluations over the course of 52 weeks. Healing
is evaluated during the first 10 weeks after treatment, so primary effectiveness data for healing are anticipated by the end of calendar Q1
2016. The secondary effectiveness endpoints are evaluated for each patient 24
weeks after treatment. Durability of wound healing will be monitored for the
full 52 weeks after treatment.
Andrew Quick, Avita’s
Vice President of Research Technology, said, “Our clinical development
strategy is to drive mainstream adoption of ReCell® for burn surgery. We were able to find the right cohort for this
study within the planned timeframe, which is particularly difficult for acute
wounds such as burns. We have recruited a complete cohort of subjects that meet
the selection criteria and consented to participate for the duration of the
trial. This means that our data
collection completion and analysis are all on track.”
continued, “As with many clinical trials, successful recruitment of patients in
a burn study is challenging and uncertain. Particularly with burn studies, care
is regionalized and patients’ homes may be a great distance from the burn
center. Burn patients also often experience other challenges in their lives
that can interfere with their ability to comply with the study’s schedule of
return visits to the burn center for follow-up evaluations. The research teams
must be accordingly selective in determining whether a potential patient can
meet the requirements for study participation. The timely completion of
recruitment for this study is a reflection of the diligent efforts of the
research teams at the burn centers involved and we thank them for their
involved in the trial are Wake Forest Baptist University Medical Center Burn
Center in Winston-Salem, North Carolina, the Burn Center at MedStar Washington
Hospital Center in Washington, D.C., the Army Institute for Surgical Research
in San Antonio, Texas, the Firefighter’s Burn Center at Regional Medical Center
in Memphis, Tennessee, the Arizona Burn Center at Maricopa Medical Center in
Phoenix, Arizona, the North Carolina Jaycee Burn Center at University of North
Carolina Health Care in Chapel Hill, and the Regional Burn Center at Tampa
General Hospital and University of South Florida in Tampa, Florida.
Avita Medical is in discussion with the FDA regarding the accelerated timelines
under the EAP guidance, which is aimed at helping patients to get more timely
access to life-saving medical devices while preserving the statutory standards
of safety and effectiveness for Premarket Approval (PMA). The device has been
granted an EAP designation, as “the device may offer significant, clinically
meaningful advantages over existing legally marketed alternatives” said the
FDA. The Company had originally estimated that regulatory approval would come
in calendar Q3 17.
that ReCell® is a unique offering for healing burns victims, and we welcome the
opportunity for submission and approval in the U.S. as soon as possible,” said
Adam Kelliher, CEO of Avita Medical.
Whilst in the U.S. ReCell® requires PMA and is thus an
investigational device, it is already available for commercial use in a number
of countries: ReCell® is CE‐marked for Europe, TGA‐registered in Australia, and
CFDA‐cleared in China.
RECELL® AND RES™
ReCell® is Avita Medical’s unique proprietary
technology that enables a clinician to rapidly create, at point of care in
approximately 30 minutes, Regenerative Epithelial Suspension (RES™) using a
small sample of the patient’s skin. RES™ is an autologous suspension comprising
the cells and wound healing factors necessary to regenerate natural, healthy
skin. RES™ has a broad range of applications and can be used to restart healing
in unresponsive wounds, to repair burns using less donor skin yet with improved
functional and aesthetic outcomes, and to restore pigmentation and improve
cosmesis of damaged skin.
Avita Medical develops and distributes regenerative
products for the treatment of a broad range of wounds, scars and skin defects.
Avita’s patented and proprietary collection and application technology provides
innovative treatment solutions derived from a patient’s own skin. The Company’s
lead product, ReCell®, is used in the treatment of a wide variety of burns,
plastic, reconstructive and cosmetic procedures. ReCell® is patented, CE‐marked
for Europe, TGA‐registered in Australia, and CFDA‐cleared in China. In the
United States, pending the approval trial, ReCell® is an investigational device
limited by federal law to investigational use. To learn more, visit www.avitamedical.com.
FOR FURTHER INFORMATION
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Avita Medical Completes Patient Recruitment FDA Burns Study.pdf
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