Avita Medical Initiates US FDA Study of Its ReCell® Spray-On-Skin™ for Reconstructive and Aesthetic Indications
May 15 2012 - 3:27PM
Business Wire
Avita Medical Ltd. (ASX: AVH), (OTC:
AVMXF), (OTCQX: AVMXY),the regenerative medicine
company, today announced that it has commenced enrolment in the US
FDA-approved feasibility study for the use of ReCell®
Spray-On-Skin™ in the treatment of hypertrophic dyspigmented
scars (raised and/or discoloured scars).
The initial three patients were treated by Dr Rajiv Sood, at the
Richard M. Fairbanks Burn Center of Wishard Hospital, Indiana
University, Indianapolis, Indiana, for scarring resulting from
previous grafting due to burn injuries.
The approved FDA protocol permits the Company to treat 20
patients with scars at up to four U.S. study sites; patients will
be assessed for healing and pain on a weekly basis during the
initial four weeks post-treatment; at weeks 12 and 24 the treatment
site will be assessed for healing and aesthetic outcomes by both
the patient and an independent observer.
"Commencement of the FDA scar study is an important milestone
for Avita," said Dr William Dolphin, Avita Medical’s CEO. "ReCell
has shown the potential to provide significant benefits over
current options in the treatment of acute and chronic wounds and
for a wide range of skin defects. We are confident that this study
will demonstrate the effectiveness of ReCell in the corrective
treatment of scars, making ReCell directly applicable and
immediately relevant to the very large aesthetic markets.”
The feasibility study is primarily designed to confirm the
effectiveness of ReCell for the treatment of scars in a single
session in comparison to the current standard of care involving
dermabrasion of the scar and often requiring multiple treatment
sessions; study endpoints are time-to-healing and aesthetic
outcomes. Following completion of the study, Avita will submit the
feasibility data and seek FDA approval for a statistically powered,
pivotal clinical trial.
The study is funded by the US Department of Defense in
partnership with the OSD Manufacturing Technology Program and Rapid
Fielding Directorate for the “Limb Salvage and Regenerative
Medicine Initiative.” The contract is a Technology Investment
Agreement that is focused on the transition of the capability to
meet DoD needs. ReCell was selected as it has the potential to be a
quantum advance over the existing ability to treat and re-grow
tissue and to substantially reduce the effects and appearance of
scarring and thereby profoundly assist in the treatment and
rehabilitation of wounded warriors suffering from disfigurement and
impeded function due to combat injuries.
An interview with Dr Sood regarding the use of ReCell in
treatment of scars and acute wounds is available at
http://soundmedicine.iu.edu/segment/3245/Spray-on-Skin.
ABOUT AVITA MEDICAL LTD.
Avita Medical (www.avitamedical.com) develops and distributes
regenerative and tissue-engineered products for the treatment of a
broad range of wounds, scars and skin defects. The company’s lead
product, ReCell® Spray-On-SkinTM, is used in a wide variety of
burns, plastic, reconstructive and cosmetic procedures. ReCell is
patented, CE-marked for Europe, TGA-registered in Australia, and
SFDA-cleared in China. ReCell is not available for sale in the
United States; in the U.S. ReCell is an investigational device
limited to investigational use.