Avita Medical Announces First Patient Treated
The first patient has been treated in the study, which is funded through a US Department of Defense research program and taking place at the Walter Reed National Military Medical Center in Bethesda, Maryland. Avita Medical will play an advisory supporting role in the trial.
Researchers, led by principal investigator Dr. J. Peter Rubin, M.D., Chair of the Department of Plastic Surgery at the McGowan Institute for Regenerative Medicine at the University of Pittsburgh and investigator for the Armed Forces Institute of Regenerative Medicine (AFIRM), hope to recruit up to 20 patients in the randomized, within-patient controlled, feasibility study. The investigator-initiated trial is aimed at evaluating whether ReCell® treatment combined with widened split-thickness skin grafts is more effective in treating full-thickness traumatic wounds than conventional skin grafts. Outcomes for the area treated with Regenerative Epithelial Suspension (RES™) produced using the ReCell® device will be compared to outcomes of another area on the same patient treated with only conventional meshed autografting.
"When treating injuries associated with severe trauma, physicians are often limited in choice of donor sites for skin grafts, and so there is a real need for an acceptable alternative to conventional full and partial thickness skin autografting," said Andrew Quick, Avita Medical VP Research & Technology.
The July/August 2015 issue of Army Technology Magazine reported that the ReCell® device was regarded as having great potential for treating burn injuries among US military personnel. Previous use of ReCell® at Walter Reed, under compassionate use dispensations granted by the FDA, has included treatment of soldiers wounded in Afghanistan and Iraq. The Company believes the device, being fully portable, battery-powered, and needing only ambient storage temperatures, is well suited for deployment in field hospitals.
"It is great to see that the team at Walter Reed have commenced this study, which we believe has great potential for improving the treatment of civilians and wounded warriors who have suffered traumatic injuries," said Adam Kelliher, Chief Executive Officer of Avita Medical. "We look forward to further updates from the investigators as the trial progresses."
ABOUT 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.
ABOUT AVITA MEDICAL LIMITED
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, ReCell® is an investigational device limited by federal law to investigational use. A pivotal US trial is underway, with patient enrollment completion anticipated by the end of 2015. To learn more, visit www.avitamedical.com.