VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical (ASX: AVH, OTCQX: AVMXY) today announced that results from two U.S. pivotal clinical trials demonstrating the effectiveness and clinical benefits of the RECELL® Autologous Cell Harvesting Device were presented in the plenary session at the U.S. Defense Department Military Health System Research Symposium (MHSRS) in Kissimmee, Florida. The results were presented by James H. Holmes, IV, MD, FACS Wake Forest Baptist Medical Center, Winston-Salem North Carolina.
“The RECELL Device addresses an unmet need in the treatment of burn patients and provides the opportunity with a point-of-care technology to reduce the amount of skin required for epidermal regeneration and definitive closure of burns,” said Dr. Holmes. “The trial results demonstrate comparable burn wound healing between the RECELL Device and standard skin grafts while utilizing significantly less skin and resulting in improved healing of donor sites harvested for treatment with the RECELL Device.”
The MHSRS is the Department of Defense’s premier scientific meeting and provides a venue for presenting new scientific knowledge resulting from military-unique research and development. The MHSRS is the only military or civilian meeting that focuses specifically on the unique medical needs of the Warfighter. MHSRS provides a collaborative setting for the exchange of information between military providers with deployment experience, research and academic scientists, international partners, and industry on research and related health care initiatives falling under the topic areas of Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Medical Simulation and Information Sciences, Military Infectious Diseases, and the Radiation Health Effects.
Key highlights of Dr. Holmes’ presentation included:
- The pivotal randomized, controlled clinical trial of the RECELL Device in the treatment of deep partial-thickness (second-degree) burns demonstrated statistically significant reduction in donor skin requirements (97.5 percent reduction) and pain, increased patient satisfaction and improved donor scar outcomes.
- The pivotal randomized, controlled clinical trial in mixed and full-thickness (third-degree) burns met its co-primary endpoints and demonstrated statistically significant reduction in donor skin requirements (32.0 percent reduction).
Currently the RECELL Device is not approved for sale in the U.S. and is limited by federal law to investigational use.
The RECELL Device is designed to enable medical professionals to produce, at the point-of-care, a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™) using a small sample of the patient’s own skin. The autologous suspension contains cells necessary to regenerate epidermis and provides a new way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery. Reduction in donor-site skin requirements has important benefits from both clinical and health economic perspectives. A U.S. Premarket Approval (PMA) application for the treatment of burn injuries is currently under review by the U.S. Food and Drug Administration (FDA). AVITA Medical expects completion of the FDA review of the PMA during the third quarter of calendar 2018, followed by U.S. approval and market launch.
Funding for the two U.S. pivotal clinical trials was provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C. In addition, funding for the trials was provided by the U.S. Department of the Army, AFIRM 1 Contract #W81XWH-08-2-0032.
ABOUT AVITA MEDICAL LIMITED
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. Our medical devices work by preparing a Regenerative Epithelial Suspension (RES), an autologous suspension comprised of the patient’s own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This is then applied to the area to be treated.
In all countries outside of Europe, our portfolio is marketed under the RECELL brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics.
RECELL is TGA-registered in Australia, and CFDA-cleared in China. In the United States, RECELL is not approved for sale and is limited by federal law to investigational use.
In Europe, our portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. RECELL is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell™ has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell™ is tailored for aesthetic applications including the restoration of pigmentation.
To learn more, visit www.avitamedical.com.
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