Findings Presented at ABA Southern Region Burn Conference
NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM -- (Marketwired) -- Dec 09, 2015 -- Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, today said a presentation of a series of 12 cases showed length of hospital stay for patients with extensive burn injuries decreased by 63% when treated with ReCell®.
The findings were presented by Ryan Rebowe, MD, of the Wake Forest Baptist Medical Center Burn Center (WFBMC), at the 28th Annual Southern Region Burn Conference, held November 20 - 22, 2015 in Dallas, Texas. The presentation, titled "The Use of ReCell® in the Treatment of Large Burns: A Single Center Experience," achieved 2nd place honours at the event.
Surgeons at the WFBMC Burn Center performed the 12-case series, which included eight adult and four pediatric cases of large, thermal burns treated using ReCell® as an adjunct to grafting. They compared the lengths of hospital stay observed for patients treated with ReCell® under Avita's Compassionate Use Investigational Device Exemption (IDE) with published age-matched averages from the American Burn Association's National Burn Repository database. When the participants in the case series were compared to age-matched averages, the hospital length of stay was 63% lower in the ReCell-treated group, the researchers reported.
The use of ReCell in conjunction with autografting appears to reduce risks of graft loss and poor functional/aesthetic outcomes commonly associated with widely expanded meshed autografts, enabling the surgeons to confidently achieve primary closure for these patients of up to 12,000 cm2 in a single procedure that would ordinarily require multiple, staged operations. The reduction in multiple, staged operations means that patients' burn injuries are healed earlier and they can be appropriately discharged from the hospital.
"We are very pleased with the apparent decreased length of stay that we were able to achieve for these massive burns with the use of ReCell," commented Dr. James H. Holmes IV, MD FACS, Director of the WFBMC Burn Center.
Earlier this fall, the U.S. Food and Drug Administration (FDA) approved an expansion of Avita's Compassionate Use Investigational Device Exemption (IDE) program for ReCell®. As part of the expansion, the FDA doubled the patient number to a total of 24 patients who have insufficient healthy skin available for standard skin grafting of their injury.
"This series of compassionate use cases highlights the excellent clinical and economic outcomes that we expect through the use of ReCell® in burn care," commented Andrew Quick, Avita's Vice President of Research and Technology. "Relative to normative data, Wake Forest Baptist Medical Center Burn Center showed a 63% reduction in their patient's length of hospital stay, saving both patients and the healthcare system valuable time and resources."
ReCell® first gained prominence as a treatment for burn victims following the 2002 bombing in Bali, Indonesia, and it has been deployed in other mass casualty events, including the Taiwan waterpark disaster in June 2015. The single-use device is simple to use, and allows medical professionals to quickly make a Regenerative Epithelial Suspension (RES™), which can be immediately applied to a burn. Clinical data have shown that the method can improve short-term healing and provide superior long-term outcomes. In terms of autograft-sparing capability, RES™ can be created using only small skin samples, significantly reducing the need for skin donor sites.
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 U.S. trial is underway, with patient enrollment completion anticipated by the end of 2015. To learn more, visit www.avitamedical.com.
FOR FURTHER INFORMATION Avita Medical Ltd Adam Kelliher Chief Executive Officer Phone: +44 (0) 1763 269 772 [email protected] Avita Medical Ltd Tim Rooney Chief Financial Officer Phone: + 1 (818) 356-9400 [email protected] Avita Medical Ltd Gabriel Chiappini Company Secretary Phone +61(0) 8 9474 7738 [email protected] UK/EU Instinctif Partners Gemma Howe/Sue Charles Phone +44 (0)20 7866 7860 [email protected] USA The Ruth Group Lee Roth, Investor Relations Kirsten Thomas, Public Relations Phone: +1 (646) 536-7012 / +1 (508) 280-6592 [email protected] / [email protected] Australia Monsoon Communications Rudi Michelson Investor Relations / PR Phone: +61 3 9620 3333 [email protected]
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