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AVITA Medical Announces Nine RECELL® System Abstracts Accepted for Presentation at American Burn Association (ABA) 51st Annual Meeting
RECELL System clinical benefits and cost savings featured in 26 presentations
at four burn conferences in early 2019
Valencia, Calif., USA, and Melbourne, Australia, 29 January 2019 — AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that 26 abstracts highlighting the clinical and cost savings benefits of the RECELL® Autologous Cell Harvesting Device (RECELL® System) have been selected for presentation at four burn conferences in early 2019. Nine of the presentations will be made at the largest burn conference, the American Burn Association (ABA) 51st Annual Meeting to be held in Las Vegas April 2-5, 2019, including a Top-Five Abstract presentation in plenary session. Each of the presentations will be made by clinical investigators who will share their experiences and observations treating patients with the RECELL System.
NINE PRESENTATIONS AT ABA MEETING
The nine presentations at the ABA meeting include the clinical results and benefits of the RECELL System in the treatment of burns in specific subgroups of patients and types of burn injuries, including:
Pediatric patients (selected as a Top-Five Abstract to be presented in plenary session)
Extensive burn injuries in an adult population (life threatening burns greater than 50 percent total body surface area or TBSA)
Burn injuries of the hands
Burn injuries of joints and rehabilitation considerations
Budget impact of use of the RECELL System versus standard of care in treatment of severe burns at Arizona Burn Center
Post-operative wound management following treatment with the RECELL System
Treatment and healing of donor sites with the RECELL System in patient with large TBSA burns
Case study of 60% TBSA patient with life-threatening burn injuries and limited donor skin
A summary of ten years of clinical experience using RECELL System in the point-of-care treatment of burn injuries
The U.S. Food and Drug Administration (FDA) approved the RECELL System in September 2018 for the treatment of acute thermal burns in patients 18 years and older. Patients included in seven of the ABA presentations were treated as part of the Compassionate Use and Continued Access Investigational Device Exemption (IDE) programs made available to more than 150 burn patients prior to the FDA approval. Several of the presentations include classes of burns or patients that fall outside of the currently approved U.S. product labeling. Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings and precautions.
“These abstracts build upon and greatly advance the pivotal clinical trial results and health economic data presented at last year’s ABA meeting,” said Dr. Michael Perry, Avita Medical’s Chief Executive Officer. “The presentations to be made this April at the 2019 ABA meeting highlight the positive clinical outcomes that burn surgeons have observed in a broad range of patients and burn types. The clinical results demonstrate that the RECELL System is a major innovation in the treatment of burn patients as evidenced by the prominent featuring of this product candidate at the ABA conference. We appreciate the strong support we have received from the medical professionals and patients participating in these studies and thank them for their efforts in advancing the care of burn patients.”
NINE ADDITIONAL PRESENTATIONS MADE AT TWO BURN CONFERENCES LAST WEEK
During the North American Burn Society 37th Annual Conference (NABS) held 20-23 January 2019 in Park City, Utah, eight presentations were made supporting the clinical and economic benefits of the RECELL System. Kevin Foster, MD, MBA, FACS, Arizona Burn Center, made a series of presentations detailing the results from two U.S. pivotal clinical trials which demonstrated the effectiveness, safety and clinical benefits of the RECELL System, and which were used as the primary basis for the FDA approval. Dr. Foster also presented a case study of the successful treatment with the RECELL System of a patient with a large soft-tissue defect caused by necrotizing fasciitis, or flesh-eating bacteria. Other presentations at the NABS conference included:
An overview of the protocols for two randomized controlled U.S. trials of the RECELL System in the treatment of pediatric patients
A case study of the successful treatment of a 60% TBSA burn patient with the RECELL System in combination with a biodegradable temporizing matrix
At the LA-ACS/SAL Annual Meeting held 18-20 January 2019 in New Orleans, Louisiana, Blake Platt, MD, University Medical Center New Orleans Burn Center and LSU Health New Orleans School of Medicine, presented data demonstrating a reduction in length of stay for burn patients treated with the RECELL System. Dr. Platt presented the results of 18 patients treated in the Compassionate Use and Continued Access programs who had a mean length of stay of 24 days compared to the expected mean length of stay of 55 days based on data from the American Burn Association National Burn Repository, a greater than 50 percent reduction.
EIGHT PRESENTATIONS AT UPCOMING JOHN A BOSWICK BURN & WOUND SYMPOSIUM
An additional eight presentations have been accepted for presentation at the John A Boswick Burn & Wound Symposium to be held 2-7 February 2019 in Maui. These describe the clinical and cost savings benefits of treatment with the RECELL System, and the presentations include:
Pivotal trials in 2nd and 3rd degree burns
Health economic model demonstrating cost savings benefit of the RECELL System
Treatment with the RECELL System combined with dermal substitutes