AVITA releases encouraging RECELL® results
AVITA Medical (ASX:AVH, OTCQX:AVMXY) has today announced results from a clinical study highlighting the potential benefits of the RECELL® Autologous Cell Harvesting Device.
The results have indicated exceptional cosmetic outcomes for the treatment of deep second degree facial burns, an injury for which treatment usually involves dyspigmentation and hypertrophic scarring at the seams of skin grafts.
The results were presented by Nicholas Walker, MD, Wake Forest University School of Medicine, North Carolina, at the American Burn Association (ABA) 50th Annual Meeting in Chicago.
Joseph A. Molnar, MD, PhD at Wake Forest University School of Medicine in North Caroline, spoke on the study outcome, “These preliminary results demonstrate excellent cosmetic outcomes when RECELL was used on deep partial-thickness facial burns.
“Patient satisfaction with the cosmetic outcome is critically important for these injuries, and I look forward to further evaluating how and where RECELL can be best utilized to treat patients with facial burns,” he said.
About the study
A total of 26 patients were treated at Wake Forest University School of Medicine, North Carolina.
Patients in the facial burn study ranged from two to 40 years of age and had burns covering 35 percent to 62 percent of their total body surface area.
The results of the study demonstrated that the addition of RECELL to either of two dermal substitutes accelerated epithelialisation.
Full-thickness burns are sometimes treated in a two-step process in which a dermal substitute is placed first, followed by a skin graft approximately two weeks later.
This technique improves scarring, but also requires multiple operations and the potential for donor site morbidity.
In the study, full-thickness wounds were treated with one of two dermal substitutes, RECELL alone, or RECELL in combination with each of the dermal substitutes. The study suggests that a dermal matrix combined with RECELL could be used as a one-stage procedure in the management of full-thickness burns.
Of course, as with any clinical study, success is not guaranteed — consider your own personal circumstances before investing, and seek professional financial advice.
The study, led by Dr. Walker, performed a retrospective review of the patients in the study, including subjective complications and number of reoperations.
Detailed photographic documentation was showcased during the presentation, which demonstrated patient progress through various stages of the treatment process.
“We are pleased to see researchers evaluate additional ways in which RECELL may potentially be used to treat patients with severe burn injuries,” said Dr. Michael Perry, AVITA Medical’s Chief Executive Officer.
“These earlier-stage studies complement the broader body of scientific evidence supporting the benefits of RECELL, including our pivotal clinical trials presented this week, and we look forward to the continued exploration of the benefits of RECELL in high-unmet-need burns.”
What is Recell?
RECELL enables medical professionals to produce, at the point-of-care, a REGENERATIVE EPIDERMAL SUSPENSIONTM(RESTM) using a small sample of the patient’s own skin.
The process utilises cells required to regenerate epidermis which achieves 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, due to the challenging nature of reconstructive facial surgery.
In the United States, the RECELL Device is currently an investigational device limited by federal law to investigational use.
In September 2017, AVITA Medical submitted a PreMarket Approval (PMA) for the device to the FDA for the treatment of burns.
The RECELL Device is TGA-registered in Australia, and CFDA-cleared in China.