Avita Medical (ASX:AVH) said yesterday that the FDA approved an investigational device exemption for a pivotal trial of its Recell autologous cell harvesting device.
The Valencia, Calif.-based company said the 65-patient study is designed to compare conventional skin grafting with and without Recell system. Each patient is slated for a control wound treated with a conventional graft and wound treated with a Recell graft. The primary outcomes are non-inferiority of confirmed healing and superiority of expansion ratio (a way to measure the amount of donor skin spared), both at eight weeks as determined by a blinded evaluator.
Other outcomes are patient and blinded evaluator scar assessment at 26, 36 and 52 weeks and patient treatment preference at 52 weeks, according to ClinicalTrials.gov.
Prior studies showed that Recell used 97.5% less donor skin in treating second-degree burns and 32% less donor skin with third-degree burns. Patients also reported less pain, increased satisfaction and improved scar outcomes, but the healing results were comparable to the standard of care, according to the company.
“FDA approval of our IDE for a soft tissue reconstruction pivotal clinical trial is an important next step in expanding the potential indications of our Recell system technology platform,” CEO Dr. Michael Perry said in prepared remarks. “We are pleased with the strong interest expressed by the clinical community in participating in this study and we look forward to working with physicians and their patients upon study commencement. Many burn specialists who have experience treating burn patients with the Recell system also treat patients with trauma injuries in their clinics. The treatment protocols for burns and trauma are well-aligned and as such, we anticipate a positive transfer of clinical experience to benefit this patient population during the clinical trial.”
“Based on the compelling safety and effectiveness of the Recell system in treating burn wounds, we believe our innovative technology is ideally positioned to be evaluated as a treatment to heal trauma and surgery-related wounds,” added CTO Andy Quick. “With a clear opportunity to improve the standard-of-care, we look forward to sharing results upon completion of this pivotal trial.”
In February, Avita said it raised $14.4 million in an equity round. A month later, the company announced a Japanese marketing and distribution deal with Cosmotec for the Recell device.
AVH shares closed up 1.0% at A$0.52 apiece today in Sydney; AVMXY shares up 2.3% to $7.28 each in mid-afternoon trading in New York.
