The ReCell device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Cambridge, U.K.-based said.
The company said that the data from the 30-patient trial would be submitted to the FDA as it pursues PMA approval for its ReCell autologous cell harvesting device, which it hopes to submit in mid-2017, with a hopeful timeline of approval by the 2nd quarter of next year.
“The positive results from both clinical trials clearly demonstrate the efficacy of ReCell for treating burn injuries. Submission of the PMA, and FDA approval, will be the final steps on a long road to improve burn care. The addition of ReCell to the U.S. burn surgeon’s armamentarium is eagerly awaited and will undoubtedly advance burn care in the U.S.,” pivotal trial lead Dr James Holmes of N.C.’s Wake Forest Medical Center said in prepared remarks.
Co-primary endpoints showed effectiveness of the ReCell device combined with expanded skin grafting in the closure of deep-partial and full-thickness burn injuries, Avita said.
The 1st endpoint measured superiority of donor skin expansion, determining whether the system would reduce the amount of donor skin required, and found that just over 30% less donor skin was required compared to the control. The 2nd endpoint measured the incidence of healing within 8 weeks, and was found to be statistically non-inferior to conventional treatment.
“Both studies validate our broader view that this unique regenerative approach will transform the way burns are treated in the U.S., a sector that has been starved of innovation for many years. The successful trial data represent years of hard work and commitment from patients and physicians across the U.S., all of whom we would like to thank for their participation. We look forward to publication of the complete data set in a peer-reviewed journal,” clinical development senior VP Andy Quick said in a prepared statement.
The trial measured 3 secondary endpoints, including patient preference of scar outcomes, as well as patient and blinded-observer opinions using a standardized scar assessment scale. No statistical difference was observed between the ReCell and control groups, Avita said.
“This significant data readout, from a total of 131 burns patients evaluated under randomized controlled settings, takes us one step further along the approval pathway. The Avita team will now push ahead with completing and submitting the PMA, our next big milestone as we work towards launching ReCell into the U.S. burns market,” CEO Adam Kelliher said in a press release.
Avita shares are up 5.2% so far today, at $1.41 as of 11:52 a.m. EDT.
The company saw a similar jump in shares in April after the FDA approved an expansion to the number of patients that can be treated in a trial of its ReCell regenerative device.
The federal watchdog has expanded the number of patients treatable under the compassionate use protocol up to 68, the company said, and also increased the number of hospitals which are cleared to deploy the device from 15 to 18.