Avita ReCell pivotal meets endpoints, shares jump

Avita Medical (ASX:AVH) saw shares rise over 5% today after announcing that the pivotal clinical trial of its regenerative ReCell device for treating severe burns met both co-primary endpoints. 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 ski...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Regenerative Medicine Avita Medical Ltd. Source Type: news