FDA approves increase of number of Avita Medical's ReCell patients
The U.S. Food and Drug Administration has approved a further increase in the number of patients who can be treated in the United States with the ReCell regenerative medical device under special compassionate use protocols, Avita Medical said. The regenerative medicine company, which specializes in the treatment of wounds and skin defects, said the FDA had given a third expansion of its Compassionate Use Investigational Device Exemption program for ReCell, allowing the company to treat up to 48 patients who have insufficient healthy skin available for standard skin grafting of their injury. The FDA also increased to 15 the number of hospitals that could deploy the protocol. Several of these hospitals have been introduced to Avita's autologous cell harvesting approach under the Company's FDA approval trial, which is on schedule and now in a safety and observation period following treatment of all enrolled patients. Under the compassionate use protocol, use of ReCell may be granted in cases where the patient's treating physician believes that there is no suitable alternative treatment. The FDA first approved the initial IDE for up to 12 subjects in life-threatening circumstances in April 2014. Applications have increased from surgeons to access the exemption, and in October 2015, the FDA doubled the number of patients permitted under the IDE, from 12 to 24 patients. In July this year, the number was again increased to 36 patients.