Avita Medical Announces Third Expansion of Compassionate Use Investigational Device Exemption for ReCell

Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY) announced that the US FDA has approved another increase in the number of patients who can be treated with the ReCell® regenerative medical device according to special compassionate use protocols.
According to the press release:

“The FDA had given a third expansion of its Compassionate Use Investigational Device Exemption (IDE) 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.”

CEO Adam Kelliher said the following:

“We welcome this compassionate use expansion, which will allow surgeons to further deploy our devices in the U.S. for patients who suffer extensive injuries, and are in a life-threatening condition. It underlines our key proposition, that ReCell is a safe, powerful and effective means of facilitating healing. Most of the cases to date have been in burns, indicating the growing interest we are seeing within the U.S. burns community for our unique approach.”

Read the full press release here.