Aethlon Medical Inc (AEMD)

[Murph1953]

14 December 2015

FDA Grants ReCell® Expedited Access Pathway Designation


April 8, 2017

U.S. FDA has approved a further increase in patients who can be treated in the U.S. with the Avita Medical's ReCell regenerative medical device under a compassionate use protocol, now allowing treatment of up to 68 patients who have insufficient healthy skin available for standard skin grafting treatment of their injury.

The FDA also approved an increase to the total number of hospitals that could deploy the protocol from 15 to 18, enabling other hospitals not already involved in the ongoing continued access protocol to be introduced to Avita’s autologous cell harvesting approach in cases where the patients’ treating physicians believe there to be no suitable alternative treatment.