Avita Medical Ltd (RCEL)

[Windbag1014]

As previously disclosed, on June 30, 2023, AVITA Medical, Inc. (the
“Company”) submitted a premarket approval supplement application
(the “PMA”) to the U.S. Food and Drug Administration (the “FDA”)
for its latest device, RECELL GO™. The submission initiated a
prioritized, interactive review of the PMA under the FDA’s
Breakthrough Device program, which follows a 180-day review
cycle.


At the halfway point of the process, the Company received notice
from the FDA that additional information regarding the PMA is
required for the continuation of a substantive review. This
request, which is not unique to the Breakthrough Device Program,
places the application file on hold for approximately 4 to 6 months
while the Company addresses the FDA's questions. Upon the Company’s
submission of a complete response to the FDA’s request, the
application will reenter the 180-day cycle, with 90 days remaining
in the review period. This timing would imply a product launch
between May 1 and July 1, 2024.