Avita Medical submits response to FDA for Recell Go PMA

AVITA Medical announced it has submitted its response to the FDA for additional information requested in connection to its premarket approval, or PMA, supplement for Recell Go. This submission resumes the substantive interactive review process under the breakthrough devices program. The response addresses various questions and incorporates data from in-house testing to support the PMA supplement and fulfil the additional information request, which we received in October of 2023. Upon receipt by the FDA, the application of the PMA supplement resumes its 180-day real time review, with 90 days remaining in the review period. Therefore, we expect FDA approval on May 30, positioning us for a product launch on May 31.