Avita Medical CEO Shareholder Letter And Quarterly Report
VALENCIA, Calif. & PERTH, Australia & LONDON--(BUSINESS WIRE)--Today, the CEO of Avita Medical Limited (ASX: AVH) (OTCQX: AVMXY) issued the following letter to shareholders:
Dear Shareholder,
At the conclusion of another quarter, I would like to update you on the work undertaken and completed during the last three months. Certainly, the pace has been furious at our Valencia office near Los Angeles, where the team made significant progress toward submitting our Premarket Approval (PMA) dossier to the US Food and Drug Administration (FDA). Expectations are running quite high about the outcome of the clinical data for the trial, which will be at heart of the dossier. The completed data set is now with independent statisticians, and as soon as we receive the complete results, we will be reporting back to you with topline outcomes.
As we await the completion of the clinical data analyses, the team has been assembling a host of other information required by the FDA. There is a reason why an FDA approval, more so for a Class 3 medical device such as ReCell® – a breakthrough device that has no predicate -- is regarded by many as the gold standard for regulatory approval. The level of scrutiny is very high, and we must provide evaluations on a whole host of areas, such as product stability, sterility, validation of our cell suspension, and a validated supply chain. These projects are all in progress, and will be concluded in short order as we work to meet our stated ambitious timeframes for PMA submission. In parallel, this work brings us closer to achieving other key milestones such as the first procurement from the US Biomedical Advanced Research and Development Authority (BARDA), which is valued at USD$8m.
US Market Evaluation Reveals Positive Prospects
Dear Shareholder,
At the conclusion of another quarter, I would like to update you on the work undertaken and completed during the last three months. Certainly, the pace has been furious at our Valencia office near Los Angeles, where the team made significant progress toward submitting our Premarket Approval (PMA) dossier to the US Food and Drug Administration (FDA). Expectations are running quite high about the outcome of the clinical data for the trial, which will be at heart of the dossier. The completed data set is now with independent statisticians, and as soon as we receive the complete results, we will be reporting back to you with topline outcomes.
As we await the completion of the clinical data analyses, the team has been assembling a host of other information required by the FDA. There is a reason why an FDA approval, more so for a Class 3 medical device such as ReCell® – a breakthrough device that has no predicate -- is regarded by many as the gold standard for regulatory approval. The level of scrutiny is very high, and we must provide evaluations on a whole host of areas, such as product stability, sterility, validation of our cell suspension, and a validated supply chain. These projects are all in progress, and will be concluded in short order as we work to meet our stated ambitious timeframes for PMA submission. In parallel, this work brings us closer to achieving other key milestones such as the first procurement from the US Biomedical Advanced Research and Development Authority (BARDA), which is valued at USD$8m.
US Market Evaluation Reveals Positive Prospects