Interesting read., page-8

Hi Lefevre, and thanks Roy.
Sorry I didn't have time to explain myself earlier.
I was more interested in the expedited process. namely this paragraph.

" The ruling came under new FDA guidelines called the Expedited Access Pathway (EAP), which are aimed at helping patients get more timely access to life-saving medical devices, while preserving the statutory standards of safety and effectiveness for Premarket Approval (PMA). In a written response to the Company’s formal request for an EAP designation, the FDA said ReCell® meets the EAP criterion in that “the device may offer significant, clinically meaningful advantages over existing legally marketed alternatives."

As you rightly pointed out we have a totally none invasive procedure/application.
In other words, I would assume that this is the sort of treatment we could expect on application to the FDA.