No idea. Only recently been approved, after 12 months in the FDA system. Maybe announcement will come out is week?
2RT has been proven to be equivalent at treating DME as traditional photo coagulation (from memory) but with drastically reduced energy levels.
This was how the CE mark was obtained. And finally FDA (I would assume the FDA approval is for DME, can't think what else it would be for).
Early AMD is the big kahuna. Untreated and a simply unimaginable target market and opportuniity.
I think CE submission for AMD treatment has gone in upon basis of limited initial trials. The USA is much tougher and will require randomised clinical trial which is the one underway (Retilase trial I think its called, lead by CERA).
I would guess that FDA approval as an investigatory device may be being progressed for AMD as well. But no idea how hard hat might be to obtain.
In any case, this is awesome news as Ellex can now sell 2RT into USA (but likely with limitations on what it can be used for I.e. not AMD).
Now that Latina patent expired, they won't need to pay royalties either I would assume.
I hope we get some more detailed progress info soon.
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