Absolutely, based on the latest updates, the trial should complete around May, and if all goes to plan, we could be looking at a label extension for percutaneous delivery sometime around September or October. That would be a significant milestone, especially for broader adoption.
The company has also indicated they intend to submit the TGA application in the first half of this year, so that’s another potential catalyst.
TGA does accept MDR certification, which should make the process a bit smoother. But they can still come back with questions, so approval could land mid-year if it’s straightforward—or a bit later if there’s more back and forth.
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