I can only refer you to the latest quarterly, in particular the statement:
“We continued to make important progress toward our final PMA submission in Q3 2024, underpinned by our positive engagement with the FDA."
and prior to that a communication I received by email (dated 12 June 2024) from Andrew Shute, Snr VP Business Development, responding to a couple of questions I posed to the Company,:
"The statement you quote in your first paragraph remains true, [that] we remain on track for Q3 submission to the FDA.
Regarding device verification program, this is quite an extensive testing program. We had only highlighted the specific abrasion testing as an example, as that was the item that delayed our submission timelines. As above, these are progressing as planned, and we remain on track for Q3 submission.
There is no requirement to retest the Battery. You might recall the issue we announced in October 2022, was related to the Transmitter, but manifested itself as premature Battery depletion."
My feeling is that if there was any further issues regarding battery depletion it would likely have been reported in the last quarterly, or soon after the Company would have become aware of it.
Additionally:
Earlier, quarterly Q4, 2023:
"...Costs associated with the new testing schedule are nominal and are unrelated to the design change in the transmitter previously announced in late 2022."
The initial news relating to the Transmitter/battery depletion issue:
“As part of our ongoing technical assessments, we have identified a transmitter issue occurring in a small percentage of implanted systems that can cause the battery to deplete more rapidly than predicted. It is important to note that in these instances the system continues to function as designed and the device remains fully operational until battery depletion."
Investor Presentation, May 2023:
"Identified a design solution✓
Componentry manufactured and delivered ✓
Testing and validation to commence, prior to submission of final PMA module"
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