According to my research and the annual report published few weeks ago:
- IDE submission in Q125, ie in the next few days
- Response by FDA within 30 days of submission
- If IDE is approved, recruitment should start for the pivotal trial around May/ June 25
- as we will receive around US$25,000 for each implant, so technically speaking we will be generating revenue
- PMA could be by the end of 2027
Not advice, DYOR
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Ann: Annual Report to shareholders, page-35
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