@hofathat’s a weirdly aggressive post. I was previously invested in it, and I keep an eye on it because I thought it was / could be great. I remain very cautious, and recent events have only increased my scepticism.
@Tristan576,once again – well done on your research and your trading. you must be feeling pretty good about it, and rightly so!
I wasn’tgoing to post again, but I really feel that this announcement needs to be addressed.
FramingProblems and Omission Risks
- No apology or ownership for submitting a flawed application — this is not how experienced medtech teams usually handle major strategic regulatory setbacks.
- Fails to mention that:
- A reconsideration request was not pursued, despite being an available remedy
- Similar tech (e.g., Ultromics EchoGo) has already received CPT codes, so this is not “uncharted” territory
- Implies "use" equals clinical readiness, when the CPT Panel clearly didn’t agree.
Mybiggest concern is that there is still no substantive comment regarding the twogeneral criteria. The company hasn’t even informed shareholders which of the two criteria were not met, let alone why and how the company proposes to address these deficiencies.
If I wasstill invested, I would be taking my money off the table until I had a better understandingon this. Not advice, just what Iwould do. It is always very concerning to me when there’s a lack of transparency. Here, there are three things that the company should tell investors, and it hasn’t told investors anyof them.
I’massuming that a lot of posters on here are taking the company at its word – andmaybe you should. However, if nothing else, please cast your eye over the following:
- https://academicentrepreneurship.pubpub.org/pub/1fani3y6/release/4 - particularly slide 19
- https://biodesign.stanford.edu/content/dam/sm/biodesign/documents/programs/policy-program/CPT_Capstone_Innovator_2_webinar_AMA.pdf - particularly slide 50
- Noting that this document (and slide) highlight, amongst many other things, that CPT Cat III are successful 87% of the time…
The above is based on facts and information. Inferences that could be drawn:
- If the company does have very experienced US medical people, they would know this process.
- The process involves a reasonably large degree of consultation well before the panel is convened to make a decision.
- Given the failures were on two of five of the mandatory / basic general criteria, this should have been evident:
- potentially pre-submission; and
- certainly post-submission during the consultation phase.
This begs the question what the company knew (or oughtto have known) and when, even more so when such a significantly large and unexpectedsum of money was raised ($17m+).
If theyknew they would most likely be rejected, and revenue was (at least) anadditional 6+ months away, then it is indeed a very convenient time to raise avery large sum of money…
Food for thought my friends, food for thought.
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- Ann: Update on Category III CPT Code Application
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@hofathat’s a weirdly aggressive post. I was previously invested...
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Open | High | Low | Value | Volume |
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Price($) | Vol. | No. |
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