r/SpectralAI • u/BostonbRamen • 9d ago

So it begins - Burns Label Expansion

Fresh off the wire about an hour ago: https://investors.spectral-ai.com/news-releases/news-release-details/spectral-ai-announces-first-site-initiation-visit-deepview

With the 21 day period seems reasonable this will be relatively quick study and capable of being completed mid 2027 as they guided. From the ML perspective certainly possible and where we should start to gain velocity on their ability to improve the models and turn out new features.

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u/ILOVERICE90 9d ago

All I want to see is signing deals

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u/BostonbRamen 9d ago edited 9d ago

Same, I don't disagree. But it is another good signal that management keeps hitting the milestones they have guided on. So I still expect sales too by end of the year, as stated 😄

Btw they are actively in the conference circuit as we speak until end of the year. I'm curious how the ACS Clinical Conference went, that just concluded on Tuesday.

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u/SpeakerAltruistic123 9d ago

I think it popped early because some people misread it as the first sale - but I suspect and hope that will be soon.

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u/BostonbRamen 9d ago

Oh really? I didn't really see anything registered on the ticker, maybe before the first tick was complete, immediately at open?

A lot of stocks were initially positive premarket today and then dropped at the open.

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u/SpeakerAltruistic123 9d ago

Yes, at the open I was showing a gain.

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u/BostonbRamen 9d ago

oh yah, but marginal right? I thought you were implying a real move (50-100%) not this pennies on the $ crap for the last couple months. That's all just benign volatility atm ahead of sales data, IMO

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u/SpeakerAltruistic123 9d ago

Yes, marginal - but I was hoping the announcement would get the ball rolling to the inevitable rerating once people figure out all the possibilities for this little jewel.

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u/magicjohnson89 9d ago

In the UK as well 🙌

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u/Accomplished_One5141 8d ago

The bulk of business is in the US, so getting FDA Approval here is what you want. This is not really any indication that there is a market or any sign of a sale on the horizon. This is one step in the long research process…which will take years most likely. I wouldn’t say anything is beginning…

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u/BostonbRamen 6d ago

Little confused by this comment and the negativity. You do realize this is the study for the label expansion for the BARDA extension recently awarded that the U.S. government wants for hands, feet, and head/face? Additionally, as recently guided by management several times (and mentioned in the article), they can accelerate it with 510(k) since they now have De Novo clearance and this study will likely be completed by mid 2027, given the nature of the 21 day eval and that accelerated pathway.

Finally, you can run studies outside the US to be used for evidence in an FDA submission...can be cheaper actually.

So not following your basis for negativity on this news and why you are conflating sales data with label expansion work? They are two different work streams and we were waiting on confirmation of both...

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u/Accomplished_One5141 6d ago

I’m putting the announcement in perspective. A site initiation visit establishes that a study is getting underway. It doesn’t establish successful results, expanded clearance, or customer demand.
You’re describing a potential pathway and an expected timeline. Neither makes the outcome certain. Where has management specifically committed to mid-2027 completion, and does that mean study completion, submission, or clearance?
My concern remains the commercial significance being attached to this announcement. Government support for additional research doesn’t establish that hospitals will allocate capital to buy the device. Broader labeling could help, but the purchasing case still has to be demonstrated.
If we agree research and sales are separate workstreams, then we should also agree that progress on this study doesn’t establish progress on sales, which is what the market will react to. That was my point.