DeepView Formally Added to BARDA's FDA Approval Page

Another small but notable marketing event for DeepView. BARDA made a post a couple weeks back on LinkedIn, that MDAI highlighted too, about the success of DeepView as relates to BARDA's purpose in helping bring novel medical countermeasures to market.

https://www.medicalcountermeasures.gov/barda/fdaapprovals

Product 113 from the link above.

Hopefully this is one of many that is slowly getting the word out as they accelerate commercialization.

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u/BostonbRamen — 10 days ago

Spectral IP, INC. S-1 Withdrawal: IPO Abandoned

Saw this quietly filed a couple weeks ago: https://www.sec.gov/Archives/edgar/data/2042176/000121390026081386/ea0299132-rw_spectral.htm

The interesting thing is it still was a subsidiary of Spectral AI and registered at the same Dallas office from what I could cross reference from publicly available data. So was technically an overhang on the books for Spectral AI until recently. I haven't seen if the Texas entity was formally dissolved yet (Spectral IP, Inc.).

I'm speculating this should be good for MDAI? Spangenberg seems to have moved on, we know he already sold most of his shares, and Spectral appears to now be cleaning up their books. For me personally, when I first discovered Spectral AI others I knew really didn't like the investment because of Spangenberg's involvement and this spinoff. It seemed to raise the eyebrow of suspicion. Curious if this will change how the street views MDAI as a serious investment. It certainly helps with future M&A to have this cleaned up.

Anyone have any thoughts on this? I'm curious if it will come up on earnings tomorrow.

* This was the spinoff that was long talked about where current MDAI shareholders would get shares in the Spectral IP IPO as a one time dividend. This now seems to be officially dead for the forseeable future.

* I believe Reed Smith LLP is still counsel for MDAI

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u/BostonbRamen — 10 days ago

The silver lining

A Form 4 quietly dropped from none other than Dr. DiMaio.  He personally bought 32,233 shares throughout Tuesday’s chaotic trading session, post FDA approval announcement.

To be specific — this was an open market purchase with his own money at a weighted average of $2.61, on the same day as the approval announcement, bringing his total direct ownership to over 2.67 million shares.

Source: https://investors.spectral-ai.com/node/9731/html

Conventional investment wisdom believes this is as good of a bullish signal as we can get!

>Insiders might sell their shares for any number of reasons, but they buy them for only one: they think the price will go up.

- Peter Lynch

This is a positive and reassuring sign in my book.  I will sleep well tonight and in the weeks and months ahead as we allow the great Spectral AI team to focus on execution and commercial rollout and allow time for the thesis to mature.  Hopefully they show us some amazing results in the earnings calls ahead. 

Hoping for a continued great year ahead!

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u/BostonbRamen — 3 months ago

Annual Meeting: Vote FOR on everything

Title Edit - I'm voting FOR on everything

I think it is important we listen to management's recommendation and vote FOR on all proxy campaign questions for the annual shareholder meeting.

Before I hear the hedge fund hate about Hudson Bay, dilution fears, etc. hear me out.

If you go to your broker's proxy campaign page (look up the specifics it varies), you will find a link to the Schedule 14A Proxy Statement Dated April 6, 2026. Here is the link from Spectral AI's investor page: https://investors.spectral-ai.com/node/9531/html

Everything is standard governance stuff and I'm selecting FOR and voting as management recommends. But I expect from what I've read in several comments over the weeks and months that people are misunderstanding Proposal No. 3. So let's go over it.

Why I'm thinking voting FOR on Proposal No. 3 (and everything else) makes most sense to focus on commercialization:

  1. It already happened!
  2. This is purely a legal technicality because of Nasdaq Listing Rule 5635(d), which requires shareholder approval since the issuance will result in over 20% of issued or voting eligible shares.
  3. If you don't, you will needlessly costs us all money and time until it is!

Spectral AI signed a contract with Hudson Bay in Oct. 2025, it is legally binding, and largely complete with the common shares already in the float. Our lack of acceptance of this fact will just force Spectral AI's management to keep calling for a vote every 90 days...

>The failure of our stockholders to approve this proposal will mean that the Company shall convene subsequent stockholder meetings no less frequently than once every 90 days until such time as the stockholder approval is obtained or the Warrants are no longer outstanding. The Company shall incur the cost of hosting subsequent stockholder meetings.

But this means dilution!

Yes it does. This is the difficult game of early stage medical device startups. This stuff happens and when this deal happened it was necessary to fund the final stages of the "valley of death" to commercialization. But I don't think this will have much of a material impact in the long term on how much I'm modeling for the stock price, I'll get to those calculations in a second. But first, let's review management's formal rational:

>Reasons for the Financing

>We believe that the Hudson Bay Transaction provides additional sources of capital to the Company. The proceeds that we have received, and will receive in the future, from the Hudson Bay Transaction allow the Company to fund its business operations. We believe that the Hudson Bay Transaction is a natural progression for the Company and is attractive relative to other alternatives. We remain focused on creating long-term value for our stockholders, and the Hudson Bay Transaction will allow us to be strategic in how we access and deploy capital primarily in support of the ongoing commercialization and development of our AI-driven DeepView® System.

It is easy to loose context here in hindsight. There was a lot of uncertainty back in fall of 2025, particularly with the government shutdown. Did Hudson Bay get a nice discount to where we are trading today, sure. But guess what, a lot of risk has been removed, easy to be a critic now. Additionally, let's qualify our emotion, if you understand finance the other traditional capital raise options are not great. Interest rates are high, we don't want a loan that will burn even more capital that Spectral AI is trying to preserve (the interest payments). Finally if they tried to do an open market the algos work against you creating volatility that would be hard for them to hit the capital raise number they need. Private sale avoids that uncertainty and mechanics, but yah the big guys get a nice discount for the risk they are taking on.

The math on potential dilution / future cap table

Alright with all that behind us, let's conclude with determining the current cap table so we maintain some reasonable price targets for the days, months, and years ahead.

I'm going to summarize but you can figure this out by reading the latest 10-Q thoroughly and then the private sale agreements like the Hudson Bay deal.

The Fully Diluted Cap Table

When you aggregate the outstanding shares with every single derivative explicitly identified in the 10-Q, here is the true fully diluted denominator for M&A modeling / future valuation:

  • Base Shares Outstanding (as of May 11, 2026): 31,823,985
  • Total Warrants Outstanding: 13,943,422
  • Management Equity (Options + RSUs): 3,652,028
  • Avenue Convertible Note Shares: 1,004,016
  • Total Modeled Shares (Executed Liabilities): ~50.42 Million Shares

The $200 long term price target:

Alright now we can sanity check some of my earlier long term price projections.

$200 per share with about 50.42 million outstanding shares gives us a market cap around $10 billion dollars. Let us assume the street gives us a more modest 10x multiple (I think 14x though will be reasonable with time and execution), that means we need to show $1 billion annual revenue. Let's now check that math with current realistic TAM for DeepView and Spectral AI's pipeline. Current assumed TAM is about $14 billion (burns and DFU), that means we need to capture just 7% of the market for this to be reasonable. Given the De Novo clearance we are well on our way to becoming the standard of care, so not out of the realm of possibility. Now comes the judgement part of this game. Is this reasonable or not? I think it is, but it won't happen overnight. And finally, there is A LOT more very real TAM that could be on the horizon long term given management's vision and how DeepView is expanded.

Let me know your thoughts. In summary, I think it is best to effectively absorb the dilution cost vs a proxy battle, with financial costs to Spectral, and the real time distraction it will have at a critical point in the commercial execution stage. Thank you for your time and consideration. I respect if others disagree, but I don't think anyone has time for emotional insults.

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u/BostonbRamen — 3 months ago
▲ 46 r/aktieraketer+5 crossposts

What we know so far

Alright, alright, so some of you have been paying attention and learning to read and think for yourselves. Well good on you! A low bar, but a bar passed no less in this age of AI slop ;)

And AI is the business we are in, so we ought to know, right? So know this, DeepView is no slop. This is the real F'in deal. Uncle Sam has officially said so. Congrats, and you all knew it or you wouldn't have stayed with this investment for so long (except for puplmusik who apparently had a druckenmiller moment...but sold! Seriously?!? Seriously...somebody check on him and make sure he/she is ok please).

So what do we know thus far? Let us take a quick peruse of the grant details:

De Novo Number DEN250028
Device Name DeepView AI® System
Requester spectralmd, inc. 2515 mckinney ave. suite 1000 dallas,  TX  75201
Contact trudy estridge
Classification Product Code SHY
Date Received 06/27/2025
Decision Date 05/21/2026
Decision granted (DENG)
Review Advisory Committee General & Plastic Surgery
Type Direct
Predetermined ChangeControl Plan Authorized No

First the major win, Decision = granted (DENG) means we are go for commercialization. DeepView can be sold, the binary risk event is officially removed for the stock. Cheers!

Next, Uncle Sam gave us our own product code, SHY. The moat is now established, we own the space. Sure, anybody that wants to compete must file a 510(k) and show they are "substantially equivalent" but you all should know that is an extremely expensive and timely pipe dream - you need to train your model for ground truth on a large biopsied dataset and we all know how cheap that is, not!

And we aren't sharing, or maybe we will, but it will cost you -> money please!

Let's see decision date, about 11 months (like I told you) based on FDA's trend since shutdown - checks out.

Finally, the predetermined change control plan authorized, says no, crap, what does this mean? Sounds bad... Relax, it really isn't. It means Spectral AI can't simply make changes to the DeepView model and push software changes on the fly. Sorry this isn't your MMORPG or tiktok app. This is medical software, it needs a little more rigor than what those pampered FAANG engineers are accustomed to. This aligns with Capone's guidance last call when analysts asked about implications of the new features BARDA wants and label expansion. He said they simply file a 510(k), way less overhead, and should easily be granted in 30 days for minor changes and 90 to 150 for major label expansion. Again Spectral though has a great advantage on the turn around time because they own the product code now, they are the standard, proving they are "substantially equivalent" is mute - they are DeepView.

That about covers the facts we know for now until management discloses more. I think they were following a standard playbook of having held this news for Tuesday open because we were going into a holiday weekend. If they released it on Friday they could have dampen any rally. Happy to have helped with the previous intel if you weren't aware of these databases. Was a great real world example of how to find the arbitrage and how news like this can be slightly delayed in practice.

Congrats everyone, here is to an exciting week ahead!

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u/BostonbRamen — 3 months ago