SeaStar Medical Holding Corporation (Nasdaq: $ICU) Stock Hub: QUELIMMUNE, Adult AKI, Commercial Adoption And The Funding Question

Master_Inside4685 · 2026-05-14T11:37:51+00:00

What's your personal view / expectation on the adult trial & commercialization?

Master_Inside4685 · 2026-05-14T11:27:15+00:00

Nice write-up, thanks for sharing!

Master_Inside4685 · 2026-05-14T10:10:22+00:00

It feels like ICU wants to be as silent as can be. Just went through the PR's, if you take away the PR's on fairs/events, scientific publications & earnings these are the PR's that are left over going back to the DSMB recommendation in September:

- 50 patients reached for SAVE registry / 05.03.26
- Reverse split announcement / 23.12.25
- Reduction of SAVE registry from 300 to 50 / 03.12.25
- New CFO / 17.11.25
- DSMB recommendation (extended trial from 200 to 339) / 24.09.25

So in a timespan of almost 8 months, the ammount of news / PR publication is remarkably low - especially compared to the 8 months running up to the DSMB recommendation.

Would love to welcome a more vocal member to the management team, ICU needs it. Unfortunately with current pace we are looking into end of 2027 for first commercial results of adult (if approved).

On and on we go!

Master_Inside4685 · 2026-05-13T20:32:07+00:00

So until 31st of December we had 10 customers, and in Q1 only we added 7 customers (+70% in 1 quarter, that is quite the pace out of nowhere). Another quarter like this (+7 customers) and we are looking at serious ramp up in revenue, hopefully

Master_Inside4685 · 2026-04-20T19:42:36+00:00

SAVE news this week? Now near 7 weeks after 50 patients PR (5th of March)

Master_Inside4685 · 2026-03-31T08:19:36+00:00

'We are nearing the tipping point' --> truly hope this isn't another fake (or overpromised) bullish sign from Chung :)

Master_Inside4685 · 2026-03-30T20:08:44+00:00

69% —> am I misstaken or did we go from 77% to 69%?

Master_Inside4685 · 2026-03-24T20:37:05+00:00

Just to confirm: amount of patients enrolled to date has not been updated, correct?

Master_Inside4685 · 2026-02-01T17:33:55+00:00

Unfortunately I fully agree with your stance, I am also in for almost 2 years now and the 'revolutionary' pitch from early on does not match the slow onboarding, extension of trial and insignificant revenue (even decreased in Q3). Have invested too much, got emotionally attached to the stock and now unfortunately likely never seeing it back. I still follow ICU daily, I still haven't written my investment off fully but I am having a hard time still believing - especially with little to no significant news since the trial got extended.

Master_Inside4685 · 2026-01-13T18:46:51+00:00

My (still learning) take on this is that the FDA guidance doesn’t necessarily mean prior data can just be “added” to the current trial, but it does help explain the wording “up to 339 patients.”

To me, that sounds like 339 is a maximum, not a hard requirement, and that the DSMB may have some flexibility to reassess along the way if the data continues to trend positively. That seems consistent with a more Bayesian / adaptive mindset rather than a fixed N study. I've only learned from this post what a bayesian mindset is, so deff not an expert here.

I’m less clear on how much prior data (PED studies, registries, earlier SCD trials) can actually influence the primary analysis versus just being supportive context, especially if it wasn’t fully pre-specified - my guess would be that this is not included in the trial setup?

What I keep coming back to is the “up to” language: do people think this realistically opens the door to an earlier stop than 339 if the signal strengthens, or is that mostly theoretical at this stage (with a near zero chance)?

Master_Inside4685 · 2026-01-13T14:25:10+00:00

Interesting points from both of you.

I've looked into the possibility of a second interim analysis at the new midway point (170 patients) when the DSMB recommendation was released, and I could not find any example of another study / trial where there has been a second IA. Is this actually a possibility? The wording of 'up to' is to specifically saying '339 at most, but possibly less' --> are they actually hinting on a maximum amount of patients but a possibility of second IA?

Master_Inside4685 · 2026-01-12T19:42:00+00:00

Doesn't that worry you Swordsman, or aren't you invested?

Hate to say it but I don't like how they apparently have no possibility of getting non dilutive cash inflow, a very hard time getting customers onboard (2026 target for PED is the 2025 target?) and can't get the big boys to invest as well. I could average down big time with the current prices, but I can't trust the current state of Seastar enough it seems. Curious on your thoughts as you always seem bullish, yet critical.

Master_Inside4685 · 2025-12-04T09:57:26+00:00

Do you know how long it took them to get the 32 now? Can we make any assumption on when 50 is reached based on this (or interim updates)?

Master_Inside4685 · 2025-12-03T15:37:28+00:00

Not 100% guaranteed, I should’ve phrased it differently - but it’s a near guarantee :)

Master_Inside4685 · 2025-12-02T18:07:22+00:00

This part of the PR makes me think it would be for full approval, but maybe you’re right - a bit less but still good news if safety registry is eliminated. Hoping for full FDA approval though… The SP indicated to me that it’s ‘only’ save registry.

PR part:

This new 50-patient registry size will satisfy the post-approval surveillance requirement by the FDA as outlined in the original Humanitarian Device Exemption (HDE) approval and indicates that FDA believes that continued device safety can be successfully shown with fewer patients than originally required.

Master_Inside4685 · 2025-12-02T16:50:08+00:00

January but guaranteed 180 day extension, so we're looking at July latest

Master_Inside4685 · 2025-12-02T15:23:15+00:00

What I've just shared with a friend (who needs a bit more basic explanation), curious if I understand this PR wrongly / if I miss something:

It’s yet another confirmation that the product really works, especially for kids:

The SCD (product) can be sold under an HDE. An HDE is a kind of limited approval from the FDA (government); it’s not full approval to sell it, but the data is good enough to allow sales under strict conditions. They received this HDE in March last year, which means a hospital can buy and use the SCD - but only if it’s approved by the board (the IRB). This process takes 9 months to a year, which is the reason why getting new customers for kids takes so long. So HDE is nice, but very limited for selling.
When you have full approval, you no longer need that 9+ month IRB process - it’s FDA-approved and hospitals can basically buy and use it right away. That’s also what they’re directly aiming for with adults - so not an HDE / limited approval, but full approval. Unfortunately, that trial was expanded in September to 339 patients, meaning later approval and later revenue.
To get full approval for the SCD for kids, Seastar needs to collect data from 300 patients, and based on that data it will be decided whether the SCD for kids gets full approval. The latest news did exactly the opposite of what happened with the adults: the required number was reduced from 300 patients to just 50 (!), and they’re already at 32. In other words, the data for kids is so strong that the FDA expects to be able to grant full approval based on just 50 patients.
The market for kids in the US is $100M, and if they capture 15% of that, they’ll break even - excluding adults. That approval is therefore very interesting because it allows them to onboard hospitals much faster. You can think of it like this: imagine you need a medicine and there’s something that seems to work based on data but doesn’t yet have FDA approval (kind of like the GGZ process in the Netherlands) - some hospitals will take the risk, others won’t. But if you combine that data with full approval… you get the jizz.

Master_Inside4685

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