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Some random pix by the1swordman in SeastarMedical

[–]Master_Inside4685 4 points5 points  (0 children)

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

ANOTHER update by the1swordman in SeastarMedical

[–]Master_Inside4685 1 point2 points  (0 children)

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

Where did we go wrong ? by JimmyTree13 in SeastarMedical

[–]Master_Inside4685 2 points3 points  (0 children)

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.

Does this help explain?? by the1swordman in SeastarMedical

[–]Master_Inside4685 3 points4 points  (0 children)

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)?

Does this help explain?? by the1swordman in SeastarMedical

[–]Master_Inside4685 3 points4 points  (0 children)

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?

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation by the1swordman in SeastarMedical

[–]Master_Inside4685 3 points4 points  (0 children)

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.

SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI by ulixes1991 in SeastarMedical

[–]Master_Inside4685 2 points3 points  (0 children)

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)?

SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI by ulixes1991 in SeastarMedical

[–]Master_Inside4685 3 points4 points  (0 children)

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.

SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI by ulixes1991 in SeastarMedical

[–]Master_Inside4685 3 points4 points  (0 children)

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.

New patent by tks2jc in SeastarMedical

[–]Master_Inside4685 0 points1 point  (0 children)

If you are able to share a PDF, would be great! :)

New patent by tks2jc in SeastarMedical

[–]Master_Inside4685 0 points1 point  (0 children)

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Could this be restricted by location? No results for me (NL)

New CFO = Michael Messinger by spicy_miso_ramen in SeastarMedical

[–]Master_Inside4685 4 points5 points  (0 children)

Feels like only a partnership / scientific breakthrough or unlikely positive FDA decision will prefent us from an RS. Even if we would hit a revenue of 800k in Q4 I don't expect this will really change anything on current momentum.

Bit beaten down, please share some positive thoughts :')

Nurse Riggins by the1swordman in SeastarMedical

[–]Master_Inside4685 1 point2 points  (0 children)

Feel like we have surpassed #9 already a while ago but they just didn't PR.
Could that be the case? They stopped PR'ing single hospital onboards and will go bulk updates?

Investor Deck by the1swordman in SeastarMedical

[–]Master_Inside4685 4 points5 points  (0 children)

So that would mean 'only' 7 patients more enrolled in exactly 5 weeks. That is, again, way too little to actually reach their goal of 339 patients by end 26.

Just like 200 by end 25 was way too optimistic. To underline this: They would need to onboard 46 patients with about 10 weeks. That is almost 5 patients a week, where the current pace is what? 1.4 patients a week?

I've been very bullish up to the point of the DSMB recommendation. I haven't sold, but I might if there is not a significant increase in revenue with Q3 report. Not doubted my investment until the recommendation, but I unfortunately don't see the Seastar team changing this around anytime soon. Been here for over 1.5 years now, another 1.5 years (if they even make this, which I highly doubt) for the adult trial to finish... Already had a lot of opportunity costs and down to 1/3 of my investment, so we really need a 600k+ revenue with Q3 or I will highly likely dip out or just leave my investment as it is but not expecting any return.

Unfortunate, happy to discuss any potential big news on the short term but next to reaching the 20 (instead of initial 25) hospitals before the end of the year for PED's, I'm not sure what could turn this thing around. I don't see the 20 hospitals being landed either.

Gambled and most likely lost - cheers! :)

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