SeaStar Medical (ICU) Q3 2026 earnings review
SeaStar's device helps children survive, but its cash runs low
SeaStar Medical, maker of a kidney-failure device for sick children, produced strong survival data while its adult trial fell behind. Sales more than tripled from a weak quarter a year earlier, but edged up only 3% from last quarter. The company now expects the adult trial to finish enrolling by mid-2027, later than it said in August.
| Sales | $635K +3% from last quarter; +247% from a year ago |
|---|---|
| Loss per share | $1.03 $1.30 a year ago |
| Cash at end of September | $4.0M $7.0M in June; $3.3M warrant money arrived in October |
| Adult trial enrollment finish | Mid-2027 year-end 2026 or early 2027 in August |
⚖️ Verdict: 🔴 Bearish
The story got worse because the adult trial, SeaStar's route to a far bigger market, now needs more time than its cash allows. By our math, cash plus October's warrant money covers only about two quarters of spending. The good news: treated children survived more often than a comparison group, and the FDA ended a registry rule that slowed hospitals.
The question now is whether SeaStar can raise enough money to reach the adult trial's results. Warrant exercises and small share sales may be enough, or it may need one large stock sale soon. Year-end cash, due with fourth-quarter results, will tell.
🐂 Bull Case
More Children Survived With Quelimmune Treatment
Quelimmune is SeaStar Medical's device that calms overactive immune cells in critically ill children with kidney failure. Until now, the US group cited survival data from only the first 21 patients in its SAVE Registry, a study the FDA required after approval.
At ASN Kidney Week, a major meeting of kidney doctors, SeaStar presented results for all 50 registry children. Treated patients showed “statistically significant higher survival” against comparison groups at day 60, day 90 and hospital discharge, and none suffered a device-related adverse event.
Doctors choose devices on evidence like this, so the data should help sales. But the registry did not assign treatment at random, and the release gives no survival rates for the full group.
What to watch: the full survival rates, once SeaStar publishes them. A wide gap against the comparison group would give hospitals still holding back a reason to start.
Hospitals Can Now Use Quelimmune Without Registry Work
Until this quarter, every hospital using Quelimmune, SeaStar's kidney device for critically ill children, had to enrol patients in the SAVE Registry, a study the FDA required. In our view, that research work held back new hospitals and made orders uneven.
SeaStar met the FDA's post-approval requirements, so hospitals can now use the device “without the research infrastructure that the SAVE Registry demanded”. New billing codes from CMS, the agency that runs Medicare, also took effect on October 1.
Both changes cut paperwork, which “may increase availability” for these children, SeaStar said. But they arrived at the end of the quarter, so the worry that hospital paperwork slows orders stands until sales show an effect.
What to watch: the year-end count of hospitals using Quelimmune, which SeaStar did not update this quarter. A clear rise would show that paperwork was the main barrier.
First Part of Adult Approval Filing Reached FDA
SeaStar's bigger aim is approval of its SCD therapy, the technology behind Quelimmune, for adults with acute kidney injury. Chief executive Eric Schlorff said it files its premarket approval application, or PMA, in parts “in hopes that our modular submission will speed this potential approval”.
SeaStar submitted the first module to the FDA this quarter. The agency also granted the therapy a seventh Breakthrough Device Designation, a status that speeds review, this time for adults with sepsis-driven inflammation.
These steps save time later, but they do not shorten the trial itself. Schlorff tied priority review to the final module, “provided a positive outcome in the trial”.
What to watch: a date for the final module, because the release did not repeat the late-2027 target. That date will show what the trial delay costs.
Positives this quarter didn't test
Two positive points from earlier quarters got no new evidence in this release, so neither moved the case this quarter in either direction.
- Careful patient selection in the adult trial: SeaStar's preference for the right patients over fast enrolment; the first trial results would test it.
- Earlier use at experienced children's hospitals: an anecdote from earlier calls; usage data per hospital would test it.
🐻 Bear Case
Cash Covers Only About Two More Quarters
SeaStar Medical earns no profit yet, so investors' money pays for its adult trial. At the end of September it held $4.0 million in cash, against $7.0 million at the end of June. Operating activities used $3.4 million in the quarter, by our math.
- Research spending: up 42% from last quarter, against the finance chief's earlier plan of about 5%
- Unpaid supplier bills: nearly doubled since June, which held down the quarter's cash use
- October warrant exercises: $3.3 million, not in the September cash figure
SeaStar tied the research jump to more clinical work on the adult trial. By our math, cash plus the October money covers about two quarters at this pace, and suppliers will want their bills paid.
This matters because the trial now runs into mid-2027, and results follow later. So SeaStar will need to sell more shares, which shrinks each owner's stake, well before it learns whether the adult device works.
What to watch: the year-end cash balance and any share sale before it, due with fourth-quarter results. A large sale at that point would confirm that funding, not the trial, sets the company's pace.
Children's Sales Barely Moved From Last Quarter
“The strength of the QUELIMMUNE therapy adoption in this ultra-rare pediatric AKI market provides great promise for our pipeline indications,” chief executive Eric Schlorff said. Quelimmune is SeaStar's device for children whose kidneys fail during a severe infection.
The release leads with sales up 247% from a year ago. That comparison flatters the trend, because the third quarter of 2025 was the weakest of that year.
- Sales change from last quarter: up 3%, after 24% in the second quarter
- Hospitals using Quelimmune: no update, after 20 in June
This matters because new hospitals stock up at the start, and SeaStar does not split first orders from repeat ones. A stall may mean fewer sites joined.
What to watch: fourth-quarter sales, due early next year. A result well above the roughly $255,000 the $2 million yearly target implies, by our math, would show repeat orders carry the business.
Adult Trial Enrollment Now Runs Into Mid-2027
NEUTRALIZE-AKI is SeaStar Medical's pivotal trial, the final test before approval, of its SCD device in 339 adults with acute kidney injury in intensive care. Management has said the adult market is about 50 times the size of the children's market, so this trial decides the company's future.
The trial added 28 patients since mid-August and now stands at 251. SeaStar wrote that the trial is “expected to complete enrollment by mid-year 2027”. In August it had pointed to year-end 2026 or early 2027.
The delay matters because results come only after each patient's 90-day follow-up, so approval moves later too. Each extra month also costs money SeaStar has not yet raised. The quarter's pace matched earlier ones, so even the new date assumes a speed-up.
What to watch: patients added by the next quarterly report. Fewer than about 35 in a quarter would put mid-2027 out of reach, by our math.
Risks this quarter didn't answer
Two standing risks got no new numbers in this release. Each still depends on a disclosure that SeaStar has not yet made, so neither moved this quarter.
- Whether the adult device works: no efficacy data until enrollment ends and follow-up finishes; the first trial results settle it.
- Warrants left after October: the release gives no count; the quarterly filing will show how many new shares could still follow.
💲 Other KPIs
Shareholders' equity, what remains after subtracting all debts and bills from assets, shrank to $0.5 million from $4.3 million in June. It stood at $10.4 million at the end of 2025. Losses outran the small amount of stock SeaStar sold, though the October warrant money will add to it.
Gross margin, the share of sales left after the cost of making the devices, held at 92.4%, against 92.3% a year ago. It has stayed above 90% for five quarters, so almost every extra dollar of sales reaches the operating line.
Overhead costs fell 16% from a year ago and 13% from last quarter. SeaStar cited lower personnel, legal, audit and SEC-related costs, partly offset by professional services, director fees and franchise taxes. The saving helped, but research spending climbed far more.
The medical-device group's average share count rose 64% from a year ago, as share sales and warrant exercises added stock. Shares outstanding climbed 5% from June to 4.46 million. Growth has slowed from 260% in the second quarter, but the October warrant exercises will add more.
🔮 Guidance
Cut. SeaStar now plans to finish enrolling all 339 adult patients by the middle of 2027. In August it pointed to year-end or the first quarter of 2027. By our math, the new date needs about 12 patients a month, against about 9 since mid-August. That is the second delay in two quarters.
❓ Key Questions
Is the $2 million sales target for 2026 still the plan?
The release did not repeat it. Nine-month sales already reached $1.745 million, so the target leaves a weak fourth quarter. Either SeaStar set it cautiously or it sees orders slowing.
How many children's hospitals use Quelimmune today?
SeaStar reported 20 hospitals in June and aims for 25 by year end. This release gave no count, so readers cannot tell whether sales stalled because fewer hospitals joined.
Why did research spending rise so much in one quarter?
The finance chief had described increases of about 5% a quarter. Readers need to know how much of the jump repeats, because it sets how long the cash lasts.
How will SeaStar fund the trial through mid-2027?
Cash and October's warrant money cover roughly two quarters by our math, while enrollment now runs to mid-2027. The size and timing of the next share sale decide how much existing owners lose.
When will SeaStar file the final part of its application?
The release dropped the late-2027 date for the final module. Readers need the gap between the last patient and trial results to judge when an adult approval could arrive.