SeaStar Medical Reports Third Quarter 2026 Financial Results and Provides Business Updates
Research and development spending rose to $3.574 million as the adult trial advanced, while quarter-end cash fell from December levels.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
SeaStar Medical (Nasdaq: ICU) reported third-quarter 2026 net revenue of $635 thousand as sales of its QUELIMMUNE pediatric therapy increased. Revenue rose 247% year over year, with gross profit margins above 90%. Net loss widened to $4.529 million from $3.472 million, while loss per share narrowed to $1.03 from $1.30.
Cash was $3.989 million at September 30, excluding $3.3 million in gross proceeds from October warrant exercises. The adult NEUTRALIZE-AKI trial enrolled 251 of 339 patients; the company expects enrollment completion by mid-year 2027. The first module of its FDA approval application was submitted. Pediatric SAVE Registry results showed statistically significant higher survival versus comparator cohorts, with no device-related adverse events. FDA post-approval registry requirements were fulfilled, allowing hospitals to use QUELIMMUNE without the registry’s research infrastructure.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointOctober warrant exercises raised $3.3 million in gross proceeds, excluded from September 30 cash. 33% of market cap
- Moderate pointThird-quarter net revenue rose 247% year over year to $635 thousand on increased QUELIMMUNE sales.
- Moderate pointSAVE Registry primary analysis showed statistically significant higher survival at Day 60, Day 90 and hospital discharge versus comparator cohorts.
- Moderate pointFDA post-approval registry requirements were fulfilled, removing the registry research infrastructure requirement for hospitals using QUELIMMUNE.
- Moderate point. Forward-looking: it has not happened yet and may not happen.NEUTRALIZE-AKI enrolled 251 of 339 patients; the company expects enrollment completion by mid-year 2027.
- Moderate pointThe adult acute kidney injury approval application’s first module was completed and submitted to FDA.
6 minor points
- Minor pointQUELIMMUNE gross profit margins remained greater than 90%.
- Minor pointQUELIMMUNE-treated patients in the 50-patient SAVE Registry had no device-related adverse events.
- Minor pointSCD received its seventh Breakthrough Device Designation, for hyperinflammation in adults with sepsis or a septic condition.
- Minor pointThird-quarter general and administrative expenses fell to $1.594 million from $1.898 million a year earlier.
- Minor pointNine-month net revenue increased to $1.745 million from $814 thousand in the comparable 2025 period.
- Minor pointNotes payable, net of financing costs, fell to zero at September 30, 2026, from $525 thousand at December 31, 2025.
Negative
- Major pointThird-quarter net loss widened to $4.529 million from $3.472 million; loss per share narrowed to $1.03 from $1.30.
- Moderate pointCash declined to $3.989 million at September 30, 2026, from $11.980 million at December 31, 2025.
- Moderate pointStockholders’ equity declined to $469 thousand at September 30, 2026, from $10.416 million at December 31, 2025.
- Moderate pointCommon shares outstanding increased to 4,461,965 from 3,844,613 between December 31, 2025, and September 30, 2026, diluting holders.
- Minor pointThird-quarter research and development expenses rose to $3.574 million from $1.850 million a year earlier.
7 minor points
- Minor pointThird-quarter operating loss widened to $4.581 million from $3.579 million a year earlier.
- Minor pointThird-quarter net other income declined to $52 thousand from $107 thousand a year earlier.
- Minor pointNine-month net loss widened to $11.780 million from $9.246 million; loss per share narrowed to $2.85 from $5.96.
- Minor pointNine-month research and development expenses increased to $8.438 million from $5.318 million in the comparable 2025 period.
- Minor pointNine-month general and administrative expenses increased to $5.134 million from $4.614 million in the comparable 2025 period.
- Minor pointNine-month operating loss widened to $11.975 million from $9.159 million in the comparable 2025 period.
- Minor point. Forward-looking: it has not happened yet and may not happen.Adult acute kidney injury priority review depends on positive trial results and submission of the final application module.
News Explained
The reported common-share count rose from
Key Figures
- Net revenue growth
- 247% to $635 thousand
- Q3 2026 compared with Q3 2025
- Gross profit margin
- >90%
- Q3 2026
- Trial enrollment
- 251 of 339 patients
- NEUTRALIZE-AKI pivotal trial
- Expected enrollment completion
- Mid-year 2027
- NEUTRALIZE-AKI pivotal trial
- Net loss
- $4,529 thousand
- Three months ended September 30, 2026
- Net loss per share
- $(1.03) per share
- Three months ended September 30, 2026
- Cash
- $3,989 thousand
- At September 30, 2026; compared with $11,980 thousand at December 31, 2025
- Warrant exercise proceeds
- $3.3 million gross
- October 2026; not included in September 30 cash
Previous Earnings Reports
-
Revenue rose 82%, gross margin was approximately 91%, and NEUTRALIZE-AKI enrollment reached 223 of 339.
-
Revenue reached $0.5 million and NEUTRALIZE-AKI enrollment advanced to 198 of 339 patients.
-
Revenue was approximately $0.2 million, and the pivotal trial had enrolled 146 patients toward its revised target.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
crrt medical
premarket approval (pma) regulatory
breakthrough device designation regulatory
icd-10-pcs codes technical
humanitarian device exemption regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Continued adoption of the QUELIMMUNE® therapy yielded
Achieved nearly
Reported statistically significant higher survival for QUELIMMUNE-treated patients versus comparator cohort at ASN Kidney Week 2026 late-breaking presentation
Fulfilled FDA post-approval requirements for SAVE Registry study
Webcast today at 4:30 p.m. Eastern Time
DENVER, Nov. 11, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today financial results for the three months ended September 30, 2026, and provided business updates on key initiatives.
“The strength of the QUELIMMUNE therapy adoption in this ultra-rare pediatric AKI market provides great promise for our pipeline indications,” said Eric Schlorff, CEO of SeaStar Medical. “And we continue to build momentum in educating the critical care pediatric health care community. In addition to several medical meeting presentations by Dr. Kevin Chung, our CMO, we have already begun sharing with critical care professionals the statistically significant higher survival in QUELIMMUNE-treated patients that was presented at the late-breaking presentation at ASN Kidney Week 2026.”
Mr. Schlorff continued, “The NEUTRALIZE-AKI pivotal clinical trial has enrolled nearly
Key Business Highlights
Since the beginning of the third quarter, SeaStar Medical’s key business updates include the following:
- Expanded the use of the QUELIMMUNE (SCD-PED) therapy as a treatment for ultra-rare sepsis-associated AKI in pediatric patients receiving renal replacement therapy (RRT), increasing net revenue
247% to$635 thousand compared to the third quarter of 2025. Gross profit margins remained at greater than90% . - Presented at ASN Kidney Week 2026 real-world pediatric patient survival data from the commercial use of the QUELIMMUNE therapy based on results from the SAVE Registry of 50 critically ill pediatric patients with life-threatening sepsis-associated AKI. The QUELIMMUNE (SCD-PED) therapy group showed statistically significant higher survival in the primary analysis at Day 60, Day 90, and at hospital discharge versus comparator cohorts. No device-related adverse events occurred in patients treated with the QUELIMMUNE (SCD-PED) therapy.
- Fulfilled FDA post-approval requirements for the SAVE Registry study for QUELIMMUNE for the treatment of sepsis-associated AKI in pediatric patients. FDA’s decision now enables hospitals to employ the QUELIMMUNE therapy without the research infrastructure that the SAVE Registry demanded, which may increase availability for these critically ill pediatric patients.
- Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial evaluating the SCD therapy as a potential treatment for adult patients with AKI in the ICU receiving continuous renal replacement therapy (CRRT). The trial is nearly
75% enrolled, with 251 of 339 patients enrolled to date. The NEUTRALIZE-AKI pivotal clinical trial is expected to complete enrollment by mid-year 2027. - Completed and submitted to the FDA the first module of a modular premarket approval (PMA) application for the potential approval of the SCD therapy as a treatment for adult patients with AKI in the ICU receiving CRRT.
- Granted Breakthrough Device Designation from the FDA for the SCD therapy for the treatment of hyperinflammation in adult patients with sepsis or a septic condition. The Breakthrough Device Designation is a regulatory pathway designed to provide for accelerated development, assessment, and review for FDA approval of medical devices and potentially more effective treatments of life-threatening or irreversibly debilitating diseases or conditions. This marks the seventh Breakthrough Device Designation for the SCD therapy thus far across a range of indications.
- Received dedicated International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS codes) from the Centers for Medicare & Medicaid Services (CMS). These codes, which took effect on October 1, 2026, enable administrative, billing, and statistical reporting for the use of SeaStar Medical’s SCD therapy in patients with AKI requiring RRT in the inpatient hospital setting.
Financial Results for the Third Quarter 2026
Net revenue for the three months ended September 30, 2026, and 2025, was approximately
Cost of goods sold for the three months ended September 30, 2026, and 2025, was
Research and development expenses for the three months ended September 30, 2026, and 2025, were
General and administrative expenses for the three months ended September 30, 2026, and 2025, were approximately
Other income (net) for the three months ended September 30, 2026, was approximately
Net loss for the three months ended September 30, 2026, was approximately
Cash at September 30, 2026, was
SeaStar Medical Third Quarter Financial Results Conference Call
| Date/Time: | Wednesday, November 11, 2026, at 4:30 p.m. ET / 2:30 p.m. MT | |
| Webcast: | The live webcast and replay can be found here. | |
| Register for the call: | Preregistration is required to attend the live call and can be accessed here. A pin code and dial in number will be provided with registration. | |
A replay of the call will be available after 7:30 p.m. ET and can be accessed here.
About QUELIMMUNE
The QUELIMMUNE® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or a septic condition weighing 10 kilograms or more and aged ≤22 years who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application.
Data from two clinical trials of the QUELIMMUNE therapy, published in Kidney Medicine, showed a
The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and could have broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.
QUELIMMUNE was approved by FDA under a Humanitarian Device Exemption based on safety and probable benefit. The effectiveness of this device for this use has not been demonstrated. Adverse reactions observed in clinical studies include hypotension, hypothermia, tachycardia, hyperglycemia, and thrombocytopenia. Additional risks may include blood loss or extracorporeal circuit complications. QUELIMMUNE must be used with citrate anticoagulation.
For complete risk information, please see: https://seastarmedical.com/quelimmune
About the SeaStar Medical Selective Cytopheretic Device (SCD) Therapy
The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy is designed for broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing CRRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future CRRT, including dialysis, and prevent loss of life.
About NEUTRALIZE-AKI Pivotal Trial
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in AKI) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
About Acute Kidney Injury (AKI) and Hyperinflammation
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as severe infections or other septic conditions, severe trauma, surgery, and organ failures. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
About SeaStar Medical
SeaStar Medical is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening Acute Kidney Injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT) in critically ill pediatric patients. SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for seven therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.
For more information visit www.seastarmedical.com or visit us on LinkedIn or X.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to expanded access to critically ill pediatric patients as a result of the fulfillment of the SAVE Registry requirements, the potential benefit from the SCD-PED therapy with a favorable observed safety profile; anticipated improved survival in real-world critical care practice; anticipated adoption our products; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; and the ability of SeaStar Medical to meet the expected timeline. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact:
IR@SEASTARMED.COM
QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.
— Financial Tables to Follow —
| SeaStar Medical Holding Corporation Condensed Consolidated Balance Sheets (in thousands, except for share and per-share amounts) | ||||||||
| September 30, 2026 | December 31, 2025 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash | $ | 3,989 | $ | 11,980 | ||||
| Accounts receivable, net of allowance for credit losses of | 178 | 237 | ||||||
| Inventory | 45 | 66 | ||||||
| Prepaid expenses | 755 | 1,297 | ||||||
| Total current assets | 4,967 | 13,580 | ||||||
| Other assets | 343 | 578 | ||||||
| Total assets | $ | 5,310 | $ | 14,158 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,467 | 948 | |||||
| Accrued expenses | 3,373 | 2,268 | ||||||
| Notes payable, net of deferred financing costs | — | 525 | ||||||
| Liability classified warrants | 1 | 1 | ||||||
| Total current liabilities | 4,841 | 3,742 | ||||||
| Total liabilities | 4,841 | 3,742 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock - | — | — | ||||||
| Common stock - | 4 | 4 | ||||||
| Additional paid-in capital | 163,959 | 162,126 | ||||||
| Accumulated deficit | (163,494 | ) | (151,714 | ) | ||||
| Total stockholders’ equity | 469 | 10,416 | ||||||
| Total liabilities and stockholders’ equity | $ | 5,310 | $ | 14,158 | ||||
| SeaStar Medical Holding Corporation Condensed Consolidated Statements of Operations (unaudited) (in thousands, except for share and per-share amounts) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Net revenue | $ | 635 | $ | 183 | $ | 1,745 | $ | 814 | ||||||||
| Cost of goods sold | 48 | 14 | 148 | 41 | ||||||||||||
| Gross profit | 587 | 169 | 1,597 | 773 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 3,574 | 1,850 | 8,438 | 5,318 | ||||||||||||
| General and administrative | 1,594 | 1,898 | 5,134 | 4,614 | ||||||||||||
| Total operating expenses | 5,168 | 3,748 | 13,572 | 9,932 | ||||||||||||
| Loss from operations | (4,581 | ) | (3,579 | ) | (11,975 | ) | (9,159 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 54 | 107 | 214 | 200 | ||||||||||||
| Interest expense | (2 | ) | — | (16 | ) | (18 | ) | |||||||||
| Other financing costs | — | — | — | (298 | ) | |||||||||||
| Change in fair value of warrants liability | — | — | — | 32 | ||||||||||||
| Total other income (expense), net | 52 | 107 | 198 | (84 | ) | |||||||||||
| Loss before provision for income taxes | (4,529 | ) | (3,472 | ) | (11,777 | ) | (9,243 | ) | ||||||||
| Provision for income taxes | — | — | 3 | 3 | ||||||||||||
| Net loss | $ | (4,529 | ) | $ | (3,472 | ) | $ | (11,780 | ) | $ | (9,246 | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | (1.03 | ) | $ | (1.30 | ) | $ | (2.85 | ) | $ | (5.96 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 4,390,541 | 2,669,340 | 4,132,784 | 1,551,212 | ||||||||||||
| SeaStar Medical Holding Corporation Condensed Consolidated Statements of Cash Flows (unaudited) | ||||||||
| Nine Months Ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (11,780 | ) | (9,246 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities | — | — | ||||||
| Amortization of deferred financing costs | 16 | 18 | ||||||
| Change in fair value of liability classified warrants | — | (32 | ) | |||||
| Shares issued for the standby equity purchase agreement commitment fee | — | 298 | ||||||
| Stock-based compensation | 155 | 554 | ||||||
| Change in operating assets and liabilities | ||||||||
| Accounts receivables, net | 59 | (109 | ) | |||||
| Inventory | 21 | (83 | ) | |||||
| Prepaid expenses | 542 | 1,028 | ||||||
| Other assets | 235 | 236 | ||||||
| Accounts payable | 519 | (1,028 | ) | |||||
| Accrued expenses | 1,105 | (1,141 | ) | |||||
| Net cash used in operating activities | (9,128 | ) | (9,505 | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of shares | 1,678 | 14,337 | ||||||
| Proceeds from exercise of warrants | — | 1,818 | ||||||
| Proceeds from issuance of pre-funded warrants | — | 5,886 | ||||||
| Payment of notes payable | (541 | ) | (592 | ) | ||||
| Net cash provided by financing activities | 1,137 | 21,449 | ||||||
| Net increase in cash | (7,991 | ) | 11,944 | |||||
| Cash, beginning of period | 11,980 | 1,819 | ||||||
| Cash, end of period | $ | 3,989 | $ | 13,763 | ||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were SeaStar Medical’s third-quarter 2026 revenue and net loss?
SeaStar Medical reported $635 thousand in net revenue and a $4.529 million net loss for the three months ended September 30, 2026. Revenue increased 247% year over year. Net loss compared with $3.472 million a year earlier, while loss per share narrowed to $1.03 from $1.30.
When does SeaStar Medical expect NEUTRALIZE-AKI enrollment to finish?
SeaStar Medical expects NEUTRALIZE-AKI to complete enrollment by mid-year 2027. The adult acute kidney injury trial has enrolled 251 of its intended 339 patients, nearly 75% of its target.
What is the primary endpoint of SeaStar Medical’s NEUTRALIZE-AKI trial?
The primary endpoint is a composite of 90-day mortality or dialysis dependency. The trial compares SCD therapy plus continuous renal replacement therapy, a continuous form of blood filtration, against continuous renal replacement therapy alone in adults with acute kidney injury in intensive care.
What do SeaStar Medical’s new SCD procedure codes cover?
The dedicated ICD-10-PCS procedure codes support administrative, billing and statistical reporting for inpatient SCD use in patients with acute kidney injury requiring renal replacement therapy. The Centers for Medicare & Medicaid Services codes took effect on October 1, 2026.