SeaStar Medical Reports First Quarter Financial Results and Provides Business Updates
Rhea-AI Summary
SeaStar Medical (Nasdaq: ICU) reported Q1 2026 net revenue of $0.5 million from QUELIMMUNE, a 69% increase versus Q1 2025, after adding 7 top-rated children’s hospitals, bringing its pediatric AKI customer base to 17.
The company advanced enrollment to 198 of 339 patients in the NEUTRALIZE-AKI pivotal adult trial, completed SAVE Registry enrollment of 50 pediatric patients, and reported no device-related safety events with QUELIMMUNE. Q1 2026 net loss was $3.5 million, with $9.3 million in cash at March 31, 2026.
Positive
- QUELIMMUNE net revenue rose to $0.5 million, up 69% year-over-year
- Pediatric AKI customer base expanded to 17 hospitals, adding 7 in Q1 2026
- NEUTRALIZE-AKI adult pivotal trial enrolled 198 of 339 planned patients
- SAVE Registry completed enrollment of 50 pediatric patients
- Reported no device-related safety events in first 21 QUELIMMUNE SAVE patients
- Q1 2026 net loss narrowed to $3.5 million from $3.8 million year-over-year
- Company targets approximately $2 million in net product revenue for full-year 2026
- FDA Breakthrough Device Designations granted for adult AKI and cardiorenal indications
Negative
- Q1 2026 net loss of approximately $3.5 million
- Cash balance declined to $9.3 million from $12.0 million at year-end 2025
- Research and development expenses remained high at $2.3 million in Q1 2026
- General and administrative expenses were approximately $1.7 million in Q1 2026
News Market Reaction – ICU
In the May 14 session, ICU declined 8.70%, reflecting a notable negative market reaction. Argus tracked a trough of -16.0% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 25 | Full-year 2025 results | Positive | +22.4% | Reported higher 2025 revenue, narrower net loss, stronger cash and trial progress. |
| Nov 13 | Q3 2025 results | Positive | -17.4% | Showed positive registry data, trial expansion, capital raise and revenue but shares fell. |
| Aug 13 | Q2 2025 results | Positive | +21.0% | Delivered revenue growth, trial enrollment gains, positive registry survival and new grants. |
| May 14 | Q1 2025 results | Positive | +0.8% | Reported four-fold revenue increase, improved loss and new customers with strong trial progress. |
| Mar 27 | FY 2024 results | Negative | -22.7% | Highlighted larger expenses, significant net loss despite early revenue and financing progress. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings and business updates have often coincided with sizable one-day moves, more frequently positive than negative.
Over the past year, SeaStar Medical’s earnings releases have combined widening QUELIMMUNE adoption with steady clinical progress. Prior updates highlighted revenue growth from pediatric SCD therapy, narrowing net losses, cash raises, and advancing NEUTRALIZE-AKI enrollment, alongside multiple Breakthrough Device Designations. Price reactions to these earnings events have frequently been sizable, with several double-digit moves both up and down, indicating that financial and pipeline updates tend to be meaningful trading catalysts for ICU.
Key Terms
pma regulatory
breakthrough device designation regulatory
renal replacement therapy medical
rrt medical
cardiorenal syndrome medical
left ventricular assist device medical
humanitarian use regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Added 7 top-rated children’s hospitals to QUELIMMUNE® pediatric acute kidney injury (AKI) customer base, increasing first quarter revenue
Advanced enrollment in the NEUTRALIZE-AKI pivotal clinical trial in adult patients with AKI
Initiated efforts for the submission of a modular post-marketing application (PMA)
Webcast today at 4:30 pm Eastern Time
DENVER, May 13, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today financial results for the three months ended March 31, 2026, and provided business updates on key initiatives.
“Our QUELIMMUNE customer base continues to grow with a groundswell of enthusiasm among key experts that is driving our penetration into new accounts,” said Eric Schlorff, CEO of SeaStar Medical. “We saw a significant jump in revenue of
Mr. Schlorff continued, “We are working diligently to enroll adult patients with AKI in the NEUTRALIZE-AKI pivotal trial. We have activated multiple new clinical sites in the last six months and believe that a successful outcome of this trial would position us to file a PMA with the FDA for the adult AKI indication in 2027. Our success in building the QUELIMMUNE market now will provide critical support for this potential future opportunity.”
Key Business Highlights
SeaStar Medical’s achievements since the beginning of 2026 include the following:
- Expanded the use of QUELIMMUNE (SCD-PED) therapy for ultra-rare pediatric AKI, adding 7 new customers from top-rated children’s hospitals, bringing the total customer base to 17 and building increased depth in customer orders. This led to first quarter 2026 net revenue of
$0.5 million for QUELIMMUNE product sales, an increase of69% versus the first quarter of 2025. - Advanced enrollment in the NEUTRALIZE-AKI pivotal trial that is evaluating the Selective Cytopheretic Device (SCD) therapy as a potential treatment of adult patients with AKI in the ICU receiving continuous renal replacement therapy (RRT). The trial has enrolled 198 of 339 patients to date.
- Completed the required enrollment in the SAVE Registry, a post-approval surveillance registry evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening AKI and sepsis or a septic condition. The registry has successfully enrolled 50 patients, and the company will be reporting the 28-day safety results from the SAVE Registry to the FDA upon completion of its analysis of the data.
- Announced the publication of early post-approval, real-world experience from the use of the QUELIMMUNE therapy in the prestigious, peer-reviewed journal Pediatric Nephrology. The publication, co-authored by leading experts in pediatric critical care management, highlights early experience from the first 21 pediatric patients in the SAVE Registry. The published data from the commercial use of the QUELIMMUNE therapy showed no device related safety events with the QUELIMMUNE therapy with
76% of patients surviving through 60 days and71% surviving through 90 days. These results are on track to validate a nearly50% reduction in loss of life compared to historical data, as reported previously in Kidney Medicine. - Presented new data at the 31st International Conference on Advances in Critical Care Nephrology, also known as AKI & CRRT 2026, highlighting patient experience from the first 32 pediatric patients in the SAVE Registry. The clinical experience from the updated cohort demonstrated trends consistent with those previously reported from the initial cohort of 21 patients and the QUELIMMUNE registrational studies, and continue to support the QUELIMMUNE therapy safety and potential benefit in this critically-ill patient population.
- Assembled leading experts in the treatment of pediatric AKI to speak at the SeaStar Medical educational symposium at the AKI & CRRT 2026 meeting to discuss the complex pathophysiology of pediatric AKI with sepsis, the SAVE Registry, the immunomodulatory effects of the QUELIMMUNE therapy which may ameliorate dysregulated hyperinflammatory disease states, and other topics of interest to the nephrology community.
- Initiated efforts for the submission of a modular PMA to potentially speed the FDA review and approval process for the SCD therapy as a potential treatment for adult patients with AKI in the ICU receiving continuous RRT. SeaStar Medical has also been granted Breakthrough Device Designation by the FDA for this indication, which may expedite the PMA approval process for novel devices that will save lives and treat debilitating diseases.
Anticipated 2026 Milestones
- Broaden QUELIMMUNE adoption to include 15 additional top-ranked children’s medical centers, more than doubling the total number of sites from the beginning of the year and building increased depth in customer orders. SeaStar Medical also anticipates achieving approximately
$2 million in net product revenue in 2026. - Advance the SCD therapy for the adult AKI indication through completion of enrollment in the NEUTRALIZE-AKI pivotal trial around the end of 2026 and begin submission of relevant PMA modules to the FDA to facilitate the PMA review and approval process.
- Evaluate broader applicability of the SCD therapy through the conduct of a clinical trial of the SCD therapy in patients with chronic heart failure with cardiorenal syndrome awaiting left ventricular assist device implantation. SeaStar Medical has also been granted Breakthrough Device Designation by the FDA for this indication given the severity of the disease and lack of current effective treatments.
- Explore rapid regulatory pathways to commercialization of the SCD therapy as a first-in-class therapy, designed to save lives and spare organ function in numerous destructive hyperinflammatory conditions. SeaStar Medical will seek additional Humanitarian Use and Breakthrough Device Designations to potentially provide lifesaving support to these patients as rapidly as possible.
Financial Results for the First Quarter 2026
For the three months ended March 31, 2026, net revenue was approximately
Research and development expenses for the three months ended March 31, 2026, and 2025, were
General and administrative expenses for the three months ended March 31, 2026, and 2025, were approximately
Other income (net) increased approximately
Net loss for the three months ended March 31, 2026, was approximately
The Company reported cash of
| SeaStar Medical First Quarter Financial Results Conference Call | |
| Date/Time: | Wednesday, May 13, 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 septic condition weighing 10 kilograms or more 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
In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.
In February 2026, data published in the prestigious, peer-reviewed journal, Pediatric Nephrology, highlighted the early experience from the QUELIMMUNE SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, preliminary outcomes analyses show a
The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy and has broad applications for treating the destructive hyperinflammation that shuts down organ function and causes loss of life.
About NEUTRALIZE-AKI Pivotal Trial
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving continuous RRT. 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 continuous RRT as the standard of care, compared with the control group receiving only continuous RRT 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 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 continuous RRT 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 continuous RRT, including dialysis, and prevent loss of life.
About SeaStar Medical
SeaStar Medical is a commercial-stage healthcare company focused on transforming 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 six 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, 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 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations with respect to product revenue in 2026; anticipated patient enrollment and the expansion of the clinical trial sites; the total addressable market for the SCD applications; the ability of SeaStar Medical to gain market share and generate sales with respect to anticipated revenue in 2026; broadening QUELIMMUNE adoption by the addition of top-ranked children’s medical centers; the amount and timing of future QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; 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
— Financial Tables to Follow —
| SeaStar Medical Holding Corporation Condensed Consolidated Balance Sheets (in thousands, except for share and per-share amounts) | |||||||
| March 31, 2026 | December 31, 2025 | ||||||
| (unaudited) | |||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash | $ | 9,348 | $ | 11,980 | |||
| Accounts receivable, net of allowance for credit losses of | 179 | 237 | |||||
| Inventory | 57 | 66 | |||||
| Prepaid expenses | 1,180 | 1,297 | |||||
| Total current assets | 10,765 | 13,580 | |||||
| Other assets | 499 | 578 | |||||
| Total assets | $ | 11,263 | $ | 14,158 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 719 | 948 | ||||
| Accrued expenses | 2,897 | 2,268 | |||||
| Notes payable, net of deferred financing costs | 331 | 525 | |||||
| Liability classified warrants | 1 | 1 | |||||
| Total current liabilities | 3,948 | 3,742 | |||||
| Total liabilities | 3,948 | 3,742 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity | |||||||
| Preferred stock - | — | — | |||||
| Common stock - | 4 | 4 | |||||
| Additional paid-in capital | 162,546 | 162,126 | |||||
| Accumulated deficit | (155,235 | ) | (151,714 | ) | |||
| Total stockholders’ equity | 7,315 | 10,416 | |||||
| Total liabilities and stockholders’ equity | $ | 11,263 | $ | 14,158 | |||
| SeaStar Medical Holding Corporation Condensed Consolidated Statement of Operations (in thousands, except for share and per-share amounts) (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 2026 | 2025 | ||||||
| Net revenue | $ | 495 | $ | 293 | |||
| Cost of goods sold | 46 | — | |||||
| Gross profit | 449 | 293 | |||||
| Operating expenses | |||||||
| Research and development | 2,344 | 2,431 | |||||
| General and administrative | 1,708 | 1,684 | |||||
| Total operating expenses | 4,052 | 4,115 | |||||
| Loss from operations | (3,603 | ) | (3,822 | ) | |||
| Other income (expense) | |||||||
| Interest income | 91 | 48 | |||||
| Interest expense | (6 | ) | (11 | ) | |||
| Change in fair value of warrants liability | — | 16 | |||||
| Total other income (expense), net | 85 | 53 | |||||
| Loss before provision for income taxes | (3,518 | ) | (3,769 | ) | |||
| Provision for income taxes | 3 | 3 | |||||
| Net loss | $ | (3,521 | ) | $ | (3,772 | ) | |
| Net loss per share of common stock, basic and diluted | $ | (0.90 | ) | $ | (4.38 | ) | |
| Weighted-average shares outstanding, basic and diluted | 3,918,339 | 861,794 | |||||
| SeaStar Medical Holding Corporation Condensed Consolidated Statement of Cash Flow (in thousands, except for share and per-share amounts) (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 2026 | 2025 | ||||||
| Cash flows from operating activities | |||||||
| Net loss | $ | (3,521 | ) | $ | (3,772 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities | |||||||
| Amortization of deferred financing costs | 6 | 11 | |||||
| Change in fair value of liability classified warrants (exercised and outstanding) | — | (16 | ) | ||||
| Stock-based compensation | 91 | 167 | |||||
| Change in operating assets and liabilities | |||||||
| Accounts receivables, net | 58 | 2 | |||||
| Inventory | 9 | (44 | ) | ||||
| Prepaid expenses | 117 | 501 | |||||
| Other assets | 79 | 79 | |||||
| Accounts payable | (229 | ) | 351 | ||||
| Accrued expenses | 629 | 67 | |||||
| Net cash used in operating activities | (2,761 | ) | (2,654 | ) | |||
| Cash flows from financing activities | |||||||
| Proceeds from issuance of shares, net of offering costs | 329 | 1,566 | |||||
| Proceeds from exercise warrants | — | 2 | |||||
| Proceeds of pre-funded warrants | — | 4,785 | |||||
| Payment of notes payable | (200 | ) | (222 | ) | |||
| Net cash provided by financing activities | 129 | 6,131 | |||||
| Net increase in cash | (2,632 | ) | 3,477 | ||||
| Cash, beginning of period | 11,980 | 1,819 | |||||
| Cash, end of period | $ | 9,348 | $ | 5,296 | |||
QUELIMMUNE is a registered trademark of SeaStar Medical Holding Corporation.
