SeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business Updates
- Four-fold increase in QUELIMMUNE revenue to $293,000 in Q1 2025
- 50% enrollment achieved in NEUTRALIZE-AKI pivotal trial
- Secured three new customers for QUELIMMUNE therapy
- Received two new FDA Breakthrough Device Designations
- Reduced net loss from $12.7M in Q1 2024 to $3.8M in Q1 2025
- Successfully completed FDA site inspection for QUELIMMUNE kitting operations
- Continued net losses of $3.8 million in Q1 2025
- Increased R&D expenses to $2.4 million from $1.7 million year-over-year
- Limited cash position of $5.3 million despite recent offering
- Required additional funding through $6.0 million registered direct offering
Insights
SeaStar Medical showed impressive revenue growth with QUELIMMUNE, strong clinical progress in adult AKI trials, and improved financial position despite ongoing losses.
SeaStar Medical's Q1 2025 results demonstrate encouraging commercial traction for their QUELIMMUNE therapy, with revenue jumping
The company's customer acquisition strategy appears to be working, with three new customers secured in 2025, including a nationally recognized children's medical center. This market penetration is crucial since the pediatric Acute Kidney Injury (AKI) space addressed by QUELIMMUNE represents a specialized but high-value segment.
From a financial standpoint, SeaStar remains in investment mode with R&D expenses of
The company's cash position improved to
The reduction in G&A expenses to
Six Breakthrough Device Designations now in their portfolio, including two new ones for SCD therapy in cardiac surgery applications, create multiple paths for growth and potential preferential reimbursement dynamics. This diversification strategy reduces overall business risk while leveraging their core technology platform across multiple indications.
SeaStar's QUELIMMUNE therapy shows strong commercial adoption while their adult AKI trial progresses rapidly, expanding their SCD technology into multiple critical care applications.
The four-fold sequential revenue increase for SeaStar's QUELIMMUNE therapy represents significant clinical adoption for their Selective Cytopheretic Device (SCD) in pediatric Acute Kidney Injury. This rapid uptake signals strong physician confidence in the therapy's ability to address a critical unmet need in severely ill children.
Reaching
The FDA's granting of two additional Breakthrough Device Designations for SCD therapy in cardiac surgery applications—both adult and pediatric—is particularly significant. These designations acknowledge the SCD's potential to address serious conditions with limited treatment options and provide SeaStar with enhanced FDA communication, priority review, and potential Medicare reimbursement advantages post-approval through the Transitional Coverage for Emerging Technologies (TCET) pathway.
The company's successful completion of an FDA site inspection for QUELIMMUNE kitting operations represents an important operational milestone. By bringing this process in-house instead of using contract manufacturers, SeaStar gains greater control over quality, potentially reducing costs and improving supply chain reliability—critical factors for a medical device targeting critically ill patients.
The new IDE approval for evaluating SCD therapy as a bridging strategy to left ventricular assist device (LVAD) implantation in heart failure patients represents a strategic expansion into the cardiovascular space. This application leverages the SCD's anti-inflammatory mechanism in a completely different organ system, demonstrating the platform potential of their technology beyond kidney applications.
The National Kidney Foundation's Corporate Innovator Award provides external validation of QUELIMMUNE's impact, potentially enhancing adoption among nephrologists and intensivists who treat pediatric AKI patients.
- QUELIMMUNE adoption drives four-fold increase in sequential quarter net revenue
- NEUTRALIZE AKI trial exceeds
50% enrollment, triggers start of Interim Analysis - Webcast Today at 4:30 pm Eastern Time
DENVER, May 14, 2025 (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, 2025, and provided business updates on key initiatives.
“This is our second full quarter of the QUELIMMUNE launch and we believe our four-fold increase in revenue represents the strong commitment by our customers to improve outcomes in their pediatric patients with Acute Kidney Injury (AKI) with this potential life-saving therapy,” said Eric Schlorff, CEO of SeaStar Medical. “We also continue to attract new customers, including a nationally recognized children’s medical center that just completed Institutional Review Board (IRB) approvals and placed its first order for the QUELIMMUNE therapy.”
Mr. Schlorff continued, “Importantly, we are now looking to expand access to our promising technology into the adult AKI market, where this is also a very high unmet need. Our NEUTRALIZE-AKI trial in adult AKI patients is now
Key Business Highlights in 2025
Since the beginning of 2025, SeaStar Medical’s key business updates include the following:
- Reported a four-fold increase in QUELIMMUNE net product revenue in the first quarter of 2025 to approximately
$293 thousand compared to approximately$68 thousand in the fourth quarter of 2024. - Broadened the QUELIMMUNE customer base, securing three new customers in 2025, including a nationally recognized children’s medical center that recently completed IRB approvals and placed an initial order for QUELIMMUNE therapy.
- Achieved
50% enrollment in the NEUTRALIZE-AKI pivotal trial, triggering the initiation of the prespecified, per protocol Interim Analysis by the trial’s independent Data Safety Monitoring Review Board (DSMB). SeaStar Medical anticipates the DSMB will report its findings to the company in the third quarter of 2025. - Awarded two new Breakthrough Device Designations for use of the SCD therapy to treat systemic inflammatory response in 1) adult patients undergoing cardiac surgery and 2) pediatric patients undergoing cardiac surgery towards prevention of post-operative adverse complications and outcomes. This brings SeaStar Medical’s total Breakthrough Device Designations to six therapeutic indications, enabling a potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch.
- Successfully completed an FDA site inspection of SeaStar Medical’s facility for QUELIMMUNE kitting operations, eliminating its contract manufacturer and enabling internal controls over the entire kitting process.
- Received from the FDA an Investigational Device Exemption (IDE) for a clinical trial to evaluate the SCD therapy as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with chronic heart failure who have progressed to acute decompensated heart failure. This indication has been granted Breakthrough Device Designation by the FDA. It represents a market where there is serious unmet need for effective treatments.
- Awarded the NKF 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.
Financial Results for the First Quarter 2025
Net revenue for the three months ended March 31, 2025, was approximately
Research and development expenses for the three months ended March 31, 2025, and 2024, were
General and administrative expenses for the three months ended March 31, 2025, and 2024, were approximately
Other expenses (net) decreased approximately
Net loss for the three months ended March 31, 2025, SeaStar Medical was approximately
The Company reported cash, cash equivalents and long-term investments of
SeaStar Medical First Quarter Financial Results Conference Call
| Date/Time: | Wednesday, May 14, 2025, at 4:30 p.m. ET / 2:30 p.m. MT |
| Webcast: | The live webcast and replay can be found here. |
| Conference ID: | 2078693 |
| Dial-in numbers: | 1 (800) 715-9871 within the U.S. |
| 1 (646) 307-1963 from outside the U.S. | |
A replay of the call will be available after 7:30 pm ET and can be accessed as follows:
- The webcast replay is available here.
- The call replay number is 1 (609) 800-9909 and will be available through May 20, 2025.
About QUELIMMUNE
The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with Renal Replacement Therapy (RRT). The QUELIMMUNE therapy was approved in February 2024 under a Humanitarian Device Exemption application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. SeaStar Medical commenced its commercial launch of the QUELIMMUNE therapy in July 2025. 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.
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 200 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 sepsis, severe trauma, surgery and COVID-19. 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 Therapy
The Selective Cytopheretic Device (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 has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing nearly a million 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 renal replacement therapy (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 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’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 in critically ill pediatric patients. SeaStar’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 a pivotal 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 anticipated patient enrollment and the expansion of the clinical trial sites; the total addressable market for adult SCD applications; the ability of SeaStar Medical to gain market share and generate sales with respect to the total addressable market for adult SCD applications; 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, 2025 | December 31, 2024 | ||||||
| (unaudited) | |||||||
| ASSETS | |||||||
| Current assets | |||||||
| Cash | $ | 5,296 | $ | 1,819 | |||
| Accounts receivable, net | 110 | 112 | |||||
| Inventory | 44 | — | |||||
| Prepaid expenses | 1,334 | 1,835 | |||||
| Total current assets | 6,784 | 3,766 | |||||
| Other assets | 813 | 892 | |||||
| Total assets | $ | 7,597 | $ | 4,658 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY/(DEFICIT) | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 3,397 | $ | 3,046 | |||
| Accrued expenses | 3,255 | 3,188 | |||||
| Notes payable, net of deferred financing costs | 363 | 574 | |||||
| Liability classified warrants | 17 | 33 | |||||
| Total current liabilities | 7,032 | 6,841 | |||||
| Total liabilities | 7,032 | 6,841 | |||||
| Commitments and contingencies (Note 10) | |||||||
| Stockholders’ equity/(deficit) | |||||||
| Preferred stock - | — | — | |||||
| Common stock - | 2 | 2 | |||||
| Additional paid-in capital | 143,899 | 137,379 | |||||
| Accumulated deficit | (143,336 | ) | (139,564 | ) | |||
| Total stockholders’ equity/(deficit) | 565 | (2,183 | ) | ||||
| Total liabilities and stockholders’ equity/(deficit) | $ | 7,597 | $ | 4,658 | |||
| SeaStar Medical Holding Corporation Condensed Consolidated Statements of Operations (unaudited) (in thousands, except for share and per-share amounts) | |||||||
| Three Months Ended March 31, | |||||||
| 2025 | 2024 | ||||||
| Net revenue | $ | 293 | $ | — | |||
| Cost of goods sold | — | — | |||||
| Gross profit | 293 | — | |||||
| Operating expenses | |||||||
| Research and development | 2,431 | 1,697 | |||||
| General and administrative | 1,684 | 2,253 | |||||
| Total operating expenses | 4,115 | 3,950 | |||||
| Loss from operations | (3,822 | ) | (3,950 | ) | |||
| Other income (expense) | |||||||
| Interest expense | (11 | ) | (143 | ) | |||
| Interest income | 48 | — | |||||
| Change in fair value of convertible notes | — | (5,758 | ) | ||||
| Change in fair value of liability classified warrants | 16 | (2,846 | ) | ||||
| Total other income (expense), net | 53 | (8,747 | ) | ||||
| Loss before provision for income taxes | (3,769 | ) | (12,697 | ) | |||
| Provision for income taxes | 3 | — | |||||
| Net loss | $ | (3,772 | ) | $ | (12,697 | ) | |
| Net loss per share of common stock, basic and diluted | $ | (0.44 | ) | $ | (4.73 | ) | |
| Weighted-average shares outstanding, basic and diluted | 8,617,932 | 2,684,243 | |||||
| SeaStar Medical Holding Corporation Condensed Consolidated Statements of Cash Flows (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 2025 | 2024 | ||||||
| Cash flows from operating activities | |||||||
| Net loss | $ | (3,772 | ) | $ | (12,697 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities | |||||||
| Amortization of deferred financing costs | 11 | 27 | |||||
| Change in fair value of convertible notes (issued, converted and outstanding) | — | 5,758 | |||||
| Change in fair value of liability classified warrants (exercised and outstanding) | (16 | ) | 2,846 | ||||
| Stock-based compensation | 167 | 434 | |||||
| Change in operating assets and liabilities | |||||||
| Accounts receivables, net | 2 | — | |||||
| Inventory | (44 | ) | — | ||||
| Prepaid expenses | 501 | 614 | |||||
| Other assets | 79 | 2 | |||||
| Accounts payable | 351 | (493 | ) | ||||
| Accrued expenses | 67 | 21 | |||||
| Net cash used in operating activities | (2,654 | ) | (3,488 | ) | |||
| Cash flows from financing activities | |||||||
| Proceeds from issuance of convertible notes | — | 979 | |||||
| Proceeds from issuance of shares, net of issuance costs | 1,566 | 4,543 | |||||
| Proceeds from sale of pre-funded warrants | 4,785 | 3,769 | |||||
| Proceeds from exercise of warrants | 2 | 853 | |||||
| Payment of notes payable | (222 | ) | (1,813 | ) | |||
| Net cash provided by financing activities | 6,131 | 8,331 | |||||
| Net increase in cash | 3,477 | 4,843 | |||||
| Cash, beginning of period | 1,819 | 176 | |||||
| Cash, end of period | $ | 5,296 | $ | 5,019 | |||
| Supplemental disclosure of cash flow information | Three Months Ended March 31, | ||||||
| 2025 | 2024 | ||||||
| Cash paid for interest | $ | — | $ | — | |||
| Exercise of pre-funded warrants | $ | — | $ | 3,106 | |||
| Shares issued as payment of convertible notes | $ | — | $ | 9,387 | |||
| Issuance of convertible note warrants | $ | — | $ | 586 | |||
FAQ
What was SeaStar Medical's (ICU) revenue growth for QUELIMMUNE in Q1 2025?
What is the status of SeaStar Medical's NEUTRALIZE-AKI trial in 2025?
How much cash does SeaStar Medical (ICU) have as of Q1 2025?
What was SeaStar Medical's (ICU) net loss in Q1 2025?
How many FDA Breakthrough Device Designations does SeaStar Medical have in 2025?
