SeaStar Medical Secures ICD-10 Codes for QUELIMMUNE Therapy Billing
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 23 2026
0mins
Source: Newsfilter
- Billing Code Approval: SeaStar Medical's QUELIMMUNE® therapy has received ICD-10-PCS codes from CMS, enabling standardized billing for acute kidney injury treatments in inpatient settings, expected to take effect on October 1, 2026, thereby simplifying logistics for existing customers and facilitating rapid adoption in the adult AKI market.
- Significant Market Potential: Tim Varacek noted that the adult AKI market is approximately $4.5 billion, which is 50 times larger than the pediatric market, and the acquisition of reimbursement codes is expected to significantly accelerate QUELIMMUNE's adoption in this market, enhancing the company's market share in acute kidney injury treatments.
- Clinical Data Validation: The QUELIMMUNE therapy demonstrated a 77% survival rate in clinical trials, representing a roughly 50% reduction in mortality compared to standard care, with 87.5% of survivors showing normal kidney function 60 days post-discharge, establishing a strong foundation for broader application of the therapy.
- Award Recognition: SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contributions to improving the lives of pediatric patients with AKI through the introduction of QUELIMMUNE therapy, further enhancing the company's reputation in the healthcare industry.
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About ICU
SeaStar Medical Holding Corporation is a commercial-stage medical technology company, which is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. The Company’s Selective Cytopheretic Device (SCD) 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. It has broad potential applications for patients suffering from both acute and chronic kidney disease as well as cardiovascular and other serious inflammatory diseases. Its SCD therapy is an extracorporeal synthetic membrane device designed to bind activated leukocytes (neutrophils and monocytes) when integrated into an existing continuous renal replacement therapy (CRRT) circuit in conjunction with the use of regional citrate anticoagulation (RCA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Biotech Companies See Significant Stock Gains
- Can-Fite Surge: Can-Fite BioPharma Ltd. (CANF) saw its stock soar over 55% to $4.63 following an update on its pancreatic cancer study, where the Phase 2a trial of Namodenoson met primary safety endpoints and showed durable survival outcomes, indicating strong future market potential as the company plans to advance to a Phase 2b combination study with chemotherapy.
- SeaStar Revenue Growth: SeaStar Medical Holding Corp. (ICU) experienced a stock increase of over 30% to $4.86, driven by no specific news, yet its flagship product QUELIMMUNE received FDA approval in 2024, with projected net product revenue of approximately $2 million in 2026, up from $1.2 million in 2025, reflecting strong market demand in critical care treatments.
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- Regentis European Rollout: Regentis Biomaterials Ltd. (RGNT) rose over 29% to $4.57, with no specific news, but its GelrinC product received CE Mark approval, and the company plans to begin European surgeon training this quarter as part of its commercial rollout preparations, indicating significant market expansion potential in regenerative medicine.
See More
SeaStar Medical Secures ICD-10 Codes for QUELIMMUNE Therapy Billing
- Billing Code Approval: SeaStar Medical's QUELIMMUNE® therapy has received ICD-10-PCS codes from CMS, enabling standardized billing for acute kidney injury treatments in inpatient settings, expected to take effect on October 1, 2026, thereby simplifying logistics for existing customers and facilitating rapid adoption in the adult AKI market.
- Significant Market Potential: Tim Varacek noted that the adult AKI market is approximately $4.5 billion, which is 50 times larger than the pediatric market, and the acquisition of reimbursement codes is expected to significantly accelerate QUELIMMUNE's adoption in this market, enhancing the company's market share in acute kidney injury treatments.
- Clinical Data Validation: The QUELIMMUNE therapy demonstrated a 77% survival rate in clinical trials, representing a roughly 50% reduction in mortality compared to standard care, with 87.5% of survivors showing normal kidney function 60 days post-discharge, establishing a strong foundation for broader application of the therapy.
- Award Recognition: SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contributions to improving the lives of pediatric patients with AKI through the introduction of QUELIMMUNE therapy, further enhancing the company's reputation in the healthcare industry.
See More
SeaStar Medical Reports Q1 2026 Earnings Highlights
- Customer Expansion Progress: In Q1 2026, SeaStar Medical successfully attracted 7 new hospitals to adopt QUELIMMUNE therapy, representing a nearly 70% increase from Q1 2025, which not only enhances market penetration but also lays the groundwork for achieving the goal of 15 new customers this year.
- Significant Revenue Growth: QUELIMMUNE's net revenue reached $495,000 in the first quarter, a 69% increase from the same period last year, indicating a rebound in customer orders that is expected to drive the company closer to its revenue target of approximately $2 million for 2026.
- Clinical Trial Progress: Currently, the NEUTRALIZE-AKI trial has enrolled 198 patients out of a planned total of 339, with completion expected by the end of 2026, paving the way for future market opportunities and potentially reporting top-line results in mid-2027.
- Regulatory Pathway Optimization: The company is discussing a modular PMA submission for the adult AKI indication with the FDA to expedite the approval process, while also seeking to transition the SAVE Registry from mandatory to voluntary post-marketing study to reduce administrative burdens on children's hospitals and facilitate broader adoption of QUELIMMUNE.
See More
SeaStar Medical Reports Q1 2026 Earnings Results
- Earnings Report: SeaStar Medical's Q1 2026 GAAP EPS of -$0.90 missed expectations by $0.08, indicating challenges in profitability that could affect investor confidence.
- Revenue Growth: The company reported revenue of $0.49 million, beating estimates by $0.05 million, suggesting that despite overall profitability issues, SeaStar has achieved some revenue growth, potentially laying a foundation for future business development.
- Cash Flow Status: As of March 31, 2026, the company's cash reserves stood at $9.3 million, down from $12.0 million as of December 31, 2025, reflecting potential pressures in operational funding management and raising concerns about liquidity risk.
- Market Reaction: Given the reported losses and cash decline, market reactions to SeaStar Medical may lean towards caution, prompting investors to closely monitor subsequent financial performance and strategic adjustments.
See More
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Stockholder Action: The sale is being conducted by selling stockholders, indicating a potential shift in ownership or investment strategy.
See More
SeaStar Medical Presents New Therapy Data at AKI Conference
- Therapy Efficacy Validation: SeaStar Medical's QUELIMMUNE SAVE Registry data presented at the AKI & CRRT 2026 conference indicates no device-related adverse events among the first 21 pediatric patients treated with the Selective Cytopheretic Device (SCD), achieving a 76% survival rate at Day 28 and Day 60, and 71% at Day 90, demonstrating an approximate 50% reduction in mortality compared to historical data, validating the therapy's effectiveness.
- Immunomodulatory Mechanism: Research shows that SCD therapy modulates the immune response by shifting pro-inflammatory monocytes to an anti-inflammatory reparative phenotype, potentially counteracting the hyperinflammation that drives organ failure in AKI, thereby enhancing the clinical applicability of the therapy.
- Educational Symposium Held: SeaStar Medical hosted an educational symposium featuring leading pediatric nephrology experts during the conference, introducing the first Advanced Practice Provider Panel to support broader adoption of QUELIMMUNE, reflecting the company's commitment to promoting the new therapy's accessibility.
- Adult Trial Advancement: The company is advancing its NEUTRALIZE-AKI pivotal trial targeting AKI in adults, a condition affecting over 200,000 adults annually in the U.S. with no effective treatment options, highlighting SeaStar Medical's strategic significance in addressing a critical market need.
See More
Biotech Companies See Significant Stock Gains
- Can-Fite Surge: Can-Fite BioPharma Ltd. (CANF) saw its stock soar over 55% to $4.63 following an update on its pancreatic cancer study, where the Phase 2a trial of Namodenoson met primary safety endpoints and showed durable survival outcomes, indicating strong future market potential as the company plans to advance to a Phase 2b combination study with chemotherapy.
- SeaStar Revenue Growth: SeaStar Medical Holding Corp. (ICU) experienced a stock increase of over 30% to $4.86, driven by no specific news, yet its flagship product QUELIMMUNE received FDA approval in 2024, with projected net product revenue of approximately $2 million in 2026, up from $1.2 million in 2025, reflecting strong market demand in critical care treatments.
- Elicio Strategic Refinement: Elicio Therapeutics Inc. (ELTX) jumped over 31% to $5.14, as it was added to the Russell 2000 and 3000 Indexes in 2026, despite its EL-002 product not meeting the primary endpoint in the AMPLIFY-7P trial, the company has refined its Phase 3 development strategy based on trial insights and plans to initiate a Phase 3 trial pending financing, showcasing ongoing R&D progress.
- Regentis European Rollout: Regentis Biomaterials Ltd. (RGNT) rose over 29% to $4.57, with no specific news, but its GelrinC product received CE Mark approval, and the company plans to begin European surgeon training this quarter as part of its commercial rollout preparations, indicating significant market expansion potential in regenerative medicine.
See More
SeaStar Medical Secures ICD-10 Codes for QUELIMMUNE Therapy Billing
- Billing Code Approval: SeaStar Medical's QUELIMMUNE® therapy has received ICD-10-PCS codes from CMS, enabling standardized billing for acute kidney injury treatments in inpatient settings, expected to take effect on October 1, 2026, thereby simplifying logistics for existing customers and facilitating rapid adoption in the adult AKI market.
- Significant Market Potential: Tim Varacek noted that the adult AKI market is approximately $4.5 billion, which is 50 times larger than the pediatric market, and the acquisition of reimbursement codes is expected to significantly accelerate QUELIMMUNE's adoption in this market, enhancing the company's market share in acute kidney injury treatments.
- Clinical Data Validation: The QUELIMMUNE therapy demonstrated a 77% survival rate in clinical trials, representing a roughly 50% reduction in mortality compared to standard care, with 87.5% of survivors showing normal kidney function 60 days post-discharge, establishing a strong foundation for broader application of the therapy.
- Award Recognition: SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contributions to improving the lives of pediatric patients with AKI through the introduction of QUELIMMUNE therapy, further enhancing the company's reputation in the healthcare industry.
See More
SeaStar Medical Reports Q1 2026 Earnings Highlights
- Customer Expansion Progress: In Q1 2026, SeaStar Medical successfully attracted 7 new hospitals to adopt QUELIMMUNE therapy, representing a nearly 70% increase from Q1 2025, which not only enhances market penetration but also lays the groundwork for achieving the goal of 15 new customers this year.
- Significant Revenue Growth: QUELIMMUNE's net revenue reached $495,000 in the first quarter, a 69% increase from the same period last year, indicating a rebound in customer orders that is expected to drive the company closer to its revenue target of approximately $2 million for 2026.
- Clinical Trial Progress: Currently, the NEUTRALIZE-AKI trial has enrolled 198 patients out of a planned total of 339, with completion expected by the end of 2026, paving the way for future market opportunities and potentially reporting top-line results in mid-2027.
- Regulatory Pathway Optimization: The company is discussing a modular PMA submission for the adult AKI indication with the FDA to expedite the approval process, while also seeking to transition the SAVE Registry from mandatory to voluntary post-marketing study to reduce administrative burdens on children's hospitals and facilitate broader adoption of QUELIMMUNE.
See More
SeaStar Medical Reports Q1 2026 Earnings Results
- Earnings Report: SeaStar Medical's Q1 2026 GAAP EPS of -$0.90 missed expectations by $0.08, indicating challenges in profitability that could affect investor confidence.
- Revenue Growth: The company reported revenue of $0.49 million, beating estimates by $0.05 million, suggesting that despite overall profitability issues, SeaStar has achieved some revenue growth, potentially laying a foundation for future business development.
- Cash Flow Status: As of March 31, 2026, the company's cash reserves stood at $9.3 million, down from $12.0 million as of December 31, 2025, reflecting potential pressures in operational funding management and raising concerns about liquidity risk.
- Market Reaction: Given the reported losses and cash decline, market reactions to SeaStar Medical may lean towards caution, prompting investors to closely monitor subsequent financial performance and strategic adjustments.
See More
SEASTAR MEDICAL HOLDING CORP - PROSPECTUS FOR THE RESALE OF UP TO 2 MILLION SHARES OF COMMON STOCK BY SELLING STOCKHOLDER
Company Overview: SeaStar Medical Holding Corp is involved in the sale of up to 2 million shares of its common stock.
Stockholder Action: The sale is being conducted by selling stockholders, indicating a potential shift in ownership or investment strategy.
See More
SeaStar Medical Presents New Therapy Data at AKI Conference
- Therapy Efficacy Validation: SeaStar Medical's QUELIMMUNE SAVE Registry data presented at the AKI & CRRT 2026 conference indicates no device-related adverse events among the first 21 pediatric patients treated with the Selective Cytopheretic Device (SCD), achieving a 76% survival rate at Day 28 and Day 60, and 71% at Day 90, demonstrating an approximate 50% reduction in mortality compared to historical data, validating the therapy's effectiveness.
- Immunomodulatory Mechanism: Research shows that SCD therapy modulates the immune response by shifting pro-inflammatory monocytes to an anti-inflammatory reparative phenotype, potentially counteracting the hyperinflammation that drives organ failure in AKI, thereby enhancing the clinical applicability of the therapy.
- Educational Symposium Held: SeaStar Medical hosted an educational symposium featuring leading pediatric nephrology experts during the conference, introducing the first Advanced Practice Provider Panel to support broader adoption of QUELIMMUNE, reflecting the company's commitment to promoting the new therapy's accessibility.
- Adult Trial Advancement: The company is advancing its NEUTRALIZE-AKI pivotal trial targeting AKI in adults, a condition affecting over 200,000 adults annually in the U.S. with no effective treatment options, highlighting SeaStar Medical's strategic significance in addressing a critical market need.
See More
