SeaStar Medical Completes Patient Enrollment in SAVE Registry
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
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Should l Buy ICU?
SeaStar Medical announced that it has completed the required enrollment in the SAVE Registry, a Post-Approval Study, PAS, required by the FDA that is designed to confirm the safety of the Quelimmune therapy as a treatment for children with acute kidney injury due to sepsis or a septic condition requiring renal replacement therapy. 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.
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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.
SeaStar Medical CEO to Join Investor Forum
- Investor Forum Participation: SeaStar Medical's CEO Eric Schlorff will participate in the Life Sciences Investor Forum on March 11, 2026, hosted by VirtualInvestorConferences.com, providing real-time interaction opportunities with investors, which is expected to enhance the company's visibility among investors.
- Product Adoption Progress: SeaStar's first approved product, QUELIMMUNE, has achieved commercial adoption for pediatric patients with acute kidney injury and sepsis, demonstrating the company's market potential in treating critically ill patients, which is anticipated to drive future sales growth.
- Ongoing Clinical Trials: The company is conducting the NEUTRALIZE-AKI clinical trial to evaluate the safety and efficacy of its SCD therapy in adult patients with acute kidney injury, which is expected to provide new treatment options in a market with urgent demand for effective therapies.
- Breakthrough Device Designation: SeaStar's Selective Cytopheretic Device (SCD) therapy has received FDA Breakthrough Device Designation for four therapeutic indications, potentially accelerating the approval process and improving reimbursement dynamics post-commercialization, further solidifying its market position.
See More
Life Sciences Virtual Investor Forum Agenda Announced
- Agenda Announcement: Virtual Investor Conferences has announced the Life Sciences Virtual Investor Forum scheduled for March 11-12, 2026, inviting individual and institutional investors to participate for free, aiming to broaden the investor base and enhance company-investor interactions.
- Company Presentation Schedule: The forum will feature presentations from several life sciences companies, including SeaStar Medical Holding Corporation and Nasus Pharma Ltd., with one-on-one management meetings arranged to facilitate direct communication of strategies to investors.
- Platform Advantages: The Virtual Investor Conferences provide a real-time investor engagement solution that replicates the components of an on-site investor conference, enabling companies to access investors more efficiently and enhance presentation effectiveness, thereby increasing investor participation.
- Focus on Industry Innovation: The forum highlights innovators in the life sciences sector, with the EVP of OTC Markets Group stating that the conference offers a unique opportunity for companies to engage with a broader investor audience, fostering strategic communication within the industry.
See More
SeaStar Medical CEO to Participate in Investor Forum
- CEO Forum Participation: SeaStar Medical's CEO Eric Schlorff will participate in the Life Sciences Investor Forum on March 11, 2026, hosted by VirtualInvestorConferences.com, providing real-time interaction opportunities with investors, which is expected to enhance the company's visibility among investors.
- Product Adoption Progress: SeaStar's first approved product, QUELIMMUNE, has seen expanded commercial adoption for pediatric patients with acute kidney injury and sepsis, indicating the company's increasing market penetration in critical healthcare sectors, potentially leading to significant revenue growth.
- Ongoing Clinical Trials: The company is conducting the NEUTRALIZE-AKI clinical trial to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD) in adult patients with acute kidney injury, which is expected to provide crucial data to support future product marketing efforts.
- Breakthrough Device Designation: SeaStar's SCD therapy has received FDA Breakthrough Device Designation for four therapeutic indications, which will expedite its product approval process and improve reimbursement dynamics post-commercialization, further solidifying its market position.
See More
SeaStar Completes Patient Enrollment in SAVE Registry for QUELIMMUNE Therapy
- Patient Enrollment Completed: SeaStar Medical announced the successful enrollment of 50 patients in the SAVE Registry, fulfilling FDA requirements for confirming the safety of QUELIMMUNE™ therapy, which will provide critical data for treating acute kidney injury in children.
- Safety Data Analysis: The company plans to report 28-day safety results to the FDA upon completion of data analysis, with early results indicating a 77% survival rate for QUELIMMUNE therapy, representing approximately a 50% reduction in mortality compared to standard care.
- Market Expansion Potential: With QUELIMMUNE therapy being adopted by renowned children's medical centers in the U.S., SeaStar anticipates further expanding its customer base, particularly in children's hospitals, overcoming the complexities of patient registry to accelerate therapy adoption.
- Innovation Recognition: SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its significant contributions to improving the quality of life for pediatric patients with acute kidney injury, highlighting its efforts and achievements in this area.
See More
SEASTAR MEDICAL CONFIRMS FULFILLMENT OF FDA ENROLLMENT CRITERIA FOR SAVE SURVEILLANCE REGISTRY ASSESSING QUELIMMUNE SAFETY IN PEDIATRIC AKI
Completion of Enrollment Requirement: SEA STAR Medical has announced the completion of enrollment for the SAVE surveillance registry.
Evaluation of Safety: The registry aims to evaluate the safety of the Quelimmunes device for pediatric use.
See More
SeaStar Medical Releases Survival Data for QUELIMMUNE Therapy
- Significant Survival Rates: The QUELIMMUNE therapy demonstrated a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 among 21 critically ill pediatric patients, indicating its effectiveness in treating Acute Kidney Injury and sepsis, potentially leading to a significant reduction in patient mortality.
- Favorable Safety Profile: No device-related adverse events or infections were reported during the use of QUELIMMUNE therapy, showcasing its safety in clinical applications and laying a solid foundation for broader adoption in the future.
- Registry Study Support: Preliminary data from the SAVE Registry indicates that the survival rates of QUELIMMUNE therapy align with those observed in FDA-approved registration trials, further validating its clinical efficacy and potentially facilitating wider adoption in medical institutions.
- Expanded Clinical Applications: QUELIMMUNE therapy has been adopted by several renowned children's medical centers in the U.S., expected to provide treatment opportunities for more critically ill pediatric patients, thereby enhancing SeaStar Medical's market share in the pediatric Acute Kidney Injury sector.
See More
SeaStar Medical CEO to Join Investor Forum
- Investor Forum Participation: SeaStar Medical's CEO Eric Schlorff will participate in the Life Sciences Investor Forum on March 11, 2026, hosted by VirtualInvestorConferences.com, providing real-time interaction opportunities with investors, which is expected to enhance the company's visibility among investors.
- Product Adoption Progress: SeaStar's first approved product, QUELIMMUNE, has achieved commercial adoption for pediatric patients with acute kidney injury and sepsis, demonstrating the company's market potential in treating critically ill patients, which is anticipated to drive future sales growth.
- Ongoing Clinical Trials: The company is conducting the NEUTRALIZE-AKI clinical trial to evaluate the safety and efficacy of its SCD therapy in adult patients with acute kidney injury, which is expected to provide new treatment options in a market with urgent demand for effective therapies.
- Breakthrough Device Designation: SeaStar's Selective Cytopheretic Device (SCD) therapy has received FDA Breakthrough Device Designation for four therapeutic indications, potentially accelerating the approval process and improving reimbursement dynamics post-commercialization, further solidifying its market position.
See More
Life Sciences Virtual Investor Forum Agenda Announced
- Agenda Announcement: Virtual Investor Conferences has announced the Life Sciences Virtual Investor Forum scheduled for March 11-12, 2026, inviting individual and institutional investors to participate for free, aiming to broaden the investor base and enhance company-investor interactions.
- Company Presentation Schedule: The forum will feature presentations from several life sciences companies, including SeaStar Medical Holding Corporation and Nasus Pharma Ltd., with one-on-one management meetings arranged to facilitate direct communication of strategies to investors.
- Platform Advantages: The Virtual Investor Conferences provide a real-time investor engagement solution that replicates the components of an on-site investor conference, enabling companies to access investors more efficiently and enhance presentation effectiveness, thereby increasing investor participation.
- Focus on Industry Innovation: The forum highlights innovators in the life sciences sector, with the EVP of OTC Markets Group stating that the conference offers a unique opportunity for companies to engage with a broader investor audience, fostering strategic communication within the industry.
See More
SeaStar Medical CEO to Participate in Investor Forum
- CEO Forum Participation: SeaStar Medical's CEO Eric Schlorff will participate in the Life Sciences Investor Forum on March 11, 2026, hosted by VirtualInvestorConferences.com, providing real-time interaction opportunities with investors, which is expected to enhance the company's visibility among investors.
- Product Adoption Progress: SeaStar's first approved product, QUELIMMUNE, has seen expanded commercial adoption for pediatric patients with acute kidney injury and sepsis, indicating the company's increasing market penetration in critical healthcare sectors, potentially leading to significant revenue growth.
- Ongoing Clinical Trials: The company is conducting the NEUTRALIZE-AKI clinical trial to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD) in adult patients with acute kidney injury, which is expected to provide crucial data to support future product marketing efforts.
- Breakthrough Device Designation: SeaStar's SCD therapy has received FDA Breakthrough Device Designation for four therapeutic indications, which will expedite its product approval process and improve reimbursement dynamics post-commercialization, further solidifying its market position.
See More
SeaStar Completes Patient Enrollment in SAVE Registry for QUELIMMUNE Therapy
- Patient Enrollment Completed: SeaStar Medical announced the successful enrollment of 50 patients in the SAVE Registry, fulfilling FDA requirements for confirming the safety of QUELIMMUNE™ therapy, which will provide critical data for treating acute kidney injury in children.
- Safety Data Analysis: The company plans to report 28-day safety results to the FDA upon completion of data analysis, with early results indicating a 77% survival rate for QUELIMMUNE therapy, representing approximately a 50% reduction in mortality compared to standard care.
- Market Expansion Potential: With QUELIMMUNE therapy being adopted by renowned children's medical centers in the U.S., SeaStar anticipates further expanding its customer base, particularly in children's hospitals, overcoming the complexities of patient registry to accelerate therapy adoption.
- Innovation Recognition: SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its significant contributions to improving the quality of life for pediatric patients with acute kidney injury, highlighting its efforts and achievements in this area.
See More
SEASTAR MEDICAL CONFIRMS FULFILLMENT OF FDA ENROLLMENT CRITERIA FOR SAVE SURVEILLANCE REGISTRY ASSESSING QUELIMMUNE SAFETY IN PEDIATRIC AKI
Completion of Enrollment Requirement: SEA STAR Medical has announced the completion of enrollment for the SAVE surveillance registry.
Evaluation of Safety: The registry aims to evaluate the safety of the Quelimmunes device for pediatric use.
See More
SeaStar Medical Releases Survival Data for QUELIMMUNE Therapy
- Significant Survival Rates: The QUELIMMUNE therapy demonstrated a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 among 21 critically ill pediatric patients, indicating its effectiveness in treating Acute Kidney Injury and sepsis, potentially leading to a significant reduction in patient mortality.
- Favorable Safety Profile: No device-related adverse events or infections were reported during the use of QUELIMMUNE therapy, showcasing its safety in clinical applications and laying a solid foundation for broader adoption in the future.
- Registry Study Support: Preliminary data from the SAVE Registry indicates that the survival rates of QUELIMMUNE therapy align with those observed in FDA-approved registration trials, further validating its clinical efficacy and potentially facilitating wider adoption in medical institutions.
- Expanded Clinical Applications: QUELIMMUNE therapy has been adopted by several renowned children's medical centers in the U.S., expected to provide treatment opportunities for more critically ill pediatric patients, thereby enhancing SeaStar Medical's market share in the pediatric Acute Kidney Injury sector.
See More
