SeaStar Medical

What SeaStar Medical does

SeaStar Medical is a commercial-stage medical device company headquartered in Denver, Colorado that develops the patented Selective Cytopheretic Device (SCD), a cell-directed extracorporeal therapy that selectively targets and neutralizes activated neutrophils and monocytes responsible for destructive hyperinflammatory responses. The SCD is connected in-line to existing continuous renal replacement therapy (CRRT) circuits in hemodialysis delivery systems, allowing the therapy to integrate into established ICU workflows without equipment replacement. The company's first commercial product, QUELIMMUNE (SCD-PED), received FDA approval under a Humanitarian Device Exemption (HDE) in February 2024 for treating pediatric patients weighing at least 10 kg with acute kidney injury (AKI) due to sepsis or a septic-like condition requiring renal replacement therapy. QUELIMMUNE was commercially launched in July 2024 and is the only FDA-approved therapeutic for this ultra-rare condition.

SeaStar Medical operates a direct enterprise field sales model, selling QUELIMMUNE to top-rated U.S. children's hospitals that meet specific equipment requirements (Prismaflex or PrisMax CRRT machines), commit to regional citrate anticoagulation and the SAVE Surveillance Registry, and obtain IRB approval. Revenue grew from $135,000 in 2024 (partial-year post-launch) to $1.234 million in full-year 2025, with Q1 2026 revenue of $495,000 representing 69% year-over-year growth. As of Q1 2026, 17 top-rated children's hospitals were using QUELIMMUNE, and the company has guided to approximately $2 million in net product revenue for full-year 2026.

Beyond pediatric AKI, SeaStar Medical is advancing an SCD-platform pipeline into substantially larger indications: the NEUTRALIZE-AKI pivotal trial for adult AKI (198 of 339 patients enrolled as of Q1 2026, targeting completion around year-end 2026), cardiorenal syndrome awaiting LVAD implantation (supported by a $3.6M NIH grant), hepatorenal syndrome, end-stage renal disease chronic inflammation, and systemic inflammatory response in adult and pediatric cardiac surgery. The FDA has granted Breakthrough Device Designations for six different therapeutic indications of the SCD platform, and CMS assigned dedicated ICD-10-PCS billing codes effective October 1, 2026 to enable standardized inpatient hospital billing. The adult AKI market is estimated at approximately $4.5 billion, about 50 times larger than the pediatric market currently served.

Name

SeaStar Medical

Legal name

SeaStar Medical, Inc.

Website

https://seastarmedical.com

Company type

Public

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

SeaStar Medical is a commercial-stage medical device company that develops the patented Selective Cytopheretic Device (SCD) extracorporeal therapy. Its QUELIMMUNE product is FDA-approved under HDE for pediatric acute kidney injury, with a pipeline targeting adult AKI, CRS, HRS, and ESRD.

Ownership category

akta.pro rank

Product category

Critical Care Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Continuous Renal Replacement Therapy (CRRT) & Acute Dialysis Systems (HLAHAKAF)

Keywords

• Critical care medical devices
• Extracorporeal immunomodulation therapy
• Pediatric renal replacement therapy
• Acute kidney injury treatment
• Cytokine storm therapy

Headquarters

HQ city

Denver

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Medical Device Sales - QUELIMMUNE: SeaStar Medical generates revenue through the sale of its QUELIMMUNE (SCD-PED) medical device to hospitals. The device is sold to pediatric hospitals that meet specific criteria (use of Prismaflex/PrisMax CRRT machines, commitment to SAVE Registry participation). Revenue has grown from $135,000 in 2024 to approximately $1.234 million in full-year 2025, with Q1 2026 revenue of $495,000 representing 69% year-over-year growth.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

SeaStar Medical manufactures and sells the QUELIMMUNE (SCD-PED) medical device, an FDA-approved (HDE, February 2024) cell-directed extracorporeal therapy for pediatric patients (>10kg) with life-threatening acute kidney injury (AKI) due to sepsis or septic conditions requiring continuous renal replacement therapy (CRRT). The product is sold directly to qualified U.S. children's hospitals that use Prismaflex or PrisMax CRRT machines and commit to participation in the SAVE Surveillance Registry. The company is also developing the broader SCD platform for adult AKI, cardiorenal syndrome, hepatorenal syndrome, ESRD, and systemic inflammatory response in cardiac surgery.

Product overview

SeaStar Medical is a commercial-stage healthcare company with a platform-based product architecture centered on its patented Selective Cytopheretic Device (SCD) technology. The core SCD platform is a cell-directed extracorporeal therapy that connects in-line to existing CRRT/hemodialysis circuits. The company's first commercial product is QUELIMMUNE (SCD-PED), FDA-approved under HDE in February 2024 for pediatric acute kidney injury. Multiple pipeline products based on the same SCD technology are in development for adult AKI (NEUTRALIZE-AKI pivotal trial), cardiorenal syndrome, hepatorenal syndrome, ESRD, and systemic inflammatory response in cardiac surgery—all supported by FDA Breakthrough Device Designations.

Differentiator

Problem solved

Functional benefit

Brands

• QUELIMMUNE: Humanitarian medical device (SCD-PED) approved for treating pediatric patients with acute kidney injury due to sepsis or septic condition, also known as Selective Cytopheretic Device for Pediatrics

Products and services

• QUELIMMUNE (SCD-PED) FDA-approved humanitarian medical device (Selective Cytopheretic Device for Pediatrics) that treats pediatric patients (>10kg) with acute kidney injury (AKI) due to sepsis or septic conditions requiring renal replacement therapy (CRRT). The SCD-PED cartridge is connected in-line to existing hemodialysis delivery systems' CRRT circuit and selectively targets activated neutrophils and monocytes to neutralize destructive hyperinflammation. Sold directly to qualified U.S. pediatric hospitals that use Prismaflex or PrisMax CRRT machines and commit to the SAVE Surveillance Registry.
• SCD-Adult (NEUTRALIZE-AKI) Investigational Selective Cytopheretic Device therapy for adult patients with acute kidney injury requiring continuous renal replacement therapy (CRRT). Currently in NEUTRALIZE-AKI pivotal trial enrolling 339 patients to evaluate safety and efficacy. FDA has granted Breakthrough Device Designation. The adult market is estimated at approximately $4.5 billion, about 50 times larger than the pediatric market.
• SCD Therapy for Cardiorenal Syndrome SCD therapy for reduction of inflammation in adult patients with acute heart failure and worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting left ventricular assist device (LVAD) implantation. FDA granted Breakthrough Device Designation in September 2023. NIH provided a $3.6 million grant to fund a feasibility study with H. David Humes, MD as lead investigator. Estimated 60,000 patients annually in the U.S.
• SCD Therapy for Hepatorenal Syndrome SCD therapy for ICU patients with AKI and acute on chronic liver failure due to hepatorenal syndrome. FDA granted Breakthrough Device Designation in October 2023. Approximately 50,000 patients annually in the U.S. affected by hepatorenal syndrome, with unacceptably high mortality driven by hyperinflammatory process in advanced liver cirrhosis.
• SCD Therapy for ESRD (End-Stage Renal Disease) SCD therapy for chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis. FDA granted Breakthrough Device Designation in November 2024. Approximately 80,000 patients on chronic dialysis annually incur chronic systemic inflammation associated with 42% 5-year survival rate.
• SCD Therapy for Systemic Inflammatory Response in Cardiac Surgery SCD therapy to treat systemic inflammatory response in adult and pediatric patients undergoing cardiac surgery. FDA granted Breakthrough Device Designations for both adult and pediatric cardiac surgery indications in April 2025.
• Selective Cytopheretic Device (SCD) Platform Patented cell-directed extracorporeal therapy platform that selectively targets activated neutrophils and monocytes responsible for destructive hyperinflammatory response. The technology connects in-line to existing CRRT/hemodialysis circuits and can stop the cytokine storm and potentially reverse damage from hyperinflammation. Underlies all SeaStar Medical products including the commercial QUELIMMUNE and pipeline indications.

Quantifiable outcome

• 77% survival rate at Day 60 in pediatric AKI patients treated with QUELIMMUNE
• +4 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• University of Michigan - Center for Integrative Research in Critical CarecoreStrategic or Co-development PartnerH. David Humes, MD serves as Scientific Advisor and lead investigator for CRS study. Dr. Humes is Professor in the Division of Nephrology, Internal Medicine at the University of Michigan and developed the SCD technology.
• Mayo CliniccoreStrategic or Co-development PartnerMayo Clinic is one of the clinical trial sites for the NEUTRALIZE-AKI pivotal trial, which has expanded to 15 active sites at Mayo Clinic for the adult AKI study.

Scale indicators10 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Spectral Medical: Spectral Medical is developing extracorporeal therapies for sepsis and AKI (PMX hemoperfusion), targeting endotoxin-driven hyperinflammation in critically ill patients. Comparable in mechanism (extracorporeal blood treatment), indication overlap (sepsis-induced AKI), and stage (late-stage pivotal trials).
• ExThera Medical: ExThera Medical develops the Seraph 100 blood purification device, an extracorporeal cartridge that selectively binds pathogens and inflammatory mediators from blood. Comparable to SeaStar's SCD in targeting blood-borne inflammatory drivers via extracorporeal therapy in critically ill patients.
• CytoSorbents Corporation: CytoSorbents develops the CytoSorb extracorporeal blood purification cartridge that removes cytokines and inflammatory mediators from blood — the most direct therapeutic competitor to SeaStar's SCD technology. Both target the same hyperinflammation/cytokine storm mechanism in critically ill ICU patients via extracorporeal circuits.

Broad incumbents

• Outset Medical: Outset Medical manufactures the Tablo hemodialysis system, an innovative dialysis platform for acute and chronic settings. Comparable as a small/mid-cap medical device innovator in the renal replacement therapy space, sharing commercial-stage dynamics with SeaStar including enterprise hospital sales and reimbursement-driven adoption.
• Baxter International: Baxter manufactures the Prismaflex and PrisMax CRRT machines that QUELIMMUNE requires to operate. While not a direct therapeutic competitor, Baxter is both the indispensable platform provider for SeaStar's commercial product and a strategic threat if it develops or acquires competing immunomodulation therapies.
• Fresenius Medical Care: Fresenius is the global leader in dialysis and CRRT, operating both equipment and dialysis service networks. Comparable as a renal replacement therapy incumbent whose installed base and clinical relationships overlap with SeaStar's target hospital segment, even though Fresenius does not currently offer a competing immunomodulation cartridge.

Others

• ChemoCentryx (acquired by Amgen): While Amgen's acquisition of ChemoCentryx was for a rare disease pharmaceutical (not a device), the precedent is relevant: small-cap critical care/rare disease companies addressing inflammation can command large strategic premiums. Amgen's commercial infrastructure contrasts with SeaStar's lean structure.

Emerging players

• Aethlon Medical: Aethlon Medical develops the Hemopurifier, an immunomodulation device that removes circulating viruses, exosomes, and immunosuppressive substances from blood. Comparable as a small-cap immunomodulation/cytokine removal medical device company targeting critical care and infectious disease applications.
• Inflammatix: Inflammatix develops host-response diagnostics for acute infections and sepsis. Comparable as an emerging company addressing hyperinflammation and critical care decision-making, though focused on diagnostics rather than therapeutic intervention.
• Talphera (formerly AcelRx): Talphera is a small-cap specialty pharmaceutical/medical device company focused on critical care and hospital-administered therapies. Comparable as a similarly-sized commercial-stage healthcare company navigating hospital sales cycles, capital constraints, and pipeline development — a useful comparator for SeaStar's current operational scale and challenges.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xtwitter.com/SeaStarMedical
• LinkedInlinkedin.com/company/seastarmed

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds8 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SeaStar Medical