SeaStar Medical (NASDAQ:ICU) reported second-quarter net revenue of $615,000, up 82% from approximately $338,000 a year earlier, as demand increased for its QUELIMMUNE therapy for pediatric patients with acute kidney injury (AKI) and sepsis.
The company said it has now recorded $1.1 million in QUELIMMUNE net revenue during the first six months of 2026 and continues to target $2 million in full-year net revenue. Chief Financial Officer Michael Messinger said the company maintained a gross profit percentage above 90% for the fifth consecutive quarter.
Hospital Adoption Expands
Varacek attributed second-quarter revenue to a combination of new hospital customers and repeat purchases from existing accounts. He said existing sites have shown a “very high repurchase rate,” while new sites generally stock product after adoption so they can treat eligible patients.
The company has participated in medical meetings and educational events intended to increase awareness of pediatric sepsis-associated AKI and QUELIMMUNE. Varacek said SeaStar Medical also held an educational webinar featuring pediatric nephrologists, critical-care physicians, advanced practice providers and nurses.
Management described hospital adoption as an ongoing process that includes vendor qualification, institutional approvals, staff education and clinical support for early cases. Varacek said continuous education is needed because large hospital systems have multiple shifts and employee turnover.
Chief Medical Officer Dr. Kevin Chung said newer sites have generally used the therapy as a rescue option, while more established sites are beginning to identify potential patients earlier. He said clinicians at mature sites have gained familiarity with the product through prior cases.
Billing Code and Pediatric Registry Update
SeaStar Medical said the Centers for Medicare & Medicaid Services assigned ICD-10-PCS codes for its Selective Cytopheretic Device therapy, allowing hospitals to bill more efficiently for QUELIMMUNE when treating pediatric sepsis-associated AKI. The new code is scheduled to take effect Oct. 1.
Varacek said the company believes the same PCS code could apply to future potential indications for the device. He also said SeaStar Medical completed the 50-patient SAVE registry required by the FDA to further assess QUELIMMUNE safety. A preliminary report has been submitted, and the company is preparing its final report for FDA review.
The company previously reported results from the first 21 registry patients in the peer-reviewed journal Pediatric Nephrology, which Varacek said has contributed to interest in adoption.
Adult AKI Trial Enrollment Advances
SeaStar Medical is conducting its NEUTRALIZE-AKI pivotal trial evaluating a larger version of its Selective Cytopheretic Device in critically ill adults with AKI requiring continuous renal replacement therapy, or CRRT. The trial’s primary endpoint is a composite of mortality or dialysis dependence at 90 days.
Chung said the company has enrolled 223 of a planned 339 patients. Enrollment has averaged roughly eight to 12 patients per month over recent months, though the company is adding sites in an effort to increase that pace to approximately 15 to 20 patients monthly.
- Two additional clinical sites have been onboarded and have enrolled patients.
- Four more sites were expected to begin screening patients shortly.
- At least eight additional sites have committed to participate, according to management.
Chung said the company expects to complete enrollment around the end of 2026 or during the first quarter of 2027. He emphasized that SeaStar Medical is prioritizing enrollment of patients it believes are appropriate for assessing treatment effect, including patients with C-reactive protein levels above 3.5 mg/dL, an inflammation marker used as an enrollment criterion.
The company continues to target a late-2027 premarket approval application submission for the adult indication. SeaStar Medical plans to use a modular PMA process, under which the FDA may review portions of the application before the final clinical module is submitted following trial database lock and analysis.
The company has received FDA Breakthrough Device Designation for the adult AKI indication, which management said could support an expedited and collaborative review process. SeaStar Medical also has Breakthrough Device Designations for other potential uses, including systemic inflammation from cardiac surgery and chronic inflammation in end-stage renal disease.
Expenses, Loss and Cash Position
Second-quarter operating expenses totaled $4.4 million, compared with $2.1 million in the prior-year period. Messinger said research and development spending rose primarily because of added clinical sites and increased enrollment in the adult AKI trial. General and administrative costs increased due to compensation, legal and professional fees, and certain Securities and Exchange Commission-related expenses.
SeaStar Medical expects sequential quarterly research and development costs to continue rising at a roughly mid-single-digit rate through the remainder of 2026 as it pursues enrollment goals.
The company reported a net loss of approximately $3.7 million, or $0.91 per share, compared with a net loss of approximately $2 million, or $1.77 per share, in the second quarter of 2025. Cash totaled approximately $7 million as of June 30, down from $12 million at Dec. 31, 2025.
About SeaStar Medical (NASDAQ:ICU)
SeaStar Medical, Inc (NASDAQ: ICU) is a medical device company focused on the development and commercialization of cerebral embolic protection systems for patients undergoing transcatheter aortic valve replacement (TAVR) procedures. The company’s mission is to reduce the risk of stroke and other neurologic events associated with structural heart interventions by capturing or deflecting embolic debris that can travel to the brain during catheter-based therapies.
The company’s flagship product, TriGUARD® 3, is a next-generation embolic deflection device designed to provide coverage of all three cerebral vessels during TAVR.
