SeaStar Medical Holding Corporation Q1 FY2025 earnings call

• Added a prestigious nationally recognized Children's Hospital to QUELIMMUNE customers and achieved 50% enrollment in the NEUTRALIZE-AKI trial. - Granted two new breakthrough device designations by the FDA for addressing hyperinflammation in adult and pediatric cardiac surgery. - QUELIMMUNE therapy saw a fourfold revenue increase from Q4 2024, with repeat orders from existing sites and new customers being added. - NEUTRALIZE-AKI pivotal trial for adult AKI with CRRT is well underway, with 100 patients enrolled out of 200 planned, and an interim analysis by the DSMB anticipated in Q3 2025. - Focus on growing the customer base for QUELIMMUNE, with plans to bring on new pediatric sites by year-end. - SCD therapy has breakthrough device designations for five other indications, with commercial and medical affairs teams assessing market penetration for these indications.

The primary product segment is QUELIMMUNE therapy. In the first quarter of 2025, revenue from QUELIMMUNE therapy was $293,000, which is a fourfold increase compared to the fourth quarter of 2024 ($68,000) and a significant jump from $0 in the year-ago first quarter. QUELIMMUNE therapy is the key driver of revenue, with increased adoption from existing customers and new customers being added.

• Plan to file a PMA for the adult AKI indication in CRRT in 2026 if the NEUTRALIZE-AKI trial goes as planned. - Anticipate commercial growth as new pediatric hospitals are activated and adopt QUELIMMUNE therapy. - Expect forward momentum as the company progresses with the NEUTRALIZE-AKI trial and prepares for potential PMA filing, aiming to bring life-saving therapy to more patients.

No specific risks explicitly detailed in the transcript, but potential risks could include delays in clinical trial enrollment or results, regulatory hurdles in obtaining approvals, and challenges in market adoption of new therapies.

Q: Can you tell me how many sites are currently activated for the adult clinical trial?

A: Kevin Chung states they currently have 15 activated and plan to activate another five over the next three months.

Q: What's the total number of pediatric hospitals that you have as customers currently?

A: Tim Varacek replies there are six sites that are commercially active and multiple others moving through the IRB process.

Q: Talking about the IRB process and pipeline, what sort of pipeline growth have you seen in the first quarter compared to the fourth quarter?

A: Tim Varacek explains it's a combination of word of mouth from existing sites sharing experiences and active engagement with hospitals, with no shortage of interest in QUELIMMUNE therapy.

Q: Can you talk about the new breakthrough designations and how you're prioritizing regulatory processes?

A: Kevin Chung discusses the clinical unmet need in cardiac surgery and the need for additional trials, while Eric Schlorff adds that commercial and medical affairs teams are assessing market need penetration dynamics for the five additional breakthrough device designations, with the SCD therapy being agnostic to disease states, making subsequent approvals potentially quicker once the first adult approval is achieved.