SeaStar Medical (ICU) H.C. Wainwright 28th Annual Global Investment Conference summary

Conference overview

• The event was the H.C. Wainwright 28th Annual Global Investment Conference, featuring presentations and panels from September 14-16.

• SeaStar Medical presented its mission to transform treatments for critically ill patients facing organ failure, focusing on neutralizing hyperinflammation.

• The lead product, QUELIMMUNE, targets pediatric acute kidney injury and has received FDA Humanitarian Device Exemption and six Breakthrough Device Designations.

• The pediatric market is valued at $100 million annually, while the adult market is estimated at $4.5 billion in the U.S.

• CMS assigned an ICD-10-PCS code effective October 1, 2026, supporting future reimbursement and adoption.

Clinical and commercial progress

• QUELIMMUNE demonstrated a 77% survival rate in pediatric studies, with no dialysis dependency or device-related serious adverse events.

• The commercial strategy targets the top 50 children's hospitals, with current penetration at about 40%.

• Healthcare economics show hospitals can earn about $46,000 profit per patient by reducing length of stay and mortality.

• Adult studies showed improved outcomes over historical controls, prompting a pivotal 339-patient NEUTRALIZE-AKI trial, now over 65% enrolled.

• NEUTRALIZE-CRS, a smaller NIH-funded study, explores use in cardiac patients and potential for outpatient and chronic indications.

Forward-looking statements and financials

• Anticipated PMA filing for adult indication is targeted for 2027, with a modular approach to speed approval.

• The company holds a market cap of $15 million, $6-7 million in cash as of June 30, and no long-term debt.

• Goals include expanding to 25 customers by year-end, completing NEUTRALIZE-AKI enrollment by Q1 2027, and advancing new indications.

• The therapy is positioned as a high-margin, pharmaceutical-like device with broad potential applications.

• Ongoing investment in medical affairs and peer-reviewed publications supports scientific credibility and adoption.