SeaStar Medical Holding Corporation (Nasdaq: ICU) is strategically positioning its Selective Cytopheretic Device (SCD) to address a substantial U.S. market, estimating a total addressable market between $25 and $33 billion across five clinical indications, contingent upon FDA approvals. The company's focus is on leveraging the SCD's immunomodulating technology to mitigate hyperinflammation in critically ill patients.
Target Indications and Market Size
SeaStar Medical's SCD is being developed for several critical conditions, each representing a significant market opportunity:
- Adult Acute Kidney Injury (AKI): Affecting 210,000 patients annually, this indication represents a market opportunity of $4.7 to $6.3 billion.
- Cardiorenal Syndrome (no LVAD): With 580,000 patients, this is the largest market, estimated at $13.1 to $17.4 billion.
- Adult Acute Respiratory Distress Syndrome (ARDS): Targeting 200,000 patients, the market size is projected at $4.5 to $6.0 billion.
- Adult Hepatorenal Syndrome: Addressing 250,000 patients, this market is valued at $1.1 to $1.5 billion.
- Cardiorenal Syndrome with LVAD: Impacting 60,000 patients, the market is estimated at $1.4 to $1.8 billion.
Eric Schlorff, SeaStar Medical CEO, stated, "The estimated size of these U.S. markets versus our projected clinical trial costs clearly warrant pursuing FDA approvals in these indications... Additionally, we expect future commercial sales for the SCD in adult AKI to help cover clinical trial costs."
Regulatory and Clinical Milestones
The SCD has been granted FDA Breakthrough Device Designation (BDD) for adult AKI, hepatorenal syndrome, cardiorenal syndrome with LVAD and chronic dialysis. This designation offers several advantages, including priority review and enhanced access to FDA resources, potentially accelerating the device's development and market entry.
SeaStar Medical has already achieved a regulatory milestone with the FDA approval of QUELIMMUNE™, the SCD-Pediatric device, for treating critically ill children with AKI and sepsis. This approval, granted under a Humanitarian Device Exemption (HDE), underscores the safety and probable benefit of the SCD in a vulnerable patient population.
NEUTRALIZE-AKI Trial
The ongoing NEUTRALIZE-AKI trial is a pivotal study evaluating the SCD in adult patients with AKI. This randomized clinical trial aims to enroll up to 200 adult subjects. As of December 2024, 69 subjects have been enrolled. The primary endpoint is a composite of 90-day mortality or dialysis dependency. Secondary endpoints include mortality at 28 days, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year. Subgroup analyses will explore the effectiveness of SCD therapy in AKI patients with sepsis and ARDS.
Selective Cytopheretic Device (SCD) Mechanism
The SCD is a patented extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT). By modulating the immune response, the SCD aims to promote long-term organ recovery and reduce the need for future renal replacement therapy, including dialysis.
