SeaStar Medical Reduces FDA Surveillance Requirement to 50 Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
0mins
Source: Newsfilter
- Reduced Monitoring Requirement: The FDA has decreased the mandatory enrollment size for the SAVE Surveillance Registry from 300 to 50 patients, indicating confidence that device safety can be demonstrated with fewer patients, thereby accelerating the market adoption of QUELIMMUNE therapy.
- Significant Survival Rate Improvement: Among the first 21 patients in the SAVE Surveillance Registry, QUELIMMUNE therapy reported zero device-related adverse events and a 70% survival rate at 90 days, providing new hope for pediatric patients suffering from acute kidney injury.
- Expanded Market Opportunity: SeaStar Medical anticipates that by reducing the required patient enrollment, it can facilitate smoother adoption of QUELIMMUNE therapy, potentially capturing a share of the estimated $100 million pediatric acute kidney injury market in the U.S., thus enhancing revenue potential.
- Clinical Data Validation: Preliminary results from the SAVE Surveillance Registry indicate survival rates of 76% at Day 28 and 71% at Day 60 for QUELIMMUNE therapy, demonstrating a 50% reduction in mortality compared to historical data, further validating the therapy's efficacy.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy ICU?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on ICU
Wall Street analysts forecast ICU stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for ICU is 1.00 USD with a low forecast of 1.00 USD and a high forecast of 1.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.335
Low
1.00
Averages
1.00
High
1.00
Current: 2.335
Low
1.00
Averages
1.00
High
1.00
No data
About ICU
SeaStar Medical Holding Corporation is a commercial-stage medical technology company, which is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. The Company’s Selective Cytopheretic Device (SCD) is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. It has broad potential applications for patients suffering from both acute and chronic kidney disease as well as cardiovascular and other serious inflammatory diseases. Its SCD therapy is an extracorporeal synthetic membrane device designed to bind activated leukocytes (neutrophils and monocytes) when integrated into an existing continuous renal replacement therapy (CRRT) circuit in conjunction with the use of regional citrate anticoagulation (RCA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
SeaStar Medical Expands QUELIMMUNE Adoption, Anticipates $2 Million Revenue in 2026
- Market Expansion: SeaStar Medical plans to broaden QUELIMMUNE adoption to 15 additional top-ranked children's medical centers in 2026, more than doubling its customer base and anticipating approximately $2 million in net product revenue, thereby strengthening its leadership in the ultra-rare pediatric AKI market.
- Clinical Trial Progress: The company aims to accelerate enrollment in the NEUTRALIZE-AKI pivotal trial, expected to complete by the end of 2026, and plans to submit a Premarket Approval application in 2027, which will rapidly drive adoption of the SCD therapy in the adult AKI market upon successful outcomes.
- FDA Fast Track: SeaStar Medical's SCD therapy has received Breakthrough Device Designation from the FDA, designed to expedite treatment for adult AKI and acute heart failure patients, potentially opening up multi-billion-dollar market opportunities for the company.
- Survival Rate Data: The QUELIMMUNE therapy has demonstrated a 76% survival rate at 60 days and 71% at 90 days in clinical applications, with expectations to validate its effectiveness in reducing mortality rates, further solidifying its market position.
Continue Reading
SeaStar Medical Announces 1-for-10 Reverse Split, Shares Drop 9.5%
- Reverse Split Impact: SeaStar Medical's announcement of a 1-for-10 reverse split led to a 9.5% drop in pre-market trading, bringing the share price down to $0.21, reflecting market concerns about the company's future prospects.
- Market Reaction: Following the reverse split news, SeaStar's stock price quickly declined, indicating a lack of investor confidence in the company's financial health, which could affect its ability to raise capital and its market image.
- Other Stock Movements: Coincheck Group NV and Ascent Solar Technologies also saw declines in pre-market trading, dropping 11% and 7.6% respectively, indicating a broader bearish sentiment in the market that may influence investor risk appetite.
- Industry Trends: In light of the market's reaction to the reverse split, SeaStar Medical may need to reassess its capital structure and future strategy to restore investor confidence and improve stock performance.
Continue Reading