SeaStar Medical Rises on FDA Enrollment Reduction
SeaStar Medical Holding Corp's stock increased by 5.10% as it crossed above the 5-day SMA. This rise follows the FDA's decision to reduce the mandatory enrollment size for the SAVE Surveillance Registry from 300 to 50 patients, indicating confidence in the safety of QUELIMMUNE therapy.
The reduction in patient enrollment is expected to accelerate the market adoption of QUELIMMUNE therapy, which has shown promising survival rates in preliminary results. Among the first 21 patients, the therapy reported zero device-related adverse events and a 70% survival rate at 90 days, providing hope for pediatric patients suffering from acute kidney injury.
This development not only enhances SeaStar Medical's revenue potential by facilitating smoother adoption of QUELIMMUNE therapy but also positions the company to capture a share of the estimated $100 million pediatric acute kidney injury market in the U.S.
Trade with 70% Backtested Accuracy
Analyst Views on ICU

No data
About ICU
About the author


- 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.
- 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.
- Significant Revenue Growth: Multi Ways Holdings reported net revenue of $26.44 million for the first half of 2025, representing an impressive 87.65% increase from $14.09 million in the same period last year, indicating strong market demand and business expansion capabilities.
- Surge in Stock Price: Following the positive earnings report, the company's shares jumped 59.6% to $0.40 in pre-market trading, reflecting investor confidence in the company's future growth potential.
- Positive Market Reaction: The release of the financial results has significantly increased market attention on Multi Ways Holdings, which is expected to attract more investors to its future developments and strategic plans.
- Strategic Growth Outlook: The robust financial performance not only solidifies the company's position in the industry but also provides ample funding for future expansion and investments, potentially driving further increases in market share.

- Reverse Split Implementation: SeaStar Medical announced a 1-for-10 reverse stock split effective January 5, 2026, aimed at increasing the stock price to comply with Nasdaq's $1 minimum bid requirement, thereby enhancing market confidence and attracting more investors.
- Shareholder Approval: The reverse split plan was approved at the special shareholder meeting on December 18, 2025, reflecting shareholder support and trust in the company's future, which may help improve corporate governance perception.
- Trading Adjustments: Post-split, every 10 shares of common stock will convert into 1 share, with shareholders receiving information regarding their adjusted holdings, ensuring no adverse impact on shareholder rights and further strengthening trust in the company.
- New CUSIP Number: Following the reverse split, the company's stock will trade under the new CUSIP number 81256L302, which will help streamline trading processes and enhance market transparency.
Reverse Stock Split Announcement: SeaStar Medical Holding Corporation has initiated a ten-for-one reverse stock split, approved by shareholders, which will take effect on January 2.
Impact on Shares: Following the announcement, SeaStar Medical's shares have dropped by 20.38%, trading at $0.24 at the time of publication.
Share Consolidation Details: The reverse split will consolidate every 10 shares into 1, resulting in approximately 3.8 million shares of common stock outstanding, with no fractional shares issued.
Market Reaction: The significant drop in share price indicates market concerns regarding the company's financial health and the implications of the reverse stock split.

Oracle's Stock Surge: Oracle Corp's shares rose 5.7% in pre-market trading following TikTok's announcement of a new U.S. entity formed with investors including Oracle, with the deal expected to close on January 22.
Pre-Market Gainers: Several stocks saw significant gains in pre-market trading, including Vision Marine Technologies (up 48.7%), Inspire Veterinary Partners (up 32.2%), and WhiteFiber Inc (up 18.2%).
Pre-Market Losers: Notable declines were observed in pre-market trading for Zeta Network Group (down 29.4%), cbdMD Inc (down 19.2%), and Aimei Health Technology (down 15.8%).
Nike's Performance: Nike Inc's shares dipped 9.9% despite reporting better-than-expected earnings and sales, attributed to a decline in gross margins for the second consecutive quarter.








