DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a medical device company, announced the inclusion of Brooke Army Medical Center (BAMC) and the United States Army Institute of Surgical Research (USAISR) in its NEUTRALIZE-AKI trial. The trial examines the safety and efficacy of its Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients.
The activation of these military medical facilities brings the total number of clinical sites to 11, with 48 subjects enrolled thus far. The SCD has been recognized by the FDA with Breakthrough Device Designation, highlighting its potential to offer substantial improvement over existing therapies for adults with AKI.
The NEUTRALIZE-AKI trial aims to enroll up to 200 adults and focuses on a primary endpoint of 90-day mortality or dialysis dependency. Secondary endpoints include 28-day mortality, ICU-free days within the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year.
AKI is marked by a rapid loss of kidney function and can result from various conditions, leading to hyperinflammation and potentially multi-organ dysfunction or failure. The SCD device is designed to modulate the immune response during continuous kidney replacement therapy (CKRT), potentially improving long-term organ recovery and reducing the need for future kidney replacement therapies.
In addition to the trial expansion, SeaStar Medical has begun shipping the SCD Pediatric, named QUELIMMUNE™, for pediatric patients with AKI and sepsis following FDA approval under a Humanitarian Device Exemption earlier in 2024.
The company also noted the payoff of all interest-bearing debt in September 2024, marking a financial milestone.
This news is based on a press release statement from SeaStar Medical, which is developing cell-directed extracorporeal therapies to mitigate the effects of excessive inflammation on vital organs.
In other recent news, SeaStar Medical has hit some significant milestones. The company has fully retired its long-term debt, which was previously over $9 million. This achievement is expected to be reflected in the upcoming quarterly financial report for the period ending September 30, 2024. SeaStar Medical has also received coverage from the U.S. Centers for Medicare & Medicaid Services for its NEUTRALIZE-AKI trial costs, which is anticipated to accelerate patient enrollment and site activations.
Another major development is the company's announcement of a $10 million stock and warrant sale, which is expected to generate funds for general corporate purposes, including working capital and capital expenditures. However, the company is also facing a shareholder class action lawsuit alleging material misstatements and omitted information about its business operations and regulatory approvals.
The company has also received FDA approval for the final labeling of its QUELIMMUNE device for pediatric patients and has seen significant board changes with the appointment of Jennifer A. Baird, Bernadette N. Vincent, and John Neuman. These are among the recent developments at SeaStar Medical.
InvestingPro Insights
SeaStar Medical's recent developments in clinical trials and product shipments come against a backdrop of financial challenges. According to InvestingPro data, the company's market capitalization stands at a modest $17.02 million, reflecting its current position as a small-cap medical device company.
InvestingPro Tips highlight that SeaStar Medical is not profitable over the last twelve months, with an adjusted operating income of -$14.3 million. This aligns with the company's focus on research and development, particularly in its NEUTRALIZE-AKI trial and the recent FDA approval of its pediatric device.
The stock's performance has been notably weak, with InvestingPro data showing a 69.71% price decline over the past year. This significant drop may be attributed to the company's ongoing financial losses and the inherent risks associated with medical device development.
Despite these challenges, SeaStar Medical's recent debt payoff, as mentioned in the article, could be seen as a positive step towards improving its financial health. However, an InvestingPro Tip notes that the company's short-term obligations still exceed its liquid assets, suggesting ongoing financial pressures.
For investors interested in a deeper analysis, InvestingPro offers 10 additional tips for SeaStar Medical, providing a more comprehensive view of the company's financial situation and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.