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DENVER - Medical Holding Corporation (NASDAQ:ICU), a micro-cap healthcare company with a market capitalization of approximately $9 million, has regained compliance with Nasdaq’s minimum stockholders’ equity requirement of $2.5 million, the company announced Wednesday. According to InvestingPro data, the stock has experienced significant volatility, falling over 94% in the past year while showing recent signs of recovery with a 15% gain in the past week.
The healthcare company, which focuses on treatments for critically ill patients facing organ failure, said the previously disclosed listing matter has now been closed, allowing it to focus on its commercial and clinical activities. InvestingPro analysis reveals the company maintains a strong balance sheet with more cash than debt, though it currently operates at a loss with negative earnings per share of $3.04 in the last twelve months.
"We are very pleased to have this hurdle behind us and can now turn our full attention to commercializing QUELIMMUNE and our clinical development of potential organ-sparing and life-saving therapies," said Eric Schloff, CEO of SeaStar Medical.
The company is currently commercializing QUELIMMUNE, a therapy approved in February 2024 under a Humanitarian Device Exemption for children with acute kidney injury (AKI) and sepsis who weigh at least 10 kilograms and are receiving renal replacement therapy in intensive care units.
Medical Holding Corporation is also conducting its NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) therapy in 200 adults with AKI in intensive care units who are receiving continuous renal replacement therapy.
The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency compared to standard care. Secondary endpoints include 28-day mortality, ICU-free days, and dialysis dependency at one year.
The company’s SCD therapy has received Breakthrough Device Designation from the FDA for four therapeutic indications, potentially enabling a faster approval pathway.
According to the company’s press release statement, AKI affects over 200,000 adults annually in the United States and is characterized by sudden, temporary loss of kidney function that can lead to hyperinflammation and potential multi-organ dysfunction. Analysts tracking the company maintain optimistic projections, with revenue growth forecast at 7.5% for the current fiscal year. For deeper insights into Medical Holding Corporation’s financial health and growth prospects, investors can access comprehensive analysis and 12 additional ProTips through InvestingPro’s detailed research reports.
In other recent news, SeaStar Medical Holding Corporation has undertaken significant measures to regain compliance with Nasdaq’s listing requirements. The company completed a $4 million public offering of common stock and warrants, which was priced at $0.65 per share. This offering is expected to close around June 23, 2025, with H.C. Wainwright & Co. serving as the exclusive placement agent. SeaStar Medical also reported increased adoption of its FDA-approved QUELIMMUNE therapy for pediatric patients with acute kidney injury and sepsis. In addition, the U.S. Centers for Medicare & Medicaid Services will cover expenses for Medicare and Medicaid patients in the NEUTRALIZE-CRS clinical trial, which investigates the efficacy of SeaStar Medical’s Selective Cytopheretic Device therapy. The company is also involved in a pivotal trial for this therapy in adult patients with acute kidney injury. Furthermore, the U.S. Department of Defense has awarded a $2 million grant to study the use of SeaStar Medical’s therapy for severe burns and related injuries. These developments highlight SeaStar Medical’s ongoing efforts to advance its therapies and secure necessary funding and approvals.
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