DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a medical device company, announced that its Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) has received Humanitarian Device Exemption (HDE) Approval from the U.S. Food and Drug Administration (FDA). This clearance allows the SCD-PED to be marketed for children with acute kidney injury (AKI) due to sepsis, who weigh at least 10 kilograms and require kidney replacement therapy (KRT).
The SCD-PED is the inaugural product in SeaStar Medical’s Quelimmune product line. Eric Schlorff, CEO of SeaStar Medical, expressed that this FDA approval is a significant milestone for the company and offers a new therapy option for critically ill children with AKI, a condition with a high mortality rate in pediatric intensive care units.
Clinical studies have indicated that the Quelimmune pediatric device can reduce mortality rates and the dependency on dialysis in affected children. The FDA’s decision was based on clinical data demonstrating the device’s safety and probable benefit in this patient population. The studies reported a 77% reduction in mortality and no dialysis dependency at 60 days post-treatment.
Nuwellis, SeaStar Medical’s U.S. licensing and distribution partner, is expected to initiate the commercial launch of the Quelimmune pediatric device in the near future. Nestor Jaramillo, Jr., President and CEO of Nuwellis, commented on the potential of the Quelimmune device to positively impact children suffering from hyperinflammation.
The Quelimmune technology is designed to selectively target and modulate proinflammatory neutrophils and monocytes during CKRT, aiming to reduce the hyperinflammatory state that can lead to organ failure and death in critically ill patients. SeaStar Medical is also conducting the NEUTRALIZE-AKI clinical trial to evaluate the device in the adult AKI population and is exploring other potential applications.
This press release statement serves as the source of the information reported.
InvestingPro Insights
Following the recent FDA approval for SeaStar Medical Holding Corporation's Quelimmune pediatric device, the company's financial metrics and market performance provide additional context for investors. According to InvestingPro data, SeaStar Medical has a market capitalization of $89.07 million, reflecting the market's current valuation of the company.
Investors tracking the performance of SeaStar Medical (NASDAQ:ICU) may note the significant return over the last week, with a 55.91% increase in price total return. This surge is part of a broader trend, with the company also experiencing a strong return over the last month and three months, at 103.42% and 271.79%, respectively. These metrics suggest a recent bullish sentiment among investors towards SeaStar Medical's stock.
One of the InvestingPro Tips for SeaStar Medical indicates that the stock price often moves in the opposite direction of the market, which could imply a degree of resilience or non-correlation with broader market trends. Moreover, the company does not pay a dividend to shareholders, which may be a consideration for income-focused investors.
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