CytoPherx

About CytoPherx

CytoPherx, Inc., now operating as SeaStar Medical Holding Corporation (NASDAQ: ICU), is a commercial-stage medical device company that originated in July 2007. The company was founded by Dr. H. David Humes, a professor in the Division of Nephrology at the University of Michigan, based on his research. Initially established as Nephrion Inc., the firm rebranded to CytoPherx, a name derived from 'cytopheresis,' the process of removing specific blood cells to treat blood disorders. A significant milestone in the company's trajectory was the acquisition of Immunocept Medical Products in late 2020, a move that expanded its technology portfolio and led to the rebranding as SeaStar Medical. In 2022, SeaStar Medical became a publicly listed company on Nasdaq through a business combination with LMF Acquisition Opportunities, Inc.

SeaStar Medical is focused on addressing hyperinflammation in critically ill patients within the intensive care unit (ICU). The company's core technology is the Selective Cytopheretic Device (SCD), a patented, cell-directed extracorporeal therapy. The SCD is designed to be integrated with standard continuous renal replacement therapy (CRRT) or dialysis machines. Its primary function is to modulate the body's inflammatory response by targeting and neutralizing highly activated neutrophils and monocytes, which are key drivers of systemic inflammation that can lead to organ failure and death. The device works by creating a low calcium environment that causes these overactive immune cells to adhere to the SCD's fibers, where they are reprogrammed to a less inflammatory state before being released back into the body. This 'catch-and-release' mechanism helps to quell the inflammatory storm without depleting the body's immune cells.

The company's business model centers on the commercialization of its SCD technology for various critical care indications. Its initial product, QUELIMMUNE™ (SCD-PED), received U.S. FDA approval under a Humanitarian Device Exemption for pediatric patients with acute kidney injury (AKI) due to sepsis. This represents the company's initial revenue stream, with sales to children's hospitals. SeaStar Medical is actively pursuing broader market opportunities, with a pivotal trial, NEUTRALIZE-AKI, underway for the significantly larger adult AKI market, estimated to be a $4.5 billion annual opportunity in the U.S. The firm generates revenue from the sale of the disposable SCD cartridges. While currently unprofitable with significant operating expenses dedicated to research and development, the company has demonstrated sequential revenue growth from its initial product launch. The FDA has granted the SCD multiple Breakthrough Device Designations for conditions including adult and pediatric AKI, hepatorenal syndrome, and for use in patients undergoing cardiac surgery, which could expedite future review and approval processes.