SeaStar Medical
Overview
SeaStar Medical Holding Corporation is a healthcare company specializing in medical devices designed to mitigate hyperinflammation's impacts on vital organs. Established in Denver, Colorado, the company focuses on developing extracorporeal therapies targeting effector cells responsible for systemic inflammation. While specific details about its founding date and founders are less transparent, SeaStar Medical is a publicly traded entity on the Nasdaq under the ticker ICU. As of early 2025, the company is positioning its proprietary devices, like the Selective Cytopheretic Device (SCD), for substantial market expansion in medical applications covering conditions such as acute kidney injury and sepsis.
Recent Developments
- December 2024: SeaStar Medical activated its 14th hospital site for the NEUTRALIZE-AKI pivotal trial. This trial seeks to evaluate the efficacy and safety of their Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) patients. The enrollment reached 70 out of 200 participants.
- November 2024: The Food and Drug Administration (FDA) granted SeaStar's SCD a Breakthrough Device Designation for chronic dialysis treatments, extending its potential U.S. patient population significantly.
- July 2024: The Centers for Medicare & Medicaid Services (CMS) provided Category B coverage for patients in their pivotal AKI trial, which may encourage industry adoption by offsetting related medical expenses.
- February 2024: The SCD, branded as QUELIMMUNE™, was approved by the FDA for pediatric use in treating acute kidney injury and sepsis. This marked a significant milestone, as such approvals in pediatrics often bolster confidence in subsequent adult applications.
SeaStar Medical's recent activities highlight their commitment to expanding their device applications and securing regulatory approval, which are vital steps towards commercial success and patient care improvements.
Company Information
| Attribute | Information |
|---|---|
| Founding Date | Not publicly available |
| Headquarters | Denver, Colorado, USA |
| Founders | Not publicly available |
| Revenue | Not publicly available |
| Profits | Not publicly available |
| Key Investors | Not publicly available |
| Industry | Biotechnology, Medical Devices |
| Number of Employees | Not publicly available |
Early History
SeaStar Medical was founded to address the critical need for innovative therapeutic solutions to manage hyperinflammation, a condition that can have catastrophic impacts on organ function. From its inception, the company focused on extracorporeal therapies—a method of outside-the-body blood treatment to remove harmful substances. Although detailed information on its early history is sparse, SeaStar quickly attained recognition for its unique approach. Its early development of the Selective Cytopheretic Device (SCD) was pivotal, attracting attention and investments that positioned it well within the biomedical technology field. Their strategic focus on targeting inflammatory responses set the stage for sustainable growth into various therapeutic applications.
Company Profile and Achievements
SeaStar Medical's business model centers around extracorporeal therapies, leveraging technology to manage inflammation. The Selective Cytopheretic Device (SCD) stands out as a flagship product, employing immunomodulating technology to target and regulate inflammation-causing cells effectively. Key achievements include:
- FDA Approvals and Recognitions: Securing Breakthrough Device Designations for multiple indications, including acute kidney injury and pediatric applications.
- Pivotal Trials: Launching substantial clinical trials such as NEUTRALIZE-AKI, positioning the SCD as a critical intervention in intensive care units across several sites.
- Commercialization of QUELIMMUNE™: Initiating sales and deployment of its pediatric SCD, QUELIMMUNE, with early results suggesting meaningful clinical and cost benefits. These achievements underscore SeaStar Medical's commitment to leveraging cutting-edge technology to improve patient outcomes and gain a competitive foothold in the healthcare landscape.
Current Operations and Market Position
SeaStar Medical is deeply engaged in ongoing clinical trials of their SCD and its subsequent commercial applications. Their current operations are directed at scaling these trials, securing further regulatory approvals, and expanding market penetration in the U.S. healthcare system. With a focus on treating hyperinflammation through innovative extracorporeal methods, SeaStar is poised for significant market growth. In a medical technology market where competition is fierce, the company's FDA designations offer a distinct advantage by ensuring priority reviews and potential market differentiation. Their strategic partnerships and trial expansions indicate a strong commitment to achieving broader integration of their devices within medical institutions.
Conclusion
SeaStar Medical stands as a promising contender in the medical technology sector, particularly in managing conditions characterized by hyperinflammation. By targeting the immunological responses underlying many severe medical conditions, SeaStar's technology has the potential to transform patient care. The company's strategic initiatives, including robust clinical trials and obtaining key regulatory designations, reflect a well-structured roadmap to market success. As SeaStar continues to innovate and expand its device applications, it holds significant potential for reshaping therapeutic approaches and improving healthcare outcomes across various critical conditions.