Interest continues to grow in developing new strategies to reduce systemic inflammation as a means of improving outcomes in heart failure patients
The manuscript, titled “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD’s potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure. The manuscript reviews the positive effect of the Adult SCD in a previously announced first-in-human case report of a 71-year-old patient with cardiorenal syndrome who was deemed ineligible for cardiac transplantation or a LVAD due to worsening renal function and right ventricular dysfunction. Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications. This study was the basis for Adult SCD receiving a Breakthrough Device Designation in cardiorenal syndrome from the U.S. Food and
“Systemic inflammation is one component in the multi-factorial pathophysiology of heart failure, and the use of anti-inflammatory strategies in patients with acute or worsening heart failure is not novel ,” said lead manuscript author and heart failure expert
“Our novel extracorporeal device has shown significant promise in targeting active neutrophils and monocytes to quell systematic inflammation, leading to improved outcomes in hyperinflammatory acute conditions including acute kidney injury, acute respiratory distress syndrome and cardiorenal syndrome,” said manuscript co-author
On
About Hyperinflammation
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.
About the Selective Cytopheretic Device (SCD)
The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis.
About SeaStar Medical
SeaStar Medical is a medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or X.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, the SCD’s ability to treat hyperinflammation and the expected results of clinical trials and studies. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements, including the equity line of credit and forward purchase agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the
Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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