FDA Grants Breakthrough Device Designation to SeaStar Medical’s Selective Cytopheretic Device for Cardiorenal Syndrome

2023-09-29

DENVER, Sept. 29, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough DeviceDesignation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD). The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population. This is only the ninth Breakthrough Device Designation granted by the FDA’s Center for Biologics Evaluation and Research (CBER) since the program’s inception in 2015. “Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “The SCD is able to halt the downward spiral often perpetuated by a hyperinflammatory state driven by the innate immune system, giving these patients a fighting chance.” In addition to preclinical data, SeaStar Medical’s Breakthrough Device submission included a first-in-human study under a National Institutes of Health (NIH) grant to the University of Michigan under which a patient with severe chronic heart failure who was ineligible for heart transplantation or LVAD implantation was treated with the SCD. The patient achieved the primary endpoint of a successful LVAD implantation and was discharged to home. Additionally, the procedure was safe and there were no SCD-related serious adverse events (SAEs), which is consistent with the SCD’s record of no device-related SAEs across multiple clinical trials in critically ill adults and children with acute kidney injury (AKI) and multi-organ failure. “We believe the SCD represents a novel, innovative and transformative approach to treating hyperinflammation in severely ill patients with chronic heart failure. Receipt of Breakthrough Device Designation in adult AKI previously and now in cardiorenal syndrome, coupled with highly promising data from studies across multiple disease conditions, strengthens our position that the SCD’s proprietary mechanism of action of targeting dysregulated immune responses is organ-agnostic, with potential applicability in multiple high-value, unmet medical needs where hyperinflammation plays a role,” said Eric Schlorff, SeaStar Medical CEO. “We plan to work in partnership with the University of Michigan to conduct a larger clinical study in the same patient population to gather additional evidence to support the submission of a Premarket Approval (PMA) application to the FDA.” About Hyperinflammation and the SCD 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. Unlike pathogen removal and other blood-purification tools, the SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. The Company has observed that these most highly activated immune cells are turned off in a low calcium environment. The SCD therapy mimics nature by creating a unique micro-environment, attracting these highly activated effector cells and neutralizing them in such an environment. These cells are then returned back into the body through the blood, and the body is signaled to focus on repair. In 2022 the SCD received Breakthrough Device Designation for use in adult acute kidney injury. AboutSeaStarMedical 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 or visit us on LinkedIn or Twitter. Forward-LookingStatements 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, SeaStar Medical’s expectations with respect to the ability of SCD to treat patients with cardiorenal syndrome and other diseases and the ability to obtain regulatory approval of SCD under the Breakthrough Device Designation. 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 SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Contact: LHA Investor Relations Jody Cain (310) 691-7100 Jcain@lhai.com # # #