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

Rhea-AI Summary

SeaStar Medical receives FDA Breakthrough Device Designation for its Selective Cytopheretic Device

Positive

• SeaStar Medical has received FDA Breakthrough Device Designation for its Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute kidney injury (AKI) and acute on chronic liver failure.
• The designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.
• Positive clinical outcomes were seen in two patients with hepatorenal syndrome who were treated with the SCD, suggesting its potential to treat acute on chronic liver failure as a bridge to evaluation or successful intervention for liver transplantation.
• The SCD has also shown the potential to improve solid organ function in a variety of preclinical and clinical studies, including sepsis, AKI, cardiorenal syndrome, and COVID-19.

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• None.

DENVER, Oct. 18, 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 Device Designation 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 kidney injury (AKI) and acute on chronic liver failure. This is the third Breakthrough Device Designation granted by the FDA to SeaStar Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

“Hepatorenal syndrome is characterized by an abrupt deterioration of kidney function, driven by a hyperinflammatory process in people with advanced liver cirrhosis, and is associated with an unacceptably high mortality,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Based on our observations to date, the SCD may play a critical role in allowing the kidneys to recover such that these patients might become candidates for a life-saving liver transplant.”

Without treatment, the prognosis for patients with hepatorenal syndrome is poor with most dying within weeks of the onset of renal failure. In fact, the mortality rate for patients with severe acute on chronic liver failure with four or more organ failures at 28 days is 100%. Approximately 700,000 cases of heptorenal syndrome are reported in the U.S. annually. In 2019 the economic burden for hepatorenal syndrome hospitalization was estimated at $4.2 billion.

An investigator-initiated pilot study conducted at the University of Michigan assessed treatment with the SCD in two patients with type 1 hepatorenal syndrome. Positive clinical outcomes were seen in both cases - one patient with hepatorenal syndrome due to acute alcoholic hepatitis was alive at day 90 after seven days of SCD treatment and undergoing liver transplantation evaluation, and the other patient with hepatorenal syndrome due to non-alcoholic steatohepatitis or NASH had a successful liver transplantation 6 days after SCD therapy ended. This suggested a role of SCD immunomodulation to treat acute on chronic liver failure, regardless of the etiology, as a bridge to evaluation or successful intervention for liver transplantation. Both of these cases were recently published in the American Society for Artificial Internal Organs Journal in August of this year (Yessayan et al., 2023., doi: 10.1097/MAT.0000000000002033).

“We are grateful for FDA’s decision to award Breakthrough Device Designation to the SCD in hepatorenal syndrome, which follows similar awards for adult AKI in 2022 and for cardiorenal syndrome last month,” said Eric Schlorff, SeaStar Medical CEO. “The SCD now has three Breakthrough Device Designations in total granted by the FDA’s Center for Biologics Evaluation and Research (CBER). We view this award as further validation of the potential life-saving approach of targeting dysregulated immune responses. In addition to hepatorenal syndrome, the SCD has shown the potential to improve solid organ function in a variety of preclinical and clinical studies, including sepsis, AKI, cardiorenal syndrome and COVID-19, among other conditions. We expect the ongoing pilot study at the University of Michigan to provide valuable insight into the design and execution of the pivotal study in this indication.”

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.

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 https://seastarmedical.com/or visit us on LinkedIn or Twitter.

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, SeaStar Medical’s expectations with respect to the ability of SCD to treat patients with AKI and chronic liver failure 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

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FAQ

What is the Breakthrough Device Designation granted to SeaStar Medical?

The Breakthrough Device Designation granted to SeaStar Medical is for its Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute kidney injury (AKI) and acute on chronic liver failure.

What are the potential benefits of the Breakthrough Device Designation?

The designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.

What were the positive clinical outcomes observed with the SCD?

Positive clinical outcomes were seen in two patients with hepatorenal syndrome who were treated with the SCD. One patient was alive at day 90 after seven days of SCD treatment and undergoing liver transplantation evaluation, while the other patient had a successful liver transplantation 6 days after SCD therapy ended.

What other conditions has the SCD shown potential to improve?

The SCD has shown potential to improve solid organ function in a variety of preclinical and clinical studies, including sepsis, AKI, cardiorenal syndrome, and COVID-19.