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SeaStar Medical (Nasdaq: ICU), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, has filed an Investigational Device Waiver Application (IDE) with the U.S. Food and Drug Administration (FDA) requesting approval to initiate a pivotal study to evaluate the efficacy of the company’s selective cytopheresis device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) requiring continuous renal replacement therapy (CKRT).
The randomized controlled trial is expected to enroll 200 subjects, with a primary endpoint of a composite of 90-day mortality and dialysis dependence of patients with SCD compared to the control group. Details of the study design will be provided following FDA approval of the IDE. The study is expected to begin in the first quarter of 2023 with interim results expected in the fourth quarter of 2023 and key findings and submission for pre-market approval (PMA) in the third quarter of 2024.
“We are delighted to take this important step in our journey towards creating the new standard of care for reducing harmful hyperinflammation. The FDA has demonstrated continued support in the SCD in granting breakthrough therapy status in adults and a substantial review of a Humanitarian Device Exemption (HDE) for pediatric patients with AKI,” said Eric Schlorff, chief executive officer of SeaStar Medical “We now aim to demonstrate efficacy and health economics attractiveness when the therapy is used to treat adults with AKI.”
SCD, the company’s innovative therapy platform, is a patented extracorporeal cell-directed therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to arrest the cytokine storm that causes organ failure and possible death in critically ill patients. Therapy is currently delivered through continuous CKRT to target and neutralize pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis. The SCD received Breakthrough device designation by the FDA in May 2022.
Approximately 6 million cases of AKI are diagnosed in adults each year in the United States. SCD has been shown to be successful in adult patients with critically ill AKI requiring CKRT, a condition with a high mortality rate. In the previously completed pilot of the Company Clinical study SCD 005 evaluating the safety and feasibility of SCD in COVID-19 patients with AKI and/or acute respiratory distress syndrome (ARDS), patients experienced reductions in activated neutrophils and monocytes, which led to reduction of proinflammatory cytokines and improvement of clinical outcomes. Based on the per-protocol minimum of four days of therapy, the mortality of treated patients was significantly lower (41%) than the contemporary control population who had been treated with the current standard of care (81%). All patients received CKRT as the delivery vehicle for therapy.
“The submission of this IDE represents the rigorous first step toward our goal of delivering this life-saving therapy into the hands of the adult nephrology and critical care community, and we look forward to receiving FDA feedback and initiating the study,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We have been in active discussions with several major US institutions that have expressed interest in participating in the study. We look forward to starting registrations as soon as possible.”
In July 2022, SeaStar Medical announced that it has submitted its application to the FDA for Humanitarian Device Exemption (HDE) for the use of selective cytopheresis device (SCD) for critically ill children with AKI. The HDE submission to the FDA was based on results from SeaStar Medical’s pilot study (NCT02820350) in pediatric patients with AKI demonstrating that the SCD was safe for use in pediatric patients. The Company expects the FDA to complete its material review of HDE in the first quarter of 2023, with a commercial launch in the second quarter of 2023.
About SeaStar Medical, Inc.
SeaStar Medical is a medical technology company focused on redefining how extracorporeal therapies can reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s new technologies are based on science and innovation to provide life-saving solutions to critically ill patients. The company is developing and commercializing extracorporeal therapies targeting effector cells that drive systemic inflammation, causing direct tissue damage, and secreting a range of pro-inflammatory cytokines that initiate and propagate deranged immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or Chirping.
Starfish Doctor Forward-Looking Statements
This press release contains certain forward-looking statements pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical’s expectations regarding the timing of regulatory approval of its products and of other company milestones, SCD’s ability to treat patients with AKI and the potential benefits of SCD to treat other diseases. Words like ‘believe’, ‘plan’, ‘expect’, ‘anticipate’, ‘estimate’, ‘intend’, ‘strategy’, ‘future’, ‘opportunity’, ‘plan’, ‘can’, ‘should’ ” “will”, “would”, “will”, “continue”, “probably will result” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are forecasts, projections and other statements about future events that are based on expectations and current assumptions and, accordingly, are subject to significant risks and uncertainties that could cause actual results to differ materially from anticipated results.Most of these factors are beyond the control of SeaStar Medical and are difficult to predict.I factors that could cause actual future events to differ materially from anticipated results include, but are not limited to: (i) an inability to recognize the anticipated benefits of the LMAO business combination, which may be affected, t inter alia, competition and the post-combination company’s ability to grow and manage growth profitability and retain its key employees, (ii) costs related to the business combination, (iii) the outcome of any legal proceedings which may be brought against SeaStar Medical as a result of the business combination, (iv) the ability to maintain the listing of its securities on the NASDAQ, (v) the ability to implement business plans, forecasts and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vii) the risk that SeaStar Medical and its current and future employees are unable to successfully develop and market its products or services, or experience significant delays in doing so, including failure to obtain approval from its products by applicable federal and state regulators, (viii) the risk that SeaStar Medical may never achieve or sustain viability; (ix) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that third party suppliers and manufacturers may not be able to fully and timely meet their obligations, (xi) the risk of product liability or lawsuits or regulatory proceedings relating to SeaStar Medical products and services, ( xii) the risk that SeaStar Medical cannot guarantee or protect its intellectual property and (xiii) other risks and uncertainties set forth in SeaStar Medical’s registration statement from time to time on Form S-4, as amended (file no. 333-264993), including those under the “Risk Factors” section herein and in SeaStar Medical’s other filings with the SEC. The above list of factors is not exhaustive. Forward-looking statements speak only as of the date they were made. Readers are cautioned not to place undue reliance on forward-looking statements, and SeaStar Medical undertakes no obligation and does not intend to update or revise any such forward-looking statements, whether as a result of new information, future events, or otherwise.
Media: PSC Consulting Patty Caballero (973) 348-5055[email protected]
Investors: LHA Investor Relations Jody Cain (310) 691-7100[email protected]
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Source: SeaStar Medical Holding Corporation