– Company to advance clinically proven therapeutic platform, the Selective Cytopheresis Device (SCD)), to deal with the life-threatening consequences of hyperinflammation
– SCD main program in Acute Kidney Injury (ARI) with potential FDA approval for ppediatric AKI targeted for Q1 2023 and beginning of pivotal trial in aadult AKI targeted in the first quarter of 2023
– OIn progress exploratory clinical research to refine patient populations where sickle cell disease may be effective to feed the pipeline with potential inot high value hyperinflammatory indications
– Starfish Medical started trade on the Nasdaq under the symbol “ICU” today, monday october 31st
Denver, Colo., Oct. 31, 2022 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq:ICU) (“SeaStar Medical” or the “Company”), a medical technology company developing proprietary solutions to reduce the impact of hyperinflammation on vital organs, today announced the start trading on the Nasdaq Capital Market under the symbol “ICU” having successfully completed its previously announced definitive agreement for a business combination transaction with LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special purpose acquisition company. The Company also provided business outlook and outlined key next steps.
“SeaStar Medical has continued to deliver on its promise with operational excellence. I am incredibly pleased with the progress made and proud of the team who have worked so hard to bring the company to where we are today,” commented Eric Schlorff, President and CEO of SeaStar Medical. “As a publicly traded company, we have valuable access to capital markets, which I believe will help build momentum and propel the company to the next level of growth. In addition to the progress we’ve made on the business front, we continue to advance our innovative SCD therapy platform. We have a number of value-creating milestones planned, including our potential near-term evolution to a commercial-stage company, driven by potential FDA approval in our lead program, the Pediatric IRA. We remain committed to advancing the SCD with the goal of providing patients and physicians with a new standard of care for dealing with the life-threatening consequences of hyperinflammation. I’m excited for what’s to come and look forward to providing updates as we move through the next steps.
Selective Cytopheresis Device (SCD))
The Company’s innovative therapeutic platform, SCD, is a patented extracorporeal cell-directed therapy that selectively targets the most activated neutrophils and pro-inflammatory monocytes to stop the cytokine storm that causes organ failure and possible death in critically ill patients. The therapy works with Continuous Kidney Replacement Therapy (CKRT) to target and neutralize neutrophils and pro-inflammatory monocytes allowing the body to return to homeostasis.
Cytokines are small signaling molecules produced by immune cells that act as a beacon for the immune system, directing them where to go. But sometimes cytokines go into overproduction and overwhelm the body, creating the cytokine storm. Too many pathogens enter the body at once and the body reacts with cytokines which can attack the body with high death rates. SCD therapy mimics nature, creating an environment that allows the body to return to a healing state so that the patient can proceed with necessary treatments for underlying conditions.
Pediatric acute renal failure on CKRT Program
In the United States, approximately 4,000 pediatric patients with AKI require CKRT annually and these patient profiles are associated with high morbidity and mortality. The mortality rate in children with ARI requiring CKRT is approximately 50%. Children who survive an episode of ARI are at risk for long-term illnesses, including chronic kidney disease (CKD).
Based on the positive results of SeaStar Medical’s pilot study (NCT02820350) in pediatric patients with ARF, which demonstrated that the SCD was safe for use in pediatric patients, the company filed an application for Humanitarian Device Exemption (HDE) with the United States Food and Drug Administration (FDA). for the use of the SCD for critically ill children over 20 kg with ARI.
Coming Expected Value generator Milestones
Acute renal failure in adults on CKRT Program
Mortality rates are high in patients with AKI requiring CKRT. In the company’s previously completed pilot clinical study SCD 005 evaluating the safety and feasibility of SCD in COVID-19 patients with acute kidney injury (ARI) and/or acute respiratory distress syndrome (ARDS), the patients showed reductions in neutrophils and activated monocytes, which led to reductions in pro-inflammatory cytokines and improved clinical outcomes. Based on a minimum of four days of treatment per protocol, the mortality of treated patients was significantly lower than that of the contemporaneous control population treated according to the current standard of care. Based on the results of the pilot study which suggested a favorable benefit/risk ratio in the patient population, the Company plans to evaluate SCD for the treatment of adult patients with AKI on CKRT in a pivotal trial, which is expected to start in the first quarter of 2023.
Coming Expected Value generator Milestones
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Q1 2023: start of the pivotal study
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Q4 2023: interim results of the pivotal study
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Q3 2024: main results of the pivotal study
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Q3 2024: PMA submission
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H1 2025: PMA approval
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H2 2025: Commercial launch of the SCD for the adult IRA
Pipeline Expansion Opportunities
The Company is evaluating additional indications where SCD may be effective under an ongoing exploratory clinical research agreement with the University of Michigan. Other indications include, but are not limited to: acute respiratory distress syndrome, cardio-renal syndrome, and hepatorenal syndrome.
The SCD received FDA Breakthrough Device designation in May 2022. For more information about the SCD, visit the company’s website, seastarmedical.com.
About Starfish Medical Holding company
Denver-based SeaStar Medical (Nasdaq: ICU) 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 leverage science and innovation to provide life-saving solutions to critically ill patients. It develops and commercializes extracorporeal therapies that target effector cells responsible for 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 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, but are not limited to, SeaStar Medical’s expectations regarding the timing of regulatory approval. of its products and other company milestones, SCD’s ability to treat patients with AKI and the potential benefits of SCD to treat other diseases. Words such as “believe”, “project”, “expect”, “anticipate”, “estimate”, “intend”, “strategy”, “future”, “opportunity”, “plan” , “may”, “should”, “will”, “would”, “will”, “will”, “will probably 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, therefore, are subject to significant risks and uncertainties that could cause actual results to differ differ significantly from the expected results. Most of these factors are beyond SeaStar Medical’s control and are difficult to predict. Factors that could cause actual future events to differ materially from expected results include, but are not limited to: (i) failure to recognize the anticipated benefits of the business combination with LMAO, which may be adversely affected, among other things, by competition and the ability of the post-combination company to grow and manage the profitability of growth and to retain its key employees, (ii) the costs associated with the business combination, (iii) the outcome of any proceedings legal action that may be brought against SeaStar Medical as a result of the business combination, (x) the ability to maintain the listing of its securities on NASDAQ, (iv) the ability to implement business plans, forecasts and other expectations after the completion of the proposed business combination, and to identify and realize additional opportunities, (v) the risk of recession and the possibility of rapid change in the high-tech industry. competitive environment in which SeaStar Medical operates, (vi) the risk that SeaStar Medical and its current and future associates may not be able to successfully develop and market its products or services, or suffer significant delays in doing so, including the inability to obtain approval of its products by applicable federal and state regulatory authorities; (vii) the risk that SeaStar Medical may never achieve or maintain profitability; (viii) the risk that SeaStar Medical will need to raise additional capital to execute its business plan, which will often not be available on acceptable terms or at all; (ix) the risk that third-party suppliers and manufacturers may not be able to fully and timely fulfill their obligations, (x) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar’s products and services Medical, (xi) the risk that SeaStar Medical may not be able to secure or protect its intellectual property, and (xiii) other risks and uncertainties set forth from time to time in SeaStar Medical’s registration statement on Form S-4, as amended (File No. 333-264993), including those under the “Risk Factors” section therein and in SeaStar’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 place undue reliance on forward-looking statements, and SeaStar Medical undertakes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information , future events or otherwise.
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