–Company advancing clinically proven platform therapy,the Selective Cytopheretic Device (SCD),to address the life-threatening consequences of hyperinflammation
–SCD lead program in Acute Kidney Injury (AKI) with potential FDA approval forpediatric AKItargeted for Q1 2023 and commencement of pivotal trial in adult AKI targeted in Q1 2023
– Ongoing exploratory clinical research to refine patient populations where SCD may be effective to fuel pipeline with potential in high-value hyperinflammatory indications
– SeaStarMedical commenced trading on Nasdaq under the ticker “ICU”today, Monday, October 31st
Denver, Colorado, 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 consequences of hyperinflammation on vital organs, today announced the commencement of trading on the Nasdaq Capital Market under the ticker 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 a business outlook and outlined key upcoming milestones.
“SeaStar Medical has continued to deliver on its promises with operational excellence. I am incredibly pleased with the progress made and proud of the team that has put in a tremendous amount of effort to get the Company to where we are today,” commented Eric Schlorff, Chief Executive Officer of SeaStar Medical. “As a publicly listed company, we gain valuable access to the 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 corporate front, we continue to advance our innovative SCD therapy platform. We have a number of value-driving anticipated milestones, including our potential near-term evolution to a commercial stage company driven by potential FDA approval in our lead program, pediatric AKI. We remain dedicated to driving the SCD forward with the goal of providing patients and physicians a new standard of care to address the life-threatening consequences of hyperinflammation. I am excited for what is to come and look forward to providing updates as we execute on the milestones ahead.”
Selective Cytopheretic Device (SCD)
The Company’s innovative platform therapy, the SCD, is a patented cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and 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 pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis.
Cytokines are small signaling molecules produced by immune cells that act like a beacon for the immune systems, 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 that can attack the body with high rates of mortality. The SCD therapy mimics nature, creating an environment that allows the body to return to a healing state so that patient can proceed with needed treatments for underlying conditions.
Pediatric Acute Kidney Injury on CKRT Program
Roughly 4,000 pediatric patients in the U.S. each year with AKI require CKRT and those patient profiles are associated with high morbidity and mortality. The mortality rate in children with AKI requiring CKRT is approximately 50 percent. Children who survive an AKI episode are at risk of long-term conditions, including chronic kidney disease (CKD).
Based on positive findings from SeaStar Medical’s Pilot Study (NCT02820350) of pediatric patients with AKI which demonstrated that the SCD was safe for use in pediatric patients, the Company filed for Humanitarian Device Exemption (HDE) with the U.S. Food and Drug Administration (FDA) for use of the SCD for critically ill children over 20 kg with AKI.
Upcoming Expected Value-Driving Milestones
- Q1 2023: FDA approval under HDE
- Q2 2023: Commercial launch of SCD for pediatric AKI
Adult Acute Kidney Injury on CKRT Program
Mortality rates are high among patients with AKI requiring CKRT. In the Company’s previously completed pilot SCD 005 clinical study evaluating the safety and feasibility of the SCD in COVID-19 patients with acute kidney injury (AKI) and/or acute respiratory distress syndrome (ARDS), patients experienced reductions in activated neutrophils and monocytes, which led to reduction in proinflammatory cytokines and improved clinical outcomes. Based on a minimum of four days of therapy per protocol, the mortality of treated patients was significantly lower than the contemporaneous control population that was treated under the current standard of care. Based on the findings from the pilot study which suggested favorable benefit-to-risk ratio in the patient population the Company plans to evaluate the SCD for the treatment of adult patients with AKI on CKRT in a pivotal trial, targeted to commence in Q1 2023.
UpcomingExpected Value-Driving Milestones
- Q1 2023: Commence pivotal study
- Q4 2023: Pivotal study interim results
- Q3 2024: Pivotal study topline results
- Q3 2024: PMA submission
- H1 2025: PMA approval
- H2 2025: Commercial launch of SCD for adult AKI
Pipeline Expansion Opportunities
The Company is evaluating additional indications where the SCD may be effective through 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 Hepato-Renal 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 SeaStar Medical Holding Corporation
Denver-based SeaStar Medical (Nasdaq: ICU) is a medical technology company that is focusing on 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. It is developing and commercializing 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 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 timing of regulatory approval of its products and other corporate milestones, the ability of SCD 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 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 inability to recognize the anticipated benefits of the business combination with LMAO, which may be affected by, among other things, competition and the ability of the post-combination company 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 that may be instituted against SeaStar Medical following 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 identify and realize additional opportunities, (v) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vi) 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, (vii) the risk that SeaStar Medical may never achieve or sustain profitability; (viii) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which many not be available on acceptable terms or at all; (ix) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (x) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (xi) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (xiii) other risks and uncertainties indicated 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 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.
Media Contact:
PSC Consulting
Patty Caballero
patty@pscconsulting.net
(973) 348-5055
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
SeaStar@jtcir.com
