– Company advancing clinically confirmed platform remedy, the Selective Cytopheretic Device (SCD), to handle the life-threatening penalties of hyperinflammation
– SCD lead program in Acute Kidney Injury (AKI) with potential FDA approval for pediatric AKI focused for Q1 2023 and graduation of pivotal trial in adult AKI focused in Q1 2023
– Ongoing exploratory scientific analysis to refine affected person populations the place SCD could also be efficient to gas pipeline with potential in high-value hyperinflammatory indications
– SeaStar Medical commenced buying and selling on Nasdaq underneath the ticker “ICU” at the moment, Monday, October 31st
Denver, Colorado, Oct. 31, 2022 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical expertise firm growing proprietary options to scale back the results of hyperinflammation on very important organs, at the moment introduced the graduation of buying and selling on the Nasdaq Capital Market underneath the ticker image “ICU” having efficiently accomplished its beforehand introduced definitive settlement for a business mixture transaction with LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a particular function acquisition firm. The Company additionally supplied 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 modern platform remedy, the SCD, is a patented cell-directed extracorporeal remedy that selectively targets probably the most activated pro-inflammatory neutrophils and monocytes to cease the cytokine storm that causes organ failure and potential loss of life in critically ailing sufferers. The remedy works with steady kidney substitute remedy (CKRT) to focus on and neutralize pro-inflammatory neutrophils and monocytes permitting the physique to return to homeostasis.
Cytokines are small signaling molecules produced by immune cells that act like a beacon for the immune programs, directing them the place to go. But typically, cytokines go into overproduction and overwhelm the physique, creating the cytokine storm. Too many pathogens enter the physique without delay and the physique reacts with cytokines that may assault the physique with excessive charges of mortality. The SCD remedy mimics nature, creating an atmosphere that enables the physique to return to a therapeutic state in order that affected person can proceed with wanted therapies for underlying circumstances.
Pediatric Acute Kidney Injury on COkayRT Program
Roughly 4,000 pediatric sufferers within the U.S. annually with AKI require CKRT and people affected person profiles are related to excessive morbidity and mortality. The mortality charge in kids with AKI requiring CKRT is roughly 50 %. Children who survive an AKI episode are prone to long-term circumstances, together with persistent kidney illness (CKD).
Based on constructive findings from SeaStar Medical’s Pilot Study (NCT02820350) of pediatric sufferers with AKI which demonstrated that the SCD was secure to be used in pediatric sufferers, the Company filed for Humanitarian Device Exemption (HDE) with the U.S. Food and Drug Administration (FDA) to be used of the SCD for critically ailing kids over 20 kg with AKI.
Upcoming Expected Value-Driving Milestones
- Q1 2023: FDA approval underneath HDE
- Q2 2023: Commercial launch of SCD for pediatric AKI
Adult Acute Kidney Injury on COkayRT Program
Mortality charges are excessive amongst sufferers with AKI requiring CKRT. In the Company’s beforehand accomplished pilot SCD 005 scientific examine evaluating the protection and feasibility of the SCD in COVID-19 sufferers with acute kidney damage (AKI) and/or acute respiratory misery syndrome (ARDS), sufferers skilled reductions in activated neutrophils and monocytes, which led to discount in proinflammatory cytokines and improved scientific outcomes. Based on a minimal of 4 days of remedy per protocol, the mortality of handled sufferers was considerably decrease than the contemporaneous management inhabitants that was handled underneath the present commonplace of care. Based on the findings from the pilot examine which recommended favorable benefit-to-risk ratio within the affected person inhabitants the Company plans to judge the SCD for the remedy of grownup sufferers with AKI on CKRT in a pivotal trial, focused to start in Q1 2023.
Upcoming Expected Value-Driving Milestones
- Q1 2023: Commence pivotal examine
- This autumn 2023: Pivotal examine interim outcomes
- Q3 2024: Pivotal examine topline outcomes
- Q3 2024: PMA submission
- H1 2025: PMA approval
- H2 2025: Commercial launch of SCD for grownup AKI
Pipeline Expansion Opportunities
The Company is evaluating extra indications the place the SCD could also be efficient by an ongoing exploratory scientific analysis settlement with the University of Michigan. Other indications embrace however should not restricted to: Acute Respiratory Distress Syndrome, Cardio Renal Syndrome, and Hepato-Renal Syndrome.
The SCD acquired FDA Breakthrough Device designation in May 2022. For extra details about the SCD, go to the Company’s web site, seastarmedical.com.
About SeaStar Medical Holding Corporation
Denver-based SeaStar Medical (Nasdaq: ICU) is a medical expertise firm that’s focusing on redefining how extracorporeal therapies could cut back the results of extreme irritation on very important organs. SeaStar Medical’s novel applied sciences rely on science and innovation to offer life-saving options to critically ailing sufferers. It is growing and commercializing extracorporeal therapies that concentrate on the effector cells that drive systemic irritation, inflicting direct tissue harm and secreting a variety of pro-inflammatory cytokines that provoke and propagate imbalanced immune responses. For extra data go to www.seastarmedical.com or go to us on LinkedIn or Twitter.
Forward-Looking Statements
This press launch comprises sure forward-looking statements inside the that means of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements embrace, with out limitation, SeaStar Medical’s expectations with respect to the timing of regulatory approval of its merchandise and different company milestones, the power of SCD to deal with sufferers with AKI, and the potential advantages of SCD to deal with different ailments. Words comparable to “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and comparable expressions are supposed to determine such forward-looking statements. Forward-looking statements are predictions, projections and different statements about future occasions which are primarily based on present expectations and assumptions and, consequently, are topic to vital dangers and uncertainties that might trigger the precise outcomes to vary materially from the anticipated outcomes. Most of those components are outdoors SeaStar Medical’s management and are tough to foretell. Factors that will trigger precise future occasions to vary materially from the anticipated outcomes, embrace, however should not restricted to: (i) the shortcoming to acknowledge the anticipated advantages of the business mixture with LMAO, which can be affected by, amongst different issues, competitors and the power of the post-combination firm to develop and handle progress profitability and retain its key staff, (ii) prices associated to the business mixture, (iii) the end result of any authorized proceedings which may be instituted in opposition to SeaStar Medical following the business mixture, (x) the power to take care of the itemizing of its securities on NASDAQ, (iv) the power to implement business plans, forecasts, and different expectations after the completion of the proposed business mixture, and determine and notice extra alternatives, (v) the danger of downturns and the potential for fast change within the extremely aggressive business wherein SeaStar Medical operates, (vi) the danger that SeaStar Medical and its present and future collaborators are unable to efficiently develop and commercialize its services or products, or expertise vital delays in doing so, together with failure to attain approval of its merchandise by relevant federal and state regulators, (vii) the danger that SeaStar Medical could by no means obtain or maintain profitability; (viii) the danger that SeaStar Medical might have to boost extra capital to execute its business plan, which many not be accessible on acceptable phrases or in any respect; (ix) the danger that third-parties suppliers and producers should not capable of absolutely and well timed meet their obligations, (x) the danger of product legal responsibility or regulatory lawsuits or proceedings referring to SeaStar Medical’s services, (xi) the danger that SeaStar Medical is unable to safe or defend its mental property, and (xiii) different dangers and uncertainties indicated occasionally in SeaStar Medical’s registration assertion on Form S-4, as amended (File No. 333-264993), together with these underneath the “Risk Factors” part therein and in SeaStar’s different filings with the SEC. The foregoing checklist of things will not be exhaustive. Forward-looking statements converse solely as of the date they’re made. Readers are cautioned to not put undue reliance on forward-looking statements, and SeaStar Medical assume no obligation and don’t intend to replace or revise these forward-looking statements, whether or not on account of new data, future occasions, or in any other case.
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