– Firm advancing clinically confirmed platform remedy, the Selective Cytopheretic System (SCD), to deal with the life-threatening penalties of hyperinflammation
– SCD lead program in Acute Kidney Harm (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 gasoline pipeline with potential in high-value hyperinflammatory indications
– SeaStar Medical commenced buying and selling on Nasdaq underneath the ticker “ICU” at this time, Monday, October 31st
Denver, Colorado, Oct. 31, 2022 (GLOBE NEWSWIRE) — SeaStar Medical Holding Company (Nasdaq: ICU) (“SeaStar Medical” or the “Firm”), a medical know-how firm growing proprietary options to cut back the results of hyperinflammation on very important organs, at this time 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 enterprise mixture transaction with LMF Acquisition Alternatives, Inc. (NASDAQ: LMAO) (LMAO), a particular function acquisition firm. The Firm additionally supplied a enterprise outlook and outlined key upcoming milestones.
“SeaStar Medical has continued to ship on its guarantees with operational excellence. I’m extremely happy with the progress made and pleased with the staff that has put in an incredible quantity of effort to get the Firm to the place we’re at this time,” commented Eric Schlorff, Chief Govt Officer of SeaStar Medical. “As a publicly listed firm, we acquire helpful entry to the capital markets which I imagine will assist construct momentum and propel the Firm to the following degree of development. Along with the progress we’ve made on the company entrance, we proceed to advance our modern SCD remedy platform. We now have numerous value-driving anticipated milestones, together with our potential near-term evolution to a business stage firm pushed by potential FDA approval in our lead program, pediatric AKI. We stay devoted to driving the SCD ahead with the objective of offering sufferers and physicians a brand new customary of care to deal with the life-threatening penalties of hyperinflammation. I’m excited for what’s to come back and look ahead to offering updates as we execute on the milestones forward.”
Selective Cytopheretic System (SCD)
The Firm’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 techniques, directing them the place to go. However generally, 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 permits the physique to return to a therapeutic state in order that affected person can proceed with wanted therapies for underlying situations.
Pediatric Acute Kidney Harm on COkayRT Program
Roughly 4,000 pediatric sufferers within the U.S. every year with AKI require CKRT and people affected person profiles are related to excessive morbidity and mortality. The mortality price in youngsters with AKI requiring CKRT is roughly 50 p.c. Youngsters who survive an AKI episode are vulnerable to long-term situations, together with continual kidney illness (CKD).
Primarily based on constructive findings from SeaStar Medical’s Pilot Research (NCT02820350) of pediatric sufferers with AKI which demonstrated that the SCD was secure to be used in pediatric sufferers, the Firm filed for Humanitarian System Exemption (HDE) with the U.S. Meals and Drug Administration (FDA) to be used of the SCD for critically ailing youngsters over 20 kg with AKI.
Upcoming Anticipated Worth-Driving Milestones
Grownup Acute Kidney Harm on COkayRT Program
Mortality charges are excessive amongst sufferers with AKI requiring CKRT. Within the Firm’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. Primarily 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 customary of care. Primarily based on the findings from the pilot examine which prompt favorable benefit-to-risk ratio within the affected person inhabitants the Firm plans to judge the SCD for the remedy of grownup sufferers with AKI on CKRT in a pivotal trial, focused to begin in Q1 2023.
Upcoming Anticipated Worth-Driving Milestones
Q1 2023: Start 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: Business launch of SCD for grownup AKI
Pipeline Enlargement Alternatives
The Firm is evaluating further indications the place the SCD could also be efficient by means of an ongoing exploratory scientific analysis settlement with the College of Michigan. Different indications embody however usually are not restricted to: Acute Respiratory Misery Syndrome, Cardio Renal Syndrome, and Hepato-Renal Syndrome.
The SCD obtained FDA Breakthrough System designation in Could 2022. For extra details about the SCD, go to the Firm’s web site, seastarmedical.com.
About SeaStar Medical Holding Company
Denver-based SeaStar Medical (Nasdaq: ICU) is a medical know-how firm that’s specializing in redefining how extracorporeal therapies could scale back the results of extreme irritation on very important organs. SeaStar Medical’s novel applied sciences depend on science and innovation to offer life-saving options to critically ailing sufferers. It’s growing and commercializing extracorporeal therapies that focus on the effector cells that drive systemic irritation, inflicting direct tissue injury and secreting a spread 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.
This press launch accommodates sure forward-looking statements throughout the which means of the “secure harbor” provisions of the Personal Securities Litigation Reform Act of 1955. These forward-looking statements embody, with out limitation, SeaStar Medical’s expectations with respect to the timing of regulatory approval of its merchandise and different company milestones, the flexibility of SCD to deal with sufferers with AKI, and the potential advantages of SCD to deal with different illnesses. Phrases equivalent to “imagine,” “undertaking,” “count on,” “anticipate,” “estimate,” “intend,” “technique,” “future,” “alternative,” “plan,” “could,” “ought to,” “will,” “would,” “can be,” “will proceed,” “will possible outcome,” and comparable expressions are meant to determine such forward-looking statements. Ahead-looking statements are predictions, projections and different statements about future occasions which might be based mostly on present expectations and assumptions and, because of this, are topic to vital dangers and uncertainties that would 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. Components which will trigger precise future occasions to vary materially from the anticipated outcomes, embody, however usually are not restricted to: (i) the shortcoming to acknowledge the anticipated advantages of the enterprise mixture with LMAO, which can be affected by, amongst different issues, competitors and the flexibility of the post-combination firm to develop and handle development profitability and retain its key workers, (ii) prices associated to the enterprise mixture, (iii) the end result of any authorized proceedings which may be instituted in opposition to SeaStar Medical following the enterprise mixture, (x) the flexibility to keep up the itemizing of its securities on NASDAQ, (iv) the flexibility to implement enterprise plans, forecasts, and different expectations after the completion of the proposed enterprise mixture, and determine and understand further alternatives, (v) the danger of downturns and the potential for speedy change within the extremely aggressive trade 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 realize 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 lift further capital to execute its marketing strategy, which many not be accessible on acceptable phrases or in any respect; (ix) the danger that third-parties suppliers and producers usually are 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 shield its mental property, and (xiii) different dangers and uncertainties indicated on occasion in SeaStar Medical’s registration assertion on Kind S-4, as amended (File No. 333-264993), together with these underneath the “Threat Components” part therein and in SeaStar’s different filings with the SEC. The foregoing checklist of things is just not exhaustive. Ahead-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 because of new data, future occasions, or in any other case.
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