ICU was LMAO SeaStar Medical commenced trading on Nasdaq

ICU was LMAO
SeaStar Medical 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.
Upcoming Expected 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.