Seastar Medical Holding Corporation · NASDAQ:ICU
Seastar Medical — Investor Presentation (February 2023)
28 slides from Seastar Medical's investor presentation, Feb 15, 2023
Slide 1: Innovative Solutions for the Consequences of Hyperinflammation
Innovative Solutions for the Consequences of Hyperinflammation February 2023 Investor Presentation Exhibit 99.1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation 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 respe
Slide 3: About SeaStar Medical
About SeaStar Medical We are advancing an innovative platform therapy to address the life-threatening consequences of hyperinflammation The overproduction of inflammatory cells (i.e., cytokine storm) can damage vital organs, resulting in multi-organ failure and death Our SCD cell-directed extracorpo
Slide 4: Investment Highlights
Investment Highlights SCD addresses hyperinflammation in multiple acute and chronic large, high-value indications SCD’s unique mechanism of action provides cell-directed extracorporeal therapy at the patient point of care under an FDA medical device regulatory pathway Initial indications in pediatri
Slide 5: Hyperinflammation: Serious Condition Can Lead to Permanent Organ Damage and Death
Hyperinflammation: Serious Condition Can Lead to Permanent Organ Damage and Death Key Drivers Pulmonary infiltrates Lung injury Acute respiratory distress syndrome (ARDS) Cardiovascular shock Disseminated intravascular coagulant Renal failure End-Organ Damage and Failure Permanent Organ Damage or De
Slide 6: Current Treatment Options Have Limited Efficacy
Therapeutic approaches intended to block soluble mediator targets – such as cytokines or free radicals – have not been proven to be efficacious IV Fluids Drugs to Reduce Fever Ventilation Dialysis Blood Transfusion Current Treatment Options Have Limited Efficacy There is an urgent clinical need to a
Slide 7: SCD Modulates the Immunological Effector Cells that Promote Cytokine Release
SCD Modulates the Immunological Effector Cells that Promote the Release of Cytokines and Other Harmful Mediators SeaStar Medical Confidential Innate immune response Activated monocytes Activated neutrophils IMPROVED CLINICAL OUTCOMES Cytokines Hyperinflammation/ Cytokine storm Effector cell immunomo
Slide 8: SCD Microenvironment Mimics Nature to Restore Immune Homeostasis
SCD Microenvironment Mimics Nature to Restore Immune Homeostasis Source: Caster et al Re-Examining Neutrophil Participation in GN JASN August 2017 Vol 28 (8): 2275 - 2289 SCD Activated Neutrophil Neutrophil Neutrophils are captured, roll, stop and enter endothelial cells Activated neutrophils releas
Slide 9: Simple Integration into the ICU at the Point of Patient Care
Simple Integration into the ICU at the Point of Patient Care + + = Leverages Current Hemodialysis Equipment Flow Pattern Citrate Lowers Ionized Calcium in Circuit Filter Immune System homeostasis Pathway for normal hemofilter Standard of Care Kidney Replacement Therapy
Slide 10: Significantly Reduced Mortality and Elimination of Dialysis Dependency Across AKI Studies
Significantly Reduced Mortality and Elimination of Dialysis Dependency Demonstrated Across Multiple AKI Clinical Studies Mortality Rate (60 Days) Control Dialysis Dependency (60 Days) Control Non-COVID AKI Studies Patients Treated Mortality Reduction SCD Control SCD Control OUS Study 9 22% 78%1 0% 2
Slide 11: Significantly Reduced Mortality of SCD-Treated COVID-19 Patients
Significantly Reduced Mortality of SCD-Treated COVID-19 Patients Control patients 50% 31% 81% SCD-treated patients p=0.10* ITT=intent to treat; PP=per protocol; SOC=standard of care. ITT population are all patients on SCD treatment enrolled in study, regardless of withdrawal; PP population are the p
Slide 12: What Types of Patients Have Been Treated with the SCD?
What Types of Patients Have Been Treated with the SCD? On average 3 Organ Failure Among patients 50%-60% Sepsis Comorbidities Include (but are not limited to): All in ICU BMI’s over 40 (morbidly obese) COVID-19 positive Insults Include (but are not limited to): Surgery Trauma Bacterial infection Vir
Slide 13: SCD For the Treatment of Pediatric AKI
SCD For the Treatment of Pediatric AKI Potential FDA approval targeted H1 2023 Submitted HDE application to the FDA in June 2022 Received $1.6 million grant from the FDA orphan products division to fund clinical study There are ~4,000 cases of pediatric AKI in the U.S. annually $
Slide 14: Pediatric AKI Is an Unmet Need
Pediatric AKI Is an Unmet Need The overall incidence of AKI is 27% in the pediatric ICU setting1 Patients with AKI stay in the ICU twice as long, 8 days vs 4 days2 Half of children with AKI and multi-organ dysfunction requiring continuous kidney replacement therapy die3-5 The incidence of chronic ki
Slide 15: Positive Results in Pivotal Pediatric AKI Study
Positive Results in Pivotal Pediatric AKI Study SCD-PED-01 Pilot Study (NCT02820350) 16 Subjects 4-21 years Primary Endpoint Treatment-related adverse events occurring during treatment and Day 60 post-treatment initiation Design Open-label, multicenter pilot study assessed the safety and feasibility
Slide 16: Pediatric AKI to Establish Commercial Presence
Pediatric AKI to Establish Commercial Presence 1. https://www.childrenshospitals.org; 2. America Hospital Directory Database Export January 2020; 3. https://www.beckershospitalreview.com/lists-and-statistics/30-largest-childrens-hospitals-in-the-united-states.html Market Overview Ability to penetrat
Slide 17: SCD For the Treatment of Adult AKI
SCD For the Treatment of Adult AKI Pivotal study to commence in Q1 2023 with PMA submission targeted for 2024 Provides potential for massive market expansion beyond initial pediatric AKI opportunity Targeting ~6 million U.S. cases of adult AKI annually1 FDA Breakthrough Device designation 1. Centers
Slide 18: SCD-006 Study Design
SCD-006 Study Design Study Objective Assess the safety & efficacy of the selective cytopheretic device (SCD) in patients with acute kidney injury (AKI) requiring kidney replacement therapy Patient Population Adults aged 18-80 admitted to ICU with AKI > stage 2 requiring CKRT (CKRT > 12 h < 48 h) One
Slide 19: Platform Therapy Addressing Multiple High-Value Indications
Platform Therapy Addressing Multiple High-Value Indications LVAD: Left Ventricular Assist Device American College of Physicians, ACP Hospitalist, Coding information from July 2019 Jamil, K et al The burden of illness of hepatorenal syndrome (HRS) in the United States: a retrospective analysis of ele
Slide 20: Corporate Overview
Corporate Overview 2 SEASTAR MEDICAL
Slide 21: Comprehensive IP Protection
Comprehensive IP Protection U.S. Patent Portfolio 17 granted, 4 pending Of the granted patents, the last will expire in 2032* Ex-U.S. Patent Portfolio 20 granted, 16 pending Of the granted patents, the last will expire in 2032* ✓ Modulating Information ✓ Composition-of-Matter ✓ Methods-of-Use
Slide 22: Experienced Management Team
Experienced Management Team Eric Schlorff CEO Caryl Baron Interim Chief Financial Officer Tom Mullen VP, Manufacturing and Product Development Kevin Chung, MD Chief Medical Officer Sai Iyer, PhD VP, Medical Affairs and Clinical Development Scientific Advisor: H. David Humes, MD Professor, Division o
Slide 23: Board of Directors
Board of Directors Rick Barnett – Chairman Past President & CEO of Satellite Healthcare Board Chair National Kidney Foundation, Northern California Andres Lobo Dow Chemical Company Manages ~$16 billion NAV Allan Collins, MD Former Chief Medical Officer of NxStage, Fresenius Medical Care Past Preside
Slide 24: Financial Update
Financial Update Merged into SPAC (NASDAQ: LMAO) on October 28, 2022 Completed simultaneous: PIPE of $7 MM Secured forward agreements for approximately 1.15 MM shares $100 MM Equity Line of Credit Warrants at $11.50 (NASDAQ: ICUCW) As of February 14, 2023 Proceeds of $1.9 MM were received from 378,0
Slide 25: Key Upcoming Potential Value-Driving Milestones
Key Upcoming Potential Value-Driving Milestones H1 2023 FDA Approval H1 2023 Commercial Launch Pediatric Acute Kidney Injury 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 Launc
Slide 26: In Summary
In Summary SCD addresses hyperinflammation in multiple acute and chronic large, high-value indications SCD’s unique mechanism of action provides cell-directed extracorporeal therapy at the patient point of care under an FDA medical device regulatory pathway Initial indications in pediatric and adult
Slide 27: Appendix
Appendix 2 SEASTAR MEDICAL
Slide 28: Significantly Reduced Pro-inflammatory Cytokines by Addressing Activated Neutrophils & Monocytes
Presented at the American Society of Nephrology Kidney Week 2021, November 4-7, 2021 (virtual) ePoster #PO2523 Significantly Reduced Pro-inflammatory Cytokines by Directly Addressing Activated Neutrophils & Monocytes Cytometric analysis of cell surface markers reflective of neutrophil activation (CD
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