# EDGAR Filing Document

**Accession Number:** 0001831868
**File Stem:** 0001193125-23-040217
**Filing Date:** 2023-2
**Character Count:** 42868
**Document Hash:** 5da39b07b52705a68ee537813e8b2d60
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-040217.hdr.sgml**: 20230215

**ACCESSION NUMBER**: 0001193125-23-040217

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 46

**CONFORMED PERIOD OF REPORT**: 20230214

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230215

**DATE AS OF CHANGE**: 20230215

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** SeaStar Medical Holding Corp
- **CENTRAL INDEX KEY:** 0001831868
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 853681132
- **STATE OF INCORPORATION:** CO
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39927
- **FILM NUMBER:** 23635513

**BUSINESS ADDRESS:**
- **STREET 1:** 3513 BRIGHTON BLVD
- **STREET 2:** SUITE 410
- **CITY:** DENVER
- **STATE:** CO
- **ZIP:** 80216
- **BUSINESS PHONE:** 844-427-8100

**MAIL ADDRESS:**
- **STREET 1:** 3513 BRIGHTON BLVD
- **STREET 2:** SUITE 410
- **CITY:** DENVER
- **STATE:** CO
- **ZIP:** 80216

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** LMF Acquisition Opportunities Inc
- **DATE OF NAME CHANGE:** 20201109

?xml version="1.0" encoding="utf-8" ? Form 8-K

------

### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

------

### FORM 8-K

------

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of the Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): February 14, 2023

------

## SEASTAR MEDICAL HOLDING CORPORATION

#### (Exact name of registrant as specified in its charter)

------

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-39927** | **85-3681132** |
| **(State or other jurisdiction of**<br> **incorporation or organization)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

---

---

| | |
|:---|:---|
| **3513 Brighton Blvd., Suite 410**<br> **Denver, CO** | **80216** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

#### Registrant's telephone number, including area code: (813) 222-8996

------

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (*see* General Instruction A.2, below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange**<br> **on which registered** |
| Common Stock, $0.0001 par value | ICU | The Nasdaq Stock Market LLC |
| Warrants, each whole warrant exercisable for one share of Common Stock for $11.50 per share | ICUCW | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

------

---

| | |
|:---|:---|
| **Item 7.01.** | **Regulation FD Disclosure.**  |

---

On February 14, 2023, SeaStar Medical Holding Corporation (the "Company") announced that it will hold a conference call to discuss business updates including the recent FDA approval to conduct a pivotal trial evaluating the effectiveness of its Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) and an update regarding the Humanitarian Device Exemption (HDE) submission for market approval for use of the SCD for critically ill children with AKI on Wednesday, February 15, 2023 4:00 p.m. ET / 1:00 p.m. PT. A copy of the presentation slide deck that was presented is being furnished as Exhibit 99.1 to this report on Form 8-K. The recorded webcast of the presentation may be accessed by visiting the Investors Events & Presentations section of the Company's website at https://investors.seastarmedical.com/events-and-presentations/default.aspx.

The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K.

---

| | |
|:---|:---|
| **Item 8.01.** | **Other Events.**  |

---

On February 14, 2023, the Company issued a press release announcing a business update and the recent FDA approval to conduct a pivotal trial. A copy of this press release is being filed herewith as Exhibit 99.2 to this Current Report on Form 8-K.

Additionally, on February 15, 2023, the Company issued a press release announcing details of its pivotal NEUTRALIZE-AKI study evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). A copy of this press release is being filed herewith as Exhibit 99.3 to this Current Report on Form 8-K.

---

| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.**  |

---

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit**<br>**No.** | **Description** |
| 99.1 | [Presentation distributed by SeaStar Medical Holding Corporation dated February 15, 2023, furnished hereto.](d430794dex991.htm) |
| 99.2 | [Press Release issued by SeaStar Medical Holding Corporation dated February 14, 2023.](d430794dex992.htm) |
| 99.3 | [Press Release issued by SeaStar Medical Holding Corporation dated February 15, 2023.](d430794dex993.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

------

#### SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **SeaStar Medical Holding Corporation** | **SeaStar Medical Holding Corporation** |
| Date: February 15, 2023 | By: | /s/ Eric Schlorff |
|  |  | Eric Schlorff |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

![Slide 1](g430794ex99_1s1g1.jpg)

Innovative Solutions for the Consequences of Hyperinflammation February 2023 Investor Presentation Exhibit 99.1

------

![Slide 2](g430794ex99_1s2g1.jpg)

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 respect to the timing of regulatory approval of its products, the expected timing on enrollment, generation of study results, submission of PMA 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, (iv) the ability to maintain the listing of its securities on Nasdaq, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vii) 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, (viii) the risk that SeaStar Medical may never achieve or sustain profitability; (ix) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (xi) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical's products and services, (xii) 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 Medical'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.

------

![Slide 3](g430794ex99_1s3g1.jpg)

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 extracorporeal therapy can bring activated cells back to a reparative state and homeostasis SeaStar Medical came public in October 2022 through a de-SPAC process Selective Cytopheretic Device (SCD) quells the hyperinflammatory process and cytokine storm by targeting and neutralizing activated effector cells

------

![Slide 4](g430794ex99_1s4g1.jpg)

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 pediatric and adult acute kidney injury (AKI) are supported by clinical results demonstrating significantly reduced mortality and the elimination of dependency on hemodialysis Multiple near-term regulatory and clinical milestones provide a cadence of company news and the potential to create significant value for shareholders Targeting FDA approval of pediatric SCD for pediatric AKI in the first half of 2023 under the humanitarian device exemption (HDE) process Pivotal clinical trial with SCD for adult AKI to begin in the first quarter of 2023, with interim results expected in the fourth quarter of 2023 Seasoned leadership with highly relevant business experience and a proven track record of execution

------

![Slide 5](g430794ex99_1s5g1.jpg)

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 Death Bacterial Infection Viral Infection Trauma Surgery Condition that Develops when Immune System Responds too Aggressively to Injury or Infection Hyperinflammation / Cytokine Storm Can Lead To

------

![Slide 6](g430794ex99_1s6g1.jpg)

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 address hyperinflammation at its source

------

![Slide 7](g430794ex99_1s7g1.jpg)

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 immunomodulation and deactivation SCD\* Infection (Endotoxins/ pathogens) Injury Deactivated neutrophils Deactivated monocytes Other inflammatory mediators \*SCD is currently under investigation and has not been approved. There is no guarantee that the product will receive authority approval and become commercially available for the uses being investigated.

------

![Slide 8](g430794ex99_1s8g1.jpg)

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 release cytokines SCD deactivates neutrophils (apoptosis) Deactivated neutrophils may signal the immune system can focus on reparative functions

------

![Slide 9](g430794ex99_1s9g1.jpg)

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](g430794ex99_1s10g1.jpg)

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% 25% U.S. Adult Pilot 002 35 31% 50%3 0% 25% U.S. Adult ARF 003 19/272 16% 41% 0% 25% U.S. Peds SCD 001 16 25% 50%3 0% 15%-25% 56% Note: All subjects in these studies were patients with Acute Kidney Injury (AKI) 1. Case matched controls based on SOFA Scores and age 2. Treated per protocol (iCa in therapeutic range using citrate) 3. Historical control based on published studies ARF: Acute Renal Failure 19% 25% 25%

------

![Slide 11](g430794ex99_1s11g1.jpg)

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 patients on SCD treatment for ≥96 hours. \*P values calculated using c2 with Yate's correction. †Indicates significance. 60-day mortality of SCD-treated patients in ITT population and PP population was lower than in the control group Continues to build upon cell-directed extracorporeal therapy that is insult\* agnostic \*Examples of "insults" include bacterial, viral, surgical, trauma, etc.

------

![Slide 12](g430794ex99_1s12g1.jpg)

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 Viral infection

------

![Slide 13](g430794ex99_1s13g1.jpg)

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](g430794ex99_1s14g1.jpg)

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 kidney disease among pediatric patients with AKI ranges from 10%-60%6-8 27% ICU 2x Longer 50% Mortality 10%-60% Chronic Disease 1. Kaddourah A, et al. N Engl J Med. 2017;376:11-20. 2. De Zan F, Amigoni A, Pozzato R, Pettenazzo A, Murer L, Vidal E: Acute Kidney Injury in Critically Ill Children: A Retrospective Analysis of Risk Factors. Blood Purif 2020;49:1-7 s 3. Symons JM, Chua AN, Somers MJ, et al. Demographic characteristics of pediatric continuous renal replacement therapy: a report of the prospective pediatric continuous renal replacement therapy registry. Clin J Am Soc Nephrol 2007; 2: 732-738. 4. Modem V, Thompson M, Gollhofer D, et al. Timing of Continuous Renal Replacement Therapy and Mortality in Critically Ill Children. Crit Care Med 2013. 5. Goldstein SL, Somers MJ, Baum MA, et al. Pediatric patients with multi-organ dysfunction syndrome receiving continuous renal replacement therapy. Kidney Int 2005; 67: 653-658. 6. Menon S, Kirkendall ES, Nguyen H, et al. Acute kidney injury associated with high nephrotoxic medication exposure leads to chronic kidney disease after 6 months. J Pediatr 2014; 165: 522-527 e522. 7. Mammen C, Al Abbas A, Skippen P, et al. Long-term Risk of CKD in Children Surviving Episodes of Acute Kidney Injury in the Intensive Care Unit: A Prospective Cohort Study. Am J Kidney Dis 2012; 59: 523-530. 8. Madsen NL, Goldstein SL, Froslev T, et al. Cardiac surgery in patients with congenital heart disease is associated with acute kidney injury and the risk of chronic kidney disease. Kidney Int 2017; 92: 751-756.

------

![Slide 15](g430794ex99_1s15g1.jpg)

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 of SCD in pediatric patients with AKI and multi-organ dysfunction requiring continuous kidney replacement therapy Age range Results No SCD-related adverse events 94% of patients survived SCD therapy 75% of patients survived to ICU discharge 100% of ICU survivors were dialysis independent and had normal kidney function at Day 60

------

![Slide 16](g430794ex99_1s16g1.jpg)

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 penetrate pediatric AKI market with small/niche salesforce 220 Children's Hospitals1 ~4,000 AKI pediatric patients2 7,200 ICU beds2,3 Targeting Pediatric Critical Care / Nephrology Approach Potential FDA Approval in H1 2023 ~20% of Top 50 children's hospitals have direct experience with SCD Commercial Preparations Underway Building awareness with prescribers and hospital staff Preparing commercial supply with manufacturer Engaged license and distribution partner for pediatric SCD Top 50 Children's Hospitals ~2,200 AKI pediatric patients2 4,030 ICU beds2,3

------

![Slide 17](g430794ex99_1s17g1.jpg)

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 for Medicare and Medicaid Services (CMS) MEDPAR data

------

![Slide 18](g430794ex99_1s18g1.jpg)

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 additional life-threatening organ dysfunction Commitment to maintain current level of care for > 96 h C-Reactive Protein > 3.5 mg/dL

------

![Slide 19](g430794ex99_1s19g1.jpg)

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 electronic health records Journal of Medical Economics 2019;22(5):421-429 Agrawal, S et al Temporal Trends in Hospitalization for Acute Decompensated Heart Failure in the United States, 1998–2011, American Journal of Epidemiology 2016: 183(5) 462-470. (assumes only systolic patients) Expansion opportunities beyond AKI include: Acute Respiratory Distress Syndrome (TAM: 200, 0001) Hepato-Renal Syndrome (TAM: 700, 0002) Cardio Renal Syndrome (TAM: 400, 0003) Pediatric Acute Kidney Injury on CKRT Adult Acute Kidney Injury on CKRT Cardiorenal Syndrome in Congestive Heart Failure (no LVAD) Cardiorenal Syndrome in Congestive Heart Failure (LVAD) Myocardial Stunning in End-Stage Renal Disease Hepatorenal Syndrome Exploratory clinical research underway to refine patient populations where SCD may be effective HDE accepted for Review by FDA in July 2022 Potential FDA approval targeted H1 2023, ~4,000 U.S. patients Pivotal Trial Ready Pivotal trial to commence Q1 2023, ~210,000 U.S. patients

------

![Slide 20](g430794ex99_1s20g1.jpg)

Corporate Overview

------

![Slide 21](g430794ex99_1s21g1.jpg)

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](g430794ex99_1s22g1.jpg)

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 of Nephrology, Internal Medicine University of Michigan Center for Integrative Research in Critical Care

------

![Slide 23](g430794ex99_1s23g1.jpg)

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 President of National Kidney Foundation Kenneth Van Heel Dow Chemical Company Former Board Member of Pfenex, Inc. Bruce Rodgers CEO – LM Funding America, Inc. and LMF Acquisition Opportunities Experienced M&A lawyer Richard Russell CFO – LMF Acquisition Opportunities Experienced public CFO Eric Schlorff CEO – SeaStar Medical Dow Chemical Company MS Pharmacology

------

![Slide 24](g430794ex99_1s24g1.jpg)

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 378,000 shares under the forward purchase agreement Equity line of credit is available to company

------

![Slide 25](g430794ex99_1s25g1.jpg)

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 Launch Adult Acute Kidney Injury

------

![Slide 26](g430794ex99_1s26g1.jpg)

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 acute kidney injury (AKI) are supported by clinical results demonstrating significantly reduced mortality and the elimination of dependency on hemodialysis Multiple near-term regulatory and clinical milestones provide a cadence of company news and the potential to create significant value for shareholders Targeting FDA approval of pediatric SCD for pediatric AKI in the first half of 2023 under the humanitarian device exemption (HDE) process Pivotal clinical trial with SCD for adult AKI to begin in the first quarter of 2023, with interim results expected in the fourth quarter of 2023 Seasoned leadership with highly relevant business experience and a proven track record of execution

------

![Slide 27](g430794ex99_1s27g1.jpg)

Appendix

------

![Slide 28](g430794ex99_1s28g1.jpg)

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 (CD11b,CD10) and monocyte activation (CD11b,CD14) demonstrated that SCD sequestered more activated neutrophils and monocytes from circulation. WBC=white blood cell. SCD treatment reduced mean absolute neutrophil and WBC counts after 4 days Absolute WBC counts P<0.0001 SCD treatment significantly\* reduced the elevated levels of multiple key predictive biomarkers of mortality in patients with COVID-19, including IL-6, IL-2, IL-15, and IL-10 Treatment days Cytokines (pg/mL) WBC (k/uL) Treatment days Treatment days \*Paired t tests were significant for all presented cytokines, calculated by comparing baseline level to lowest level during treatment. Pre Post 1 2 3 4 5 6 7 8 9 10 Pre 1 3 5 7 9 Post SCD-treated subgroup (n=13) Control (n=9) Pre 1 3 5 7 9 Post Data was collected from COVID-19 patients in the SCD 005 Clinical Study

## Exhibit 99.2

**Exhibit 99.2**![LOGO](g430794g0215024813278.jpg)

**SeaStar Medical to Hold Business Update Conference Call on February 15, 2023** 

**DENVER (February 14, 2023)** – SeaStar Medical (Nasdaq: ICU), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces it will hold a conference call to discuss business updates including the recent FDA approval to conduct a pivotal trial evaluating the effectiveness of its Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) and an update regarding the Humanitarian Device Exemption (HDE) submission for market approval for use of the SCD for critically ill children with AKI.

---

| | |
|:---|:---|
| **Date/Time:** | Wednesday, February 15, 4:00 p.m. ET / 1:00 p.m. PT |
| **Pre-Registration:** | Participants can pre-register for the conference call <u>here</u>: |
|  | Callers who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the call start time. |
| **Dial In:** | Those who choose not to pre-register can access the live conference call by dialing the following and requesting the SeaStar Medical call: |
|  | 866-777-2509 within the U.S. |
|  | 412-317-5413 from outside the U.S. |

---

The live webcast of the conference call also will be available <u>here</u>. A replay of the call will be available for 48 hours beginning two hours after its completion by dialing 877-344-7529 from within the U.S., 855-669-9658 from Canada or 412-317-0088 from outside the U.S., and entering conference ID 8400913. The webcast will also be archived <u>here</u>.

**About SeaStar Medical, Inc.** 

SeaStar Medical is a medical technology company 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. The Company 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 **<u>www.seastarmedical.com</u>** or visit us on **<u>LinkedIn</u>** or **<u>Twitter</u>**.

**SeaStar Medical 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, the expected timing on enrollment, generation of study results,

------

submission of PMA 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, (iv) the ability to maintain the listing of its securities on Nasdaq, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vii) 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, (viii) the risk that SeaStar Medical may never achieve or sustain profitability; (ix) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (xi) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical's products and services, (xii) 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 Medical'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.

**Contacts:** 

<u>Media</u> 

PSC Consulting

Patty Caballero

(973) 348-5055

**patty@pscconsulting.net** 

<u>Investors</u> 

LHA Investor Relations

Jody Cain

(310) 691-7100

**Jcain@lhai.com** 

\# \# \#

## Exhibit 99.3

**Exhibit 99.3**![LOGO](g430794g98e86.jpg)

**SeaStar Medical Announces Details of the Selective Cytopheretic Device Pivotal Study in Critically ill Adults with Acute Kidney Injury** 

*The NEUTRALIZE-AKI study will evaluate safety and efficacy of the SCD's ability to target and neutralize the highly activated proinflammatory neutrophils and monocytes that drive hyperinflammation* 

**DENVER, Feb. 15, 2023 – SeaStar Medical (Nasdaq: ICU)**, a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces details of its pivotal NEUTRALIZE-AKI study evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The <u>recently approved</u> study will be initiated in March and is expected to enroll up to 200 patients at up to 30 U.S. clinical trial sites.

This randomized, controlled study, called NEUTRALIZE-AKI (**NE<u>UTR</u>**ophil and monocyte de**<u>A</u>**ctivation via se**<u>L</u>**ective cytopheret**<u>I</u>**c device – a randomi**<u>ZE</u>**d clinical trial in **<u>A</u>**cute **<u>K</u>**idney **<u>I</u>**njury), will evaluate the safety and efficacy of the SCD to quell the hyperinflammatory process and cytokine storm by targeting and neutralizing activated effector cells in critically ill adults with AKI requiring CKRT, a condition with a high mortality rate.

The study's primary endpoint is a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CKRT standard of care, compared with the control group receiving CKRT standard of care alone. Secondary endpoints include mortality at Day 28, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroups to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome (ARDS).

"We are eager to begin this study that addresses life-threatening hyperinflammation in the setting of critical illness. An estimated six million American adults and children are diagnosed with AKI each year, and more than 200,000 require CKRT as part of their care," said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. "We believe the SCD holds potential to change practice by improving outcomes in all ICU patients with this unmet medical need caused by highly activated neutrophils and monocytes."

The SCD is a patented, cell-directed extracorporeal therapy that selectively targets the most highly activated proinflammatory neutrophils and monocytes to stop the cytokine storm that can cause organ failure and death. SCD therapy is currently delivered through continuous CKRT to target and neutralize proinflammatory neutrophils and monocytes, allowing the body to return to homeostasis. The SCD received FDA <u>Breakthrough Device Designation</u> in 2022.

The SCD has demonstrated success in critically ill patients with AKI requiring CKRT in previous clinical studies. In the Company's <u>SCD 005 pilot study</u> evaluating the safety and feasibility of the SCD in COVID-19 patients with AKI and/or ARDS, patients experienced reductions in activated neutrophils and monocytes, which led to a reduction in proinflammatory cytokines and improved clinical outcomes. Based on the per-protocol minimum of 96 hours of SCD treatment, Day 60 mortality of treated patients was significantly lower at 31% compared with the control population treated under standard of care at 81%. All patients in the study were treated in the ICU and received CKRT as the SCD delivery vehicle.

------

In four additional non-COVID AKI studies in adults and children, patients treated with the SCD showed Day 60 reductions in mortality of up to 50% and no dialysis dependency, compared with 15% to 25% dialysis dependency in historical controls.

**About SeaStar Medical, Inc.** 

SeaStar Medical is a medical technology company 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. The Company is developing and commercializing extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of proinflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit <u>www.seastarmedical.com</u> or visit us on <u>LinkedIn</u> or <u>Twitter</u>.

**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, the expected timing on enrollment, generation of study results, submission of PMA 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, (iv) the ability to maintain the listing of its securities on NASDAQ, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vii) 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, (viii) the risk that SeaStar Medical may never achieve or sustain profitability; (ix) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (xi) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical's products and services, (xii) 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 Medical'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.

------

**Contacts:** 

Media

PSC Consulting

Patty Caballero

(973) 348-5055

**patty@pscconsulting.net** 

Investors

LHA Investor Relations

Jody Cain

(310) 691-7100

**Jcain@lhai.com** 

# # #