SeaStar Medical Announces Publication of Clinical Trial Results Demonstrating its SCD Significantly Lowered Mortality Rates among Critically Ill ICU COVID-19 Patients by Safely and Effectively Stopping Inflammation Causing Cytokine Storms

Rhea-AI Summary

SeaStar Medical and LMF Acquisition Opportunities announce the publication of results from the SCD 005 clinical study in the Critical Care Explorations journal. The study met primary endpoints, demonstrating the Selective Cytopheretic Device (SCD) significantly reduced 60-day mortality rates from 81% in controls to 50% in treated patients, and down to 31% with extended treatment. The SCD showed a favorable safety profile with no serious adverse events. These findings support future studies that could lead to the SCD's broader application in treating inflammatory conditions.

Positive

• SCD treatment reduced 60-day mortality from 81% in controls to 50%.
• Extended SCD treatment further reduced mortality to 31% (p < 0.012).
• The SCD demonstrated an acceptable safety profile with no serious adverse events.

Negative

• None.

Results published in the Society of Critical Care Management’s journal, Critical Care Explorations

DENVER, CO and TAMPA, FL, June 07, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, a medical technology company developing a platform therapy to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special purpose acquisition company, today announced the publication of results from SeaStar Medical’s pilot SCD 005 clinical study to evaluate the safety and clinical outcomes of extracorporeal immunomodulation treatment with SeaStar Medical’s Selective Cytopheretic Device (SCD) in COVID-19 patients with multiple organ failure in the intensive care unit (ICU). The article, "Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients," was published in the May 2022 issue of the Society of Critical Care Medicine’s (SCCM) Critical Care Explorations.

“The study met its primary endpoints, and the results published in Critical Care Explorations are an important step in validating the role neutrophils and monocytes play as the effector cells responsible for a dysregulated systemic inflammatory response. By removing the most activated neutrophils and monocytes from circulation, the SCD's immunomodulatory impact enables a return to a regulated healing process,” said Dr. H. David Humes, professor of nephrology at University of Michigan, one of the lead investigators of the study and a director of SeaStar Medical.

Mortality rates are high among intensive care patients with COVID-19 and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT) and/or acute respiratory distress syndrome (ARDS) on mechanical ventilation. In this study of 22 patients, the SCD was integrated into the CRRT blood circuit with strictly controlled low ionized calcium concentration between 0.25 and 0.4 mmol/L achieved using regional citrate anticoagulation and calcium-free dialysate. Patients were treated for up to 10 days. The SCD was changed every 24 hours or as needed.

Patients experienced reductions in activated neutrophils and monocytes, which led to reduction in proinflammatory cytokines and improved clinical outcomes. SCD-treated subjects had a reduction in 60-day mortality to 50% compared with 81% in the control cohort. The subjects who received greater than 96 hours of SCD treatment, per protocol, had a further reduction in mortality to 31% (p < 0.012). Additionally, SCD treatment demonstrated an acceptable safety profile with no device-related serious adverse events. These findings suggest a favorable benefit-to-risk ratio in the patient population.

“We are very pleased with the publication of our study results in a leading Society of Critical Care Management journal,” said SeaStar Medical President and Chief Executive Officer Eric Schlorff. “Hyperinflammation can be a devastating factor for severe COVID patients who develop multi-organ complications. This pilot study helps inform our upcoming pivotal study, which will examine how our immunomodulatory therapeutic treatment can be disease-agnostic in its efforts to return a pro-inflammatory immune system back to a reparative state.”

The SCD is a patented, cell-directed, extracorporeal immunomodulator that selectively targets activated neutrophils and monocytes to address hyperinflammation. Neutrophils and monocytes are the cellular mediators that drive systemic inflammation, which when spreading uncontrollably through the body can lead to organ damage, organ failure or death. The SCD technology targets the cellular drivers of inflammation to restore immune balance in the body and potentially reverse the damage.

As previously announced, SeaStar Medical and LMAO entered into a definitive agreement for a business combination transaction whereby SeaStar Medical will become publicly listed on Nasdaq, subject to approval by stockholders of LMAO and other customary closing conditions.

About SeaStar Medical, Inc.

Denver-based SeaStar Medical 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 http://www.seastarmedical.com/ or visit us on LinkedIn or Twitter.

About LMF Acquisition Opportunities, Inc.

LMF Acquisition Opportunities, Inc. (Nasdaq: LMAO) is a special purpose acquisition company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses. LMAO is led by Bruce M. Rodgers, Chief Executive Officer and Chairman of the Board. For more information, visit www.lmfacquisitions.com.

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, LMAO’s and SeaStar Medical’s expectations with respect to the proposed business combination between LMAO and SeaStar Medical, including statements regarding the benefits of the transaction, the anticipated timing of the transaction, the implied valuation of SeaStar Medical, the products offered by SeaStar Medical and the markets in which it operates, and SeaStar Medical’s projected future results. 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 LMAO’s and 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 risk that the business combination transaction between SeaStar Medical and LMAO may not be completed in a timely manner or at all, which may adversely affect the price of LMAO’s securities, (ii) the risk that the transaction may not be completed by LMAO’s business combination deadline, even if extended by its sponsor, (iii) the failure to satisfy the conditions to the consummation of the transaction, including the adoption of the agreement and plan of merger (“Merger Agreement”) by the stockholders of LMAO and the satisfaction of the minimum trust account amount following redemptions by LMAO’s public stockholders, (iv) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement, (v) the receipt of an unsolicited offer from another party for an alternative transaction that could interfere with the business combination, (vi) the effect of the announcement or pendency of the transaction on SeaStar Medical’s business relationships, performance, and business generally, (vii) the inability to recognize the anticipated benefits of the business combination, 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, (viii) costs related to the business combination, (ix) the outcome of any legal proceedings that may be instituted against SeaStar Medical or LMAO following the announcement of the proposed business combination, (x) the ability to maintain the listing of LMAO’s securities on the Nasdaq, (xi) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed business combination, and identify and realize additional opportunities, (xii) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (xiii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize SeaStar Medical’s products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (xiv) the risk that SeaStar Medical may never achieve or sustain profitability; (xv) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which many not be available on acceptable terms or at all; (xvi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (xvii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (xviii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, (xix) the risk that the post-combination company’s securities will not be approved for listing on Nasdaq or if approved, maintain the listing and (xx) other risks and uncertainties indicated from time to time in LMAO’s registration statement on Form S-4, as amended (File No. 333-264993), including those under the “Risk Factors” section therein and in LMAO’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 and LMAO 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.

Important Information and Where to Find It

In connection with the business combination transaction, LMAO has filed a registration statement on Form S-4 (the “Registration Statement”) with the SEC, which includes a preliminary proxy statement relating to LMAO’s solicitation of proxies for the vote by LMAO’s stockholders with respect to the transaction, as well as the preliminary prospectus relating to the offer of the securities to be issued to SeaStar Medical’s stockholders in connection with the transaction. After the Registration Statement has been filed and declared effective, LMAO intends to mail a definitive proxy statement, when available, to its stockholders. Investors and security holders and other interested parties are urged to read the proxy statement/prospectus, any amendments thereto and any other documents filed with the SEC carefully and in their entirety when they become available because they will contain important information about LMAO, SeaStar Medical and the transaction. Investors and security holders may obtain free copies of the preliminary proxy statement/prospectus and definitive proxy statement/prospectus (when available) and other documents filed with the U.S. Securities and Exchange Commission (the “SEC”) by LMAO through the website maintained by the SEC at http://www.sec.gov, or by directing a request to: LMF Acquisition Opportunities, Inc., 1200 Platt Street, Suite 1000 Tampa, FL 33602.

Participants in Solicitation

LMAO and SeaStar Medical and their respective directors and certain of their respective executive officers and other members of management and employees may be considered participants in the solicitation of proxies with respect to the business combination transaction. Information about the directors and executive officers of LMAO are set forth in LMAO’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, are included in the Registration Statement and will be contained in the other relevant materials to be filed with the SEC regarding the business combination transaction when they become available. Stockholders, potential investors and other interested persons should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. When available, these documents can be obtained free of charge from the sources indicated above.

No Offer or Solicitation

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Media Relations Contact:
Patty Caballero
Email: patty@pscconsulting.net 
Tel: 862.216.7523

Investor Relations Contact:
David Waldman or Natalya Rudman
Crescendo Communications, LLC
Email: lmao@crescendo-ir.com 
Tel: 212-671-1020

FAQ

What were the results of the SCD 005 clinical study published by SeaStar Medical and LMAO?

The SCD 005 clinical study showed that treatment with the Selective Cytopheretic Device significantly reduced 60-day mortality rates from 81% in controls to 50% in treated patients, with further reduction to 31% for those treated over 96 hours.

What is the next step for SeaStar Medical after the SCD 005 study?

SeaStar Medical plans to conduct a pivotal study to further investigate the broader application of the SCD in treating various inflammatory conditions.

When was the SCD 005 clinical study published?

The results of the SCD 005 clinical study were published in the May 2022 issue of the journal Critical Care Explorations.

What was the patient population in the SCD 005 study?

The study involved 22 patients with COVID-19 and multiple organ failure requiring intensive care.

What is the significance of the SCD device in treating hyperinflammation?

The SCD device selectively targets activated neutrophils and monocytes, helping to restore immune balance and potentially reverse organ damage caused by hyperinflammation.