SeaStar Medical Reports First Successful Treatment of Pediatric Patient with Hemophagocytic Lymphohistiocytosis (HLH) and Multi-Organ Failure with its SCD

Case report published in peer-reviewed journal, Pediatric Nephrology


DENVER, CO and TAMPA, FL, Aug. 01, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special purpose acquisition company, today announced that SeaStar Medical’s novel Selective Cytopheretic Device (SCD) was successfully used in a pediatric patient with hemophagocytic lymphohistiocytosis (HLH), a dysregulated immune disorder in children associated with Epstein Barr virus (EBV), the virus that causes mononucleosis. In its most severe form, HLH presents with signs and symptoms of hyperinflammation that can progress to multiorgan failure with life-threatening consequences. This is the first case of SCD therapy in a pediatric patient with HLH and multiorgan failure.

The patient was a 22-month-old child, weighing 14 kg (approximately 31 lbs) who presented with a fever, abdominal distension and signs of hyperinflammation (an excessive and unrelenting inflammatory response that cascades to a cytokine storm and multiorgan dysfunction). The patient developed acute kidney injury (AKI) and was entered into a clinical trial to study the SCD for immunomodulatory dysregulation in pediatric AKI patients between 10 kg and 20 kgs. The patient received SCD therapy for four days, resulting in normalization of sepsis and inflammation markers. Once the patient stabilized and recovered, a bone marrow stem cell transplant was successfully conducted, and the patient reported normal kidney function eight months later.

“The SCD treatment helped to mitigate the excessive activation of the effector cells that caused the hyperinflammation, in order to stabilize the patient,” said the treating physician and lead author of the case report, Stuart Goldstein, MD, Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital. “This allowed the patient to recover and heal, which was critical for the patient’s next step in care.”

The patient’s case report, “Use of extracorporeal immunomodulation in a toddler with hemophagocytic lymphohistiocytosis and multisystem organ failure,” was published in the peer-reviewed journal, Pediatric Nephrology, on July 23, 2022.

“We are proud to see how our SCD is helping young, critically ill patients,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical. “The promising results from this case report builds upon our growing data sets that show how the SCD therapy can be insult agnostic, helping in bacterial, viral, surgical or trauma conditions, and effective in helping the body return to a reparative, healing state, without immunosuppression.”

About the Selective Cytopheretic Device (SCD)

The Selective Cytopheretic Device (SCD) is a medical device that employs immunomodulating technology to selectively target pro-inflammatory neutrophils and monocytes during CRRT and remove the cytokine storm that causes inflammation, organ failure, and possible death in critically ill patients. The device works with hemofiltration systems to enable precise fluid and solute balance control to selectively target and transition pro-inflammatory monocytes to reparative and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may reverse injury and eliminate the need for CRRT going forward.

The SCD is currently under review by the U.S. Food and Drug Administration (FDA) for Humanitarian Device Exemption (HDE) for use of the Selective Cytopheretic Device (SCD) for critically ill children over 20 kg with acute kidney injury (AKI) under a Humanitarian Device Exemption (HDE). Dr. Goldstein serves as a consultant to SeaStar Medical for this application to the FDA.

About SeaStar Medical, Inc.

Denver-based SeaStar Medical is a privately-held 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.

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.

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. 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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 an amended 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.

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