Case report published in peer-reviewed journal, Pediatric Nephrology
DENVER, CO and TAMPA, FL — 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.