SeaStar Medical Highlights 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'

Author: Bill Haddad | June 07, 2022 07:32am

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.

Posted In: LMAO