SeaStar Medical wins FDA IDE approval to begin pilot study of immunomodulating device in COVID-19 patients

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SeaStar Medical has secured an investigational device exemption (IDE) approval from the US FDA to start a pilot study of Selective Cytopheretic Device (SCD) in COVID-19 patients with acute respiratory distress syndrome (ARDS) or acute kidney injury (AKI).

The company has designed the pilot study to assess the use of immunomodulating device for the reduction and repair of kidney injury.

According to the company, the new evidence demonstrated that multiple COVID-19 patients with ARDS are also developing AKI and require renal replacement therapy and an estimated 40% to 60% of COVID-19 patients in intensive care units (ICU) are witnessing and may need dialysis.

The company’s SCD next-generation immunomodulating device will preferentially target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) to alleviate and remove the cytokine storm that results in inflammation, organ failure and possible death in critically ill patients.

SeaStar’s device will work with hemofiltration systems to facilitate accurate and solute balance control to selectively target and transition proinflammatory monocytes to reparative and minimise activated neutrophils.

The immunomodulation approach is expected to reverse injury and avoid the requirement for CRRT in the future.
The SCD pilot study will assess 35 adult subjects in around 10 institutions in the US

The SCD pilot study will evaluate the clinical activity, safety, and tolerability of SCD among patients who have ARDS prior to CRRT and/or AKI with CRRT. It will assess 35 adult subjects in up to 10 US institutions.

SeaStar’s trial’s crucial objectives comprise of reducing mortality rates and dialysis dependency and increasing ventilation free survival. Accomplishment of these endpoints may result in the reduction of ICU and hospitalisation days.

SeaStarwill has collaborated with contract research and clinical trial management organisation EmpiriStat to conduct the clinical trial.

The ongoing phase II clinical study is evaluating the safety and efficacy of the SCD in pediatric patients with AKI and multi-organ failure. The FDA has funded the trial, which may generate the results later this year.

SeaStar Medical CEO Eric Schlorff said: “We believe the SCD is the first immunomodulating device in renal care that can quell the storm and normalize the immune system to help repair kidney injury and prevent organ failure. We have observed preliminary evidence of what the SCD can do for patients.

“We are working closely with leading medical centers and regulators to expedite this study to help COVID-19 patients and expect to share the results later this year.”