Patient enrollment in pivotal clinical study expected to begin in March
SeaStar Medical (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces today that the U.S. Food and Drug Administration (FDA) approved the Company’s investigational device exemption (IDE) application to conduct a pivotal study evaluating the effectiveness of its Selective Cytopheretic Device (SCD) in reducing hyperinflammation in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
The Company plans to begin enrollment in this 200-patient randomized, controlled trial in March 2023. We currently expect to generate interim study results during the fourth quarter of 2023 and topline study results and submission of a Pre-market Approval (PMA) application in the second half of 2024. The study’s primary endpoint is a composite of 90-day mortality and dialysis dependency of patients treated with SCD in addition to CKRT standard of care, compared with the control group receiving CKRT standard of care.
“We are excited about the potential of SCD to treat life-threatening hyperinflammation in severely ill patients with AKI requiring CKRT. With approval to begin the pivotal study, we are one step closer to bringing this potentially lifesaving therapy to nephrology and critical care professionals and the adult patients they treat,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We are eager to enroll participants quickly as we continue our rigorous evaluation of the SCD’s safety and effectiveness. We believe the SCD has the potential to change the way we treat patients who need CKRT in the ICU while saving lives along the way.”
The Company’s innovative SCD is a patented cell-directed extracorporeal therapy that selectively targets the most highly activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that can cause organ failure and death. SCD therapy is currently delivered through continuous CKRT to target and neutralize pro-inflammatory neutrophils and monocytes, allowing the body to return to homeostasis. The SCD received FDA Breakthrough Device Designation in May 2022.
Source: Company Press Release