Business
SeaStar Medical Reports Second Quarter 2023 Financial Results and Provides a Business Update
Management to hold a business update conference call on August 22 beginning at 4:00 p.m. Eastern time DENVER, Aug. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"Management to hold a business update conference call on August 22 beginning at 4:00 p.m. Eastern time DENVER, Aug. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and six months ended June 30, 2023 and provides a business update. “With the recent activation of a second clinical site, we now have two medical centers open for enrolling patients in our pivotal trial evaluating the safety and efficacy of our patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT),” said Eric Schlorff, SeaStar Medical CEO. “We are working diligently to qualify additional medical centers to join this trial and expect the activation of several more sites in the coming weeks. We plan to provide periodic updates on site activation and patient enrollment as this important trial progresses. “There are considerable differences between our adult and our pediatric AKI programs,” he added. “Among them are the FDA pathways for approval and the proprietary characteristics between the pediatric SCD-PED and the adult SCD-ADULT devices. The two devices are completely different products and meant for different patient populations, although their mechanism of action is the same. The regulatory pathway, regulatory events and decisions between these two devices are independent of each other. Additionally, the addressable adult AKI patient population approximates 200,000 per year, which is about 50-times greater than the addressable pediatric population, which we estimate at around 4,000 patients annually. While the SCD-PED addresses a smaller commercial opportunity, we are deeply committed to bringing the potentially lifesaving benefits of this therapy to critically ill children. “Most pharmaceutical development programs begin in adult populations with plans for pediatric studies once safety and efficacy have been established. We elected to lead with the Humanitarian Device Exemption (HDE) regulatory pathway for the pediatric population based on the highly promising data from our SCD-PED st...