SeaStar Medical Holding Corp Stock Price, News & Analysis

SeaStar Medical Holding Corporation (Nasdaq: ICU) provides an update and financial results for 2022, focusing on its innovative Selective Cytopheretic Device (SCD) for hyperinflammation in acute kidney injury (AKI) patients. The FDA granted Breakthrough Device Designation to the SCD for adult AKI. A pivotal clinical trial, NEUTRALIZE-AKI, aims to enroll 200 patients across 30 sites, with results expected by mid-2025. The company reported a net loss of $23 million, or $2.80 per share, due to increased expenses. Cash reserves decreased to $47,000. The firm anticipates regulatory approval for pediatric AKI and has a partnership with Nuwellis to enhance market presence.

SeaStar Medical Holding Corporation (Nasdaq: ICU) announced a $3.3 million tranche closing of a $9.8 million private placement with a single institutional investor. The investment is structured as a Senior Unsecured Original Issue 8.0% Discount Convertible Note, yielding approximately $3.0 million in proceeds. The Note matures in 15 months and can be converted into stock at an initial price of $2.70. The investor also receives warrants for 328,352 shares at an exercise price of $2.97. Following regulatory conditions, SeaStar may secure additional tranches totaling $8.8 million, aiming to enhance its financial stability and product development efforts.

SeaStar Medical Holding Corporation (Nasdaq: ICU) announced its upcoming presentation at the Emerging Growth Virtual Conference on March 22, 2023, at 2:15 p.m. Eastern time. The event will feature CEO Eric Schlorff and CMO Kevin Chung, outlining the company's innovative solutions aimed at reducing hyperinflammation effects on vital organs. Attendees can register for the presentation and submit questions in advance. Following the event, a replay will be available on the company’s and conference's respective websites. SeaStar Medical focuses on developing proprietary extracorporeal therapies for critically ill patients.

SeaStar Medical (Nasdaq: ICU) announces that Dr. Kevin Chung will present the company's Selective Cytopheretic Device (SCD) at the 5th Chronic Kidney Disease Drug Development Summit on March 7, 2023. The presentation will focus on the SCD's role in addressing systemic inflammation, a key factor in organ dysfunction, particularly in Acute Kidney Injury (AKI) and COVID-19 cases. The SCD offers a novel approach by targeting activated pro-inflammatory cells, helping restore homeostasis in critically ill patients. SeaStar Medical has received FDA approval for a pivotal study evaluating the SCD's safety and efficacy in adults with AKI requiring continuous kidney replacement therapy.

SeaStar Medical (Nasdaq: ICU) has announced the launch of its pivotal NEUTRALIZE-AKI study, aimed at assessing the safety and efficacy of its Selective Cytopheretic Device (SCD) for adults with acute kidney injury (AKI) needing continuous kidney replacement therapy (CKRT). Starting in March, the randomized controlled trial will enroll up to 200 patients across 30 U.S. sites. The study's primary endpoint focuses on 90-day mortality and dialysis dependency, while secondary endpoints include Day 28 mortality and ICU-free days. Previous studies indicate the SCD may significantly reduce mortality rates, showcasing its potential as a life-saving solution for critically ill patients.

SeaStar Medical (Nasdaq: ICU) announced a conference call on February 15, 2023, at 4:00 p.m. ET to discuss significant business updates. Key topics will include FDA approval for a pivotal trial of its Selective Cytopheretic Device (SCD) aimed at treating adults suffering from acute kidney injury (AKI) due to hyperinflammation. Additionally, updates on the Humanitarian Device Exemption (HDE) submission for use in critically ill children will be shared. The conference call will be accessible via phone or through a live webcast, and a replay will be available for 48 hours post-call.

SeaStar Medical (Nasdaq: ICU) has received FDA approval for its investigational device exemption (IDE) to conduct a pivotal study of its Selective Cytopheretic Device (SCD). This 200-patient trial will evaluate the SCD's effectiveness in treating acute kidney injury (AKI) patients requiring continuous kidney replacement therapy (CKRT). Enrollment is set to begin in March 2023, with interim results anticipated in Q4 2023 and topline results by mid-2024. The SCD targets pro-inflammatory immune cells to mitigate hyperinflammation, a condition linked to high mortality rates in AKI patients. SeaStar aims to redefine treatment protocols in critical care environments.

SeaStar Medical (Nasdaq: ICU) announced that CEO Eric Schlorff will present a company overview at the virtual Sequire Biotechnology Conference on February 2, 2023, at 3:30 p.m. Eastern Time. The conference will focus on SeaStar's innovative solutions aimed at mitigating hyperinflammation's effects on vital organs. Attendees can register for the event through the Sequire Biotechnology website. An archived webcast of the presentation will also be available on the SeaStar Medical website.

SeaStar Medical has submitted an investigational device exemption (IDE) application to the FDA for a pivotal study of its Selective Cytopheretic Device (SCD) aimed at treating adults with acute kidney injury (AKI) needing continuous kidney replacement therapy (CKRT). The study will enroll 200 participants, focusing on 90-day mortality and dialysis dependency rates. Interim results are expected by Q4 2023, with topline results and Pre-market Approval anticipated by Q3 2024. The SCD has previously shown promise in reducing mortality rates in critically ill patients.