SeaStar Medical Holding Corp Stock Price, News & Analysis

SeaStar Medical (Nasdaq: ICU) has activated its 14th hospital site for the NEUTRALIZE-AKI pivotal trial, evaluating their Selective Cytopheretic Device (SCD) in acute kidney injury patients. Currently, 70 of 200 planned subjects are enrolled, with 24 in Q4. The company expects Data Safety Monitoring Board interim results by mid-2025 after the first 100 subjects complete the 90-day primary endpoint.

The company estimates the U.S. addressable market for SCD in adult AKI at $4.7-6.3 billion, with trial costs around $15 million. The SCD has FDA Breakthrough Device Designation for adults with AKI, and received Category B coverage from CMS for certain expenses in July 2024. The trial's primary endpoint focuses on 90-day mortality or dialysis dependency comparing SCD plus CRRT versus CRRT alone.

SeaStar Medical (Nasdaq: ICU) estimates a U.S. total addressable market of $25 to $33 billion for its Selective Cytopheretic Device (SCD) across five clinical indications. The company's device, which targets inflammatory cells during continuous renal replacement therapy, has received FDA Breakthrough Device Designation in three indications: adult AKI, hepatorenal syndrome, and cardiorenal syndrome with LVAD. The largest market opportunity is in Cardiorenal Syndrome with no LVAD at $13.1-17.4 billion.

The company recently received FDA approval for QUELIMMUNE™ (SCD-Pediatric) for treating critically ill children with AKI and sepsis. The adult AKI pivotal trial, NEUTRALIZE-AKI, has enrolled 69 out of 200 planned subjects, evaluating 90-day mortality and dialysis dependency as primary endpoints.

SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company focused on hyperinflammation solutions, has announced an upcoming business update conference call scheduled for December 11, 2024, at 4:30 p.m. ET / 1:30 p.m. PT.

Participants can pre-register to receive a conference passcode and unique PIN for immediate access. Those who don't pre-register can dial 866-777-2509 (U.S.) or 412-317-5413 (international) and request the SeaStar Medical call.

A live webcast will be available, and a replay can be accessed for 48 hours after completion by dialing 877-344-7529 (U.S.), 855-669-9658 (Canada), or 412-317-0088 (international) with conference ID 3855739.

SeaStar Medical (Nasdaq: ICU) announces the activation of its thirteenth site, Sentara Norfolk General Hospital, in the NEUTRALIZE-AKI pivotal trial. The trial enrolled nine new patients in November, reaching 65 total subjects. The study aims to evaluate the safety and efficacy of the company's Selective Cytopheretic Device (SCD) in 200 adult patients with acute kidney injury (AKI) in ICU receiving continuous renal replacement therapy.

Enrollment rate has doubled in Q4's first two months compared to previous quarters. The company estimates annual peak sales of approximately $1 billion for SCD in the AKI indication, which affects about 210,000 U.S. patients annually. The trial's primary endpoint focuses on 90-day mortality or dialysis dependency comparing SCD+CRRT versus CRRT alone.

SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company, will present at NobleCon20, Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference.

The presentation is scheduled for Wednesday, December 4, 2024, at 12:00 p.m. Eastern time (9:00 a.m. Pacific time) in Boca Raton, Fla. The company will provide an overview of its proprietary solutions aimed at reducing the consequences of hyperinflammation on vital organs.

A webcast of the presentation will be available on the company's website starting December 5 and will be archived for 90 days.

SeaStar Medical has begun shipping QUELIMMUNE to its third hospital customer, marking the milestone of 100 therapeutic devices shipped since its commercial launch in July. QUELIMMUNE, the company's Selective Cytopheretic Device (SCD), treats critically ill children in ICU with acute kidney injury and sepsis. The company is on track to make QUELIMMUNE available in 4-5 leading pediatric hospitals by end of 2024. The device requires hospital-specific IRB approval and integration with existing hemodialysis equipment. Treatment typically requires 3-7 days, with daily cartridge replacement. Recent data presented at Kidney Week 2024 showed projected cost savings driven by lower expected death rates and shorter hospital stays versus standard care.

SeaStar Medical (ICU) reported Q3 2024 financial results, highlighting its first commercial sales of QUELIMMUNE™, generating revenue of $67,500. The company reported progress in its NEUTRALIZE-AKI pivotal trial with 59 subjects enrolled and expanded to 12 clinical sites. SeaStar eliminated over $9 million in long-term debt since early 2024. Q3 net loss was $4.5 million ($1.10 per share) compared to $7.2 million ($9.02 per share) in Q3 2023. Cash position as of September 30, 2024, was $2.1 million, bolstered by a $10 million registered direct offering in July 2024.

SeaStar Medical announces FDA Breakthrough Device Designation for its Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease patients requiring chronic hemodialysis. This marks the fourth Breakthrough designation for SCD, expanding the company's addressable U.S. patient population to 745,000 annually. The device targets over 480,000 U.S. individuals requiring in-center hemodialysis, with treatment costs around $100,000 per patient yearly. The SCD is designed to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially improving survival and quality of life for patients who currently face a 42% five-year survival rate.

SeaStar Medical (Nasdaq: ICU) reports record monthly enrollment of 10 patients in its NEUTRALIZE-AKI pivotal trial, bringing total enrollment to 56. The trial evaluates the company's Selective Cytopheretic Device (SCD) in adults with acute kidney injury receiving continuous renal replacement therapy. With 12 clinical sites now activated, including new teaching hospitals and military facilities, enrollment is expected to accelerate. The trial aims to enroll up to 200 adults, with an interim analysis planned at 100 subjects. The SCD has FDA Breakthrough Device Designation, and the trial received Category B coverage from Medicare & Medicaid for certain expenses.