SeaStar Medical Holding Corp - ICU STOCK NEWS

SeaStar Medical (Nasdaq: ICU) has announced a $6 million registered direct offering with a single institutional investor. The offering includes 3,529,412 shares of common stock (or pre-funded warrants) at $1.70 per share, along with warrants to purchase an additional 3,529,412 shares in a concurrent private placement.

The pre-funded warrants will have a $0.001 exercise price with immediate exercisability, while the additional warrants will have a $1.70 exercise price, exercisable upon shareholder approval with a five-year expiration. The offering is expected to close around February 3, 2025.

The company plans to use the net proceeds for general corporate purposes, including working capital and capital expenditures. H.C. Wainwright & Co. is serving as the exclusive financial advisor for this offering.

SeaStar Medical (Nasdaq: ICU) has expanded its customer base by shipping QUELIMMUNE™ to a fifth hospital, a California medical center known for pediatric research. QUELIMMUNE, their Selective Cytopheretic Device (SCD), treats critically ill children in ICU with acute kidney injury (AKI) and sepsis.

The company is actively pursuing additional hospital clearances through institutional review board (IRB) approvals, with more than a dozen new medical centers in discussion and seven advancing in the IRB process. Several existing customers have already placed reorders in 2025.

QUELIMMUNE operates under FDA approval through a Humanitarian Device Exemption for children weighing 10kg or more requiring renal replacement therapy. The device uniquely targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially promoting long-term organ recovery and eliminating future dialysis needs. The SCD has received FDA Breakthrough Device Designation in four indications.

SeaStar Medical (Nasdaq: ICU) has activated its 15th site, Mayo Clinic, for the NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI). The trial has currently enrolled 76 subjects, with 6 new enrollments since the start of 2024.

The study aims to evaluate 200 adults with AKI in ICU receiving continuous renal replacement therapy (CRRT). The primary endpoint focuses on 90-day mortality or dialysis dependency compared to standard CRRT care. The company expects a Data Safety Monitoring Board recommendation on interim results by mid-2025 after analyzing the first 100 subjects.

The SCD, which has FDA Breakthrough Device Designation for adults with AKI, targets proinflammatory neutrophils and monocytes during CRRT to reduce hyperinflammation. SeaStar Medical estimates the annual U.S. market opportunity for SCD in adult AKI at $4.7-6.3 billion.

SeaStar Medical (Nasdaq: ICU) received FDA approval for an investigational device exemption (IDE) to study their Selective Cytopheretic Device (SCD-ADULT) in reducing inflammation in adult patients with acute heart failure and worsening renal function. The feasibility study will enroll 20 patients across up to five clinical sites, funded by a $3.6 million NIH grant awarded to Innovative BioTherapies.

The study will be led by SCD inventor Dr. H. David Humes, with SeaStar Medical acting as clinical research organization. The device received Breakthrough Device Designation from FDA's CBER in September 2023 for cardiorenal syndrome with LVAD. The company estimates the total addressable U.S. market for SCD-ADULT in cardiorenal syndrome at over $1 billion annually.

SeaStar Medical (Nasdaq: ICU) has expanded its commercial reach by shipping its QUELIMMUNE™ device to a fourth hospital customer, a prominent academic medical center. QUELIMMUNE is a Selective Cytopheretic Device (SCD) designed to treat critically ill children in ICU with acute kidney injury (AKI) and sepsis.

The device, approved by FDA under Humanitarian Device Exemption, has shown clinical benefits in reducing mortality and decreasing dialysis dependency. According to company data, AKI patients treated with SCD showed no dialysis dependency 60 days post-treatment, potentially saving approximately $100,000 per patient annually in dialysis costs. The average hospital cost per pediatric ICU patient with AKI requiring continuous renal replacement therapy exceeds $350,000.

QUELIMMUNE is approved for children weighing 10 kilograms or more who require renal replacement therapy. The SCD technology uniquely targets proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially promoting long-term organ recovery.

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.