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SeaStar Medical Holding Corporation - ICU STOCK NEWS

Welcome to our dedicated page for SeaStar Medical Holding Corporation news (Ticker: ICU), a resource for investors and traders seeking the latest updates and insights on SeaStar Medical Holding Corporation stock.

SeaStar Medical Holding Corporation (ICU) is a pioneering medical technology firm focused on developing proprietary solutions to mitigate the adverse effects of hyperinflammation on vital organs. The company specializes in creating and commercializing extracorporeal therapies that specifically target effector cells responsible for systemic inflammation. This inflammation often leads to direct tissue damage and the secretion of pro-inflammatory cytokines, which can trigger and sustain imbalanced immune responses.

SeaStar Medical's core business revolves around innovative treatments designed to alleviate the intense inflammatory responses seen in various medical conditions. Their primary product offerings include advanced renal therapy systems that aim to reduce the impact of cytokine storms, often observed in severe cases of infections and autoimmune diseases.

One of the company’s notable achievements includes successful clinical trials that have demonstrated the efficacy of their therapies in reducing inflammation and improving patient outcomes. SeaStar Medical is currently engaged in several research and development projects to expand the application of their therapies across multiple medical disciplines.

Financially, SeaStar Medical Holding Corp is well-positioned, with strategic partnerships that enhance their research capabilities and product distribution. The company is committed to advancing its technology through continuous innovation and maintaining strong relationships with healthcare providers and patients.

For investors and stakeholders, SeaStar Medical represents a promising opportunity in the medical technology sector, with a focus on addressing critical health challenges through cutting-edge science and compassionate care.

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SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's management will engage in a fireside chat on September 11, 2024, at 9:00 a.m. Eastern time. Investors can access the webcast through the Events and Presentations section of SeaStar Medical's website.

The conference, scheduled for September 9-11, 2024, will be held at the Lotte New York Palace Hotel, offering both in-person and virtual attendance options. SeaStar Medical's management team will be available for one-on-one meetings throughout the event. Institutional investors and industry professionals interested in attending can register for either virtual or in-person participation.

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SeaStar Medical Holding (Nasdaq: ICU), a commercial-stage medical device company, has eliminated all long-term debt, strengthening its financial position. The company, which develops proprietary solutions to reduce hyperinflammation's impact on vital organs, reported over $9 million in convertible notes and long-term interest-bearing debt at the end of 2023. This debt retirement will be reflected in the balance sheet for the quarter ending September 30, 2024. CEO Eric Schlorff stated that SeaStar Medical is now in its strongest financial position since going public nearly two years ago, enhancing its ability to advance its business plan and deliver potentially life-saving solutions to critically ill patients.

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SeaStar Medical (Nasdaq: ICU) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. Initial commercial sales of QUELIMMUNE™ for pediatric AKI and sepsis patients.
2. Enrollment of 42 subjects at 9 sites in the NEUTRALIZE-AKI pivotal trial for adults.
3. CMS granted Category B coverage for certain trial expenses.
4. Completed a $10 million financing and retired nearly all outstanding debt.
5. Q2 2024 net loss of $3.2 million, or $1.03 per share.
6. Cash balance of approximately $6.9 million as of July 31, 2024.

The company expects U.S. regulatory approval for the SCD in adults with AKI in H1 2026, with commercial launch in H2 2026.

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SeaStar Medical Holding (Nasdaq: ICU) has announced the first commercial treatment of a pediatric patient with its FDA-approved QUELIMMUNE™ therapeutic device. This milestone meets the FDA's August 20, 2024 deadline for initiating patient treatments. QUELIMMUNE is designed to treat acute kidney injury (AKI) in pediatric patients weighing 10 kg or more with sepsis or septic conditions requiring kidney replacement therapy (KRT).

Clinical trials have shown promising results, with a 77% survival rate and no dialysis dependency at 60 days for treated children. This is significant given that approximately 4,000 children with AKI require continuous KRT annually in the U.S., with a mortality rate of about 50%. The company aims to improve outcomes and reduce long-term complications for these severely ill children.

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SeaStar Medical Holding (Nasdaq: ICU) has received a Category B Coverage Letter from CMS for its NEUTRALIZE-AKI pivotal trial, evaluating the Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI). This coverage is expected to accelerate medical site activations and cover a portion of the trial costs. The trial aims to enroll up to 200 adult patients with AKI at up to 30 clinical sites, with 38 patients already enrolled across 10 active centers.

CEO Eric Schlorff anticipates that CMS reimbursement will provide substantial overall cost savings and accelerate patient enrollment. The company plans to conduct an interim analysis after reaching the 90-day primary endpoint in 100 enrolled subjects. SeaStar Medical views the adult AKI market as a multibillion-dollar opportunity, given its population is 50 times larger than pediatric AKI.

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SeaStar Medical (Nasdaq: ICU) has announced the initial commercial sale of its QUELIMMUNE™-Pediatric to U.S. distributor Nuwellis. QUELIMMUNE, a patented cell-directed extracorporeal therapy, targets highly activated neutrophils and monocytes responsible for hyperactive immune responses in pediatric acute kidney injury (AKI) patients. The device is FDA-approved under a Humanitarian Device Exemption to treat pediatric AKI in patients weighing 10 kilograms or more. Initial studies show QUELIMMUNE has a probable benefit in reducing mortality and dialysis dependency. SeaStar Medical anticipates a significant commercial rollout by Q4 2024, with prestigious pediatric hospitals expected to meet HDE requirements this quarter. The company is also enrolling patients in the NEUTRALIZE-AKI trial for adults, presenting a multibillion-dollar market opportunity.

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SeaStar Medical (Nasdaq: ICU) announced the closing of its $10 million registered direct offering. The company issued 947,868 shares of common stock at $10.55 per share. Concurrently, unregistered warrants for an additional 947,868 shares were issued at the same price, exercisable immediately and expiring in five years. Gross proceeds totaled $10 million before fees and expenses. H.C. Wainwright & Co. acted as the exclusive placement agent. Funds will support general corporate purposes, including working capital and debt repayment. The stock offering was filed under an effective SEC registration statement, while the warrants remain unregistered under the Securities Act.

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SeaStar Medical has announced a $10 million registered direct offering priced at-the-market under Nasdaq rules. The offering involves the sale of 947,868 shares of common stock at $10.55 each, along with unregistered warrants for the same number of shares, which are exercisable immediately and expire in five years.

H.C. Wainwright & Co. is acting as the exclusive placement agent. The offering is expected to close on July 11, 2024, subject to customary conditions. The net proceeds will be used for general corporate purposes, including working capital and capital expenditures.

The shares are offered under a previously effective shelf registration statement, while the warrants are issued in a private placement and are not registered under the Securities Act.

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SeaStar Medical (Nasdaq: ICU) has finalized FDA labeling for QUELIMMUNE™, a device aimed at reducing hyperinflammation in pediatric patients with acute kidney injury (AKI) and sepsis or septic conditions requiring kidney replacement therapy (KRT). This approval under the Humanitarian Use Device (HUD) designation allows SeaStar to market QUELIMMUNE in the U.S. for children weighing 10 kilograms or more. Clinical results showed a 77% survival rate, with no dialysis dependency at 60 days and no device-related serious adverse events. The device is expected to be available for shipment this month, addressing a U.S. market of approximately 4,000 children annually.

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SeaStar Medical announced that its Selective Cytopheretic Device (SCD) will be featured in two presentations at the 42nd Vicenza Course AKI-CRRT-ECOS and Critical Care Nephrology conference. The event takes place from June 11-13, 2024, in Vicenza, Italy. The SCD is a patented, cell-directed, extracorporeal device aimed at reducing hyperinflammation's impact on vital organs. One presentation, 'A Novel Selective Cytopheretic Device,' will be delivered by Dr. Stuart Goldstein from Cincinnati Children's Hospital. Another presentation, 'Cell-directed Therapy: Promising Approach to Sepsis and Other Dysregulated Immunological States, Including Acute Kidney Injury,' will be given by Dr. H. David Humes from the University of Michigan. Dr. Kevin Chung, SeaStar Medical's Chief Medical Officer, emphasized the honor of being invited by Dr. Claudio Ronco, a renowned expert in nephrology.

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FAQ

What is the current stock price of SeaStar Medical Holding Corporation (ICU)?

The current stock price of SeaStar Medical Holding Corporation (ICU) is $4.895 as of September 13, 2024.

What is the market cap of SeaStar Medical Holding Corporation (ICU)?

The market cap of SeaStar Medical Holding Corporation (ICU) is approximately 21.7M.

What does SeaStar Medical Holding Corporation do?

SeaStar Medical develops and commercializes medical technologies that reduce the consequences of hyperinflammation on vital organs.

What are the core products of SeaStar Medical?

The company specializes in extracorporeal therapies that target effector cells causing systemic inflammation and tissue damage.

What is hyperinflammation?

Hyperinflammation is an excessive inflammatory response that can lead to direct tissue damage and imbalanced immune reactions.

What are extracorporeal therapies?

Extracorporeal therapies involve the treatment of blood outside the body to remove harmful substances like pro-inflammatory cytokines.

What diseases could benefit from SeaStar Medical's therapies?

Their therapies are useful in conditions with severe inflammatory responses, such as infections and autoimmune diseases.

Has SeaStar Medical conducted any clinical trials?

Yes, SeaStar Medical has conducted successful trials demonstrating the effectiveness of their inflammation-reducing therapies.

Who are SeaStar Medical's key partners?

The company collaborates with various healthcare providers and research institutions to enhance their product development and distribution.

Is SeaStar Medical a good investment?

SeaStar Medical offers a promising investment opportunity in the medical technology sector, focusing on innovative treatments for hyperinflammation.

What is the ticker symbol for SeaStar Medical Holding Corp?

The ticker symbol for SeaStar Medical Holding Corp is ICU.

Where can I find the latest news about SeaStar Medical?

You can stay updated with the latest news and developments about SeaStar Medical on their investor relations page and financial news websites.

SeaStar Medical Holding Corporation

Nasdaq:ICU

ICU Rankings

ICU Stock Data

21.67M
4.19M
8.5%
4.13%
3.87%
Biotechnology
Surgical & Medical Instruments & Apparatus
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United States of America
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