Latest news with #SeaStarMedical
Associated Press
3 days ago
- Business
- Associated Press
SeaStar Medical Announces CMS Coverage for Medicare and Medicaid Eligible Patients with Cardiorenal Syndrome Awaiting LVAD in Investigational Trial of SCD Therapy
Coverage marks SeaStar Medical's second award by CMS for reimbursement of medical expenses for Medicare and Medicaid patients in a clinical trial Stands out as rare award with less than 100 clinical trials covered annually DENVER, May 28, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) has agreed to pay for certain expenses incurred by medical centers treating patients covered by Medicare or Medicaid who are enrolled in the NEUTRALIZE-CRS investigational clinical trial. This follows the company's first award for reimbursement by the CMS that was granted in July 2024 for qualified patients treated in the ongoing NEUTRALIZE-AKI pivotal clinical trial. 'To receive CMS coverage of certain expenses for patients in a clinical trial is rare, with less than 100 per year, and we believe reflects the life-saving potential of our technology,' said Eric Schlorff, SeaStar Medical CEO. 'We fulfilled multiple criteria set forth by the CMS for this award, including ten study criteria elements that included assessment of how we could improve health outcomes, how generalizable the Selective Cytopheretic Device (SCD) therapy would be to the Medicare population, and how the study results would not duplicate existing knowledge.' Mr. Schlorff continued, 'As we initiate our pre-commercialization efforts for our SCD therapy in patients with Acute Kidney Injury (AKI), we recognize that CMS coverage in the commercial setting will be a key element to bringing our potential organ-sparing and life-saving therapies to more patients. We have already engaged a third-party reimbursement policy expert to analyze the feasibility of obtaining reimbursement coverage upon a potential FDA approval for our SCD therapy in adult patients with AKI. Based on the results of the analysis, the high unmet need, and Healthcare Economics and Outcomes Research (HEOR) data supporting reduced healthcare costs, we are building a compelling case that should enable CMS and private payers to understand the value of the SCD therapy in adult patients with AKI.' The NEUTRALIZE-AKI pivotal clinical trial and NEUTRALIZE-CRS investigational clinical trial are evaluating the ability of SeaStar Medical's SCD therapy to neutralize destructive hyperinflammation to improve health outcomes. The SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient's body. The NEUTRALIZE-AKI pivotal trial was granted CMS coverage in July 2024 for qualified patients. The trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. It is currently 50% enrolled, with full enrollment anticipated near the end of 2025. The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. The FDA has granted Breakthrough Device Designation for the SCD therapy in adult patients with AKI and CRRT. The NEUTRALIZE-CRS trial is designed to evaluate the safety and initial efficacy of the SCD therapy in reducing destructive hyperinflammation in adult patients with acute heart failure with worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting a left ventricular assist device (LVAD) implantation. The trial is expected to enroll 20 patients at up to five clinical sites and will be funded by a previously announced $ 3.6 million National Institutes of Health (NIH) grant awarded to Innovative BioTherapies (IBT), which is led by SCD inventor H. David Humes, MD, Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor. Dr. Humes will serve as lead investigator for the study and SeaStar Medical will act as clinical research organization (CRO). The FDA has granted Breakthrough Device Designation for the SCD in cardiorenal syndrome awaiting LVAD implantation. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar's first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar's Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1955. These forward-looking statements include, without limitation, SeaStar Medical's expectations with respect to anticipated patient benefits and cost savings from our products; the expected regulatory approval process and timeline for our products; and the ability of SeaStar Medical to meet the expected timeline. Words such as 'believe,' 'project,' 'expect,' 'anticipate,' 'estimate,' 'intend,' 'strategy,' 'future,' 'opportunity,' 'plan,' 'may,' 'should,' 'will,' 'would,' 'will be,' 'will continue,' 'will likely result,' and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical's control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to secure additional financing on acceptable terms; (vi) the risk that third-party suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical's products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical's Annual Report on Form 10-K, including those under the 'Risk Factors' section therein and in SeaStar Medical's other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. For more information visit or visit us on LinkedIn or X. Contact: SeaStar Investor Relations: [email protected]
Associated Press
21-05-2025
- Business
- Associated Press
How SeaStar Medical Is Leveraging Its Breakthrough Medical Device Designation To Help Critically Ill Patients
By Meg Flippin Benzinga DETROIT, MICHIGAN - May 21, 2025 ( NEWMEDIAWIRE ) - Eric Schlorff, CEO of SeaStar Medical Holding Corp. (NASDAQ: ICU), was recently a guest on Benzinga's All-Access. SeaStar Medical seeks to bring organ-saving and life-saving solutions to critically ill patients who are suffering from hyperinflammation. The company's first therapy, QUELIMMUNE, which was approved by the U.S. Food and Drug Administration last year, is designed to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. SeaStar is also engaged in a trial evaluating the safety and efficacy of its second proprietary Selective Cytopheretic Device (SCD) therapeutic in adults with AKI. That trial already has half of the adults enrolled and represents a market opportunity Schlorff says is worth about $4.5 billion a year. SeaStar, which has received several Breakthrough Device Status designations from the FDA, is betting its therapy can be broadly applied to many serious, life-threatening conditions. Watch the full interview here: Featured image byAnnie SprattonUnsplash. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originallypublished on further disclosureshere.
Business Insider
20-05-2025
- Business
- Business Insider
SeaStar Medical files to sell 4.74M shares of common stock for holders
17:04 EDT SeaStar Medical (ICU) files to sell 4.74M shares of common stock for holders Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Associated Press
12-05-2025
- Business
- Associated Press
SeaStar's QUELIMMUNE Therapy For Pediatric AKI Adopted By Hospitals In Multiple States, Adult Treatment In Pipeline
By Meg Flippin Benzinga DETROIT, MICHIGAN - May 12, 2025 ( NEWMEDIAWIRE ) - Pediatric acute kidney injury (AKI) impacts approximately 4,000 children in the U.S. each year, and the prognosis for these patients is grim. The mortality rate is 50%, they spend twice as long in the ICU, and more than 30% will develop chronic kidney disease following AKI - noted SeaStar Medical in its recent investor presentation. Yet finding effective treatments doesn't typically receive the same attention as adult AKI or other illnesses caused by infections, injuries and surgeries. SeaStar Medical (NASDAQ: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, is aiming to change that with QUELIMMUNE, the company's newly approved product to treat pediatric patients with AKI due to sepsis or a septic condition. The therapeutic device is connected in-line to an existing hemodialysis system's continuous renal replacement therapy (CRRT) circuit in the ICU. The QUELIMMUNE therapy was granted approval under a Humanitarian Device Exemption (HDE) by the Food and Drug Administration (FDA) in February 2024, with clinical data establishing safety and probable benefit for this use. SeaStar said pooled analysis from two non-controlled studies – SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02 – showed that pediatric patients treated with the QUELIMMUNE pediatric therapy had no device-related serious adverse events or device-related infections, a 77% survival rate and no dialysis dependency after 60 days. Clinical Benefits Beyond The Standard Of Care The FDA grants a Humanitarian Device Exemption (HDE) to medical devices for the treatment or diagnosis of rare diseases or conditions that impact fewer than 8,000 patients in the U.S. annually. What makes the QUELIMMUNE therapy so promising, reports SeaStar, is that customers are already reporting life-saving results where patients who had little hope for survival have returned to a normal life. 'In addition to compelling clinical benefits, QUELIMMUNE's ability to reduce healthcare costs is another reason for hospitals to adopt our therapeutic device,' said Eric Schlorff, SeaStar Medical CEO. 'Our data show that AKI patients treated with the SCD had no dialysis dependency 60 days after treatment. Because the cost for a single patient on dialysis is about $100,000 per year, eliminating this cost represents substantial and ongoing savings to the healthcare system. QUELIMMUNE therapy also has the potential to reduce the average length of hospital stay and to lower the rate of readmissions and post-acute emergency visits.' AKI is characterized by a sudden and temporary loss of kidney function and can be caused by several conditions, including sepsis, severe trauma, surgery and COVID-19. AKI can perpetuate destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially lead to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, patients may face complications, including chronic kidney disease or end-stage renal disease requiring dialysis. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. According to SeaStar, historical data shows that on average, U.S. hospitals incur costs of approximately $457,000 per pediatric AKI hospitalization that involves CRRT; a majority of whom had sepsis. Hospitals On Board Since QUELIMMUNE received HDE status from the FDA, SeaStar has been busy signing up hospitals as customers. The company notes that the process for hospitals to adopt a new product can be lengthy. In the case of the QUELIMMUNE therapy, a Post-Approval Registry requirement by the FDA adds an additional step to the process and that typically takes more time. Despite this additional hurdle, SeaStar says it currently has five customers using the QUELIMMUNE therapy and a robust pipeline of hospitals in the process of adoption. 'We are actively working to secure additional hospital clearances by gaining institutional review board (IRB) approvals for using the QUELIMMUNE therapy within their facilities,' said Tim Varacek, SeaStar Medical senior vice president, commercial and business operations, when announcing the most recent customer win. 'Currently, we are engaged with more than a dozen new medical centers, with seven of these hospitals advancing into the IRB approval process. Additionally, I'm pleased to report that several of our current customers have reordered QUELIMMUNE for their institutions since the beginning of this year.' Adults Up Next: A Potentially Larger Market While SeaStar is making inroads with pediatric AKI, it isn't stopping there. The company has now set its sights on treating adult patients with AKI, which it says is a bigger market to the tune of $4.5 billion. The company is currently engaged in a trial evaluating the safety and efficacy of its second proprietary SCD therapy in 200 adults with AKI in the ICU receiving continuous renal replacement therapy (CRRT). The trial is studying the 90-day mortality or dialysis dependency of patients treated with SCD in addition to CRRT as the standard of care, compared with the control group receiving only the CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. The company plans to conduct an interim analysis once it has reached the 90-day primary endpoint in the first 100 enrolled patients. The pooled data will be reviewed by an independent Data Safety Monitoring Review Board, or DSMB, to gauge patient safety, the validity of the study and whether there is scientific merit to continuing the trial. SeaStar says it anticipates this will occur later this year and, if there are no changes to the trial, the potential approval and launch of the treatment could occur sometime in 2026. Pediatric and adult AKI is a problem for many Americans, one that doesn't often get the attention it deserves. SeaStar is aiming to change that. With its pediatric product already in hospitals around the country, a trial underway for its adult-focused therapy and Breakthrough Medical Device Designation from the FDA for multiple other conditions, SeaStar is playing a progressive role in helping treat costly medical conditions that can lead to death – and is a company to watch for future developments that could impact the lives of many. Featured image byRobina WeermeijeronUnsplash This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originallypublished on Benzinga. Read further disclosureshere. View the original release on
Yahoo
30-04-2025
- Business
- Yahoo
SeaStar Medical Announces CEO Interview on Benzinga All Access to Occur Today at Approximately 10:50 am Eastern Time
DENVER, April 30, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today that Eric Schlorff, CEO of SeaStar Medical, will be a featured guest today, Wednesday, April 30th, at approximately 10:50 am Eastern Time on the Benzinga All Access Show. The event will be broadcast live and can be viewed at An archived recording of the presentation will be available on the investor relations section of the Sea Star Medical's website on the Events and Presentations page. About SeaStar Medical SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar's first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar's Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually. For more information visit or visit us on LinkedIn or X. Contact: IR@ in to access your portfolio
