Latest news with #QUELIMMUNE
Yahoo
08-07-2025
- Business
- Yahoo
SeaStar Medical Expands QUELIMMUNE Adoption for Critically Ill Pediatric Patients with Acute Kidney Injury (AKI)
Nationally Recognized Texas Children's Hospital Adds First-In-Class Therapy as a Potential Life-Saving Treatment in Ultra-Rare Cases of Pediatric AKI DENVER, July 08, 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 QUELIMMUNE therapy has been adopted for use by the nationally recognized Texas Children's Hospital. The QUELIMMUNE therapy was approved by the U.S. Food and Drug Administration (FDA) in 2024 under a Humanitarian Device Exemption application for pediatric patients with AKI due to sepsis or a septic condition on antibiotic therapy and requiring Renal Replacement Therapy (RRT). Clinical data from the FDA application and subsequently published in Kidney Medicine showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors at Day 60 after ICU discharge. 'We are thrilled that Texas Children's Hospital has begun adopting QUELIMMUNE as another potential means to save lives and help young patients avoid life-long dialysis,' stated Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. 'Since QUELIMMUNE's FDA approval, we have maintained a post-marketing registry, which has provided encouraging reports from multiple children's hospitals, highlighting organ-sparing and life-saving outcomes for pediatric patients who previously had little hope of survival.' SeaStar Medical introduced its Selective Cytopheretic Device (SCD) therapy under the brand name QUELIMMUNE to the pediatric market in mid-2024 based on the serious unmet need for organ-sparing and life-saving therapies in this patient population. The SCD therapy is designed to be broadly applicable 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. SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial that is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. It has received FDA Breakthrough Device Designation for this indication and five others, including: Systemic inflammatory response in adult cardiac surgery Systemic inflammatory response in pediatric cardiac surgery to prevent post-operative adverse complications and outcomes Adult cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation End-stage renal disease (ESRD) requiring chronic dialysis Adult hepatorenal Syndrome (HRS) About Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About QUELIMMUNE The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy. About NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. 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. 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 the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About the SeaStar Medical Selective Cytopheretic Device Therapy The Selective Cytopheretic Device (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 SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life. 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, 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. 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 enrollment and the expansion of the clinical trial sites; the total addressable market for adult SCD applications; the ability of SeaStar Medical to gain market share and generate sales with respect to the total addressable market for adult SCD applications; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; 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. Contact: IR@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-07-2025
- Business
- Yahoo
SeaStar Medical Announces Positive Nasdaq Listing Determination
DENVER, July 02, 2025 (GLOBE NEWSWIRE) -- 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 it has received confirmation from The Nasdaq Stock Market that the Company has evidenced compliance with the minimum $2.5 million stockholders' equity requirement and all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the previously disclosed listing matter has been closed. 'We are very pleased to have this hurdle behind us and can now turn our full attention to commercializing QUELIMMUNE and our clinical development of potential organ-sparing and life-saving therapies for critically ill adult patients,' stated Eric Schloff, CEO of SeaStar Medical. 'We will continue our diligent effort to manage our capital and create additional value to our stakeholders through expanded adoption of QUELIMMUNE and successful execution of our Selective Cytopheretic Device (SCD) therapy in our NEUTRALIZE-AKI pivotal trial in adult patient with Acute Kidney Injury (AKI) receiving continuous renal replacement therapy (CRRT).' About Acute Kidney Injury (AKI) and Hyperinflammation AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation. About QUELIMMUNE The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy. About the NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. 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. 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 the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About the SeaStar Medical Selective Cytopheretic Device Therapy The Selective Cytopheretic Device (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 SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life. 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. 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 managing our capital in the future; the expanded adoption of QUELIMMUNE; anticipated patient enrollment and the expansion of the clinical trial sites; the ability of SCD to treat patients with AKI and other diseases; the expected regulatory approval process and timeline for commercialization; 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. Contact: IR@ while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Associated Press
27-06-2025
- Health
- Associated Press
SeaStar's QUELIMMUNE Can Cut Pediatric Sepsis Deaths In Half
By Meg Flippin Benzinga DETROIT, MICHIGAN - June 27, 2025 ( NEWMEDIAWIRE ) - SeaStar Medical Holding Corp. (NASDAQ: ICU), the commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, has made a lot of inroads on that front with QUELIMMUNE. A humanitarian medical device, QUELIMMUNE treats pediatric patients with acute kidney injury or AKI due to sepsis or a septic condition. The QUELIMMUNE therapy received U.S. Food and Drug Administration approval in 2024 after clinical trials showed it could cut mortality in half from 50% to 25%. 'QUELIMMUNE is designed to target the innate immune response. When patients get very sick, it becomes very dysregulated and cells go haywire and trigger something called the cytokine storm,' said Dr. Kevin Chung, MD, Chief Medical Officer at SeaStar Medical. 'The QUELIMMUNE device is designed specifically to target the cytokine storm at the source of the storm and it is associated with really good outcomes, especially in the pediatric population where mortality was cut in half from 50% to 25%.' From The Golf Course To The ICU That was the case for Kurt, a young student and avid golfer who has won multiple golf awards even though he underwent two open-heart surgeries before his sixth birthday. Knowing at an early age that he couldn't compete in the sports other kids were playing, Kurt picked up golf and never looked back. But over the years, Kurt faced doctor visits and surgeries, culminating in a near-death experience. At the time, Kurt was being treated at Cincinnati Children's Hospital Medical Center, where Dr. Stuart L. Goldstein, MD, the lead researcher for QUELIMMUNE's two trials that led to the device's FDA approval, worked. Kurt went in for a planned surgery to address an artificial replacement from his pulmonary to aortic valve, but had to be opened up again two days later as a result of blood leaking from his heart at the site of surgery. Kurt was put on a ventilator and went into multiple-organ failure, caught hospital pneumonia, and ultimately endured a 12-day coma. He developed AKI and respiratory failure, and doctors prepared to put him on ECMO (Extracorporeal Membrane Oxygenation), a more invasive type of support. But Dr. Goldstein spoke with the on-staff cardiologist and Kurt's family and suggested that the QUELLIMUNE therapy would be helpful for him. 'Kurt just started to turn around within 24 to 48 hours and did not require ECMO. Kurt left the ICU within two to three weeks and resumed going back to school and golfing,' says Dr. Goldstein. 'It was quite dramatic and is emblematic of when we see this work, which is far more often than not, patients turn around really really quickly when you wouldn't expect them to.' A Christmas Miracle For Kurt's father, David, the QUELIMMUNE therapy was a last-ditch effort to save his son, who had been languishing in the ICU for eleven days. Every night, the doctors would offer up different therapies and treatment ideas to stop his son's organs from failing and as luck would have it, one evening David and his nephew, who is also a doctor, ran into Dr. Goldstein outside of his son's room. Dr. Goldstein said he thought the QUELIMMUNE therapy could help with the inflammation and the family decided, given the apparently bleak prognosis, to give it a try, recalls David. From day two on, the inflammatory markers improved and continued to get a lot better. 'The inflammatory markers improved every day,' says David. His son was woken from the coma on day six of treatment, December 24. 'It was a Christmas miracle. He was awake and his numbers were improving,' his father said. Kurt had a tough recovery ahead of him when he woke up. He entered the hospital weighing 150 pounds and left at about 120 pounds. But by the beginning of March, he had regained his strength and energy and was golfing again. That is one of the other aspects of the QUELIMMUNE therapy that astonishes Dr. Goldstein, and makes him so optimistic that the device can treat other children with AKI. Typically 10% to 30% of pediatric patients who survive an AKI episode require chronic dialysis, but Kurt didn't. 'It is nothing I've seen before in clinical medicine in the last quarter century,' said Dr. Goldstein. Featured image fromShutterstock 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.
Associated Press
27-06-2025
- Health
- Associated Press
EXECUTIVE INTERVIEW: SeaStar CMO And Pediatric Specialist Talk About Promising Therapy To Treat Pediatric AKI
By Meg Flippin, Benzinga DETROIT, MICHIGAN - June 27, 2025 ( NEWMEDIAWIRE ) - Dr. Kevin Chung, Chief Medical Officer at SeaStar Medical Holding Corporation (NASDAQ: ICU) and Dr. Stuart L. Goldstein, MD, from Cincinnati Children's Hospital Medical Center, were recently guests on Benzinga's All-Access. The two were on hand to discuss QUELIMMUNE, SeaStar Medical's humanitarian medical device that was granted U.S. FDA approval to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. Dr. Goldstein was the chief investigator for the two studies that led to the FDA approval. Pediatric AKI is a sudden episode of kidney failure that happens within a few hours or days. It can be brought on by several conditions including sepsis, severe trauma and surgery. AKI can cause 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. Treating The Untreatable There are about 4,000 cases of pediatric AKI each year in the U.S., Dr. Chung shared, and the mortality rate among those patients is high at 50%. QUELIMMUNE, which was granted approval under a Humanitarian Device Exemption (HDE) by the FDA in February 2024, was developed to treat AKI among children. 'QUELIMMUNE is designed to target the innate immune response. When patients get very sick, it becomes very dysregulated and cells go haywire and trigger something called the cytokine storm,' said Dr. Chung in the interview. 'The QUELIMMUNE device is designed specifically to target the cytokine storm at the source of the storm, and it is associated with really good outcomes, especially in the pediatric population where mortality was cut in half from 50% to 25%.' That reduction in mortality is quite promising given that while there have been medical advances in treating AKI over the years, including targeted medications, nothing has been able to help patients with AKI so severe that it requires dialysis or inflammation so bad that it has increased the chance of death, Dr. Goldstein noted. But QUELIMMUNE proved very effective in trials, surprising even Dr. Goldstein, and that is why it received FDA approval and is being used in hospitals around the country. 'What we saw as we started the initial trial is kids that had a 50% chance of mortality, not only did that go in half, but we saw a dramatic improvement almost in 24 to 48 hours, which was quite shocking to us frankly,' said Dr. Goldstein. What's more, of the patients who survived, they were off dialysis sixty to ninety days later, something unheard of. Typically, 10-30% of pediatric patients who survive an AKI episode require chronic dialysis, Dr. Goldstein shared. 'It's a dramatic improvement that you see almost within the first one to two days. It is nothing I've seen before in clinical medicine in the last quarter century,' he stated further. Looking Beyond Pediatric AKI In addition to treating pediatric AKI, SeaStar is currently engaged in a trial evaluating the safety and efficacy of QUELIMMUNE for treating adult AKI. The study has over 100 patients enrolled, and the company is shooting for a total of 200. Beyond that, Dr. Chung said the idea is to use QUELIMMUNE for any condition in which the innate immune system is disturbed. 'The therapy itself is organ- and disease-agnostic,' said Dr. Chung, noting the company has six Breakthrough Device Designations from the FDA. BDD is designed to encourage speedier development of certain medical devices when there is a reasonable chance of providing a better treatment or diagnosis than the current standard of care. The BDD status is reserved for those diseases that are life-threatening or can cause irreversibly debilitating effects on patients. 'Other disease states are definitely going to be next,' Dr. Chung told Benzinga. Featured image from Shutterstock . This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. This content was originally published on Benzinga. Read further disclosures here.
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
