FDA Grants SeaStar Medical Two New Breakthrough Device Designations for SCD Therapy to Treat Systemic Inflammatory Response in Adult and Pediatric Patients Undergoing Cardiac Surgery
SeaStar Medical (Nasdaq: ICU) has received two new FDA Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy, targeting systemic inflammatory response in both adult and pediatric cardiac surgery patients. The designations aim to prevent post-operative complications in high-risk populations.
The potential market includes approximately 45,000 patients annually - 15% of 300,000 adult cardiac surgery patients and one-third of 40,000 pediatric congenital heart surgery patients. These new designations bring SeaStar's total to six, highlighting the critical need for effective hyperinflammation treatment.
The company is currently commercializing QUELIMMUNE for pediatric acute kidney injury treatment and conducting the NEUTRALIZE-AKI pivotal trial for adult patients. SeaStar's six Breakthrough Device Designations, granted between April 2022 and March 2025, cover treatments for Adult AKI, cardiac surgery inflammation, cardiorenal syndrome, ESRD, and hepatorenal syndrome.
SeaStar Medical (Nasdaq: ICU) ha ricevuto due nuove Designazioni di Dispositivo Innovativo dalla FDA per la sua terapia con Dispositivo Citoforetico Selettivo (SCD), mirata a rispondere all'infiammazione sistemica in pazienti adulti e pediatrici sottoposti a chirurgia cardiaca. Le designazioni hanno l'obiettivo di prevenire complicazioni post-operatorie in popolazioni ad alto rischio.
Il mercato potenziale comprende circa 45.000 pazienti all'anno - il 15% dei 300.000 pazienti adulti sottoposti a chirurgia cardiaca e un terzo dei 40.000 pazienti pediatrici con malformazioni cardiache. Queste nuove designazioni portano il totale di SeaStar a sei, evidenziando la necessità critica di trattamenti efficaci contro l'iperinfiammazione.
L'azienda sta attualmente commercializzando QUELIMMUNE per il trattamento dell'insufficienza renale acuta pediatrica e conducendo lo studio clinico NEUTRALIZE-AKI per pazienti adulti. Le sei Designazioni di Dispositivo Innovativo di SeaStar, concesse tra aprile 2022 e marzo 2025, coprono trattamenti per l'insufficienza renale acuta negli adulti, infiammazione da chirurgia cardiaca, sindrome cardiorenale, ESRD e sindrome epatorenale.
SeaStar Medical (Nasdaq: ICU) ha recibido dos nuevas Designaciones de Dispositivo Innovador de la FDA para su terapia con Dispositivo Citoforético Selectivo (SCD), dirigida a responder a la respuesta inflamatoria sistémica en pacientes adultos y pediátricos sometidos a cirugía cardíaca. Las designaciones tienen como objetivo prevenir complicaciones postoperatorias en poblaciones de alto riesgo.
El mercado potencial incluye aproximadamente 45,000 pacientes anualmente - el 15% de los 300,000 pacientes adultos sometidos a cirugía cardíaca y un tercio de los 40,000 pacientes pediátricos con cirugía cardíaca congénita. Estas nuevas designaciones elevan el total de SeaStar a seis, destacando la necesidad crítica de tratamientos efectivos para la hiperinflamación.
La empresa está comercializando actualmente QUELIMMUNE para el tratamiento de la lesión renal aguda pediátrica y llevando a cabo el ensayo pivotal NEUTRALIZE-AKI para pacientes adultos. Las seis Designaciones de Dispositivo Innovador de SeaStar, otorgadas entre abril de 2022 y marzo de 2025, abarcan tratamientos para la IRA en adultos, inflamación por cirugía cardíaca, síndrome cardiorrenal, ESRD y síndrome hepatorenal.
SeaStar Medical (Nasdaq: ICU)는 성인 및 소아 심장 수술 환자에서 전신 염증 반응을 목표로 하는 선택적 사이토퍼레틱 장치(SCD) 요법에 대해 FDA의 두 가지 새로운 혁신 기기 지정(Breakthrough Device Designation)을 받았습니다. 이 지정은 고위험군에서 수술 후 합병증을 예방하는 것을 목표로 합니다.
잠재적인 시장은 매년 약 45,000명의 환자를 포함합니다 - 30만 명의 성인 심장 수술 환자의 15%와 4만 명의 소아 선천성 심장 수술 환자의 3분의 1입니다. 이러한 새로운 지정은 SeaStar의 총 지정을 여섯 개로 늘리며, 효과적인 과염증 치료의 절실한 필요성을 강조합니다.
회사는 현재 소아 급성 신장 손상 치료를 위한 QUELIMMUNE을 상용화하고 있으며 성인 환자를 위한 NEUTRALIZE-AKI 주요 임상 시험을 진행하고 있습니다. SeaStar의 여섯 가지 혁신 기기 지정은 2022년 4월부터 2025년 3월까지 부여되었으며, 성인 IRA, 심장 수술 염증, 심장신장 증후군, ESRD 및 간신증후군 치료를 포함합니다.
SeaStar Medical (Nasdaq: ICU) a reçu deux nouvelles désignations de Dispositif Innovant de la FDA pour sa thérapie avec Dispositif Cytophérétique Sélectif (SCD), ciblant la réponse inflammatoire systémique chez les patients adultes et pédiatriques en chirurgie cardiaque. Les désignations visent à prévenir les complications post-opératoires dans les populations à haut risque.
Le marché potentiel comprend environ 45 000 patients par an - 15 % des 300 000 patients adultes ayant subi une chirurgie cardiaque et un tiers des 40 000 patients pédiatriques ayant une chirurgie cardiaque congénitale. Ces nouvelles désignations portent le total de SeaStar à six, soulignant le besoin critique de traitements efficaces contre l'hyperinflammation.
L'entreprise commercialise actuellement QUELIMMUNE pour le traitement de l'insuffisance rénale aiguë pédiatrique et mène l'essai pivot NEUTRALIZE-AKI pour les patients adultes. Les six désignations de Dispositif Innovant de SeaStar, accordées entre avril 2022 et mars 2025, couvrent les traitements pour l'IRA chez les adultes, l'inflammation due à la chirurgie cardiaque, le syndrome cardiorénal, l'ESRD et le syndrome hépatocéphalique.
SeaStar Medical (Nasdaq: ICU) hat zwei neue Durchbruch-Gerätebezeichnungen von der FDA für seine selektive zytopheretische Therapie (SCD) erhalten, die sich auf die systemische Entzündungsreaktion bei erwachsenen und pädiatrischen Herzchirurgie-Patienten konzentriert. Die Bezeichnungen zielen darauf ab, postoperative Komplikationen in Hochrisikopopulationen zu verhindern.
Der potenzielle Markt umfasst jährlich etwa 45.000 Patienten - 15% der 300.000 erwachsenen Herzchirurgie-Patienten und ein Drittel der 40.000 pädiatrischen Patienten mit angeborenen Herzfehlern. Diese neuen Bezeichnungen erhöhen die Gesamtzahl von SeaStar auf sechs und heben den kritischen Bedarf an wirksamen Behandlungen gegen Hyperinflammation hervor.
Das Unternehmen vermarktet derzeit QUELIMMUNE zur Behandlung von akuten Nierenschäden bei Kindern und führt die entscheidende Studie NEUTRALIZE-AKI für erwachsene Patienten durch. Die sechs Durchbruch-Gerätebezeichnungen von SeaStar, die zwischen April 2022 und März 2025 vergeben wurden, decken Behandlungen für akute Nierenschäden bei Erwachsenen, Entzündungen durch Herzoperationen, kardiorenales Syndrom, ESRD und hepatorenales Syndrom ab.
- Received two new FDA Breakthrough Device Designations, bringing total to six
- Large addressable market of 45,000 potential patients annually
- First commercial product QUELIMMUNE already in launch phase
- Planned PMA filing in 2026 following NEUTRALIZE-AKI trial
- Rare achievement of six CBER Breakthrough Designations (only 12 granted between 2015-2024)
- PMA filing not expected until 2026
- Success of NEUTRALIZE-AKI trial still pending
- Currently to Humanitarian Device Exemption for pediatric AKI patients
Insights
SeaStar Medical securing two additional FDA Breakthrough Device Designations represents a significant regulatory milestone that substantially strengthens their portfolio. With six total designations granted between 2022-2025, this achievement is particularly remarkable considering the FDA's Center for Biologic Evaluation and Research (CBER) granted only 12 such designations between 2015-2024.
The Breakthrough Device program offers several tangible benefits: accelerated development timelines, prioritized FDA review, and enhanced communication with regulators. For a small-cap company like SeaStar, these advantages can materially reduce time-to-market and development costs while potentially providing earlier revenue generation.
The specific cardiac surgery indications targeted—both adult and pediatric—address areas with substantial unmet medical needs. Post-cardiopulmonary bypass inflammation remains a significant clinical challenge with few effective interventions currently available. The timing aligns strategically with their existing QUELIMMUNE commercialization and ongoing NEUTRALIZE-AKI pivotal trial, creating a logical pipeline expansion rather than resource-diluting diversification.
While these designations don't guarantee ultimate approval, they signal FDA recognition that SeaStar's technology could provide substantial improvements over existing treatments for life-threatening conditions. This regulatory validation substantially derisks their development pathway and positions them to potentially establish first-mover advantage in these cardiac surgery indications.
SeaStar's expansion into cardiac surgery applications unlocks substantial new market opportunities for their Selective Cytopheretic Device technology. The company has carefully quantified their target populations:
This strategic expansion effectively diversifies SeaStar's revenue potential beyond their initial pediatric AKI therapy (QUELIMMUNE) currently in early commercialization. The cardiac surgery market offers several commercial advantages: well-defined patient populations, concentrated treatment centers, established reimbursement pathways, and potentially shorter sales cycles compared to broader critical care applications.
The company's methodical approach—building a portfolio of indications addressing hyperinflammation across different conditions—positions them to leverage a common technological platform across multiple revenue streams while potentially sharing clinical development and manufacturing resources. This platform strategy typically commands higher valuation multiples than single-product companies.
For investors, these new designations strengthen SeaStar's competitive positioning in the specialized medical device sector. With one commercialized product, a pivotal trial underway, and now an expanded pipeline with regulatory advantages, the company is executing a clear strategy to address multiple underserved markets with significant unmet needs. Their focus on critical care applications with existing solutions could support premium pricing if clinical benefits are demonstrated in their development programs.
DENVER, April 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 U.S. Food and Drug Administration (FDA) has granted SeaStar Medical two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy. The two new Breakthrough Device Designations are indicated for the treatment of systemic inflammatory response in 1) adult patients undergoing cardiac surgery and 2) pediatric patients undergoing cardiac surgery towards prevention of post-operative adverse complications and outcomes. Approximately 15 percent of the estimated 300,000 adults that undergo cardiac surgery each year are considered high risk and, we believe, could benefit most from the SCD therapy to prevent post-surgical complications. Of the 40,000 pediatric patients that undergo congenital heart surgery each year, we believe that approximately one third might benefit from SCD therapy.
“These two new Breakthrough Device Designations bring our total to six, underscoring the importance and critical need for a therapy that can effectively treat hyperinflammation that destroys organs and takes far too many lives each year,” stated Eric Schlorff, SeaStar Medical CEO. “These new indications add to our growing pipeline of product candidates and extend further our total market opportunity. With our first commercial product, QUELIMMUNE, in the initial launch phase and the PMA filing in 2026 that would follow a successful NEUTRALIZE-AKI trial, we believe we are executing on our strategic commercial plans to effectively address severely underserved markets with our first-in-class SCD therapy.”
Kevin Chung, MD, Chief Medical Officer of SeaStar, stated, “Cardiopulmonary bypass (CPB) during heart surgery has long been associated with hyperinflammation with downstream clinical complications that impact multiple organs such as the kidneys, heart, brain, and lungs, among others. It is most unfortunate for someone to undergo lifesaving surgery, only to succumb to the consequences of uncontrolled inflammation. We believe the SCD therapy can optimize conditions to allow for a successful recovery after this type of surgery.”
SeaStar Medical is currently commercializing its first SCD therapy, QUELIMMUNE, under a Humanitarian Device Exemption for the treatment of critically ill pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. It plans to expand its proprietary SCD therapy into the broader adult patient population. The company is conducting a pivotal clinical trial, NEUTRALIZE-AKI, in adult patients with AKI and is also conducting an investigational study in patients with cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation. Both indications have been granted Breakthrough Device Designation by FDA.
The Breakthrough Device Designation is designed to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and provides timely access to medical devices by speeding up development, assessment, and review for FDA approval. The designation is rare. According to the FDA, just over 1000 Breakthrough Device Designations were granted by the FDA and only 12 Breakthrough Device Designations were granted by the Center for Biologic Evaluation and Research (CBER) between 2015 and September 2024. SeaStar Medical’s six Breakthrough Device Designations, including its first designation for a pediatric indication, were granted by CBER between April 2022 and March 2025 and include treatment of the following conditions:
- Adult AKI
- 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 LVAD implantation
- End-stage renal disease (ESRD) requiring chronic dialysis
- Adult hepatorenal Syndrome (HRS)
About the FDA’s Breakthrough Device Designation
FDA grants Breakthrough Device Designation when a device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. It must also represent one or more of the following: a) a breakthrough technology, b) a therapeutic treatment where no approved or cleared alternatives exist, c) offer significant advantages over existing approved or cleared alternative, and/or d) the device availability is in the best interest of patients. The Breakthrough Device Designation is designed to provide timely access to medical devices to speed up development, assessment, and review for FDA approval.
About the SeaStar Medical Selective Cytopheretic Device Therapy
The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT hemofiltration systems 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 and eliminate the need for future RRT, including dialysis.
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 Medical’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.
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 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.
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Contact:
SeaStar Investor Relations:
IR@SeaStarMed.com
FAQ
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