FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
SeaStar Medical announces FDA Breakthrough Device Designation for its Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease patients requiring chronic hemodialysis. This marks the fourth Breakthrough designation for SCD, expanding the company's addressable U.S. patient population to 745,000 annually. The device targets over 480,000 U.S. individuals requiring in-center hemodialysis, with treatment costs around $100,000 per patient yearly. The SCD is designed to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy, potentially improving survival and quality of life for patients who currently face a 42% five-year survival rate.
SeaStar Medical annuncia la Designazione di Dispositivo Innovativo da parte della FDA per il suo Dispositivo Citoforetico Selettivo (SCD) per trattare l'infiammazione sistemica cronica nei pazienti con malattia renale allo stadio terminale che necessitano di emodialisi cronica. Questo rappresenta la quarta designazione Breakthrough per l'SCD, ampliando la popolazione di pazienti potenzialmente trattabili negli Stati Uniti a 745.000 ogni anno. Il dispositivo si rivolge a oltre 480.000 persone negli Stati Uniti che necessitano di emodialisi in centro, con costi di trattamento di circa 100.000 dollari per paziente all'anno. L'SCD è progettato per colpire selettivamente i neutrofili e i monociti proinfiammatori durante la terapia sostitutiva renale continua, migliorando potenzialmente la sopravvivenza e la qualità della vita dei pazienti che attualmente affrontano un tasso di sopravvivenza del 42% a cinque anni.
SeaStar Medical anuncia la Designación de Dispositivo Innovador por parte de la FDA para su Dispositivo Citofórico Selectivo (SCD) para tratar la inflamación sistémica crónica en pacientes con enfermedad renal en etapa terminal que requieren hemodiálisis crónica. Esta es la cuarta designación Breakthrough para el SCD, ampliando la población de pacientes elegibles en EE. UU. a 745,000 anualmente. El dispositivo se dirige a más de 480,000 individuos en EE. UU. que requieren hemodiálisis en el centro, con costos de tratamiento de alrededor de 100,000 dólares por paciente al año. El SCD está diseñado para enfocarse selectivamente en neutrófilos y monocitos proinflamatorios durante la terapia de reemplazo renal continua, mejorando potencialmente la supervivencia y la calidad de vida de los pacientes que actualmente enfrentan una tasa de supervivencia del 42% a cinco años.
SeaStar Medical은 만성 신장이식 환자의 만성 전신 염증을 치료하기 위한 선택적 세포 치료 기기 (SCD)에 대해 FDA의 혁신 기기 지정을 발표했습니다. 이는 SCD에 대한 네 번째 혁신 지정으로, 회사의 미국 환자 수를 매년 745,000명으로 확장합니다. 이 장치는 센터에서 혈액 투석이 필요한 480,000명 이상의 미국인들을 대상으로 하며, 환자 당 연간 치료비는 약 100,000달러입니다. SCD는 지속적인 신장 대체 요법 중에 선택적으로 염증을 유발하는 호중구와 단핵구를 표적으로 삼도록 설계되었으며, 현재 5년 생존율이 42%에 불과한 환자들의 생존율 및 삶의 질을 개선할 가능성이 있습니다.
SeaStar Medical annonce la désignation de Dispositif Innovant par la FDA pour son Dispositif Cytophorétique Sélectif (SCD) destiné à traiter l'inflammation systémique chronique chez les patients atteints de maladie rénale terminale nécessitant une hémodialyse chronique. C'est la quatrième désignation Breakthrough pour le SCD, élargissant la population de patients potentiellement traitables aux États-Unis à 745 000 par an. Le dispositif cible plus de 480 000 individus aux États-Unis nécessitant une hémodialyse à l'hôpital, avec des coûts de traitement d'environ 100 000 dollars par patient et par an. Le SCD est conçu pour cibler sélectivement les neutrophiles et les monocytes pro-inflammatoires pendant la thérapie de remplacement rénal continue, améliorant potentiellement la survie et la qualité de vie des patients qui font actuellement face à un taux de survie de 42 % sur cinq ans.
SeaStar Medical kündigt die FDA-Zulassung für seine selektive zytophoretische Vorrichtung (SCD) zur Behandlung von chronischer systemischer Entzündung bei Patienten mit terminaler Niereninsuffizienz an, die eine chronische Hämodialyse benötigen. Dies ist die vierte Breakthrough-Zulassung für die SCD, die die adressierbare US-Patientenpopulation auf jährlich 745.000 erweitert. Das Gerät richtet sich an über 480.000 Menschen in den USA, die eine stationäre Hämodialyse benötigen, mit Behandlungskosten von etwa 100.000 Dollar pro Patient und Jahr. Die SCD ist darauf ausgelegt, selektiv proinflammatorische Neutrophile und Monozyten während der kontinuierlichen Nierenersatztherapie zu bekämpfen, was potenziell die Überlebensraten und die Lebensqualität der Patienten verbessern könnte, die derzeit eine 5-Jahres-Überlebensrate von 42 % aufweisen.
- Fourth FDA Breakthrough Device Designation expands addressable market to 745,000 patients
- Large target market of 480,000 U.S. patients requiring chronic hemodialysis
- Significant revenue potential with treatment costs of $100,000 per patient annually
- Priority FDA review and enhanced development resources due to Breakthrough status
- No clinical efficacy data presented for chronic dialysis indication
- Product still requires full FDA approval before commercialization
Insights
The FDA's fourth Breakthrough Device Designation for SeaStar Medical's SCD represents a significant milestone in addressing chronic inflammation in dialysis patients. The device's potential market expansion to 745,000 patients annually in the U.S. is substantial, considering the current
The SCD's unique immunomodulating approach differentiates it from traditional blood purification methods by targeting and modifying inflammatory cells rather than simply removing them. This could lead to improved outcomes for ESRD patients who currently face a concerning
The Breakthrough designation will accelerate development and review processes, potentially leading to faster market access. With multiple indications now covered, including AKI, HRS and CRS-LVAD, SeaStar Medical is positioned to address a broader range of inflammatory conditions, significantly expanding their market potential.
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA
DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the receipt of a Breakthrough Device Designation from the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) for the Company’s patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis, also known as chronic dialysis. More than 480,000 individuals in the U.S. with ESRD are treated by in-center hemodialysis at least three times a week at a cost of approximately
“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to save lives and improve patient outcomes by targeting dysregulated immune responses. With this and the three prior Breakthrough Device Designations granted by the FDA, our addressable patient population in the U.S. has now reached at least 745,000 patients annually,” said Eric Schlorff, SeaStar Medical CEO, “This designation holds numerous benefits including enhanced access to FDA resources resulting in faster development, as well as priority review by the FDA, early access to patients and the potential for differentiated market positioning.”
“Patients with ESRD face an unacceptably high disease burden to include chronic fatigue, malnutrition, repeat hospitalizations, and a
In addition to chronic dialysis, the SCD has shown a measurable reduction in excessive inflammatory responses such as the reduction of solid organ dysfunction in a variety of preclinical and clinical studies, including sepsis, acute kidney injury, hepatorenal syndrome, cardiorenal syndrome, ischemia/reperfusion injury, intracerebral hemorrhage, cardiopulmonary bypass, chronic kidney disease, type 2 diabetes, acute respiratory distress syndrome and COVID-19, among others.
Selective Cytopheretic Device
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.
The SCD has been awarded FDA Breakthrough Therapy Designation for a total of four (4) indications, ranked by patient population:
- Chronic Dialysis
- Adult Acute Kidney Injury (AKI)
- Hepatorenal Syndrome (HRS)
- Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD)
About SeaStar Medical
SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com 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, the ability of the SCD to treat patients with in ESRD and with other diseases; anticipated patient enrollment; the expected addressable patient population; the anticipated benefits of Breakthrough Device Designation on our ability to develop the SCD; expected patient benefits from the SCD; 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 access funding under existing agreements; (vi) the risk that third-parties 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 does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Contact:
Alliance Advisors IR
Jody Cain
(310) 691-7100
Jcain@allianceadvisors.com
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FAQ
What is the new FDA Breakthrough Device Designation for SeaStar Medical's SCD (ICU)?
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