SeaStar Medical Reaches Milestone of 100th QUELIMMUNE Commercial Device as Shipments Begin to its Third Hospital Customer
SeaStar Medical has begun shipping QUELIMMUNE to its third hospital customer, marking the milestone of 100 therapeutic devices shipped since its commercial launch in July. QUELIMMUNE, the company's Selective Cytopheretic Device (SCD), treats critically ill children in ICU with acute kidney injury and sepsis. The company is on track to make QUELIMMUNE available in 4-5 leading pediatric hospitals by end of 2024. The device requires hospital-specific IRB approval and integration with existing hemodialysis equipment. Treatment typically requires 3-7 days, with daily cartridge replacement. Recent data presented at Kidney Week 2024 showed projected cost savings driven by lower expected death rates and shorter hospital stays versus standard care.
SeaStar Medical ha iniziato a spedire QUELIMMUNE al suo terzo cliente ospedaliero, segnando il traguardo di 100 dispositivi terapeutici spediti dalla sua commercializzazione a luglio. QUELIMMUNE, il dispositivo selettivo per la citoferesi (SCD) dell'azienda, tratta bambini gravemente malati in terapia intensiva con danni renali acuti e sepsi. L'azienda è sulla buona strada per rendere QUELIMMUNE disponibile in 4-5 principali ospedali pediatrici entro la fine del 2024. Il dispositivo richiede l'approvazione dell'IRB specifico per l'ospedale e l'integrazione con le attrezzature di emodialisi esistenti. Il trattamento richiede tipicamente 3-7 giorni, con sostituzione giornaliera della cartuccia. Dati recenti presentati alla Kidney Week 2024 hanno mostrato risparmi sui costi previsti, sostenuti da tassi di mortalità più bassi e periodi di ricovero più brevi rispetto alle cure standard.
SeaStar Medical ha comenzado a enviar QUELIMMUNE a su tercer cliente hospitalario, marcando el hito de 100 dispositivos terapéuticos enviados desde su lanzamiento comercial en julio. QUELIMMUNE, el dispositivo selectivo de citoferesis (SCD) de la empresa, trata a niños gravemente enfermos en UCI con lesiones renales agudas y sepsis. La empresa está en camino de hacer que QUELIMMUNE esté disponible en 4-5 hospitales pediátricos líderes para fines de 2024. El dispositivo requiere aprobación del IRB específico del hospital e integración con el equipo de hemodiálisis existente. El tratamiento típicamente requiere de 3 a 7 días, con reemplazo diario del cartucho. Datos recientes presentados en la Kidney Week 2024 mostraron ahorros de costos proyectados impulsados por tasas de mortalidad esperadas más bajas y estancias hospitalarias más cortas en comparación con la atención estándar.
SeaStar Medical는 세 번째 병원 고객에게 QUELIMMUNE의 배송을 시작하여 7월 상업 출범 이후 100개의 치료 장치가 배송된 이정표를 세웠습니다. QUELIMMUNE은 회사의 선택적 세포 치료 장치(SCD)로, 급성 신손상 및 패혈증에 시달리는 중환자실의 심각한 질환 아동을 치료합니다. 이 회사는 2024년 말까지 4-5개의 주요 소아 병원에서 QUELIMMUNE을 이용할 수 있도록 할 계획입니다. 이 장치는 병원별 IRB 승인을 필요로 하며 기존의 투석 장비와의 통합이 필요합니다. 치료는 일반적으로 3-7일이 소요되며, 매일 카트리지를 교체해야 합니다. 2024 Kidney Week에서 발표된 최근 데이터에 따르면, 표준 치료에 비해 기대되는 낮은 사망률과 짧은 입원 기간에 의해 비용 절감 효과가 예상된다고 합니다.
SeaStar Medical a commencé à expédier QUELIMMUNE à son troisième client hospitalier, marquant le jalon de 100 dispositifs thérapeutiques expédiés depuis son lancement commercial en juillet. QUELIMMUNE, le dispositif de cytophérèse sélective (SCD) de l'entreprise, traite des enfants gravement malades en soins intensifs souffrant de lésions rénales aiguës et de sepsie. L'entreprise prévoit de rendre QUELIMMUNE disponible dans 4 à 5 hôpitaux pédiatriques de premier plan d'ici la fin de 2024. Le dispositif nécessite une approbation IRB spécifique à l'hôpital et une intégration avec l'équipement d'hémodialyse existant. Le traitement nécessite généralement entre 3 et 7 jours, avec un remplacement quotidien de la cartouche. Les données récentes présentées lors de la Kidney Week 2024 ont montré des économies de coûts projetées, entraînées par des taux de mortalité attendus plus bas et des durées de séjour à l'hôpital plus courtes par rapport aux soins standard.
SeaStar Medical hat mit dem Versand von QUELIMMUNE an seinen dritten Krankenhauskunden begonnen, was den Meilenstein von 100 seit der Markteinführung im Juli versandten therapeutischen Geräten markiert. QUELIMMUNE, das selektive zytopheretische Gerät (SCD) des Unternehmens, behandelt schwerkranke Kinder auf der Intensivstation mit akuter Niereninsuffizienz und Sepsis. Das Unternehmen ist auf Kurs, QUELIMMUNE bis Ende 2024 in 4-5 führenden pädiatrischen Krankenhäusern verfügbar zu machen. Das Gerät erfordert die spezifische IRB-Genehmigung des Krankenhauses und die Integration mit bestehenden Hämodialysegeräten. Die Behandlung dauert typischerweise 3-7 Tage, mit täglichem Austausch der Kartusche. Jüngste Daten, die auf der Kidney Week 2024 präsentiert wurden, zeigten die erwarteten Kosteneinsparungen, die durch niedrigere Sterblichkeitsraten und kürzere Krankenhausaufenthalte im Vergleich zur Standardversorgung erzielt werden.
- Reached milestone of 100 QUELIMMUNE devices shipped since July launch
- Expanded to third hospital customer
- On track to reach 4-5 pediatric hospitals by end of 2024
- Data shows cost savings potential through reduced mortality rates and shorter hospital stays
- market access due to required hospital-specific IRB approvals
- Daily cartridge replacement requirement increases treatment costs
- Restricted to patients weighing 10 kilograms or more
Insights
The milestone of 100 QUELIMMUNE device shipments and expansion to a third hospital customer represents significant commercial traction for SeaStar Medical's novel therapeutic device. The key commercial metrics include:
- Implementation of direct sales model yielding two new customers in weeks
- On track to reach 4-5 leading pediatric hospitals by end of 2024
- 100+ disposable devices shipped since July launch
- Treatment duration of 3-7 days per patient with daily cartridge replacement
The device's unique immunomodulation approach targeting hyperinflammation, combined with projected cost savings from reduced mortality and hospital stays, positions it well for further adoption. The expansion beyond initial customers validates both market demand and the company's ability to navigate complex HUD requirements and hospital clearance processes.
DENVER, Nov. 15, 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, has begun shipping QUELIMMUNE™ to a third hospital customer. QUELIMMUNE is the Company’s Selective Cytopheretic Device (SCD) for treating critically ill children in the intensive care unit (ICU) with acute kidney injury (AKI) and sepsis.
“Within weeks of implementing our direct sales model we have added two commercial customers, underscoring our team’s ability to assist hospitals with the Humanitarian Use Device (HUD) requirements and seamlessly fulfill their orders,” said Tim Varacek, SeaStar Medical Senior Vice President, Commercial & Business Operations. “We are delighted that QUELIMMUNE is now available to more children who may benefit from our potentially lifesaving therapeutic device as we continue efforts to secure additional hospital clearances. Our recent progress puts us on track for our goal of having QUELIMMUNE commercially available in the ICUs of four to five leading pediatric hospitals by the end of 2024.”
“Demand for QUELIMMUNE has been impressive as we’ve now shipped more than 100 disposable therapeutic devices since our commercial launch in July,” said Eric Schlorff, SeaStar Medical CEO. “We are supporting further adoption with data presented at Kidney Week 2024 showing the projected cost savings to hospitals treating these critically ill children, principally driven by the lower expected death rate and shorter length of hospital stay versus standard of care.”
QUELIMMUNE
QUELIMMUNE is SeaStar Medicals’ Selective Cytopheretic Device (SCD-PED) approved for the treatment of patients weighing 10 kilograms or more with AKI and sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT). QUELIMMUNE was granted U.S. Food and Drug Administration (FDA) approval under a Humanitarian Device Exemption (HDE) requiring hospitals to meet HUD requirements for commercial use. QUELIMMUNE is required to gain institutional review board (IRB) approval from each hospital, with IRBs signing off on the protocol for using the device within their facility as well as additional hospital clearances, training of critical care teams on integrating the QUELIMMUNE device into existing hemodialysis equipment and a patient registry.
QUELIMMUNE consists of an SCD-PED cartridge and blood tubing set that are connected in-line to an existing hemodialysis delivery system’s extracorporeal continuous renal replacement therapy (CRRT) circuit in a process that takes about 15 minutes. The Company expects that, on average, a full course of treatment for children with AKI will require three to seven days, with the disposable SCD-PED cartridge being replaced every 24 hours.
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 COVID-19, 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 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 chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
Selective Cytopheretic Device (SCD)
QUELIMMUNE is the brand name of SeaStar Medical’s SCD-PED. It was approved in February 2024 under an HDE application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited patient population who have few treatment options. The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CRRT. 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.
SeaStar Medical is conducting the NEUTRALIZE-AKI pivotal trial to evaluate the safety and effectiveness of its SCD in the larger patient population of adults with AKI in the ICU receiving CRRT. The SCD-ADULT device has received FDA Breakthrough Device Designation for this indication, which is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. The Company is exploring the SCD’s application across a range of acute and chronic indications involving dysregulated immune processes where proinflammatory activated neutrophils and monocytes may contribute to disease progression or severity.
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 amount and timing of future QUELIMMUNE commercial sales; the ability of SeaStar Medical to add additional new customers, including the ability to make QUELIMMUNE commercially available in the ICUs of four to five leading pediatric hospitals by the end of 2024; the ability of SeaStar Medical to meet the demand for and the revenue recognition on QUELIMMUNE commercial sales; commercial acceptance and availability of QUELIMMUNE; the benefits of QUELIMMUNE to providers and patients, including projected cost savings; the ability of SCD to treat patients with AKI and other diseases, including lower projected death rates and shorter lengths of hospital stays; 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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