SeaStar Medical to Distribute QUELIMMUNE Directly to Hospital Customers
SeaStar Medical Holding (Nasdaq: ICU) announces it has taken full responsibility for direct sales, marketing, and distribution of QUELIMMUNE™, its FDA-approved therapeutic device for treating pediatric acute kidney injury (AKI) due to sepsis. The company's CEO, Eric Schlorff, emphasizes their focus on a successful commercial rollout and their ability to fulfill customer demand. SeaStar Medical is streamlining relationships with Institutional Review Boards at pediatric hospitals and providing clinical training to integrate QUELIMMUNE into existing hemofiltration systems.
The company reports exceeding expectations with initial demand and multiple reorders from their first customer, Cincinnati Children's. By assuming direct distribution, SeaStar Medical will now recognize 100% of revenue generated from QUELIMMUNE sales in the U.S., corresponding to 3-4 times more revenue per unit. QUELIMMUNE, operating under the Humanitarian Device Exemption, has shown promising clinical results, including a 77% reduction in mortality rate and no dialysis dependency at Day 60 in pediatric AKI patients requiring continuous kidney replacement therapy.
SeaStar Medical Holding (Nasdaq: ICU) annuncia di aver assunto la piena responsabilità per le vendite dirette, il marketing e la distribuzione di QUELIMMUNE™, il suo dispositivo terapeutico approvato dalla FDA per il trattamento dell'insufficienza renale acuta pediatrica (AKI) a causa di sepsi. Il CEO dell'azienda, Eric Schlorff, sottolinea l'importanza di un lancio commerciale di successo e della loro capacità di soddisfare la domanda dei clienti. SeaStar Medical sta semplificando i rapporti con i Comitati Etici presso gli ospedali pediatrici e fornendo formazione clinica per integrare QUELIMMUNE nei sistemi di emofiltrazione esistenti.
L'azienda riporta di aver superato le aspettative con la domanda iniziale e con molteplici riordini dal loro primo cliente, Cincinnati Children's. Assumendo la distribuzione diretta, SeaStar Medical riconoscerà ora il 100% delle entrate generate dalle vendite di QUELIMMUNE negli Stati Uniti, corrispondente a 3-4 volte più entrate per unità. QUELIMMUNE, operante sotto l'Esenzione per Dispositivi Umanitari, ha mostrato risultati clinici promettenti, inclusa una riduzione del 77% del tasso di mortalità e nessuna dipendenza dalla dialisi al Giorno 60 in pazienti pediatrici con AKI che richiedono terapia di sostituzione renale continua.
SeaStar Medical Holding (Nasdaq: ICU) anuncia que ha asumido la responsabilidad total de las ventas directas, el marketing y la distribución de QUELIMMUNE™, su dispositivo terapéutico aprobado por la FDA para tratar la lesión renal aguda pediátrica (AKI) debido a sepsis. El CEO de la compañía, Eric Schlorff, enfatiza su enfoque en un lanzamiento comercial exitoso y su capacidad para satisfacer la demanda del cliente. SeaStar Medical está simplificando las relaciones con los Comités de Revisión Institucional en hospitales pediátricos y ofreciendo capacitación clínica para integrar QUELIMMUNE en los sistemas de hemofiltración existentes.
La empresa informa que ha superado las expectativas con la demanda inicial y múltiples reordenes de su primer cliente, Cincinnati Children's. Al asumir la distribución directa, SeaStar Medical ahora reconocerá el 100% de los ingresos generados por las ventas de QUELIMMUNE en los EE. UU., lo que corresponde a 3-4 veces más ingresos por unidad. QUELIMMUNE, que opera bajo la Exención de Dispositivo Humanitario, ha demostrado resultados clínicos prometedores, incluyendo una reducción del 77% en la tasa de mortalidad y ninguna dependencia de diálisis en el Día 60 en pacientes pediátricos con AKI que requieren terapia de reemplazo renal continuo.
SeaStar Medical Holding (Nasdaq: ICU)는 패혈증으로 인한 소아 급성 신손상(AKI) 치료를 위한 FDA 승인 치료 장치인 QUELIMMUNE™의 판매, 마케팅 및 유통에 대한 전적인 책임을 맡았다고 발표했습니다. 회사의 CEO인 Eric Schlorff는 성공적인 상업 출시와 고객 수요를 충족할 수 있는 능력에 대한 집중을 강조했습니다. SeaStar Medical은 소아 병원의 기관 윤리위원회와의 관계를 간소화하고, 기존의 혈액 여과 시스템에 QUELIMMUNE을 통합하기 위해 임상 교육을 제공하고 있습니다.
회사는 초기 수요를 초과 달성했으며 첫 번째 고객인 Cincinnati Children's로부터 여러 번 재주문을 받았다고 보고합니다. 직접 유통을 맡게 됨에 따라 SeaStar Medical은 미국 내 QUELIMMUNE 판매로 발생하는 수익의 100%를 인식하게 되며, 이는 단위당 3-4 배 더 많은 수익에 해당합니다. 인도적 장치 면제를 통해 운영되는 QUELIMMUNE은 임상 결과에서도 희망적인 결과를 보였으며, 소아 AKI 환자에서 사망률이 77% 감소하고 60일 차에 투석 의존성이 없었습니다.
SeaStar Medical Holding (Nasdaq: ICU) annonce avoir pris l'entière responsabilité des ventes directes, du marketing et de la distribution de QUELIMMUNE™, son dispositif thérapeutique approuvé par la FDA pour traiter l'insuffisance rénale aiguë pédiatrique (AKI) due à la septicémie. Le PDG de l'entreprise, Eric Schlorff, souligne leur concentration sur un lancement commercial réussi et leur capacité à répondre à la demande des clients. SeaStar Medical simplifie les relations avec les comités d'éthique des hôpitaux pédiatriques et propose une formation clinique pour intégrer QUELIMMUNE dans les systèmes d'hémofiltration existants.
L'entreprise rapporte avoir dépassé les attentes avec la demande initiale et de nombreuses commandes répétées de son premier client, Cincinnati Children's. En assumant la distribution directe, SeaStar Medical reconnaîtra maintenant 100 % des revenus générés par les ventes de QUELIMMUNE aux États-Unis, correspondant à 3 à 4 fois plus de revenus par unité. QUELIMMUNE, opérant sous l'Exemption de Dispositif Humanitaire, a montré des résultats cliniques prometteurs, notamment une réduction de 77 % du taux de mortalité et aucune dépendance à la dialyse au Jour 60 chez les patients pédiatriques AKI nécessitant une thérapie de remplacement rénal continue.
SeaStar Medical Holding (Nasdaq: ICU) gibt bekannt, dass es die volle Verantwortung für den direkten Verkauf, das Marketing und die Distribution von QUELIMMUNE™, seinem von der FDA zugelassenen therapeutischen Gerät zur Behandlung von pädiatrischer akuter Nierenverletzung (AKI) aufgrund von Sepsis, übernommen hat. Der CEO des Unternehmens, Eric Schlorff, betont den Fokus auf einen erfolgreichen kommerziellen Start und die Fähigkeit, die Kundennachfrage zu erfüllen. SeaStar Medical vereinfacht die Beziehungen zu den Ethikkommissionen in pädiatrischen Krankenhäusern und bietet klinische Schulungen an, um QUELIMMUNE in bestehende Hämofiltrationssysteme zu integrieren.
Das Unternehmen berichtet, die Erwartungen mit der anfänglichen Nachfrage und mehreren Nachbestellungen von ihrem ersten Kunden, Cincinnati Children's, übertroffen zu haben. Durch die Übernahme der direkten Distribution wird SeaStar Medical nun 100% der Einnahmen aus dem Verkauf von QUELIMMUNE in den USA anerkennen, was 3-4 mal mehr Einnahmen pro Einheit entspricht. QUELIMMUNE, das unter der humanitären Geräteausnahme operiert, hat vielversprechende klinische Ergebnisse gezeigt, einschließlich einer Reduzierung der Sterblichkeitsrate um 77% und keiner Dialyseabhängigkeit am Tag 60 bei pädiatrischen AKI-Patienten, die eine kontinuierliche Nierenersatztherapie benötigen.
- Assumption of direct sales, marketing, and distribution of QUELIMMUNE, potentially improving control over operations
- Initial demand from first customer (Cincinnati Children's) exceeded expectations with multiple reorders
- Revenue recognition increase to 100% of QUELIMMUNE sales, resulting in 3-4 times more revenue per unit
- Clinical results showing 77% reduction in mortality rate for pediatric AKI patients treated with QUELIMMUNE
- FDA approval under Humanitarian Device Exemption (HDE) for QUELIMMUNE in pediatric AKI treatment
- market size of approximately 4,000 children with AKI requiring CKRT annually in the U.S.
- Potential challenges in scaling up direct distribution and marketing operations
Insights
The announcement of SeaStar Medical assuming direct responsibility for sales, marketing and distribution of QUELIMMUNE is a significant development. This strategic move allows the company to capture 3x-4x more revenue per unit, potentially boosting their financial performance. The initial demand from Cincinnati Children's Hospital, with multiple reorders, indicates promising market reception.
QUELIMMUNE's unique approach to treating pediatric acute kidney injury (AKI) due to sepsis addresses a critical medical need. With approximately 4,000 children requiring CKRT for AKI annually in the U.S. and a 50% mortality rate, this therapy could significantly impact patient outcomes. The reported 77% reduction in mortality rate and absence of dialysis dependency at Day 60 in clinical studies are particularly noteworthy.
The FDA's Breakthrough Device Designation for three additional indications suggests potential for market expansion. However, investors should note that the current approval is under a Humanitarian Device Exemption, which may limit the initial market size. The company's ability to navigate IRB processes and train hospital staff will be important for successful adoption and revenue growth.
SeaStar Medical's decision to take control of QUELIMMUNE's distribution is a strategic move that could significantly impact its financial performance. The company now stands to recognize 100% of revenue from QUELIMMUNE sales in the U.S., translating to a 3x-4x increase in revenue per unit. This has the potential to substantially boost the company's top line, assuming successful market penetration.
With a current market cap of
The initial demand from Cincinnati Children's Hospital is encouraging, but broader adoption rates and the company's ability to scale operations will be critical metrics to watch. The potential for expanded indications through Breakthrough Device Designations could open larger markets, but these are still in development stages. Investors should monitor the company's cash burn rate and path to profitability as it takes on this expanded commercial role.
DENVER, Oct. 22, 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 that it has assumed all responsibility for direct sales, marketing and distribution of QUELIMMUNE™ to hospital customers. QUELIMMUNE is SeaStar Medical’s therapeutic device approved for the treatment of pediatric acute kidney injury (AKI) due to sepsis or a septic-like condition.
“The SeaStar Medical team is focused on a successful commercial rollout with this game-changing therapy, QUELIMMUNE, to treat severely ill children. We have the infrastructure and operational capabilities in place to market and ship QUELIMMUNE directly to hospital customers and are confident we can seamlessly fulfill customer demand now and in the future,” said Eric Schlorff, SeaStar Medical CEO. “We are streamlining the ongoing business relationships with Institutional Review Board (IRB) processes with pediatric hospitals committed to bringing QUELIMMUNE into their institutions under the U.S. Food and Drug Administration (FDA) Humanitarian Use Device (HUD) requirements. Our clinical training team works directly with physicians and patient care teams in the intensive care units (ICUs) to integrate QUELIMMUNE into existing hemofiltration systems.”
“SeaStar Medical now has the flexibility to build the QUELIMMUNE business with our commercial infrastructure and explore new strategic partnerships that align with our interests and can accelerate the adoption of this life-saving technology to a critically ill population of children,” said Tim Varacek, SeaStar Medical Senior Vice President, Commercial & Business Operations. “We are pleased with the initial demand from our first customer, Cincinnati Children’s, which has exceeded our expectations with multiple reorders of QUELIMMUNE. We anticipate more demand for QUELIMMUNE in the coming months as additional hospitals are cleared for its use.”
Going forward, SeaStar Medical will recognize
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.
SeaStar Medical’s Selective Cytopheretic Device (SCD)
QUELIMMUNE is the brand name for the Selective Cytopheretic Device (SCD) Pediatric. The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous kidney replacement therapy (CKRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT 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 KRT, including dialysis. In addition to the approval of QUELIMMUNE in pediatric AKI, the SeaStar Medical SCD was awarded Breakthrough Device Designation in three additional indications:
- Cardiorenal Syndrome – Left Ventricular Assist Device (CRS-LVAD)
- Adult Acute Kidney Injury (AKI)
- Hepatorenal Syndrome (HRS)
QUELIMMUNE
QUELIMMUNE is being commercialized following FDA approval under a Humanitarian Device Exemption (HDE) application in February 2024 for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. SeaStar Medical met the applicable criteria for the HDE award with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who had few treatment options. Each year in the U.S. approximately 4,000 children with AKI require CKRT and those patient profiles are associated with high mortality. The mortality rate in children with AKI requiring CKRT is approximately 50 percent. Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD). 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 10 kilograms or more with AKI requiring CKRT treated with the QUELIMMUNE pediatric device had no device-related serious adverse events or device-related infections, a
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 meet the demand for and the revenue recognition on QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; anticipated patient enrollment and the expansion of the clinical trial sites; 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:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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FAQ
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