Nuwellis Announces First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical’s QUELIMMUNE™ Therapy at Cincinnati Children’s
Nuwellis, Inc. (Nasdaq: NUWE) announced the first commercial use of QUELIMMUNE™ therapy at Cincinnati Children's hospital. QUELIMMUNE, manufactured by SeaStar Medical (Nasdaq: ICU) and exclusively distributed by Nuwellis in U.S. pediatric hospitals, is designed to treat pediatric patients with acute kidney injury (AKI) and sepsis requiring kidney replacement therapy. Dr. Stuart Goldstein, who led the multi-center studies for FDA clearance, oversaw the treatment.
The therapy aims to mitigate cytokine storms caused by AKI and sepsis, potentially improving outcomes for critically ill children. Approximately 4,000 pediatric patients are hospitalized with AKI annually in the U.S. This milestone aligns with Nuwellis' pediatric business development strategy and their partnership with SeaStar Medical to bring innovative treatments to healthcare providers.
Nuwellis, Inc. (Nasdaq: NUWE) ha annunciato il primo utilizzo commerciale della terapia QUELIMMUNE™ presso l'ospedale pediatrico di Cincinnati. QUELIMMUNE, prodotto da SeaStar Medical (Nasdaq: ICU) e distribuito esclusivamente da Nuwellis negli ospedali pediatrici degli Stati Uniti, è progettato per trattare pazienti pediatrici con lesioni renali acute (AKI) e sepsi che richiedono terapia sostitutiva renale. Il Dr. Stuart Goldstein, che ha guidato gli studi multicentrici per l'approvazione della FDA, ha supervisionato il trattamento.
La terapia mira a mitigare le tempeste di citochine causate da AKI e sepsi, migliorando potenzialmente i risultati per i bambini gravemente malati. Circa 4.000 pazienti pediatrici vengono ricoverati ogni anno negli Stati Uniti a causa di AKI. Questo traguardo si allinea con la strategia di sviluppo del business pediatrico di Nuwellis e con la loro partnership con SeaStar Medical per portare trattamenti innovativi ai fornitori di assistenza sanitaria.
Nuwellis, Inc. (Nasdaq: NUWE) anunció el primer uso comercial de la terapia QUELIMMUNE™ en el hospital infantil de Cincinnati. QUELIMMUNE, fabricado por SeaStar Medical (Nasdaq: ICU) y distribuido exclusivamente por Nuwellis en hospitales pediátricos de EE. UU., está diseñado para tratar pacientes pediátricos con lesión renal aguda (AKI) y sepsis que requieren terapia de reemplazo renal. El Dr. Stuart Goldstein, quien lideró los estudios multicéntricos para la aprobación de la FDA, supervisó el tratamiento.
La terapia tiene como objetivo mitigar las tormentas de citoquinas causadas por AKI y sepsis, mejorando potencialmente los resultados para los niños gravemente enfermos. Aproximadamente 4,000 pacientes pediátricos son hospitalizados con AKI anualmente en EE. UU. Este hito se alinea con la estrategia de desarrollo de negocios pediátricos de Nuwellis y su asociación con SeaStar Medical para llevar tratamientos innovadores a los proveedores de atención médica.
Nuwellis, Inc. (Nasdaq: NUWE)는 신시내티 아동병원에서 QUELIMMUNE™ 치료법을 상업적으로 최초로 사용했다고 발표했습니다. SeaStar Medical (Nasdaq: ICU)에서 제조하고 Nuwellis가 미국의 소아 병원에 독점적으로 배급하는 QUELIMMUNE은 신장 대체 치료가 필요한 급성 신손상(AKI) 및 패혈증이 있는 소아 환자를 치료하도록 설계되었습니다. FDA 승인을 위한 다기관 연구를 이끈 Stuart Goldstein 박사가 치료를 감독했습니다.
이 치료법은 AKI 및 패혈증으로 인한 사이토카인 폭풍을 완화하여 중증 소아 환자의 결과를 개선하는 것을 목표로 합니다. 매년 미국에서 약 4,000명의 소아 환자가 AKI로 입원합니다. 이 이정표는 Nuwellis의 소아 비즈니스 개발 전략과 SeaStar Medical과의 파트너십이 혁신적인 치료를 의료 제공자에게 제공하는 것과 일치합니다.
Nuwellis, Inc. (Nasdaq: NUWE) a annoncé le premier usage commercial de la thérapie QUELIMMUNE™ à l'hôpital pour enfants de Cincinnati. QUELIMMUNE, fabriqué par SeaStar Medical (Nasdaq: ICU) et distribué exclusivement par Nuwellis dans les hôpitaux pédiatriques américains, est conçu pour traiter des patients pédiatriques souffrant de lésion rénale aiguë (AKI) et de sepsis nécessitant une thérapie de remplacement rénal. Le Dr Stuart Goldstein, qui a dirigé les études multicentriques pour l'approbation de la FDA, a supervisé le traitement.
La thérapie vise à atténuer les tempêtes de cytokines causées par l'Aki et le sepsis, améliorant potentiellement les résultats pour les enfants gravement malades. Environ 4 000 patients pédiatriques sont hospitalisés chaque année aux États-Unis en raison de l'Aki. Cette étape s'inscrit dans la stratégie de développement commercial pédiatrique de Nuwellis et dans leur partenariat avec SeaStar Medical pour apporter des traitements innovants aux fournisseurs de soins de santé.
Nuwellis, Inc. (Nasdaq: NUWE) hat die erste kommerzielle Anwendung der QUELIMMUNE™-Therapie im Cincinnati Children's Hospital angekündigt. QUELIMMUNE, hergestellt von SeaStar Medical (Nasdaq: ICU) und exklusiv von Nuwellis in US-amerikanischen Kinderkrankenhäusern vertrieben, ist darauf ausgelegt, padiatrische Patienten mit akutem Nierenversagen (AKI) und Sepsis zu behandeln, die eine Nierentransplantation benötigen. Dr. Stuart Goldstein, der die multizentrischen Studien zur FDA-Zulassung geleitet hat, überwachte die Behandlung.
Die Therapie soll Zytokinstürme reduzieren, die durch AKI und Sepsis verursacht werden, und so potenziell die Ergebnisse für schwer kranke Kinder verbessern. Jährlich werden in den USA etwa 4.000 pädiatrische Patienten mit AKI hospitalisiert. Dieser Meilenstein steht im Einklang mit der Strategie von Nuwellis zur Geschäftsentwicklung im pädiatrischen Bereich und ihrer Partnerschaft mit SeaStar Medical, um innovative Behandlungen zu medizinischen Anbietern zu bringen.
- First commercial use of QUELIMMUNE therapy, expanding Nuwellis' product offerings
- Exclusive distribution rights for QUELIMMUNE in U.S. pediatric hospitals
- Potential to improve outcomes for critically ill pediatric patients with AKI and sepsis
- Alignment with Nuwellis' pediatric business development strategy
- None.
Insights
The introduction of QUELIMMUNE™ therapy in a commercial setting marks a significant milestone in pediatric nephrology. This novel treatment, designed for children weighing 10 kg or more with acute kidney injury (AKI) and sepsis, addresses a critical gap in current therapeutic options.
The therapy's potential to mitigate cytokine storms is particularly noteworthy. Cytokine storms, an overactive immune response, can lead to severe organ damage and are a major concern in sepsis cases. By targeting this mechanism, QUELIMMUNE™ could potentially reduce mortality rates and improve outcomes in this vulnerable patient population.
However, it's important to note that while the first commercial use is promising, long-term efficacy and safety data from wider clinical application will be essential. The approximately 4,000 pediatric patients hospitalized with AKI annually in the U.S. represent a significant market, but also underscore the need for careful monitoring of treatment outcomes.
From a research perspective, QUELIMMUNE™'s mechanism of action could open new avenues for understanding and treating immune dysregulation in other conditions. This could potentially lead to broader applications beyond AKI and sepsis in pediatric patients.
The commercial launch of QUELIMMUNE™ therapy represents a potentially significant revenue stream for Nuwellis (Nasdaq: NUWE) and SeaStar Medical (Nasdaq: ICU). With Nuwellis holding exclusive distribution rights for U.S. pediatric hospitals, this partnership could drive substantial growth in their pediatric business segment.
The addressable market of approximately 4,000 pediatric AKI patients annually in the U.S. suggests a niche but potentially lucrative opportunity. Assuming a high price point typical for specialized medical treatments, even a modest market penetration could translate to meaningful revenue.
However, investors should consider several factors:
- The rate of adoption among hospitals and physicians
- Reimbursement policies for this novel therapy
- Potential competition from other emerging treatments
- The cost of marketing and distributing the therapy
While this news is positive, it's important to note that the financial impact may take time to materialize. Nuwellis and SeaStar Medical will need to demonstrate consistent patient outcomes and cost-effectiveness to drive widespread adoption.
Investors should closely monitor upcoming quarterly reports for early indicators of QUELIMMUNE™'s commercial performance and its impact on both companies' financial health.
MINNEAPOLIS, July 26, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, today announced that the first patient has been treated with the newly launched QUELIMMUNE™ therapy in a commercial setting at Cincinnati Children’s. QUELIMMUNE, manufactured for SeaStar Medical (Nasdaq: ICU) and exclusively licensed and distributed in U.S. pediatric hospitals by Nuwellis, is a novel therapy designed to treat pediatric patients (weighing 10 kg or more) suffering from acute kidney injury (AKI) with sepsis or a septic condition and requiring kidney replacement therapy (KRT).
Dr. Stuart Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children’s, and Principal Investigator of the multi-center studies that led to FDA clearance of QUELIMMUNE, oversaw the administration of QUELIMMUNE to the first patient. Dr. Goldstein expressed his enthusiasm about the potential of this therapy: “We are excited to offer QUELIMMUNE to our critically ill pediatric patients. The ability to mitigate the devastating effects of a cytokine storm caused by acute kidney injury and sepsis holds significant promise for improving patient outcomes. This therapy represents an advancement in our efforts to provide the best care possible to these vulnerable patients.”
Nestor Jaramillo, President and CEO of Nuwellis, shared his thoughts on this milestone: “We are thrilled to introduce QUELIMMUNE to critically ill pediatric patients in need. This marks a significant step forward in Nuwellis’ mission to execute our pediatric business development strategy. By partnering with SeaStar Medical, we are committed to bringing this groundbreaking therapy to U.S. healthcare providers, offering new hope to children suffering from severe immune system reactions.”
Approximately 4,000 pediatric patients are hospitalized with AKI each year in the U.S.1 QUELIMMUNE is designed to address the underlying immune dysregulation in pediatric patients, aiming to reduce the incidence and severity of cytokine storms. This therapy represents a significant advancement in the management of AKI and sepsis, offering a novel approach to improving patient outcomes.
About QUELIMMUNE
QUELIMMUNE is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during KRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device is integrated with KRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. QUELIMMUNE selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X.
About SeaStar Medical
SeaStar Medical Holding Corporation 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. SeaStar Medical 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 https://seastarmedical.com/ or visit us on LinkedIn or X.
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2024 and beyond. 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 risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the impact of the COVID-19 pandemic, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
CONTACTS
Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
1) Data on File. America Hospital Directory Database Export January 2020
FAQ
What is QUELIMMUNE therapy and what does it treat?
Where was the first commercial treatment with QUELIMMUNE performed for Nuwellis (NUWE)?
How many pediatric patients are hospitalized with AKI annually in the U.S., according to Nuwellis (NUWE)?
Who manufactures QUELIMMUNE and who distributes it for Nuwellis (NUWE)?
