Nuwellis Marks First Commercial Sale of QUELIMMUNE™ Therapy to Cincinnati Children’s
Nuwellis, Inc. (Nasdaq: NUWE) has announced its first commercial sale of QUELIMMUNE™ therapy to Cincinnati Children's. QUELIMMUNE, developed by SeaStar Medical, is a novel treatment for pediatric patients with acute kidney injury (AKI) due to sepsis requiring kidney replacement therapy. The therapy, accessible under an FDA Humanitarian Device Exemption, has shown a 77% survival rate in early clinical data.
This milestone marks a significant advancement in pediatric critical care. Dr. Stuart Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital and Principal Investigator of the multi-center studies leading to FDA clearance, expressed enthusiasm for integrating QUELIMMUNE into their treatment arsenal. Nuwellis' exclusive U.S. license and distribution agreement with SeaStar Medical enables the commercialization of this innovative therapy.
- First commercial sale of QUELIMMUNE™ therapy to Cincinnati Children's
- Early clinical data shows 77% survival rate for patients treated with QUELIMMUNE
- Exclusive U.S. license and distribution agreement with SeaStar Medical for QUELIMMUNE
- FDA Humanitarian Device Exemption (HDE) approval for QUELIMMUNE
- None.
Insights
The introduction of QUELIMMUNE™ in the market is indeed a significant development in pediatric critical care. Early clinical data showcasing a 77% survival rate for patients treated with this therapy is promising. QUELIMMUNE, which operates under a Humanitarian Device Exemption (HDE) from the FDA, offers a novel treatment for pediatric patients with acute kidney injury (AKI) resulting from sepsis. This exemption usually indicates that the device addresses a rare condition and has potential benefits that outweigh the risks. Hence, QUELIMMUNE could become a vital tool for nephrologists and intensive care physicians.
For retail investors, understanding the rarity and seriousness of pediatric AKI could be key. Traditional therapies have not shown substantial improvement in outcomes over the past two decades, making QUELIMMUNE a potential game-changer. This can translate to significant demand and adoption in specialized pediatric centers.
The first commercial sale of QUELIMMUNE is a noteworthy milestone for Nuwellis, as it demonstrates initial market acceptance and provides a revenue stream. The partnership with Cincinnati Children’s, a highly reputed institution, also adds credibility to the product. Collaborations with reputable hospitals can often lead to wider adoption and faster market penetration. Importantly, the exclusivity agreement with SeaStar Medical positions Nuwellis favorably in the pediatric nephrology market.
For investors, this milestone can be seen as an indicator of potential future growth in a niche market. The success of QUELIMMUNE could enhance the company's revenue and market share in the long term. However, it's also important to consider the competitive landscape and other emerging therapies in the pipeline.
Financially, the first commercial sale of QUELIMMUNE is a positive indicator for Nuwellis. A successful rollout can have a favorable impact on the revenue streams and profitability of the company. Furthermore, the Humanitarian Device Exemption from the FDA suggests lower regulatory hurdles, which can reduce costs and expedite market introduction. Investors should monitor the sales trajectory and adoption rates closely, as they can significantly influence Nuwellis' financial performance in the coming quarters.
While initial sales are a positive sign, it's important to watch for the following: consistent sales growth, cost management in production and distribution and feedback from the clinical community. These factors will determine the sustainability and scale of QUELIMMUNE’s success.
MINNEAPOLIS, July 17, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, is proud to announce its first commercial sale of QUELIMMUNE™, a novel therapy developed by SeaStar Medical Holding Corporation for pediatric patients suffering from an uncontrolled inflammatory response triggered by their immune systems, to Cincinnati Children’s. We believe this milestone marks a significant advancement in pediatric critical care and underscores Nuwellis’ commitment to revolutionizing pediatric patient outcomes.
QUELIMMUNE, or Selective Cytopheretic Device for pediatrics, represents a transformative solution for pediatric patients suffering from acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring kidney replacement therapy (KRT). Early clinical data suggest a
Dr. Stuart Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital, and Principal Investigator of the multi-center studies that led to FDA clearance of QUELIMMUNE, expressed his enthusiasm for the introduction of QUELIMMUNE as standard of care: "We are excited to integrate QUELIMMUNE into our arsenal of therapies for critically ill children with sepsis and AKI requiring CKRT. This innovative treatment offers new hope for this population that had not seen improvement in outcomes for the last 20 years."
Nestor Jaramillo, President and CEO of Nuwellis, emphasized the company’s dedication to advancing pediatric healthcare through strategic collaborations and innovative solutions: "The first commercial sale of QUELIMMUNE marks a significant achievement in our pediatric business development strategy. We are excited to collaborate with SeaStar Medical to deliver this life-saving therapy to critically ill patients, reinforcing Nuwellis’ commitment to driving positive change in pediatric critical care."
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
- Goldstein, Stuart L., et al. Use of the Selective Cytopheretic Device to Support Critically Ill Children Requiring Continuous Renal Replacement Therapy: A Probable Benefit-Risk Assessment. medRxiv, 2023.08.22.23294378; doi: https://doi.org/10.1101/2023.08.22.23294378
FAQ
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