Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™

Rhea-AI Summary

Nuwellis, Inc. announces FDA approval for SeaStar Medical's pediatric Selective Cytopheretic Device, Quelimmune, to treat acute kidney injury and sepsis in children, showing a 50% mortality rate reduction. Nuwellis plans targeted commercial launch activities in 2024.

Insights

Medical Research Analyst

The FDA's Humanitarian Device Exemption (HDE) for SeaStar Medical's Quelimmune is a significant regulatory milestone, particularly for pediatric patients with acute kidney injury (AKI) and sepsis. The HDE allows for the marketing of medical devices that may help treat or diagnose conditions affecting fewer than 8,000 individuals in the United States per year. The approval of Quelimmune underscores the unmet medical need in this patient population and represents a breakthrough in pediatric nephrology.

From a medical research perspective, the 50% reduction in mortality rates and the absence of device-related adverse events in clinical studies are compelling data points. These outcomes suggest that Quelimmune could be a transformative treatment modality, potentially improving survival rates and reducing the need for dialysis, a common and burdensome treatment for AKI. Moreover, the device's ability to neutralize activated toxic immune cells addresses the cytokine storm, a critical and life-threatening complication of sepsis.

Market Research Analyst

From a market perspective, Nuwellis's exclusive U.S. distribution rights for Quelimmune signify a strategic expansion of their pediatric product portfolio. The company's previous success with the Aquadex device, which has seen a compound annual growth rate (CAGR) of over 30%, indicates a strong existing market presence and expertise in pediatric extracorporeal therapies. The commercial launch of Quelimmune is poised to capitalize on this momentum.

Considering the estimated 4,000 pediatric AKI hospitalizations annually in the U.S., the market opportunity for Quelimmune appears robust. The device's unique value proposition could facilitate rapid adoption among nephrologists and intensive care physicians, potentially resulting in a notable increase in Nuwellis's revenue. Investors should monitor the commercial rollout and adoption rates closely, as these will be critical indicators of the product's impact on the company's financial performance.

Financial Analyst

The financial implications of Quelimmune's HDE approval for Nuwellis are multifaceted. In the short term, the company is likely to incur increased costs associated with the commercial launch, including marketing and distribution expenses. However, these costs could be offset by the revenue generated from the product's sales, especially given the device's potential to meet a critical care need and its demonstrated clinical efficacy.

In the long term, the addition of Quelimmune to Nuwellis's portfolio could enhance the company's market share in the pediatric nephrology space and support sustained revenue growth. Investors should evaluate the company's guidance and projected financials, considering the potential for Quelimmune to contribute to top-line growth and possibly improve profit margins over time. It will be important to track the product's market penetration and reimbursement rates, as these factors will influence the overall financial success of the launch.

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device. Quelimmune provides a new therapy option for children weighing 10 kg or more who have acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in a hospital intensive care unit.

Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. With FDA HDE in place for Quelimmune, Nuwellis will begin commercial launch activities at targeted medical centers, with further commercial expansion expected later in the first half of 2024.

“Approximately 4,000 pediatric patients are hospitalized with AKI each year in the U.S.¹ and these children are at grave risk when their bodies enter an uncontrolled inflammatory response called a cytokine storm. The unique technology behind Quelimmune has demonstrated a 50% mortality rate reduction in children with potentially deadly hyperinflammation,²” said Nestor Jaramillo, Jr., president and chief executive officer of Nuwellis. “The pediatric segment of our business has gained significant traction since the 2020 FDA clearance of our Aquadex device for pediatric patients weighing 20kg or more – growing at a compound annual growth rate (CAGR) of over 30%. The addition of Quelimmune to our current product offering will help save the lives of many pediatric patients and should have a meaningful impact on our revenue trajectory.”

“We’re proud to receive HDE for Quelimmune, designed to address the limitations of today’s therapeutic options for critically ill pediatric patients with cytokine storm-induced hyperinflammation,” said Eric Schlorff, chief executive officer of SeaStar Medical. “Through Nuwellis’ established relationships within pediatric nephrology and critical care, we look forward to bringing Quelimmune to market quickly to the patients who need it most.”

SeaStar Medical’s Quelimmune therapy is a patented, cell-directed extracorporeal device for managing cytokine storm-induced hyperinflammation. The therapy precisely targets and neutralizes activated toxic immune cells that drive cytokine storms (an overreaction of the immune system) that can ultimately cause organ damage and failure for critically ill patients. Clinical studies have demonstrated Quelimmune’s potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients. A non-controlled pivotal study funded by the FDA Office of Orphan Products Development demonstrated that those treated with Quelimmune had no device related adverse events, a 50% reduction in mortality rate, and no dialysis required at Day 60.^2,3,4

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 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

Media:
Dunia Cristan
Health+Commerce
dunia@healthandcommerce.com

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¹ Data on File. America Hospital Directory Database Export January 2020
² Goldstein, Stuart L., et al. “Use of the Selective Cytopheretic Device in Critically Ill Children.” Kidney International Reports, vol. 6, no. 3, 18 Dec. 2020, pp. 775–784., https://doi.org/10.1016/j.ekir.2020.12.010.
³ Tumlin, James A., et al. “A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.” PLOS ONE, vol. 10, no. 8, 2015, https://doi.org/10.1371/journal.pone.0132482.
⁴ Yessayan, Lenar T., et al. “Extracorporeal Immunomodulation Treatment and Clinical Outcomes in ICU COVID-19 Patients.” Critical Care Explorations, vol. 4, no. 5, 19 May 2022, https://doi.org/10.1097/cce.0000000000000694. 

FAQ

What is the FDA approval announced by Nuwellis, Inc. related to?

Nuwellis, Inc. announced FDA approval for SeaStar Medical's Quelimmune, a pediatric Selective Cytopheretic Device, to treat acute kidney injury and sepsis in children.

What is the significance of Quelimmune's FDA approval?

Quelimmune's FDA approval provides a new therapy option for children with acute kidney injury and sepsis, potentially reducing mortality rates by 50%.

What is Nuwellis' role in the distribution of Quelimmune?

Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical for Quelimmune, targeting nephrologists and intensive care physicians trained in pediatric extracorporeal therapy.

What are the expected commercial activities for Quelimmune in 2024?

Nuwellis plans targeted commercial launch activities at medical centers in the first half of 2024, with further commercial expansion expected later in the year.

What are the benefits of Quelimmune therapy according to clinical studies?

Clinical studies show that Quelimmune has the potential to eliminate dialysis dependency, shorten intensive care unit time, and reduce mortality rates by 50% in critically ill pediatric patients.