MINNEAPOLIS - Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company, announced the first commercial sale of its QUELIMMUNE therapy to Cincinnati Children's Hospital. This novel therapy is designed for pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy who require kidney replacement therapy (KRT).
QUELIMMUNE, also known as the Selective Cytopheretic Device for pediatrics, is an immunomodulating technology that targets proinflammatory neutrophils and monocytes during KRT. It aims to reduce the hyperinflammatory response, including cytokine storm, which can lead to inflammation, organ failure, and potentially death in critically ill patients.
The therapy was made accessible through a Humanitarian Device Exemption from the Food and Drug Administration (FDA) and is distributed by Nuwellis under an exclusive U.S. license agreement with SeaStar Medical, the developer of QUELIMMUNE. Early clinical data suggest a 77% survival rate for patients treated with QUELIMMUNE.
Dr. Stuart Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital, and Principal Investigator of the studies leading to FDA clearance, welcomed the new treatment. "This innovative treatment offers new hope for this population that had not seen improvement in outcomes for the last 20 years," he said.
Nestor Jaramillo, President and CEO of Nuwellis, highlighted the significance of this first sale in the company's pediatric business development strategy. "We are excited to collaborate with SeaStar Medical to deliver this life-saving therapy to critically ill patients," Jaramillo stated.
The QUELIMMUNE device works by selectively targeting highly activated proinflammatory neutrophils and monocytes, transitioning them to a reparative state, and promoting activated neutrophils to be less inflammatory. It is integrated with KRT hemofiltration systems and aims to promote long-term organ recovery and potentially eliminate the need for future KRT, including dialysis.
Nuwellis specializes in ultrafiltration therapy through its Aquadex SmartFlow® system and is committed to transforming patient outcomes in fluid overload cases. SeaStar Medical is focused on developing cell-directed extracorporeal therapies to reduce the impact of excessive inflammation on vital organs.
The information in this article is based on a press release statement.
InvestingPro Insights
Nuwellis, Inc. (NASDAQ:NUWE) has made a significant stride with the first commercial sale of its QUELIMMUNE therapy, potentially marking a new phase in its business development. As investors assess the company's financial health and stock performance, certain metrics and tips from InvestingPro provide additional context.
InvestingPro Data:
- The company currently holds a market capitalization of $32.48 million USD, reflecting its size in the industry.
- Nuwellis has a negative price-to-earnings (P/E) ratio of -0.34, indicating that the company is not currently profitable.
- Over the last month, the stock has seen an impressive price total return of 99.74%, showcasing a strong short-term recovery.
InvestingPro Tips:
- Nuwellis operates with a moderate level of debt, which investors should consider when evaluating the company's financial leverage and risk profile.
- The stock has experienced significant price volatility and has a tendency to move in the opposite direction of the market, which could be a factor for investors looking for stability or those aiming to capitalize on market inefficiencies.
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