SeaStar Medical Ships First QUELIMMUNE Product Order to U.S. Distribution Partner
SeaStar Medical (Nasdaq: ICU) has announced the initial commercial sale of its QUELIMMUNE™-Pediatric to U.S. distributor Nuwellis. QUELIMMUNE, a patented cell-directed extracorporeal therapy, targets highly activated neutrophils and monocytes responsible for hyperactive immune responses in pediatric acute kidney injury (AKI) patients. The device is FDA-approved under a Humanitarian Device Exemption to treat pediatric AKI in patients weighing 10 kilograms or more. Initial studies show QUELIMMUNE has a probable benefit in reducing mortality and dialysis dependency. SeaStar Medical anticipates a significant commercial rollout by Q4 2024, with prestigious pediatric hospitals expected to meet HDE requirements this quarter. The company is also enrolling patients in the NEUTRALIZE-AKI trial for adults, presenting a multibillion-dollar market opportunity.
- First commercial sale of QUELIMMUNE™-Pediatric to U.S. distributor Nuwellis.
- FDA approval as a Humanitarian Use Device to treat pediatric AKI.
- Initial clinical studies show a 77% survival rate and no dialysis dependency after 60 days with QUELIMMUNE.
- No device-related serious adverse events or infections reported.
- Potential significant commercial rollout by Q4 2024.
- Multibillion-dollar market opportunity in adult AKI population.
- High mortality rate of approximately 50% for pediatric AKI patients requiring continuous KRT.
- Many survivors of AKI experience long-term complications, including chronic kidney disease and a lifetime of dialysis.
Insights
SeaStar Medical's launch of QUELIMMUNE for pediatric acute kidney injury (AKI) represents a significant advancement in medical technology. The FDA's approval under the Humanitarian Device Exemption (HDE) allows for its use in a highly specific patient population, emphasizing the critical unmet need it addresses.
QUELIMMUNE targets hyperactive immune cells, a novel approach that could significantly improve outcomes in children with sepsis-induced AKI. The treatment's reported efficacy, with a 77% survival rate and no dependency on dialysis at 60 days, suggests it could revolutionize care for this vulnerable population. This is especially compelling given the current mortality rate of approximately 50% for children requiring continuous kidney replacement therapy (KRT).
However, the clinical data comes from non-controlled studies. While promising, further studies with control groups are necessary to validate these findings conclusively. From a clinical perspective, the absence of device-related adverse events is reassuring and supports its safety profile.
In the short term, the positive data and FDA approval should bolster confidence among healthcare providers, likely leading to its adoption in pediatric hospitals. Long-term, the ongoing trials and results will define its broader impact, particularly as the company explores applications in the larger adult AKI market.
The commercial launch of QUELIMMUNE by SeaStar Medical marks a important milestone for the company. The initial shipment to Nuwellis, Inc., signals the beginning of revenue generation from this innovative product. Given the
Revenue potential is substantial, even within the pediatric segment. With the treatment requiring replacement cartridges every 24 hours over three to seven days, recurring revenue from consumables can provide a stable income stream. As prestigious pediatric hospitals adopt the device, this should lead to increased sales and market penetration.
Looking ahead, the adult AKI market, which is 50 times larger, represents a multibillion-dollar opportunity. Successful outcomes from the NEUTRALIZE-AKI trial would exponentially increase revenue potential, positioning SeaStar Medical for significant growth.
Investors should keep in mind the potential risks, including the dependency on successful trial outcomes and the competitive landscape of AKI treatments. However, the current FDA approval and early clinical success provide a solid foundation for optimistic long-term prospects.
The introduction of QUELIMMUNE to the U.S. market represents a strategic move by SeaStar Medical in targeting a niche yet critical segment of the healthcare industry. The approval as a Humanitarian Use Device (HUD) under the Humanitarian Device Exemption (HDE) highlights its importance in addressing pediatric AKI, a condition with limited treatment options.
From a market perspective, QUELIMMUNE provides SeaStar Medical with a unique selling proposition. Its ability to significantly reduce mortality and dependence on dialysis sets it apart from existing therapies. The initial adoption by prestigious pediatric hospitals will be important in establishing its reputation and market presence.
In terms of market expansion, the pediatric segment serves as an entry point. The company’s focus on the vastly larger adult AKI market through ongoing clinical trials suggests a well-planned strategy for long-term growth. This dual-market approach leverages the initial success in pediatrics to build credibility and momentum for broader applications.
For retail investors, understanding the value of this strategic market positioning is essential. The initial commercial success and strategic focus on expanding into the adult market present a compelling growth narrative. However, investors should monitor the competitive landscape and ongoing clinical trial results to gauge future market dynamics.
DENVER, July 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports the initial commercial sale of QUELIMMUNE™-Pediatric to its U.S. license and distribution partner, Nuwellis, Inc. QUELIMMUNE is SeaStar Medical’s Selective Cytopheretic Device-Pediatric (SCD-PED), a patented cell-directed extracorporeal therapy that selectively targets the most highly activated neutrophils and monocytes responsible for hyperactive immune response. QUELIMMUNE is approved by the U.S. Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) to treat pediatric acute kidney injury (AKI) in patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT).
“It’s highly gratifying to ship our first commercial QUELIMMUNE product order to Nuwellis for these patients,” said Eric Schlorff, CEO of SeaStar Medical. “QUELIMMUNE is a best-in-class therapy that across two pediatric clinical studies has been shown to have a probable benefit of reducing mortality and decreasing dialysis dependency in these severely ill children. We expect prestigious pediatric hospitals to meet the HDE requirements this quarter, with a more robust commercial rollout in the fourth quarter of 2024.”
QUELIMMUNE consists of a SCD-PED cartridge and blood tubing set that are connected in-line to an existing hemodialysis delivery system’s extracorporeal continuous KRT circuit in a process that takes about 15 minutes. The Company expects that, on average, a full course of treatment for children with AKI will require three to seven days of treatment with the disposable SCD-PED cartridge being replaced every 24 hours.
Each year in the U.S., approximately 4,000 children with AKI require continuous KRT, with a mortality rate of approximately
SeaStar Medical is actively enrolling patients in the pivotal adult NEUTRALIZE-AKI clinical trial. The adult AKI population is 50 times greater than the pediatric population, which the Company believes represents a multibillion-dollar market opportunity.
About Hyperinflammation
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.
About the Selective Cytopheretic Device (SCD)
The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous kidney renal therapy (CKRT) 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 CKRT 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 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.
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 http://www.nuwellis.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, SeaStar Medical’s expectations with respect to the amount and timing of future QUELIMMUNE commercial sales; commercial acceptance of QUELIMMUNE; the ability of SCD to treat patients with AKI and other diseases; 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 do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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