Manuscript Published on Multiorgan Failure Patients Treated with SeaStar Medical’s Selective Cytopheretic Device Who Achieved Transplant Eligibility
SeaStar Medical Holding (Nasdaq: ICU) announced the publication of a manuscript in Transplantation Direct reviewing four case studies involving their Selective Cytopheretic Device (SCD). The device demonstrated effectiveness in stabilizing and improving the clinical status of critically ill patients aged 22 months to 71 years, suffering from multiorgan failure. These patients subsequently became eligible for stem cell or liver transplants or left ventricular assist device implantation. The study highlights SCD's potential in mitigating hyperinflammation and aiding organ recovery without causing serious adverse events. The company aims to further investigate SCD's benefits through additional clinical studies and secure market approvals.
- SCD improved clinical status in critically ill patients with multiorgan failure.
- The treatment allowed patients to become eligible for transplants or assist device implantation.
- No serious device-related adverse events, infections, or signs of immuno-depletion observed.
- Publication in a peer-reviewed journal enhances credibility.
- FDA Breakthrough Device Designation for several conditions including acute kidney injury, cardiorenal syndrome, and hepatorenal syndrome.
- Ongoing data collection and clinical studies to support broader market approvals.
- The study involved only four initial pilot cases, limiting generalizability.
- Future effectiveness and safety of SCD need verification through larger clinical trials.
- No immediate market approval or financial returns reported.
Insights
This announcement highlights the potential of SeaStar Medical’s Selective Cytopheretic Device (SCD) in improving the clinical status of critically ill patients, which is noteworthy for several reasons. Firstly, the successful stabilization of patients with multiorgan failure across diverse age groups and clinical conditions indicates the device's versatility. This is important as it suggests broad applicability across different patient demographics and medical scenarios.
The fact that the SCD has shown no serious device-related adverse events further strengthens its profile. In medical device development, safety and tolerability are paramount and the absence of significant adverse effects in initial trials is a positive signal for future clinical studies. The manuscript’s publication in a peer-reviewed journal adds credibility to these findings, as peer review is a critical component in validating research results.
For retail investors, understanding the implications of these results is essential. Positive initial case studies can lead to larger clinical trials, potentially culminating in market approval. While these results are promising, it's important to remain cautious as they are preliminary. Further studies are required to substantiate these findings and assess long-term efficacy and safety.
The announcement of the SCD's effectiveness in stabilizing critically ill patients has several market implications. SeaStar Medical is positioning itself within a competitive medical device market with a unique offering. The broad application potential of the SCD, particularly if it can be used across various conditions leading to multiorgan failure, could significantly enhance its market attractiveness.
The FDA Breakthrough Device Designation already secured for several indications points towards a smoother regulatory pathway, which can expedite the time to market. This designation is important as it allows for prioritized review and potential faster commercialization, which can be a significant competitive advantage in the medical device industry.
Investors should note that while these initial case studies are promising, the company’s strategy of securing designations and conducting small clinical trials under grants indicates a careful and strategic approach to market entry. However, the journey from initial promising results to broad market adoption involves numerous regulatory, clinical and commercial hurdles. Investors should monitor further clinical outcomes and FDA interactions closely.
SCD’s ability to improve clinical status of four critically ill pediatric and adult patients across multiple clinical conditions published in Transplantation Direct
DENVER, May 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the publication of a manuscript citing four case studies in which critically ill patients between the ages of 22 months and 71 years with multiorgan failure who were treated with the Selective Cytopheretic Device (SCD) successfully stabilized and improved their clinical status prior to stem cell or liver transplant, or left ventricular assist device implantation. The abstract was published in peer-reviewed Transplantation Direct, which is available here.
Titled “Increasing Eligibility to Transplant Through the Selective Cytopheretic Device (SCD): A Review of Case Reports Across Multiple Clinical Conditions,” the manuscript by S. Iyer, C. Pino, L. Yessayan, S. Goldstein, M. Weir, A. Westover, D. Catanzaro, K. Chung and H.D. Humes notes that a stable, minimum physiological health status is required for patients to qualify for transplant or artificial organ to ensure the recipient has sufficient reserve to survive the perioperative transplant period. Excessive systemic inflammation or hyperinflammation can prevent the body from returning to immune homeostasis and toward organ recovery, potentially delaying or prohibiting a needed transplantation. The SCD is an extracorporeal device that is designed to abate hyperinflammation by selectively targeting and transitioning proinflammatory monocytes to a reparative state regardless of the underlying clinical conditions.
“SCD therapeutic treatment was used to reduce the consequences of excessive inflammation in these four patients with different etiologies yet all with high levels of organ dysfunction. In each case, the SCD was able to improve the patient’s clinical status or extend the duration of improvement prior to transplantation,” said Sai P. Iyer, PhD, SeaStar Medical Vice President, Medical Affairs and Clinical Development. “The SCD was well tolerated, with no serious device-related adverse events, infections or signs of immuno-depletion observed in any patient. Although these are initial pilot cases, the favorable results form the basis for further investigation in additional clinical studies.”
“We continue to collect data demonstrating the versatility of SCD therapy in patients with multiple organ failures and across multiple indications,” said Eric Schrolff, SeaStar Medical CEO. “We are securing breakthrough device designation in multiple indications, followed by small clinical studies, some conducted under grants, and publishing the resulting data in peer-reviewed journals. This clinical development strategy is expected to pave the way for market approvals for a therapeutic device that we believe can improve the quality of life for severely ill patients and help save lives.”
To date, the U.S. Food and Drug Administration (FDA) has granted the SCD Breakthrough Device Designation for adults with acute kidney injury, cardiorenal syndrome and hepatorenal syndrome.
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.
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, the SCD’s ability to treat hyperinflammation and the expected results of clinical trials and studies. 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 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.
Contact:
LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com
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FAQ
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