Data being presented at the American Society of Nephrology (ASN) Kidney Week 2022
Interim study data show that SCD treatment is safe to use in pediatric patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT)
The SCD is currently being evaluated by the FDA for a Humanitarian Device Exemption (HDE) marketing approval for use in children (> 20 kgs) with AKI – The Company expects the FDA to complete a substantive review of its HDE application during the first quarter of 2023, with a potential commercial launch expected in the second quarter of 2023
DENVER, COLORADO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:ICU), (“SeaStar Medical” or the “Company”), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced positive interim data in a poster presentation at the American Society of Nephrology (ASN) Kidney Week 2022 taking place November 3-6, 2022 in Orlando, FL.
The poster titled, Multi-Center Study to Assess the Safety of a Selective Cytopheretic Device (SCD) for Treatment of Immunomodulatory Dysregulation due to AKI in Children ≥10 and ≤20 kg: Report From the First 4 Patients, will be presented by Stuart Goldstein, MD, Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital as part of the session “AKI: Biomarkers, Risk Factors, Treatments, Outcomes” on Thursday, November 3, 2022 from 10:00 AM – 12:00 PM ET.
The presented poster highlights preliminary findings from the Company’s ongoing open-label clinical trial being conducted at five pediatric hospitals across the U.S. evaluating the SCD for the treatment of Immunomodulatory Dysregulation due to severe AKI. The study is evaluating children that weigh between ≥10 and ≤ 20kg, have a clinical diagnosis of AKI requiring CKRT and at least one non-renal organ failure. With these subjects the SCD was integrated post CKRT membrane, changed daily, and circuit ionized calcium (iCa) maintained <0.4 mmol/L. Subjects received SCD treatment for up to 10 days or CKRT discontinuation, whichever came first. Participants are followed through Day 60 post SCD initiation for mortality and dialysis dependence. For more information about the study, visit clinicaltrials.gov.
Dr. Goldstein commented, “I am very pleased with these positive preliminary data demonstrating that the SCD is safe and of note, provides possible benefit with survival of 83% compared to the 50% in a historical cohort. With such few therapeutic options available for pediatric AKI, I believe the SCD has the potential to provide clinical benefit and hope to patients, families, and physicians. I look forward to continuing to study its potential for the treatment of AKI.”
“We continue to be encouraged by the results being demonstrated by the SCD in children. Despite improvements in acute care and dialysis therapies, the mortality rate from the past four decades has not improved and there remains a critical unmet need in addressing uncontrollable hyperinflammation, the leading cause of kidney damage and mortality in this population,” added Eric Schlorff, Chief Executive Officer of SeaStar Medical.
Under the current study, six subjects have been treated with the SCD. Four subjects developed AKI in the presence of shock, and the other two subjects developed AKI in the setting of STEC Hemolytic Uremic Syndrome. All subjects ended SCD therapy before Day 10. Five of the subjects transitioned off CKRT for improvement in clinical status (Median 105 hours of SCD); Family chose to withdraw all care for subject on ECMO after 136 hours of SCD. Of the 660 hours of SCD treatment given, circuit iCa levels were ≤0.4 mmol/L 95% of the time. Of the subjects that reached Day 60, 5 were still inpatient and dialysis independent and 1 subject deceased after SCD therapy had ended but before ICU discharge. An additional patient was enrolled but did not continue with SCD because their iCa was not in range due to citrate intolerance. To date, no SCD-related serious adverse events have been reported in pediatrics.
Approximately 4,000 pediatric patients in the U.S. each year with AKI require CKRT and those patient profiles are associated with high morbidity and mortality. The mortality rate in children with AKI requiring CKRT is approximately 50 percent. Children who survive an AKI episode are at risk of long-term conditions, including chronic kidney disease (CKD).
The SCD is currently being evaluated by the FDA for a Humanitarian Device Exemption (HDE) marketing approval for use in children (>20 kgs) with AKI. The Company expects the FDA to complete a substantive review of its HDE application during the first quarter of 2023, with a potential commercial launch expected in the second quarter of 2023. Dr. Goldstein served as a consultant to SeaStar Medical in the preparation and submission of the HDE application.
For more information about the conference, visit the Kidney Week 2022 website.
About the Selective Cytopheretic Device (SCD)
SeaStar Medical’s innovative platform therapy, the SCD, is a patented cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that causes organ failure and possible death in critically ill patients. The therapy works with continuous kidney replacement therapy (CKRT) to target and neutralize pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis.
About SeaStar Medical Holding Corporation
Denver-based SeaStar Medical (Nasdaq: ICU) is a medical technology company that is focusing on 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. It is developing and commercializing 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 Twitter.
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 timing of regulatory approval of its products and other corporate milestones, the ability of SCD to treat patients with AKI, and the potential benefits of SCD to treat other diseases. 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 inability to recognize the anticipated benefits of the business combination with LMAO, which may be affected by, among other things, competition and the ability of the post-combination company to grow and manage growth profitability and retain its key employees, (ii) costs related to the business combination, (iii) the outcome of any legal proceedings that may be instituted against SeaStar Medical following the business combination, (x) the ability to maintain the listing of its securities on NASDAQ, (iv) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed business combination, and identify and realize additional opportunities, (v) the risk of downturns and the possibility of rapid change in the highly competitive industry in which SeaStar Medical operates, (vi) 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, (vii) the risk that SeaStar Medical may never achieve or sustain profitability; (viii) the risk that SeaStar Medical may need to raise additional capital to execute its business plan, which many not be available on acceptable terms or at all; (ix) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (x) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (xi) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (xiii) other risks and uncertainties indicated from time to time in SeaStar Medical’s registration statement on Form S-4, as amended (File No. 333-264993), including those under the “Risk Factors” section therein and in SeaStar’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 assume 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.
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