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– 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
DENVER, COLORADO, Nov. 07, 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 its Selective Cytopheretic Device (SCD) has been included in the Consensus Statement for pediatric acute kidney injury (AKI) as part of the first Pediatric Acute Disease Quality Initiative (pADQI) meeting. The outcome of the meeting, titled “Consensus-Based Recommendations on Priority Activities to Address Acute Kidney Injury in Children,” has been published in JAMA Network Open1.
The first pediatric ADQI convened in November 2021 to develop expert-driven pediatric specific recommendations on AKI. Its primary aim was to identify the work priorities across the pediatric AKI landscape of care, education, research and advocacy. The pADQI consensus meeting followed the established ADQI process to provide expert-based statements and interpretation of current published data for use by clinicians according to professional judgement and identify evidence care gaps to establish research priorities. The pADQI meeting was conducted by 47 leading multi-professional international experts in general pediatrics, nephrology and critical care focused on six areas: epidemiology; diagnostics; fluid overload; kidney support therapies; biology, pharmacology and nutrition; and education and advocacy. Using an established modified Delphi process based on existing data, workgroups derived consensus statements with recommendations.
“We are extremely pleased to have SeaStar Medical’s SCD included in the Consensus Statement of ADQI, which builds upon the existing support within the pediatric community for this important therapy. Having submitted our Humanitarian Device Exemption application with the U.S. FDA in June of this year, we are planning towards a potential approval of the SCD for use in critically ill children with AKI in the first quarter of 2023,” commented Eric Schlorff, Chief Executive Officer of SeaStar Medical. “Over the past decade, we have witnessed important progress in adult AKI research. However, there remain significant gaps in therapies to care for AKI in children. We applaud the pediatric ADQI for bringing attention to this area in need of effective solution.”
SeaStar Medical’s SCD is a patented cell-directed extracorporeal therapy works with any continuous renal replacement therapy (CRRT) system to selectively target and transition pro-inflammatory monocytes to promote reparative processes and reduce the inflammatory effects of activated neutrophils. This unique approach may reverse injury and eliminate the need for continuous renal replacement therapy (CRRT) going forward for those patients treated.
The SCD has been used with other treatments, including IL-6 blockers, corticosteroids and other common treatments, with no or few known contraindications. The SCD demonstrated to be safe with probable benefit for use in pediatric patients with AKI. By giving critically ill patients the potential to eliminate dialysis dependency, get out of the ICU faster, and restore the lives they were so close to losing, the SCD is positioned to become the new standard of care in the ICU.
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.
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.
JTC Team, LLC
1 JAMA Network Open. 2022;5(9):e2229442. doi: 10.1001/jamanetworkopen.2022.29442