Restatement of non-cash items is not expected to have a material impact on cash position or operations
DENVER, March 27, 2024 (Globe Newswire) — Seastar Medical Holding Co., Ltd. A commercial-stage medical device company (Nasdaq: ICU), which is developing a unique solution to reduce the effects of excessive inflammation on vital organs, announced its financial statements for the year ended December 31, 2022 and the interim period ended March 2022. announced that it would be re-displayed. 31, 2023, June 30, 2023, September 30, 2023.
This restatement will impact the accounting and classification of certain outstanding warrants and upfront forward purchase agreements terminated in June 2023. SeaStar Medical plans to file a Form 12b-25 with its securities firm for additional audit proceedings related to the restatement. The Exchange Commission (SEC) has given issuers a 15-day grace period to file annual reports on Form 10-K that are considered timely filed.
“The restatement does not have a material impact on our business operations or cash position, but rather relates to the reporting of non-cash accounting items,” SeaStar Medical Chief Executive Officer Eric Skruf said in a statement. said. “Due to the challenging market environment at the time, we pursued a special acquisition purpose company (SPAC) as a route to becoming a public company in late 2022. Many SPACs, including ours, invest in numerous complex financial products. Unfortunately, we have determined that certain complex financial instruments require different accounting treatment than previously determined, necessitating restatement.
“Importantly, we continue to make progress in our pivotal Adult Acute Kidney Injury (AKI) study, which has enrolled 23 subjects since our last update two weeks ago. Quelimmune With the commercial release of™ “With the introduction of pediatric treatment equipment, the first critically ill infants with AKI and sepsis or septic conditions will be treated at a high-profile children's hospital in the second quarter of 2024,” he added.
“we, symposium, New treatment for pediatric acute kidney injury, “At the AKI-CRRT 2024 conference earlier this month, key opinion leaders from the Scientific Advisory Board shared valuable insights into AKI and sepsis, as well as their experience with Quelimmune,” said Shkrolf. “I look forward to providing a more detailed update on our progress and outlook during our business update conference call.”
Conference call
SeaStar Medical's management will hold a business update conference call on Wednesday, April 17th at 4:00 PM Eastern Time (1:00 PM Pacific Time).Participants can pre-register for the conference call here. Callers who pre-register will be given a conference passcode and unique PIN, allowing them to bypass the live operator and gain instant access to the call. Participants can pre-register at any time, including after the call start time. Stockholders and other interested parties may also participate in the conference call by dialing 866-777-2509 from within the United States or 412-317-5413 from outside the United States and requesting a SeaStar Medical call.
A live webcast of the call can be viewed here and will be archived for 90 days. A replay of the call will be available starting 2 hours after the call ends until April 19, 2024 at 877-344-7529 from within the United States, 855-669-9658 from Canada, and 412-317-0088 from outside the United States. You can use it by dialing . Canada, enter conference identification number 1412301.
About Query Moone
In February 2024, the U.S. Food and Drug Administration (FDA) granted a Humanitarian Device Exemption (HDE). approval order Quelimmune pediatric device for use in children weighing 10 kg or more with AKI due to sepsis or septic conditions requiring renal replacement therapy (KRT). SeaStar Medical estimates that the target population for the Quelimmune pediatric device is approximately 4,000 children with AKI per year. Approximately 20% of the top 50 children's hospitals already have direct experience with SCD. A pediatric patient treated with an SCD, on average, will require seven her SCD units, and disposable devices are expected to be replaced every 24 hours.
About the all-important adult acute kidney injury study
The pivotal trial of NEUTRALIZE-AKI (Deactivation of Neutrophils and Monocytes with a Selective Cell Depletion Device – Randomized Clinical Trial in Acute Kidney Injury) will enroll up to 200 adults. The primary endpoint of this trial was to reduce 90-day mortality or dialysis dependence in patients treated with SCD in addition to continuous renal replacement therapy (CKRT) as standard of care compared to a control group receiving CKRT standard therapy alone. This is a comparison. Secondary endpoints include mortality at 28 days, number of her ICU-free days in her first 28 days, major renal adverse events at 90 days, and dialysis dependence at 1 year . The study will also include subgroup analyzes to investigate the efficacy of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.More information about the trial is available here.
About excessive inflammation
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can cause damage to vital organs. It occurs when the body overproduces toxic inflammatory effector cells and other molecules, which can damage vital organs and even lead to multiorgan failure and death. This is known as a cytokine storm.
About selective cell removal equipment
The Selective Cell Depletion Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulatory technology to selectively target pro-inflammatory neutrophils and monocytes during CKRT, reducing inflammation, inflammation and inflammation in critically ill patients. It reduces the hyperinflammatory environment such as cytokine storm that causes organ failure and possible death. . Unlike pathogen removal and other blood purification tools, SCD is integrated with the CKRT hemofiltration system to selectively target pro-inflammatory monocytes to a reparative state and reduce inflammation in activated neutrophils. Reduce. SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are carried back into the body through the blood, signaling the body to reduce the inflammatory environment and focus on repair. This unique immunomodulatory approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. Quelimmune is the official brand name for the FDA HDE approved pediatric selective cell removal device.
About Sea Star Medical
SeaStar Medical is a commercial-stage medical technology company redefining how extracorporeal therapies can reduce the effects of excessive inflammation in vital organs. SeaStar Medical's new technology relies on science and innovation to provide life-saving solutions for critically ill patients. The company is developing cell-directed in vitro therapies that target effector cells that secrete a range of pro-inflammatory cytokines that trigger systemic inflammation, cause direct tissue damage, and initiate and propagate an unbalanced immune response. and commercialize it.Learn more about www.seaarmedical.com Or visit us below 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, but are not limited to, his SCD's ability to treat hyperinflammation and anticipated results; Clinical trials and research. “believe”, “anticipate”, “expect”, “anticipate”, “estimate”, “intend”, “strategy”, “future”, “opportunity”, “plan”, “may” ”, “should”, “will”, “would”, “would”, “will continue”, “likely will result”, and similar words The expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, forecasts or other statements about future events that are based on current expectations or assumptions and that involve significant risks that actual results may differ materially from those expected. and may be affected by uncertainty. Most of these factors are beyond SeaStar Medical's control and are difficult to predict. Factors that could cause actual future events to differ materially from anticipated results include, but are not limited to: (i) the risk that SeaStar Medical may not obtain regulatory approval for his SCD product candidates; (ii) the risk that SeaStar Medical may not be able to obtain sufficient capital to fund its business operations, including clinical trials; (iii) the development and commercialization of SeaStar Medical and its current and future collaborators, including the inability of SeaStar Medical and its current and future collaborators to successfully develop and commercialize its products or services or to obtain product approval by applicable federal and state regulatory authorities; risk of significant delays. iv) the risk that SeaStar Medical may never achieve or maintain profitability; (v) the risk that SeaStar Medical may not be able to access financing under existing agreements, including equity credit facilities and forward purchase agreements; (vi) the risk that third party suppliers and manufacturers may not fully and timely fulfill their obligations; (vii) the risk of product liability or regulatory actions or proceedings relating to SeaStar Medical's products and services; (viii) ) SeaStar Medical is solely responsible for its intellectual property and (ix) other risks and uncertainties set forth from time to time in SeaStar Medical's Annual Report on Form 10-K (and in SeaStar Medical's “Risk Factors” section). (including those that are) cannot be protected or protected. Other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date on which they are made. Readers are cautioned not to place undue reliance on forward-looking statements, and SeaStar Medical reserves the right to discredit these forward-looking statements, whether as a result of new information, future events or otherwise. We have no obligation or intention to update or revise it.
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