DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a medical device company, announced it will restate its financial statements for the fiscal year ended December 31, 2022, and for the interim periods ended March 31, 2023, June 30, 2023, and September 30, 2023. The restatement is due to the accounting treatment of certain warrants and a prepaid forward purchase arrangement that was terminated in June 2023.
The restatement is expected to be non-material to the company's cash position or business operations, according to CEO Eric Schlorff. It pertains to non-cash accounting items and follows additional audit procedures. SeaStar Medical plans to file Form 12b-25 with the SEC to obtain a 15-day extension for filing its Annual Report on Form 10-K.
SeaStar Medical transitioned to a public company through a Special Purpose Acquisition Company (SPAC) during challenging market conditions in late 2022. The restatement arose from the reassessment of certain complex financial instruments.
In clinical developments, SeaStar Medical continues its pivotal adult acute kidney injury (AKI) study, with 23 subjects enrolled to date. The company also announced the upcoming treatment of the first critically ill child with AKI and sepsis using its Quelimmune™ pediatric therapeutic device at a recognized children's hospital in the second quarter of 2024.
The company hosted a symposium on new therapies in pediatric AKI at the AKI-CRRT 2024 conference, where key opinion leaders from the Scientific Advisory Board discussed AKI and sepsis and shared experiences with Quelimmune™.
SeaStar Medical will provide further updates during a business update conference call scheduled for Wednesday, April 17, 2024, at 4:00 p.m. Eastern time.
The Quelimmune pediatric device has been granted a Humanitarian Device Exemption (HDE) Approval Order by the FDA for children with AKI due to sepsis requiring kidney replacement therapy, and it is estimated that approximately 4,000 children annually could benefit from it.
This article is based on a press release statement.
InvestingPro Insights
As SeaStar Medical Holding Corporation (NASDAQ:ICU) navigates the intricacies of financial restatements and continues its clinical advancements, the company's market performance and financial metrics provide a nuanced picture for investors. With a market capitalization of 45.73 million USD, SeaStar Medical's valuation reflects its status as a smaller player in the medical device sector. However, recent price movements indicate a significant level of investor interest. Over the last three months, the company's stock has seen a strong return of 62.89%, and an even more impressive six-month price total return of 294.28%.
These figures suggest that despite the company's challenges, such as not being profitable over the last twelve months and having short term obligations that exceed its liquid assets, the market has responded positively to certain aspects of SeaStar Medical's operations or potential. It's worth noting that the company's stock price often moves in the opposite direction of the market, a characteristic that may appeal to certain investors looking for diversification or non-correlated assets.
InvestingPro Tips highlight that SeaStar Medical does not pay a dividend to shareholders, which is not uncommon for companies focused on growth and reinvestment. For investors seeking a deeper understanding of SeaStar Medical's financial health and stock performance, there are additional InvestingPro Tips available. By using the coupon code PRONEWS24, readers can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription to access these insights. As of now, there are six more InvestingPro Tips listed for SeaStar Medical that can provide further clarity on the company's financial standing and market performance.
For those closely following the company's developments, the next earnings date is set for March 28, 2024, which will likely shed more light on the impact of the restatement and the company's ongoing clinical trials.
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