SeaStar Medical Reports Update on Nasdaq Listing Status
SeaStar Medical (NASDAQ: ICU) has undertaken several measures to regain compliance with Nasdaq's listing requirements after receiving a notification of non-compliance in June 2024. The company completed a $4.0 million public offering and secured a $15.0 million purchase agreement with Lincoln Park Capital.
The company has expanded its customer base to six facilities for QUELIMMUNE, its FDA-approved product for pediatric patients with multiple organ failure, which has shown to reduce mortality by approximately 50%. Additionally, SeaStar implemented cost-cutting measures and restructured approximately $1.2 million in employee compensation liabilities. The company believes these actions have helped it meet the $2.5 million stockholders' equity requirement for continued Nasdaq listing, pending formal confirmation.
SeaStar Medical (NASDAQ: ICU) ha adottato diverse misure per tornare conforme ai requisiti di quotazione del Nasdaq dopo aver ricevuto una notifica di non conformità nel giugno 2024. L'azienda ha completato un offerta pubblica da 4,0 milioni di dollari e ha ottenuto un accordo di acquisto da 15,0 milioni di dollari con Lincoln Park Capital.
La società ha ampliato la propria base clienti a sei strutture per QUELIMMUNE, il suo prodotto approvato dalla FDA per pazienti pediatrici con insufficienza multiorgano, che ha dimostrato di ridurre la mortalità di circa il 50%. Inoltre, SeaStar ha implementato misure di riduzione dei costi e ristrutturato circa 1,2 milioni di dollari in passività relative alla compensazione dei dipendenti. L'azienda ritiene che queste azioni l'abbiano aiutata a soddisfare il requisito di patrimonio netto di 2,5 milioni di dollari per la continuazione della quotazione al Nasdaq, in attesa di conferma formale.
SeaStar Medical (NASDAQ: ICU) ha tomado varias medidas para recuperar el cumplimiento de los requisitos de cotización del Nasdaq tras recibir una notificación de incumplimiento en junio de 2024. La compañía completó una oferta pública de 4,0 millones de dólares y aseguró un acuerdo de compra de 15,0 millones de dólares con Lincoln Park Capital.
La empresa ha ampliado su base de clientes a seis instalaciones para QUELIMMUNE, su producto aprobado por la FDA para pacientes pediátricos con fallo multiorgánico, que ha demostrado reducir la mortalidad aproximadamente en un 50%. Además, SeaStar implementó medidas de reducción de costos y reestructuró aproximadamente 1,2 millones de dólares en pasivos por compensación a empleados. La compañía cree que estas acciones le han ayudado a cumplir con el requisito de patrimonio neto de 2,5 millones de dólares para la continuidad en la cotización del Nasdaq, a la espera de confirmación formal.
SeaStar Medical (NASDAQ: ICU)는 2024년 6월 비준수 통지를 받은 후 나스닥 상장 요건 준수를 회복하기 위해 여러 조치를 취했습니다. 회사는 400만 달러 규모의 공개 모집을 완료했고 Lincoln Park Capital과 1500만 달러 규모의 매입 계약을 체결했습니다.
회사는 FDA 승인을 받은 다기관 부전 소아 환자용 제품 QUELIMMUNE의 고객 기반을 6개 시설로 확장했으며, 이 제품은 사망률을 약 50% 감소시키는 효과를 보였습니다. 또한 SeaStar는 비용 절감 조치를 시행하고 직원 보상 부채 약 120만 달러를 구조조정했습니다. 회사는 이러한 조치들이 나스닥 상장 지속을 위한 250만 달러 주주 자본 요건을 충족하는 데 도움이 되었다고 보고 있으며, 공식 확인을 기다리고 있습니다.
SeaStar Medical (NASDAQ : ICU) a pris plusieurs mesures pour retrouver la conformité aux exigences de cotation du Nasdaq après avoir reçu une notification de non-conformité en juin 2024. La société a réalisé une offre publique de 4,0 millions de dollars et obtenu un accord d'achat de 15,0 millions de dollars avec Lincoln Park Capital.
La société a élargi sa clientèle à six établissements pour QUELIMMUNE, son produit approuvé par la FDA destiné aux patients pédiatriques en insuffisance multiviscérale, qui a démontré une réduction de la mortalité d'environ 50%. De plus, SeaStar a mis en œuvre des mesures de réduction des coûts et restructuré environ 1,2 million de dollars de passifs liés aux rémunérations des employés. La société estime que ces actions l'ont aidée à satisfaire à l'exigence de fonds propres de 2,5 millions de dollars pour la poursuite de sa cotation au Nasdaq, en attente d'une confirmation formelle.
SeaStar Medical (NASDAQ: ICU) hat mehrere Maßnahmen ergriffen, um die Einhaltung der Nasdaq-Listing-Anforderungen wiederherzustellen, nachdem im Juni 2024 eine Mitteilung über die Nichteinhaltung erhalten wurde. Das Unternehmen schloss ein 4,0 Millionen Dollar öffentliches Angebot ab und sicherte sich eine 15,0 Millionen Dollar Kaufvereinbarung mit Lincoln Park Capital.
Das Unternehmen hat seine Kundenbasis für QUELIMMUNE, sein von der FDA zugelassenes Produkt für pädiatrische Patienten mit Multiorganversagen, auf sechs Einrichtungen ausgeweitet, welches nachweislich die Sterblichkeit um etwa 50% reduziert. Zusätzlich hat SeaStar Kostensenkungsmaßnahmen umgesetzt und etwa 1,2 Millionen Dollar an Verbindlichkeiten aus Mitarbeitervergütungen umstrukturiert. Das Unternehmen ist der Ansicht, dass diese Maßnahmen geholfen haben, die 2,5 Millionen Dollar Eigenkapitalanforderung für die weitere Nasdaq-Notierung zu erfüllen, vorbehaltlich einer formellen Bestätigung.
- Secured $4.0 million through public offering of common stock and warrants
- Established $15.0 million purchase agreement with Lincoln Park Capital
- Expanded QUELIMMUNE customer base to 6 facilities
- QUELIMMUNE shows approximately 50% reduction in pediatric mortality
- Successfully reduced liabilities by $1.2 million through compensation restructuring
- Failed to maintain minimum $35 million market value requirement for Nasdaq listing
- Required implementation of cost-cutting measures
- Employees and directors had to waive accrued compensation to improve financial position
- Nasdaq compliance status still pending formal confirmation
Insights
SeaStar Medical likely regained Nasdaq compliance through multiple financial moves, awaiting official confirmation.
SeaStar Medical has executed a comprehensive strategy to address its Nasdaq compliance issues, specifically the requirement to maintain $2.5 million in stockholders' equity. The company faced potential delisting after failing to meet the $35 million market value requirement last year. Their multi-pronged approach includes a recent
The company's commercial progress with QUELIMMUNE is particularly noteworthy, expanding to six customers in the most recent quarter. This FDA-approved treatment for pediatric patients with multiple organ failure demonstrates remarkable clinical outcomes, reducing mortality by approximately
Management has demonstrated financial discipline through cost-cutting initiatives and the elimination of
DENVER, June 25, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today that it has undertaken a series of transactions to ensure compliance with Nasdaq’s continued listing standards.
Last year on June 24, 2024, SeaStar Medical received a written notification from Nasdaq’s Listing Qualifications Staff that it was not in compliance with the requirement to maintain a minimum market value of listed securities of
SeaStar Medical has completed the following capital transactions and operational improvements to evidence compliance with the Nasdaq equity rule:
Fundraising transactions:
- On June 23, 2025, SeaStar Medical completed a
$4.0 million public offering of common stock and warrants. - On April 25, 2025, SeaStar Medical entered into a purchase agreement with Lincoln Park Capital, pursuant to which Lincoln Park agreed to purchase up to an aggregate of
$15.0 million of our common stock from time to time over a three-year term.
Revenue generation:
- In the second fiscal quarter, SeaStar Medical continued to advance its business plan by increasing its customer count to six for the Company’s FDA approved product, QUELIMMUNE, which is used by ICU physicians treating pediatric patients with multiple organ failure. QUELIMMUNE has been shown to reduce pediatric mortality by approximately
50% and completely relieve pediatric patients from a lifetime of dialysis.
Operating expense reduction:
- In May 2025, SeaStar Medical began a cost cutting program that is expected to reduce operating expenses for the remainder of the current fiscal year. The Company does not anticipate that these expense reductions will have a material impact on operations.
Liability restructuring:
- In May and June of 2025, approximately
$1.2 million of employee compensation and director fee liabilities were extinguished as certain employees and directors waived their rights to bonuses and fees that had accrued but not paid.
Based on the above, SeaStar Medical believes it has regained compliance with the
About QUELIMMUNE
The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with Renal Replacement Therapy (RRT). The QUELIMMUNE therapy was approved in February 2024 under a Humanitarian Device Exemption application, having met the applicable criteria with clinical results showing safety and probable clinical benefit in a limited population of critically ill children with AKI who have few treatment options. SeaStar Medical commenced its commercial launch of the QUELIMMUNE therapy in July 2024. In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.
About NEUTRALIZE-AKI Pivotal Trial
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
About Acute Kidney Injury (AKI) and Hyperinflammation
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
About the SeaStar Medical Selective Cytopheretic Device Therapy
The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing nearly a million patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.
About SeaStar Medical
SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.
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, SeaStar Medical’s expectations with respect to Nasdaq compliance and the Company’s stockholders’ equity balance. 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 the 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:
IR@SEASTARMED.COM
FAQ
What steps has SeaStar Medical (ICU) taken to maintain Nasdaq listing compliance?
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