Thursday, April 18, 2024 7:11:57 AM
SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.
“It was exceptionally exciting to receive our first FDA approval for Quelimmune™, which is now available for treating critically ill pediatric patients suffering from acute kidney injury (AKI) and sepsis. We are proud to be the only company to develop and commercialize a therapeutic device that’s proven to save lives and decrease dialysis dependency in these extremely sick children,” said Eric Schlorff, SeaStar Medical CEO. “We are working closely with our distribution partner to commercialize Quelimmune Pediatric to leading U.S. children’s hospitals.
“In our NEUTRALIZE-AKI pivotal clinical trial, which is evaluating the safety and efficacy of our Selective Cytopheretic Device (SCD) in the significantly larger adult AKI patient population, enrollment now stands at 24 subjects and we have activated six clinical trial sites. Additional sites are advancing through the on-boarding process,” he added. “We anticipate conducting an interim analysis once we have reached the 90-day primary endpoint in 100 subjects, which we expect to occur in the second half of 2024.
“Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff. “The restatement primarily involved the accounting treatment of non-cash items and had minimal to no impact on our operating expenses, cash usage, cash position or future business potential. I would like to thank our finance team for their hard work in quickly completing this restatement.”
SeaStar Medical provides the following updates on its commercial and development programs, and corporate activities:
Pediatric Acute Kidney Injury
Only about half of patients in the pediatric ICU with AKI who require kidney replacement therapy (KRT) survive, with those surviving at risk of long-term life-threatening conditions such as chronic kidney disease. Pooled analysis from two non-controlled studies, one of which was funded by the FDA Office of Orphan Products Development, showed that children weighing 10 kilograms or more with AKI requiring continuous kidney replacement therapy (CKRT) who were treated with Quelimmune had no device-related serious adverse events or device-related infections, a 77% survival rate and no dialysis dependency at Day 60.
In February 2024 SeaStar Medical received its first U.S. regulatory approval for the SCD Pediatric (SCD-PED) device for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. The SCD-PED is the first product approval in the Company’s newly branded Quelimmune product family. Quelimmune was approved under a humanitarian device exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. The U.S. addressable population of about 4,000 pediatric patients falls within the 8,000-patient HDE criteria.
The Company is working to commercialize Quelimmune with its distribution partner Nuwellis, which has deep relationships with nephrologists and intensive care physicians trained in pediatric extracorporeal therapy. Pediatric patients undergoing treatment with Quelimmune are expected to require on average seven Quelimmune units, with the disposable device being changed once every 24 hours.
In March 2024 the Company sponsored an industry symposium titled “New Therapies in Pediatric Acute Kidney Injury” at the AKI & CRRT 2024 conference. The symposium featured key opinion leaders in nephrology and AKI, who are members of the Company’s Scientific Advisory Board.
Adult Acute Kidney Injury
SeaStar Medical is conducting the pivotal NEUTRALIZE-AKI (NEUTRophil and Monocyte DeActivation via SeLective CytopheretIc Device - a RandomiZEd Clinical Trial in Acute Kidney Injury) clinical trial to evaluate the safety and effectiveness of the SCD in adults with AKI in the ICU receiving CKRT. The SCD has received FDA Breakthrough Device Designation for adult AKI. This designation is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints.
The NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD-ADULT in addition to CKRT as the standard of care, compared with the control group receiving only CKRT 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 SCD-ADULT therapy in AKI patients with sepsis and acute respiratory distress syndrome. A more complete description of the NEUTRALIZE-AKI trial design can be found in the journal Nephron.
The Company expects to receive regulatory approval for the SCD-ADULT in the second half of 2025 and to launch the product in the first half of 2026.
Additional SCD Indications
SeaStar Medical continues to explore the application of its SCD technology across a range of indications involving dysregulated immune processes where proinflammatory activated neutrophils and monocytes may contribute to disease progression or severity, in both acute and chronic indications.
In September 2023 the Company received Breakthrough Device Designation for the SCD for use in cardiorenal syndrome. This was only the ninth Breakthrough Device Designation granted by the FDA’s Center for Biologics Evaluation and Research (CBER) since the program’s inception in 2015. The Company plans to work in partnership with the University of Michigan to conduct additional clinical studies to gather further evidence to support FDA approval.
In October 2023 the Company received Breakthrough Device Designation for the SCD for use in hepatorenal syndrome. An ongoing pilot study in this indication at the University of Michigan is expected to provide valuable insight in the design and execution of a pivotal study.
In February 2024 the manuscript “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” Pitt, B., Iyer, S.P.N. and Humes, H.D. discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the SCD was published in the peer-reviewed European Journal of Heart Failure.
Corporate Developments
In January 2024 the Company appointed healthcare industry veteran David A. Green as Chief Financial Officer. Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
In January 2024 the Company announced a $9.0 million registered direct offering priced at-the-market.
In January 2024 a U.S. patent was granted with broad claims directed to methods of using the SCD to treat subjects with inflammatory conditions and to process activated leukocytes and platelets.
In February 2024 the Canadian Intellectual Property Office issued a patent with broad claims covering the SCD technology.
2023 Financial Results
Research and development (R&D) expenses for 2023 were $6.0 million, compared with $2.5 million for 2022, with the increase primarily driven by higher clinical trial and personnel expenses, partially offset by lower external services.
General and administrative (G&A) expenses for 2023 were $8.2 million, compared with $6.9 million for 2022, with the increase primarily due to higher insurance expense, higher costs associated with SEC reporting, increases in payroll-related expenses, higher legal and professional services fees, an increase in directors’ compensation expense and a legal settlement. The increase was partially offset by lower fees associated with an equity line of credit.
Other expense for 2023 was $12.0 million, compared with other expense of $0.6 million for 2022. The increase primarily resulted from an increase in interest expense, unrealized loss on convertible notes and loss on extinguishment of convertible notes, and a reduction in unrealized gains from declines in the fair value of derivative warrants liability. This was offset by a decline in the loss recognized in the change in fair value of the forward purchase agreement derivative liability and other income. The Company incurred a loss on changes in fair value of pre-merger convertible notes payable derivative liability in 2022, with no comparable liability in 2023.
The net loss for 2023 was $26.2 million, or $1.21 per share on 21.7 million weighted-average shares outstanding. This compared with a net loss for 2022 of $12.2 million, or $1.48 per share, on 8.2 million weighted-average shares outstanding.
The Company reported cash of $176,000 as of December 31, 2023, compared with $47,000 as of December 31, 2022. In January 2023 the Company announced a $9.0 million registered direct offering priced at-the-market.
About Hyperinflammation
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.
About The Selective Cytopheretic Device
The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. Quelimmune is the official brand name for the SCD Pediatric that has received FDA HDE approval based on safety and probable efficacy.
Recent ICU News
- SeaStar Medical Announces $3.6 Million NIH Grant Award to Study the Selective Cytopheretic Device in Adult Patients with Severe Chronic Heart Failure • GlobeNewswire Inc. • 04/30/2024 12:30:00 PM
- SeaStar Medical Reports 2023 Financial Results and Provides a Business Update • GlobeNewswire Inc. • 04/17/2024 08:00:00 PM
- SeaStar Medical to Present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference • GlobeNewswire Inc. • 04/11/2024 12:30:00 PM
- SeaStar Medical to Restate Financials, Sets Business Update Call for April 17 • GlobeNewswire Inc. • 03/27/2024 12:30:00 PM
- SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients • GlobeNewswire Inc. • 03/12/2024 12:30:00 PM
- SeaStar Medical-Sponsored Symposium Featuring Experts Discussing Pediatric Acute Kidney Injury and the Selective Cytopheretic Device to be Webcast Live at AKI & CRRT 2024 • GlobeNewswire Inc. • 03/11/2024 08:05:00 PM
- Manuscript Discussing the Benefit of SeaStar Medical’s Selective Cytopheretic Device in Patients with Heart Failure and Hyperinflammation Published in European Journal of Heart Failure • GlobeNewswire Inc. • 02/27/2024 01:30:00 PM
- Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™ • GlobeNewswire Inc. • 02/22/2024 12:58:00 PM
- FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury • GlobeNewswire Inc. • 02/22/2024 12:53:00 PM
- SeaStar Medical Granted Canadian Patent with Broad Claims Covering the Selective Cytopheretic Device Technology • GlobeNewswire Inc. • 02/01/2024 01:30:00 PM
- SeaStar Medical Announces Pricing of $9.0 Million Registered Direct Offering Priced At-the-Market • GlobeNewswire Inc. • 01/26/2024 01:05:00 PM
- SeaStar Medical Appoints David A. Green as Chief Financial Officer • GlobeNewswire Inc. • 01/11/2024 09:05:00 PM
- SeaStar Medical Issued U.S. Patent with Broad Claims Covering Use of the Selective Cytopheretic Device for Multiple Clinical Indications • GlobeNewswire Inc. • 01/09/2024 01:30:00 PM
- SeaStar Medical Updates Subject Enrollment in its Pivotal Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury • GlobeNewswire Inc. • 12/28/2023 01:30:00 PM
- SeaStar Medical Forms Scientific Advisory Board of World-Renowned Pediatric and Adult Clinical Experts • GlobeNewswire Inc. • 12/13/2023 01:30:00 PM
- SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update • GlobeNewswire Inc. • 11/14/2023 09:04:00 PM
- Nuwellis’ Strategic Partner, SeaStar Medical, Receives FDA Approvable Letter for Its Pediatric Selective Cytopheretic Device • GlobeNewswire Inc. • 10/31/2023 12:00:00 PM
- FDA Issues Approvable Letter for SeaStar Medical’s Selective Cytopheretic Device for Pediatric Patients • GlobeNewswire Inc. • 10/30/2023 12:00:00 PM
- FDA Grants SeaStar Medical’s Selective Cytopheretic Device Breakthrough Device Designation for Hepatorenal Syndrome • GlobeNewswire Inc. • 10/18/2023 12:30:00 PM
- SeaStar Medical to Present at the Dawson James Small Cap Growth Conference on October 12, 2023 • GlobeNewswire Inc. • 10/05/2023 12:30:00 PM
- SeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption • GlobeNewswire Inc. • 10/03/2023 08:05:00 PM
- FDA Grants Breakthrough Device Designation to SeaStar Medical’s Selective Cytopheretic Device for Cardiorenal Syndrome • GlobeNewswire Inc. • 09/29/2023 12:30:00 PM
- Dawson James Securities Announces October Date for 8th Annual Small Cap Growth Conference • GlobeNewswire Inc. • 09/21/2023 01:35:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/30/2023 08:35:26 PM
- Case Series of Three Critically Ill Children with Acute Kidney Injury Safely Treated with SeaStar Medical’s Selective Cytopheretic Device Published in the Journal Blood Purification • GlobeNewswire Inc. • 08/29/2023 12:00:00 PM
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