| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | Small Molecule | Oncology | ||
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | Small Molecule | Oncology | ||
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | -% | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
SeaStar Medical Holding Corporation$3.12
+0.22 (+7.23%)
F 10Pipeline Score MedTech · Clinical
Market Cap
14.99 M
EPS
-4.78
P/E Ratio
-
Value Trade
341.95 K
SEC Financials
Q1 2026Dilution Risk
Revenue
495.00 K
R&D Expenses
2.34 M
Operating CF
-2.76 M
Total Assets
11.26 M
Total Liabilities
3.95 M
Equity
7.32 M
D/E Ratio
12,345
-10.93 %
Week
-14.87 %
1 Month
56.28 %
3 Month
18.48 %
6 Month
-99.85 %
5 Year
-99.85 %
All Time
Cash Data
Cash Position
9.35 M
Monthly Burn
920.00 K
Runway
8.8 mo
Burn Trend
SEC Filing
May 13, 2026
Overview
Volume
39.10 K
52 Week Range
2.07 - 13
% held by Insiders
0.9 %
% held by Institutions
3.99 %
Enterprise Value
5.97 M
Total Shares
3.79 M
Short %
3.41 %
Float Shares
3.79 M
Company Description
locked
Upcoming Catalyst
Drug Pipeline Intelligence
F10
Pipeline Score -
Pipeline ValueValuation Signal
0
Drugs Scored—
rNPV / MCap Top 9%
Micro Cap (rank 825 of 905)
Percentile RankSeaStar Medical Holding Corporation has significant pipeline risk (10/100).
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
QUELIMMUNE | Acute Kidney Injury,sepsis | Phase 2 | 2025-08-14 | |||
QUELIMMUNE | Acute Kidney Injury,sepsis | Phase 2 | 2025-08-14 | |||
QUELIMMUNE | Acute Kidney Injury,sepsis | Phase 2 | 2025-08-14 |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in ICU
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
Biotech Analyst Ratings
Symbol
Firm
Rating
Action
Price Target
Upside
date
ICU
Example Securities
Buy
Initiated
$150.00
+25%
2026-01-15
ICU
Example Securities
Buy
Initiated
$150.00
+25%
2026-01-15
ICU
Example Securities
Buy
Initiated
$150.00
+25%
2026-01-15
ICU Stock Forecast & Analyst Consensus
BUY
Analyst Ratings
Buy65.0%
Hold25.0%
Sell10.0%
Price Target Trend
Average$24.00
Low$18.00
High$32.00
ICU Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
ICUSeaStar Medical Announces New ICD-10-PCS Codes for Its SCD Therapy for Acute Kidney Injury
SeaStar Medical has announced the assignment of new ICD-10-PCS codes for its QUELIMMUNE therapy, facilitating standardized billing for acute kidney injury treatments. This development is expected to enhance the adoption of the therapy, particularly in the adult market, which is estimated to be worth $4.5 billion. The new codes will take effect on October 1, 2026, and aim to improve the logistics for hospitals using this innovative treatment.
Read more →ICUSeaStar Medical to Present at Upcoming Investor Summit Conference
SeaStar Medical will present at the Virtual Investor Summit Conference on June 24, 2026. CEO Eric Schlorff will discuss the company's focus on treatments for critically ill patients facing organ failure. SeaStar's QUELIMMUNE® product is FDA approved for life-threatening Acute Kidney Injury in pediatric patients, and the company is conducting pivotal trials for adult patients.
Read more →ICUSeaStar Medical Reports First Quarter Financial Results and Provides Business Updates
SeaStar Medical (ICU) reported strong financial results for Q1 2026, with a 69% increase in revenue compared to the same period in 2025, reflecting growth in their QUELIMMUNE pediatric acute kidney injury therapy. The company advanced its pivotal NEUTRALIZE-AKI clinical trial for adult patients and is working towards submitting a modular post-marketing application for this indication. Financial results showed a net loss that narrowed slightly compared to last year, while cash reserves decreased. The optimistic outlook includes expansions into adult markets and pending regulatory submissions with an anticipated revenue of approximately $2 million for 2026.
Read more →ICUSeaStar Medical to Report First Quarter Financial Results on May 13, 2026
SeaStar Medical Holding Corporation will report its first quarter financial results on May 13, 2026. The company is known for its innovative treatments for critically ill patients, particularly those facing organ failure. Its first product, QUELIMMUNE, is FDA-approved for a rare condition in pediatric patients, and it is currently conducting a pivotal trial for adult patients with Acute Kidney Injury.
Read more →ICUSeaStar Medical Showcases New Positive Data from the QUELIMMUNE SAVE Registry and an Analysis of the Unique Immunomodulatory Mechanism of the SCD Therapy at AKI & CRRT 2026
SeaStar Medical presented new data from the SAVE Registry at the AKI & CRRT 2026 conference, highlighting positive outcomes in pediatric patients treated with the Selective Cytopheretic Device (SCD). The data showed no device-related adverse events and promising survival rates. The company also emphasized its commitment to improving treatment options for pediatric Acute Kidney Injury (AKI).
Read more →ICUSeaStar Medical Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
SeaStar Medical reported its financial results for Q4 and the full year 2025, highlighting significant progress in its QUELIMMUNE therapy for pediatric AKI. The company exceeded the 50% enrollment milestone in its pivotal NEUTRALIZE-AKI trial for adults and initiated a new cardio-renal clinical trial. Despite a net loss of $12.2 million, the company anticipates strong revenue growth driven by expanding sales and adoption of its therapies.
Read more →ICUSeaStar Medical to Report Fourth Quarter and Year-End 2025 Financial Results on March 25, 2026
SeaStar Medical Holding Corporation will report its fourth quarter and year-end 2025 financial results on March 25, 2026. The company, which focuses on treatments for critically ill patients, has an FDA-approved product for life-threatening Acute Kidney Injury. Additionally, its Selective Cytopheretic Device therapy has received Breakthrough Device Designation for several indications, and a pivotal clinical trial is currently underway.
Read more →ICUSeaStar Medical to Present at the Life Sciences Investor Forum on March 11th
SeaStar Medical Holding Corporation (Nasdaq: ICU) is set to present at the Life Sciences Investor Forum on March 11, 2026. CEO Eric Schlorff will engage in a CEO chat, providing a platform for investors to interact with management in real-time. The company has highlighted recent successes, including the expansion of its QUELIMMUNE product for pediatric patients and ongoing clinical trials for its therapies targeting acute kidney injury and cardiorenal syndrome. This interactive online forum aims to boost engagement among investors and industry professionals.
Read more →ICUSeaStar Medical Announces Completion of FDA Enrollment Requirement for SAVE Surveillance Registry Evaluating QUELIMMUNE Safety for Pediatric AKI
SeaStar Medical has completed the FDA enrollment requirement for the SAVE Registry, confirming safety for QUELIMMUNE therapy in pediatric AKI cases. The registry successfully enrolled 50 patients, and early results indicate promising safety and efficacy. The company plans to submit the 28-day safety results to the FDA following data analysis. QUELIMMUNE therapy has garnered interest from leading children's hospitals.
Read more →ICUSeaStar Medical Announces Publication in Pediatric Nephrology of Positive Real-World Experience for QUELIMMUNE™ (SCD-PED) Therapy in Pediatric Acute Kidney Injury (AKI)
SeaStar Medical has published positive early post-approval data for its QUELIMMUNE therapy in Pediatric Nephrology. The therapy demonstrated a 76% survival rate at Day 28 and a 71% survival rate at Day 90 among pediatric patients with Acute Kidney Injury (AKI) and sepsis. Notably, there were no device-related adverse events reported, supporting the therapy's safety profile. This publication aims to promote broader adoption of QUELIMMUNE in treating critically ill pediatric patients.
Read more →ICUSeaStar Medical to Present at Upcoming Noble Capital Markets Emerging Growth Virtual Equity Conference
SeaStar Medical Holding Corporation (Nasdaq: ICU) announced that CEO Eric Schlorff will present at the Noble Capital Markets Emerging Growth Virtual Equity Conference on February 5th. The company focuses on innovative treatments for critically ill patients, with its QUELIMMUNE therapy being the first FDA-approved product for life-threatening acute kidney injury in pediatric patients. A replay of the presentation will be available on February 9th.
Read more →ICUSeaStar Medical Announces 2026 Milestones
SeaStar Medical has outlined its key milestones for 2026, focusing on the adoption of its QUELIMMUNE therapy for pediatric AKI and advancing its SCD therapy for adult AKI and heart failure. The company aims to complete enrollment in the NEUTRALIZE-AKI pivotal trial and initiate the PMA process, targeting a significant market opportunity. CEO Eric Schlorff emphasizes the potential to save lives and expand the therapy's applications.
Read more →ICUSeaStar Medical to Present at Upcoming Biotech Showcase 2026 Investor Conference
SeaStar Medical Holding Corporation (Nasdaq: ICU) announced that CEO Eric Schlorff will present at the Biotech Showcase 2026 Investor Conference on January 13, 2026. The presentation will highlight SeaStar's focus on innovative treatments for critically ill patients facing organ failure. Additionally, the company will engage with investors during the 44th Annual J.P. Morgan Healthcare Conference from January 12-14, 2026. SeaStar Medical's QUELIMMUNE therapy is notably the only FDA-approved treatment for a rare, life-threatening condition in pediatric patients.
Read more →ICUSeaStar Medical Announces 1-for-10 Reverse Split
SeaStar Medical Holding Corporation has announced a 1-for-10 reverse stock split, effective January 5, 2026, to boost its stock price and maintain compliance with Nasdaq listing rules. Stockholders will automatically see adjustments to their shareholdings. The company operates in the healthcare sector, focusing on treatments for critically ill patients, and has a commercially available therapy approved by the FDA. The announcement underscores the company's ongoing efforts to navigate the challenges of maintaining its market position.
Read more →ICUSeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI
SeaStar Medical announced FDA approval for a reduced enrollment requirement for the SAVE Surveillance Registry pertaining to QUELIMMUNE therapy, dropping the number from 300 to 50 patients. This change is based on positive efficacy data from initial patients in the registry. The reduced size is expected to expedite the post-approval surveillance process and broaden market opportunities for QUELIMMUNE, aimed at treating pediatric patients with acute kidney injury. Preliminary results have indicated significant survival benefits associated with this therapy.
Read more →ICUSeaStar Medical to Present at Upcoming NobleCon21 Investor Conference
SeaStar Medical Holding Corporation will present at the NobleCon21 Investor Conference on December 3, 2025. CEO Eric Schlorff will discuss the company's innovative therapies for critically ill patients. The QUELIMMUNE therapy, which received FDA approval in 2024, is designed for life-threatening acute kidney injury in pediatric patients. A replay of the presentation will be available on the company's website.
Read more →ICUSeaStar Medical Announces Appointment of Michael Messinger as CFO
SeaStar Medical Holding Corporation has announced the appointment of Michael Messinger as Chief Financial Officer. With over 25 years of experience in the healthcare sector, Messinger is expected to enhance the company's financial operations and prepare for further commercial opportunities, particularly with their SCD therapy. CEO Eric Schlorff expressed optimism regarding Messinger's impact on the company's strategic and financial goals. The QUELIMMUNE therapy, recently approved by the FDA, has shown promising early results in treating pediatric acute kidney injury (AKI).
Read more →ICUSeaStar Medical Reports Third Quarter 2025 Financial Results and Provides Business Updates
SeaStar Medical Holding Corporation reported its financial results for Q3 2025 and highlighted significant business developments. The company's QUELIMMUNE therapy has been adopted by three top-rated children's hospitals, and preliminary survival results for pediatric patients show promising outcomes. SeaStar has also strengthened its financial position by raising $12.4 million, though it continues to report net losses. The NEUTRALIZE-AKI pivotal trial is underway with adjusted enrollment targets following positive interim analysis results.
Read more →ICUSeaStar Medical to Report Third Quarter Financial Results on November 13, 2025
SeaStar Medical Holding Corporation will announce its third quarter financial results on November 13, 2025. The company focuses on innovative treatments for critically ill patients, particularly those facing organ failure. Its QUELIMMUNE therapy, approved by the FDA, addresses life-threatening acute kidney injury in pediatric patients. Additionally, SeaStar is conducting pivotal trials for adult AKI patients.
Read more →ICUSeaStar Medical Reports Positive Early Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) at the 5th International Symposium on Acute Kidney Injury in Children
SeaStar Medical announced positive preliminary results for its QUELIMMUNE therapy during the 5th International Symposium on Acute Kidney Injury in Children. The therapy, aimed at critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis, demonstrated a 76% survival rate at Day 28 and a 71% survival rate at Day 90, with no device-related adverse events reported. The results suggest a significant improvement in patient outcomes compared to historical data.
Read more →ICUSeaStar Medical Reports DSMB Recommendation to Continue the NEUTRALIZE-AKI Pivotal Trial in Adult Acute Kidney Injury
SeaStar Medical announced that the independent DSMB has recommended the continuation of the NEUTRALIZE-AKI pivotal trial for its Selective Cytopheretic Device therapy in adult patients with acute kidney injury. The trial's sample size will increase from 200 to 339 patients to enhance statistical power. Preliminary results show no safety issues and suggest potential clinical benefits.
Read more →ICUSeaStar Medical to Present Early SAVE Registry Data of QUELIMMUNE in Pediatric Acute Kidney Injury at the 5th International Symposium on Acute Kidney Injury in Children
SeaStar Medical Holdings Corporation announced the presentation of early results from the SAVE Surveillance Registry at the upcoming 5th International Symposium on Acute Kidney Injury in Children. The presentation will focus on the QUELIMMUNE therapy's role in treating critically ill pediatric patients with Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy. Initial results suggest encouraging safety and efficacy data, potentially supporting broader adoption of QUELIMMUNE therapy. Additionally, a second abstract covering the study design of the SAVE registry will also be presented at the event.
Read more →ICUSeaStar Medical to Participate in the HC Wainwright 27th Annual Global Investment Conference
SeaStar Medical will present at the HC Wainwright 27th Annual Global Investment Conference on September 5, 2025. The company focuses on treatments for critically ill patients, with its QUELIMMUNE therapy being the first FDA-approved product for life-threatening acute kidney injury in pediatric patients. The therapy has received Breakthrough Device Designation for several indications, and a pivotal trial is ongoing for adult patients.
Read more →ICUSeaStar Medical Announces Newly Published QUELIMMUNE Health Economic Study Projecting Significantly Reduced Health Care Costs in the Treatment of Pediatric AKI due to Estimated Shorter Hospital Stays and Increased Survival
SeaStar Medical announced a health economic analysis showing that its QUELIMMUNE therapy for pediatric Acute Kidney Injury (AKI) can save an estimated $69,146 per hospitalization compared to standard treatments. The therapy, which has shown a 77% survival rate in clinical studies, is expected to offset its costs, potentially leading to no out-of-pocket expenses for hospitals. The publication in the Journal of Medical Economics highlights the therapy's economic and clinical benefits, supporting its broader adoption in pediatric care.
Read more →ICUSeaStar Medical Reports Second Quarter 2025 Financial Results and Provides Business Updates Business highlights include: • Adult NEUTRALIZE-AKI trial enrolls 31 new patients, now over 60% enrolled • Three n
SeaStar Medical (Nasdaq: ICU) reported its second quarter 2025 financial results, highlighting promising developments in its clinical trials and product adoption. The NEUTRALIZE-AKI trial has successfully enrolled over 60% of its target patients, and QUELIMMUNE therapy has been adopted by three prestigious children's hospitals. The company reported positive survival rates in pediatric patients treated with QUELIMMUNE, with no safety events noted in the SAVE Surveillance Registry. Despite a net loss for the quarter, SeaStar Medical raised significant funds to support its operations and further development.
Read more →ICUSeaStar Medical to Report Second Quarter Financial Results on August 13, 2025
SeaStar Medical Holding Corporation (Nasdaq: ICU) announced it will report its second quarter financial results on August 13, 2025. Following this, a webcast and conference call will be hosted to discuss the results and business developments. The company, focused on treatments for critically ill patients, gained FDA approval for its product QUELIMMUNE in 2024. SeaStar is actively conducting trials for its SCD therapy for adult patients suffering from acute kidney injury.
Read more →ICUSeaStar Medical Reaches New Enrollment Milestone in NEUTRALIZE-AKI Pivotal Trial of SCD Therapy for Adult Patients with Acute Kidney Injury (AKI)
SeaStar Medical has announced that its NEUTRALIZE-AKI pivotal trial has reached a significant milestone with 125 patients enrolled out of a targeted 200. The trial, which focuses on a new therapy for adult patients with acute kidney injury, has also activated its 16th clinical site. An interim analysis is scheduled for the third quarter of 2025, aimed at evaluating the therapy's safety and efficacy.
Read more →ICUSeaStar Medical Announces $4.4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
SeaStar Medical Holding Corporation has announced a registered direct offering of approximately 4.96 million shares at $0.887 each, aiming to raise about $4.4 million. The offering is expected to close around August 1, 2025, and will support general corporate purposes. The company is also issuing unregistered warrants in a concurrent private placement.
Read more →ICUSeaStar Medical Reports Positive Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) from the First 20 SAVE Surveillance Registry Patients
SeaStar Medical Holding Corporation reported positive preliminary results for its QUELIMMUNE therapy in the treatment of pediatric Acute Kidney Injury (AKI) from the SAVE Surveillance Registry, involving 20 critically ill patients. Notably, 75% of patients survived through the 28-day mark, and there were no safety events associated with the device. The data indicates a promising reduction in loss of life compared to historical outcomes, with further analyses expected to reinforce these results. The QUELIMMUNE therapy has gained traction in top children's medical centers and has been granted FDA Breakthrough Device Designation, enhancing its potential impact in treating high-risk pediatric patients.
Read more →ICUSeaStar Medical Grows Customer Base and Expands QUELIMMUNE Surveillance Registry
SeaStar Medical announced the addition of a Texas-based children's hospital to its customer base for the QUELIMMUNE therapy, aiming for pediatric AKI treatment. The therapy's performance is being monitored through the SAVE Surveillance Registry, with data to be presented at a future medical conference. Additionally, the company reported positive results from previous studies showing improved survival rates. SeaStar's QUELIMMUNE therapy is the first FDA-approved treatment for ultra-rare pediatric AKI due to sepsis.
Read more →ICUSeaStar Medical Announces $4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules DENVER
SeaStar Medical Holding Corporation (Nasdaq: ICU) has announced a registered direct offering of $4 million, selling 5,242,464 shares at $0.763 each. The company will also issue unregistered warrants in a concurrent private placement, with proceeds aimed at general corporate purposes. SeaStar is focused on treatments for critically ill patients, having recently received FDA approval for its product QUELIMMUNE, which addresses life-threatening acute kidney injury. The company is additionally conducting a pivotal trial for its Selective Cytopheretic Device therapy in adults requiring continuous renal replacement therapy.
Read more →ICUSeaStar Medical Expands QUELIMMUNE Adoption for Critically Ill Pediatric Patients with Acute Kidney Injury (AKI)
SeaStar Medical has announced that its QUELIMMUNE therapy is now being utilized by Texas Children’s Hospital for critically ill pediatric patients suffering from acute kidney injury. Initially approved by the FDA in 2024, QUELIMMUNE has demonstrated a 77% survival rate, significantly reducing mortality risk compared to standard treatments. The therapy aims to address the urgent need for effective interventions in this vulnerable patient population. Additionally, SeaStar is conducting the NEUTRALIZE-AKI pivotal trial to further evaluate the therapy’s efficacy in adults with AKI.
Read more →ICUSeaStar Medical Announces Positive Nasdaq Listing Determination DENVER, CO., JULY 2, 2025 – SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatmen
SeaStar Medical Holding Corporation (Nasdaq: ICU) has received confirmation from Nasdaq regarding its compliance with the minimum stockholders' equity requirement for continued listing. This announcement allows the company to focus on the commercialization of its QUELIMMUNE therapy, which has demonstrated significant survival benefits in critically ill pediatric patients with acute kidney injury. The QUELIMMUNE therapy is designed to transform treatment for organ failure, while the company is also conducting pivotal trials for its Selective Cytopheretic Device therapy in adults experiencing acute kidney injury.
Read more →ICUSeaStar Medical Reports Update on Nasdaq Listing Status
SeaStar Medical Holding Corporation (Nasdaq: ICU) has reported an update regarding its compliance with Nasdaq listing standards after receiving a warning last year. The company has completed a $4.0 million public offering and entered a purchase agreement to secure additional funding, which supports its efforts to meet the $2.5 million stockholders' equity requirement. Notably, SeaStar's QUELIMMUNE therapy, aimed at critically ill pediatric patients, has demonstrated positive outcomes, significantly reducing mortality associated with acute kidney injury. Although the company believes it has regained compliance, it is still awaiting confirmation from Nasdaq.
Read more →ICUSeaStar Medical Announces Two Feature Stories on QUELIMMUNE Adoption and Patient Testimonial of Life-Saving Therapy
SeaStar Medical has announced that its QUELIMMUNE therapy will be highlighted in a two-part video series featuring patient experiences at Cincinnati Children’s Hospital. The therapy, which has received a humanitarian device exemption, is designed to aid critically ill pediatric patients suffering from acute kidney injury (AKI) due to hyperinflammation. The first part of the series discusses the adoption of QUELIMMUNE therapy, while the second focuses on a patient's recovery journey, underscoring its potential benefits in critical care settings. SeaStar's commercial launch of QUELIMMUNE began in July 2025 after receiving regulatory approval in February 2024.
Read more →ICUSeaStar Medical Announces Pricing of Up to $8 Million Public Offering $4 million upfront with up to an additional $4 million of potential aggregate gross proceeds upon the exercise in full of short-term warrants DENVER,
SeaStar Medical Holding Corporation has announced a public offering of up to $8 million, consisting of $4 million upfront and an additional $4 million from potential short-term warrants. The offering will include 6,153,847 shares of common stock and associated warrants priced at $0.65 per share. The proceeds are intended for general corporate purposes and come amid ongoing efforts to bring innovative treatments to critically ill patients. The closing of the offering is anticipated on June 23, 2025, subject to standard closing conditions.
Read more →ICUSeaStar Medical Announces CMS Coverage for Medicare and Medicaid Eligible Patients with Cardiorenal Syndrome Awaiting LVAD in Investigational Trial of SCD Therapy
SeaStar Medical has received Medicare and Medicaid coverage for patients enrolled in the NEUTRALIZE-CRS investigational trial, marking its second such award from CMS in under a year. The coverage reflects the potential life-saving impact of SeaStar’s Selective Cytopheretic Device (SCD) therapy, which targets hyperinflammation in patients with cardiorenal syndrome. Following a prior CMS award for another trial, the company aims to build a strong case for commercial reimbursement as it prepares for FDA approval of its therapies for acute kidney injury. The trials demonstrate SeaStar's commitment to addressing critical healthcare needs in severely ill patients.
Read more →ICUSeaStar Medical Reports First Quarter 2025 Financial Results and Provides Business Updates • QUELIMMUNE adoption drives four-fold increase in sequential quarter net revenue • NEUTRALIZE AKI trial exceeds 50
SeaStar Medical reported a significant increase in net revenue for QUELIMMUNE during the first quarter of 2025, driven by strong customer adoption. The NEUTRALIZE-AKI trial has reached over 50% enrollment, with expectations for interim analysis soon. The company is expanding its market reach into adult AKI patients while simultaneously enhancing its operational capabilities following FDA inspections. Overall, the company's proactive strides and favorable results signal positive momentum in its business growth and product adoption.
Read more →ICUSeaStar Medical Reaches Interim Enrollment Target for NEUTRALIZE-AKI Pivotal Trial of SCD Therapy for Adult Patients with Acute Kidney Injury
SeaStar Medical has announced the successful completion of the interim enrollment target in its NEUTRALIZE-AKI pivotal trial, evaluating SCD therapy for adult patients suffering from Acute Kidney Injury (AKI). The completion allows for a prespecified interim analysis by an independent Data Safety Monitoring Review Board, expected to report findings in Q3 2025. The ongoing trial aims to assess the safety and efficacy of SCD therapy compared to standard care in AKI patients requiring continuous renal replacement therapy. With the participation of renowned institutions and previous studies indicating positive outcomes, the trial holds significant promise for improving treatment options in this patient population.
Read more →ICUSeaStar Medical to Report First Quarter Financial Results on May 14, 2025
SeaStar Medical Holding Corporation (Nasdaq: ICU) announced it will report its first quarter financial results on May 14, 2025, following market close. The company also plans to host a webcast and conference call to discuss its financial performance and business progress. SeaStar is recognized for its FDA-approved product QUELIMMUNE, aimed at treating critically ill pediatric patients with acute kidney injury. Additionally, the company's Selective Cytopheretic Device therapy has been designated as a Breakthrough Device for six indications.
Read more →ICUSeaStar Medical Announces CEO Interview on Benzinga All Access to Occur Today at Approximately 10:50 am Eastern Time
SeaStar Medical Holding Corporation (Nasdaq: ICU) announced that CEO Eric Schlorff will be a guest on the Benzinga All Access Show today at around 10:50 am Eastern Time. The live broadcast can be accessed via YouTube, and a recorded version will be available on the company's investor relations webpage. SeaStar is recognized for its groundbreaking treatments for critically ill patients, including its recently FDA-approved product for acute kidney injury in pediatric patients.
Read more →ICUSeaStar Medical Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates Webcast Today at 4:30 pm Eastern Time DENVER, CO.
SeaStar Medical announced its fourth quarter and full year 2024 financial results, highlighting a net revenue of $0.1 million attributed to the launch of its QUELIMMUNE therapy. The company has made considerable progress in clinical trials, enrolling 94 patients in their NEUTRALIZE AKI study, while also being recognized with a Corporate Innovator Award by the National Kidney Foundation. Despite significant advancements, the company reported a net loss of $24.8 million, raising concerns about ongoing financial viability.
Read more →ICUSeaStar Medical to Report Fourth Quarter and Year-End 2024 Financial Results on March 27, 2025
SeaStar Medical Holding Corporation (Nasdaq: ICU) has announced it will report its fourth quarter and year-end 2024 financial results on March 27, 2025. The company is focused on treatment options for critically ill patients and has achieved FDA approval for its product QUELIMMUNE, targeting a rare condition. A pivotal trial for its Selective Cytopheretic Device therapy in adult patients is ongoing, addressing a significant healthcare need.
Read more →ICUSeaStar Medical Announces Closing of $6 Million Registered Direct Offering Priced At-the-Market
SeaStar Medical Holding Corporation has completed a $6 million registered direct offering priced at-the-market, involving the sale of approximately 3.5 million shares of common stock and warrants to a single institutional investor. The gross proceeds from this offering are intended for general corporate purposes, including potential working capital and capital expenditures. The offering included a concurrent private placement of warrants that may be exercised following shareholder approval. This funding reflects SeaStar Medical's commitment to addressing systemic inflammation in critically ill patients through advanced medical technologies.
Read more →ICUSeaStar Medical Announces $6 Million Registered Direct Offering Priced At-the-Market DENVER (
SeaStar Medical Holding Corporation has announced a $6 million registered direct offering, involving the sale of 3,529,412 shares of its common stock. The offering includes pre-funded warrants and is priced at $1.70 per share. The company intends to use the proceeds to bolster its working capital and fund capital expenditures. The deal is expected to close around February 3, 2025, subject to standard conditions.
Read more →ICUSeaStar Medical Adds Fifth Hospital Customer for QUELIMMUNE
SeaStar Medical Holding Corporation has secured its fifth hospital customer for its QUELIMMUNE device, which treats critically ill children suffering from acute kidney injury and sepsis. The device has been recognized for its unique approach to modifying inflammatory processes in patients. SeaStar Medical is pursuing additional approvals to broaden its use, with over a dozen medical centers currently engaged in the process. The company expresses optimism about reaching a goal of having over 20 hospitals utilizing QUELIMMUNE within the year.
Read more →ICUSeaStar Medical Activates 15th Site for its Adult Acute Kidney Injury Pivotal Trial
SeaStar Medical Holding Corporation announced the activation of its 15th site for the NEUTRALIZE-AKI pivotal trial at Mayo Clinic, enhancing its site enrollment capacity. Currently, the trial has enrolled 76 subjects, with the company aiming to reach its milestone of 100 for an interim analysis. The trial evaluates the Selective Cytopheretic Device (SCD) for treating acute kidney injury in critically ill patients. The SCD has also received FDA Breakthrough Device Designation, which may facilitate its therapeutic adoption.
Read more →ICUJanuary 2025 www.SeaStarMedical.com Nasdaq: ICU Investor Presentation Bringing organ - restoring solutions to critically ill patients Forward - looking statements This presentation contains certain forward - looking stat
SeaStar Medical's January 2025 investor presentation showcases their Selective Cytopheretic Device (SCD), designed to address critical organ failure due to hyperinflammation. The device has received FDA approval for pediatric acute kidney injury treatment and is currently enrolling patients for a pivotal trial in adults. The company highlights its potential to significantly address a large market associated with acute kidney injuries. However, the presentation also notes several risks, including the need for regulatory approvals and potential capital shortages to support clinical developments.
Read more →ICUSeaStar Medical Begins Shipping QUELIMMUNE to a Fourth Hospital Customer
SeaStar Medical has announced the shipment of its QUELIMMUNE device to a fourth hospital, marking a significant milestone in its commercial expansion. QUELIMMUNE, designed for critically ill children suffering from acute kidney injury and sepsis, has been shown to reduce mortality and dialysis dependency. The device's clinical success and potential for cost savings make it an attractive option for hospitals, particularly given the high costs associated with kidney injury treatment. This shipment follows FDA approval under a Humanitarian Device Exemption, underscoring its innovative therapeutic approach.
Read more →ICUSeaStar Medical Activates 14th Hospital for its Adult AKI Pivotal Trial
SeaStar Medical has activated its 14th site for the NEUTRALIZE-AKI pivotal trial, which assesses its Selective Cytopheretic Device for acute kidney injury patients. As of now, 70 of the planned 200 subjects have been enrolled, with expectations for interim analysis results by mid-2025. The company projects a substantial market opportunity for its device, but faces risks related to trial costs and the need for timely recruitment of subjects. The SCD previously received FDA Breakthrough Device Designation, reflecting its potential to improve treatment outcomes for critical patients.
Read more →ICUSEASTAR ALERT: Bragar Eagel & Squire, P.C. is Investigating SeaStar Medical Holding Corp on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
Bragar Eagel & Squire, P.C. is investigating SeaStar Medical Holding Corp on behalf of long-term stockholders after a class action complaint was filed against the company. The complaint alleges that SeaStar's board may have breached fiduciary duties regarding the company's compliance and financial practices. Following regulatory challenges, including a rejected FDA application, and the need for restatements of financial statements, SeaStar's stability and growth prospects are in question. The law firm encourages affected stockholders to reach out for more information.
Read more →ICUSeaStar Medical Projects Multibillion-Dollar Market Potential for its Selective Cytopheretic Device in Initial Target Indications
SeaStar Medical estimates a significant U.S. addressable market of $25 to $33 billion for its Selective Cytopheretic Device (SCD) across five initial indications, pending FDA approvals. The SCD has received FDA Breakthrough Device Designation in three indications, which may facilitate its development and market entry. The company has also achieved a major milestone by securing FDA approval for the SCD-Pediatric device, QUELIMMUNE. The upcoming conference call will discuss business progress and plans for clinical trials.
Read more →ICUSeaStar Medical to Hold Business Update Conference Call on December 11, 2024
SeaStar Medical Holding Corporation (Nasdaq: ICU) has announced it will hold a business update conference call on December 11, 2024. The purpose of the call is to discuss progress and updates regarding its proprietary solutions aimed at reducing hyperinflammation on vital organs. Participants will have the option to pre-register or dial in for the call, which will also be available via webcast.
Read more →ICUSeaStar Medical Activates Sentara Norfolk General Hospital and Provides Enrollment Update in Adult AKI Pivotal Trial
SeaStar Medical has activated Sentara Norfolk General Hospital as the thirteenth site in its pivotal NEUTRALIZE-AKI trial, aimed at evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) for treating adult acute kidney injury (AKI). The company reported a total enrollment of 65 patients as of November, with a significant increase in enrollment rates noted. The SCD has received Breakthrough Device Designation from the FDA, which recognizes its potential to improve treatment outcomes for critically ill patients. SeaStar aims to activate additional sites and expand its clinical focus to other high-value indications linked to hyperinflammation.
Read more →ICUSeaStar Medical to Present at Noble Capital Markets’ NobleCon20 on December 4, 2024
SeaStar Medical Holding Corporation (Nasdaq: ICU) will present an overview at NobleCon20, held by Noble Capital Markets, on December 4, 2024. The conference aims to highlight emerging growth companies, with SeaStar focusing on its unique solutions for hyperinflammation. A webcast of the presentation will be made available on the company's website, allowing interested parties to access the information after the event. The company's approach emphasizes innovative therapies that could benefit critically ill patients.
Read more →ICUSeaStar Medical Reaches Milestone of 100th QUELIMMUNE Commercial Device as Shipments Begin to its Third Hospital Customer
SeaStar Medical has reached a significant milestone by shipping its 100th QUELIMMUNE device, aimed at treating critically ill children suffering from acute kidney injury and sepsis. With shipments beginning to a third hospital, the company is on track to meet its goal of expanded commercial availability in several pediatric hospitals by the end of 2024. The demand for QUELIMMUNE has been remarkable, as evidenced by the data shared that indicates potential cost savings for healthcare facilities. Furthermore, the device was recently approved under a humanitarian device exemption by the FDA, allowing for its commercial use in specific patient populations.
Read more →ICUSeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business Update DENVER (
SeaStar Medical reported its third-quarter 2024 results, highlighting the commercial launch of QUELIMMUNE for pediatric patients with acute kidney injury. The company recognized $67,500 in revenue from direct sales during the quarter and anticipates significant revenue growth with direct end-user sales starting in Q4. Additionally, they announced the receipt of FDA Breakthrough Device Designation for the SCD in chronic dialysis. The NEUTRALIZE-AKI clinical trial is progressing, with record enrollment and new sites joining the effort.
Read more →ICUSeaStar Medical Adds Second Hospital Customer for QUELIMMUNE
SeaStar Medical Holding Corporation has shipped its Selective Cytopheretic Device, QUELIMMUNE, to a second hospital customer, following a transition to a direct sales model. This new model enables the company to retain full revenue from sales. QUELIMMUNE, recently approved by the FDA, aims to treat critically ill children suffering from acute kidney injury and sepsis, with expected cost savings for hospitals. The company is working to expand its customer base and ensure availability of QUELIMMUNE in multiple pediatric ICUs by the end of 2024.
Read more →ICUSeaStar Medical Announces that Stanford Medicine is Cleared to Actively Enroll Subjects in the Adult Acute Kidney Injury Pivotal Trial
SeaStar Medical Holding Corporation announced that Stanford Medicine is now authorized to actively enroll subjects in the NEUTRALIZE-AKI pivotal trial, which aims to evaluate the safety and efficacy of the Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI). With the addition of two Department of Defense medical centers, a total of 12 sites have been activated for enrollment. The trial received favorable news recently as the U.S. Centers for Medicare and Medicaid Services (CMS) decided to reimburse specific expenses incurred for Medicare patients involved in the study. The SCD device has received FDA Breakthrough Device Designation, indicating its potential to significantly improve clinical outcomes in AKI management.
Read more →ICUSeaStar Medical to Distribute QUELIMMUNE Directly to Hospital Customers
SeaStar Medical Holding Corporation has taken over the direct distribution, sales, and marketing of QUELIMMUNE, its device for treating pediatric acute kidney injury (AKI). This shift allows the company to manage its commercial operations more effectively and respond to hospital needs directly. Initial interest from hospitals like Cincinnati Children's indicates positive market reception, with expectations for increased demand as more institutions are cleared for QUELIMMUNE use. The device aims to significantly reduce mortality rates in critically ill children suffering from AKI due to sepsis or septic-like conditions.
Read more →ICUSeaStar Medical Announces that Enrollment in its Adult Acute Kidney Injury Pivotal Trial Has Exceeded the Halfway Point Toward an Interim Analysis
SeaStar Medical has announced that its NEUTRALIZE-AKI pivotal trial has exceeded the halfway point in patient enrollment, with 51 subjects now participating. The trial aims to evaluate the safety and efficacy of the Selective Cytopheretic Device in treating adults with acute kidney injury receiving continuous kidney replacement therapy. Following a period of low enrollment during the summer, the pace has significantly increased in October. The therapeutic device has also received FDA Breakthrough Device Designation, underscoring its potential benefits in clinical settings.
Read more →ICUSeaStar Medical to Showcase New Mechanistic Data Highlighting the Immunomodulatory Effect of the Selective Cytopheretic Device in Acute Kidney Injury at ASN Kidney Week
SeaStar Medical is set to present new clinical analyses at the 2024 ASN Kidney Week, emphasizing the immunomodulatory benefits of its Selective Cytopheretic Device (SCD) in patients with acute kidney injury (AKI). The SCD's efficacy is demonstrated through decreased inflammation biomarkers in critically ill patients. Additionally, the company is advancing its adult clinical trials and has received FDA approval for its pediatric SCD device, QUELIMMUNE. However, securing regulatory approvals and addressing financial uncertainties remain crucial challenges for SeaStar Medical.
Read more →ICUSeaStar Medical to Present at the 2024 Maxim Healthcare Virtual Summit
SeaStar Medical Holding Corporation (Nasdaq: ICU) will participate in the 2024 Maxim Healthcare Virtual Summit with a fireside chat hosted by Maxim Group's analyst Anthony Vendetti. The event aims to showcase the company’s advances in developing extracorporeal therapies targeted at reducing hyperinflammation in critical care. The chat is scheduled for October 16, 2024, at 12:00 p.m. Eastern time. Registration details will be available on the company’s website.
Read more →ICUSeaStar Medical Expands NEUTRALIZE-AKI Pivotal Trial Adding Two Premier Military Medical Facilities
SeaStar Medical has announced the activation of two additional sites in its NEUTRALIZE-AKI pivotal trial, aiming to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD) in treating acute kidney injury. The inclusion of Brooke Army Medical Center and the United States Army Institute of Surgical Research increases the trial's clinical capacity, with 11 active sites now recruiting participants. The SCD has received FDA Breakthrough Device Designation and is anticipated to significantly enhance treatment outcomes for critically ill patients. Additionally, SeaStar Medical has commenced shipments of its pediatric device QUELIMMUNE, following FDA approval.
Read more →ICUSeaStar Medical Reports Enrollment Momentum in Its Pivotal Adult AKI Trial
SeaStar Medical Holding Corporation (Nasdaq: ICU) has reported an uptick in enrollment for its pivotal NEUTRALIZE-AKI trial, now totaling 46 subjects. This trial assesses the safety and efficacy of the Selective Cytopheretic Device (SCD) for adults suffering from acute kidney injury. The company aims to enroll 200 participants and plans to broaden the trial by adding over a dozen sites. Success in this trial is crucial for future commercialization of the SCD, which could significantly impact treatment approaches in critically ill patients.
Read more →ICUSeaStar Medical to Webcast Fireside Chat at the H.C. Wainwright Global Investment Conference
SeaStar Medical Holding Corporation will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on September 11, 2024. The conference, taking place from September 9-11, 2024, aims to connect company management with institutional investors and industry professionals. SeaStar Medical, known for its innovations in extracorporeal therapies that address hyperinflammation, will also hold in-person and virtual meetings during the event, providing opportunities for deeper discussions about their technology and market potential.
Read more →ICUSeaStar Medical Strengthens Financial Position with Elimination of All Long-Term Debt
SeaStar Medical has announced the successful retirement of all long-term debt, which will be reflected in its balance sheet for the upcoming quarter ending September 30, 2024. The CEO, Eric Schlorff, stated that this milestone places the company in its strongest financial position since becoming public nearly two years ago. The elimination of debt is expected to facilitate the advancement of their business plan and improve their capacity to deliver innovative medical solutions to critically ill patients. This strategic move marks a significant development for the commercial-stage medical device company.
Read more →ICUSeaStar Medical Holding Corporation Investors: Please contact the Portnoy Law Firm to recover your losses. September 6, 2024 Deadline to file Lead Plaintiff Motion.
The Portnoy Law Firm has initiated a class action lawsuit on behalf of investors in SeaStar Medical Holding Corporation who purchased shares between October 31, 2022, and March 26, 2024. Investors have until September 6, 2024, to file a lead plaintiff motion. Allegations against the company include violations of federal securities laws, false statements, and inadequate compliance controls regarding its HDE Application. Following these disclosures, SeaStar announced a restatement of its financial statements, leading to a notable decline in its stock price.
Read more →ICUSeaStar Medical Holding Corporation Sued for Securities Law Violations – Investors Should Contact The Gross Law Firm Before September 6, 2024 to Discuss Your Rights – ICU
SeaStar Medical Holding Corporation is facing a class action lawsuit for alleged securities law violations. The complaint claims that the company failed to disclose significant deficiencies in its compliance controls related to the Humanitarian Device Exemption application, raising concerns over the regulatory approval of its products. Additionally, it is alleged that the company overstated its financial prospects and minimized the severity of its financial compliance issues. Shareholders who purchased shares during the specified class period are encouraged to register as potential lead plaintiffs.
Read more →ICUSeaStar Medical Reports Second Quarter 2024 Financial Results and Provides a Business Update
SeaStar Medical has reported its financial results for Q2 2024, highlighting significant advancements in their QUELIMMUNE therapy. The therapy is aimed at treating acute kidney injury in severely ill children, with initial sales occurring and positive clinical outcomes reported. The company also achieved reimbursement coverage for their pivotal adult AKI clinical trial, which is expected to ease financial burdens considerably. However, increased operational costs and a limited patient population pose ongoing challenges as the company prepares for a robust commercial rollout in the coming months.
Read more →ICUSeaStar Medical Holding Corporation Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky Before September 6, 2024 to Discuss Your Rights – ICU
SeaStar Medical Holding Corporation is currently involved in a class action securities lawsuit initiated by Levi & Korsinsky, LLP. The lawsuit targets false statements and deficiencies associated with the company's Humanitarian Device Exemption Application and financial controls, which were allegedly concealed from investors. Affected investors are encouraged to contact the firm before September 6, 2024, to discuss their rights. The lawsuit highlights significant risks for the company’s future, including potential restatements of financial statements.
Read more →ICUSeaStar Medical Ships First QUELIMMUNE Product Order to U.S. Distribution Partner
SeaStar Medical Holding Corporation has announced its first commercial sale of the QUELIMMUNE product to U.S. partner Nuwellis, Inc. The QUELIMMUNE device, designed to treat pediatric acute kidney injury, is FDA-approved as a Humanitarian Use Device and has shown promising clinical results. With a survival rate of 77% and a goal of reducing dialysis dependency among severely ill children, SeaStar anticipates an expanded commercial rollout later this year. The device addresses a significant market gap for pediatric AKI treatments.
Read more →ICUSeaStar Medical Announces Closing of $10 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
SeaStar Medical has successfully closed a $10 million registered direct offering, selling 947,868 shares of common stock at $10.55 each. The offering, managed by H.C. Wainwright & Co., also includes unregistered warrants, which could provide additional capital in the future. The company intends to use the net proceeds for general corporate purposes, including repayment of debts and operational enhancements. SeaStar Medical, focused on innovative therapies for managing inflammation, is navigating various regulatory and operational risks that could impact its future success.
Read more →ICUSeaStar Medical Announces $10 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules DENVER (
SeaStar Medical Holding Corporation announced a registered direct offering to raise approximately $10 million by selling 947,868 shares of its common stock at $10.55 each. The transaction will include a concurrent private placement issuing unregistered warrants for the same share quantity, with an exercise price matching the offering price. Proceeds from the offering are intended for general corporate needs, including working capital and capital expenditures. The closing of the offering is expected shortly, pending customary conditions.
Read more →ICUSEASTAR ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against SeaStar Medical Holding Corporation and Encourages Investors to Contact the Firm
A class action lawsuit has been initiated against SeaStar Medical Holding Corporation, alleging that the company made materially false and misleading statements regarding its business and compliance practices during the class period from October 31, 2022, to March 26, 2024. Key issues include deficiencies related to SeaStar's application for FDA approval of its Selective Cytopheretic Device and the subsequent restatement of financial statements. The lawsuit highlights concerns about the company's operational integrity and the accuracy of its prior public disclosures.
Read more →ICUSeaStar Medical Finalizes FDA Labeling Requirement for QUELIMMUNE, Paving the Way for First Commercial Sales as Humanitarian Use Device
SeaStar Medical has received FDA approval for the final labeling of its QUELIMMUNE device, enabling its launch as a Humanitarian Use Device. This innovative device is designed to treat pediatric patients with acute kidney injury (AKI) and sepsis. The approval comes as a significant advance, with clinical results indicating a 77% survival rate for the targeted demographic. The commercial sales are expected to begin soon, addressing a critical need in pediatric care for children requiring kidney replacement therapy.
Read more →ICUSeaStar Medical’s Selective Cytopheretic Device Featured in Two Presentations at the 42nd Vicenza Course AKI-CRT-ECOS and Critical Care Nephrology
SeaStar Medical Holding Corporation's Selective Cytopheretic Device (SCD) is highlighted in two presentations at the 42nd Vicenza Course AKI-CRRT-ECOS and Critical Care Nephrology. The SCD is designed to combat hyperinflammation in critically ill patients, specifically targeting proinflammatory cells to improve outcomes for acute kidney injury patients. The company is represented by key experts, emphasizing the potential to save lives and reduce dialysis dependency through innovative therapeutic approaches. This recognition at a leading conference underscores the significance of SeaStar Medical's technology in critical care nephrology.
Read more →ICUSeaStar Medical Strengthens Board of Directors and Transitions to Commercial-Stage Company DENVER (June x, 2024) – SeaStarMedical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) announces that three new member
SeaStar Medical has announced the addition of three new members to its Board of Directors as it transitions into a commercial-stage company. Jennifer A. Baird, Bernadette N. Vincent, and John Neuman bring extensive industry experience to the board. Their leadership is expected to greatly benefit SeaStar Medical as it focuses on commercializing its medical technologies aimed at reducing inflammation in critically ill patients. Former board members Bruce Rodgers and Richard Russell have stepped down, along with Andres Lobo's retirement resulting from his position at Dow Chemical.
Read more →ICUSeaStar Medical Announces 25-for-1 Reverse Stock Split
SeaStar Medical Holding Corporation has announced a 25-for-1 reverse stock split effective June 7, 2024. This decision, approved by stockholders during the 2023 Special Meeting, is intended to raise the market price of its common stock and comply with Nasdaq listing requirements. Following the split, each 25 pre-split shares will convert into one share of common stock, with appropriate adjustments made for outstanding options and warrants. Stockholders will receive updated information about their holdings from the Company's transfer agent post-split.
Read more →ICUSeaStar Medical to Present at the Virtual Emerging Growth Conference on June 12, 2024
SeaStar Medical Holding Corporation, a medical device company focused on reducing hyperinflammation, announced that CEO Eric Schlorff will present at the Virtual Emerging Growth Conference on June 12, 2024. During the conference, he will discuss the company and its Selective Cytopheretic Device (SCD). Investors are encouraged to submit questions for the event, which will also be archived online afterward. The company’s developments aim to improve outcomes for critically ill patients, though risks related to regulatory approval and capital funding remain.
Read more →ICUSeaStar Medical Reports First Quarter 2024 Financial Results and Provides a Business Update
SeaStar Medical Holding Corporation reported its financial results for Q1 2024 and detailed advancements in their product, Quelimmune Pediatric, aimed at treating pediatric acute kidney injury. The company has secured initial sales and is working to evaluate the device in five children's hospitals before a broader launch. Their NEUTRALIZE-AKI clinical trial is gaining momentum with 31 enrolled subjects, further emphasizing the potential of their Selective Cytopheretic Device for adult patients. Additionally, SeaStar Medical has improved its financial position by eliminating debt and increasing cash reserves.
Read more →ICUMAY 14, 2024 SeaStar Medical Reports First Quarter 2024 Financial Results and Provides a Business Update DENVER (
SeaStar Medical reported its financial results for the first quarter of 2024, highlighting the impending sales launch of its pediatric product Quelimmune, which aims to treat acute kidney injury in children. The company is also progressing in its NEUTRALIZE-AKI clinical trial, focusing on adult acute kidney injury, with a target enrollment of 200 patients across U.S. medical centers. Despite a strong quarterly performance, the company faced increased expenses attributed to non-cash losses and other financial adjustments. SeaStar is actively exploring the application of its SCD technology for various indications and has received several FDA Breakthrough Device Designations.
Read more →ICUSeaStar Medical Announces $3.6 Million NIH Grant Award to Study the Selective Cytopheretic Device in Adult Patients with Severe Chronic Heart Failure
SeaStar Medical Holding Corporation has received a $3.6 million grant from the NIH to support a clinical trial assessing its Selective Cytopheretic Device (SCD-ADULT) for adult patients with severe chronic heart failure. The trial aims to determine the device's effectiveness as a bridging strategy to left ventricular assist device (LVAD) implantation for patients experiencing acute decompensated heart failure (ADHF). The grant follows the SCD's designation as a Breakthrough Device by the FDA, highlighting its innovative approach in addressing cardiorenal syndrome. Successful trial outcomes may lead to further FDA marketing applications.
Read more →ICUSeaStar Medical Reports 2023 Financial Results and Provides a Business Update DENVER (
SeaStar Medical reported its financial results for 2023 along with a business update highlighting key developments. The company has received FDA approval for Quelimmune, aimed at treating pediatric patients with acute kidney injury and sepsis. Additionally, they are advancing their NEUTRALIZE-AKI clinical trial, which evaluates a device for adult patients suffering from AKI. Despite the successful developments, SeaStar faced a net loss of $26.2 million for the full year 2023, indicating significant operational challenges.
Read more →ICUSeaStar Medical to Present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference
SeaStar Medical Holding Corporation (Nasdaq: ICU) announced that management will present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 18. The event will include a formal presentation followed by a question-and-answer session. SeaStar Medical specializes in developing therapies aimed at addressing hyperinflammation in critical patients, showcasing its commitment to innovation in medical technology.
Read more →ICUSeaStar Medical to Restate Financials, Sets Business Update Call for April 17 Restatement of non-cash items is not expected to materially impact cash position or operations DENVER (
SeaStar Medical Holding Corporation announced it will restate its financial statements for 2022 and interim periods in 2023 due to misclassification of certain financial items. Despite the restatement, the company does not anticipate a significant impact on cash flow or operations. SeaStar continues to advance its pivotal study for adult acute kidney injury (AKI) and is preparing for the launch of its Quelimmune device for pediatric patients. A business update call is scheduled for April 17, 2024, to provide further insights.
Read more →ICUSeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients
SeaStar Medical has announced updates on its NEUTRALIZE-AKI pivotal clinical trial and the commercial launch of its Quelimmune pediatric device. As of now, 21 subjects have been enrolled, with expectations for accelerated enrollment as additional sites come online. The FDA has granted HDE approval for Quelimmune to treat pediatric patients, which could positively impact approximately 4,000 children annually with acute kidney injury. A business update conference call is planned for April to discuss further progress and opportunities in other indications.
Read more →ICUSeaStar Medical-Sponsored Symposium Featuring Experts Discussing Pediatric Acute Kidney Injury and the Selective Cytopheretic Device to be Webcast Live at AKI & CRRT 2024
SeaStar Medical is sponsoring an Industry Symposium titled 'New Therapies in Pediatric Acute Kidney Injury' on March 13, 2024, during the AKI & CRRT 2024 conference in San Diego. The event will discuss the Selective Cytopheretic Device (SCD-PED), which has shown promise in treating pediatric AKI associated with sepsis. Experts, including those from SeaStar's Scientific Advisory Board, will share insights on the technology, clinical data, and the recent FDA approval of the device. The symposium seeks to foster collaboration and address major challenges in the treatment of acute kidney injury in children.
Read more →ICUFDA Grants Humanitarian Device Exemption Approval to SeaStar Medical's Selective Cytopheretic Device for Pediatric Acute Kidney Injury SCD-PED (Pediatric) is the first FDA-approved product in the Company's Quelimmune pro
SeaStar Medical has received FDA Humanitarian Device Exemption approval for its Selective Cytopheretic Device (SCD-PED), intended for pediatric patients with acute kidney injury. This device, part of the new Quelimmune product family, aims to improve treatment outcomes for children suffering from hyperinflammation. The approval is based on clinical studies demonstrating significant reductions in mortality rates among patients using the device. The initial commercial launch is expected shortly through partner Nuwellis, highlighting the device's potential impact on pediatric healthcare.
Read more →ICUSeaStar Medical Granted Canadian Patent with Broad Claims Covering the Selective Cytopheretic Device Technology
SeaStar Medical Holding Corporation (Nasdaq: ICU) has been granted a Canadian patent (No. 2814586) for its Selective Cytopheretic Device (SCD) technology, which aims to address hyperinflammation that can lead to multiorgan damage. The patent broadens SeaStar's international rights and supports its ongoing development of therapies to treat inflammatory responses. While the SCD technology shows promise in enhancing treatment modalities, the company faces challenges related to regulatory approvals and funding for ongoing research and commercialization efforts. CEO Eric Schlorff emphasized the innovative nature of the SCD in moderating severe inflammation.
Read more →ICUSeaStar Medical Announces Pricing of $9.0 Million Registered Direct Offering Priced At-the-Market DENVER (
SeaStar Medical Holding Corporation (Nasdaq: ICU) has announced a registered direct offering priced at $9.0 million, under a securities purchase agreement with an institutional investor. The offering includes 10,840,761 shares of common stock and corresponding Series A and B warrants. The gross proceeds from this offering are expected to support the company's initiatives in developing therapies aimed at reducing hyperinflammation. The offering is scheduled to close on or about January 30, 2024, subject to customary conditions.
Read more →ICUSeaStar Medical Appoints David A. Green as Chief Financial Officer DENVER (
SeaStar Medical has appointed David A. Green as Chief Financial Officer effective January 10, 2024, following Caryl Baron who served as Interim CFO. Green brings extensive financial experience in healthcare and will aid in the company's efforts to launch the Selected Cytopheretic Device for pediatric patients later this quarter. The company’s innovative therapies aim to address severe inflammation to improve patient outcomes. However, SeaStar Medical faces risks related to regulatory approvals and funding for its operations.
Read more →ICUSeaStar Medical Issued U.S. Patent with Broad Claims Covering Use of the Selective Cytopheretic Device for Multiple Clinical Indications
SeaStar Medical has received U.S. Patent No. 11,866,730, which broadens the claims for its Selective Cytopheretic Device (SCD) aimed at treating inflammatory conditions. The patent solidifies the company's strategy to validate the SCD's applications in managing hyperinflammation that can damage vital organs. The SCD works by selectively targeting and neutralizing highly activated inflammatory cells, potentially reversing cellular damage. While the patent represents a significant advancement, SeaStar faces challenges including regulatory approval, capital funding, and potential delays in development.
Read more →ICUSeaStar Medical Updates Subject Enrollment in its Pivotal Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury
SeaStar Medical has announced the enrollment of 12 subjects in its NEUTRALIZE-AKI pivotal trial, which is evaluating the safety and efficacy of the Selective Cytopheretic Device for critically ill adults with acute kidney injury. The trial aims to enroll up to 200 patients, measuring important outcomes like mortality and dialysis dependency. SeaStar also anticipates FDA approval for the pediatric version of the device within 30 to 45 days, with commercialization expected in Q1 2024. The company is focused on providing better treatment options for the over 200,000 U.S. adults needing continuous kidney replacement therapy annually.
Read more →ICUSeaStar Medical Forms Scientific Advisory Board of World-Renowned Pediatric and Adult Clinical Experts
SeaStar Medical has announced the formation of its Scientific Advisory Board, comprised of leading clinicians and researchers in pediatric and adult medicine. The board aims to guide the company's development programs in critical care and acute kidney injury (AKI). Members have previously assisted with FDA discussions, which contributed to gaining a humanitarian device exemption for the SCD device. SeaStar plans to broaden the board's expertise as it expands its clinical applications and solutions.
Read more →ICUSeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update DENVER (
SeaStar Medical reported its financial results for Q3 2023, highlighting substantial progress in its clinical programs and regulatory milestones. The company is on track to receive FDA approval for its Selective Cytopheretic Device Pediatric (SCD-PED) within the next few months, which is crucial for treating children with acute kidney injury. Additionally, SeaStar is conducting a pivotal trial for adult patients with AKI, aiming for a commercial launch of its adult device in late 2025. However, the firm has experienced rising net losses and increasing operational expenses.
Read more →ICUFDA Issues Approvable Letter for SeaStar Medical's Selective Cytopheretic Device for Pediatric Patients DENVER
SeaStar Medical has received an Approvable Letter from the FDA for its Selective Cytopheretic Device for pediatric patients with acute kidney injury and sepsis. This letter is a crucial step towards confirming the potential of the device to improve outcomes for critically ill children. The company is now focused on addressing remaining administrative steps to facilitate commercialization expected by early 2024. The device aims to significantly reduce mortality rates and reliance on dialysis, as demonstrated by clinical studies showing promising results.
Read more →ICUSeaStar Medical to Present at the Dawson James Small Cap Growth Conference on October 12, 2023
SeaStar Medical Holding Corporation (Nasdaq: ICU) will present at the Dawson James Small Cap Growth Conference on October 12, 2023. CEO Eric Schlorff reported that the company anticipates receiving an FDA Approvable Letter for its Selective Cytopheretic Device for pediatric patients with acute kidney injury and septic conditions. They also received Breakthrough Device Designation for this device in treating cardiorenal syndrome. The company aims to showcase transformative regulatory developments at the conference, highlighting their focus on innovative therapies for critically ill patients.
Read more →ICUSeaStar Medical Provides Regulatory Update Regarding Selective Cytopheretic Device Use in Pediatric Acute Kidney Injury Under a Humanitarian Device Exemption Company to finalize labeling with FDA Approvable Letter expect
SeaStar Medical has received a positive update from the FDA regarding its Selective Cytopheretic Device for pediatric acute kidney injury under a Humanitarian Device Exemption. The company anticipates an Approvable Letter from the FDA within a month, detailing requirements for formal marketing approval. Clinical studies indicate the device could substantially reduce mortality rates among affected children. SeaStar Medical plans to commercialize this therapy by the end of 2023, emphasizing the urgent need for effective treatments in critically ill pediatric patients.
Read more →ICUSeaStar Medical to Hold Business Update Conference Call Today at 4:00 p.m. Eastern Time
SeaStar Medical Holding Corporation is set to hold a business update conference call today at 4:00 p.m. Eastern Time. The call will cover clinical and regulatory developments, along with an overview of the company's value proposition and commercial opportunities. A slide presentation will accompany the call, and participants can pre-register to streamline access. The event signifies SeaStar's ongoing efforts to develop therapies targeting hyperinflammation in critical care settings.
Read more →ICUSeaStar Medical Reports Second Quarter 2023 Financial Results and Provides a Business Update Management to hold a business update conference call on August 22 beginning at 4:00 p.m. Eastern time DENVER (
SeaStar Medical reported its second quarter 2023 financial results, highlighting progress in activating two clinical sites for its pivotal trial on the SCD-ADULT device aimed at treating acute kidney injury. The company plans to expand site activations and has received FDA Breakthrough Device Designation for this device. However, the pediatric device SCD-PED faced regulatory challenges, as the FDA found the initial approval application unacceptable. Financially, the company reported an increased net loss of $3.7 million for the quarter.
Read more →ICUSeaStar Medical to Sponsor the Critical Care Time Podcast Series Covering Vital Medical Issues for Healthcare Professionals Who Care for Critically Ill Patients
SeaStar Medical Holding Corporation has announced its primary sponsorship of the Critical Care Time podcast series, which focuses on vital medical issues for healthcare professionals treating critically ill patients. The inaugural season will consist of 24 weekly episodes, beginning with 'Undifferentiated Shock: I.' This initiative aims to provide educational resources and foster discussions about critical care topics, supporting healthcare providers in their efforts to save lives. SeaStar Medical's sponsorship will also highlight its innovative medical device designed to combat hyperinflammation in critically ill patients.
Read more →ICUSeaStar Medical to Present at the Maxim Group Virtual Healthcare Conference Hosted by M-Vest on June 21, 2023
SeaStar Medical Holding Corporation, a developer of medical devices targeted at hyperinflammation, announced that CEO Eric Schlorff will present at the Maxim Group Virtual Healthcare Conference on June 21, 2023. The presentation is set to offer insights into the company's innovative therapies aimed at mitigating inflammation's harmful effects on vital organs. Interested participants can register for the event via the SeaStar Medical website. The conference seeks to connect investors with emerging growth companies for information exchange and market trend analysis.
Read more →ICUSeaStar Medical Reports First Quarter 2023 Financial Results and Provides a Business Update DENVER (
SeaStar Medical has reported its first quarter 2023 financial results, with an increased net loss compared to the previous year. The company has activated the first clinical site for its pivotal NEUTRALIZE-AKI trial, and enrollment of patients is expected to begin soon. Although facing regulatory challenges, SeaStar aims to obtain a Humanitarian Device Exemption for its Selective Cytopheretic Device (SCD) to treat acute kidney injury in pediatric patients by late 2023. The SCD has shown promising results in reducing mortality rates among critically ill patients.
Read more →ICUSeaStar Medical to Present at the JMP Securities Life Sciences Conference on May 16, 2023
SeaStar Medical Holding Corporation (Nasdaq: ICU) will be presenting at the JMP Securities Life Sciences Conference on May 16, 2023. CEO Eric Schlorff will provide a company overview during the event at the New York Hilton Midtown. The conference aims to highlight advancements in medical technology, including SeaStar's solutions for hyperinflammation. A webcast of the presentation will be available on the company's website following the event.
Read more →ICUSeaStar Medical Provides Regulatory Update Related to its HDE Application for Pediatric Selective Cytopheretic Device DENVER (
SeaStar Medical has received an unfavorable decision from the FDA regarding its Humanitarian Device Exemption (HDE) application for its pediatric Selective Cytopheretic Device (SCD), intended to treat critically ill children with acute kidney injury (AKI). The FDA's letter indicates that the application is not approvable in its current state, yet it provides guidance for amendment and resubmission. The CEO expressed disappointment and emphasizes the importance of the device for critically ill children. Despite this setback, the company's ongoing pivotal trial for adults with AKI remains unaffected.
Read more →ICUSeaStar Medical Announces Activation of First Clinical Site in Pivotal Trial with Selective Cytopheretic Device in Critically Ill Adults with Acute Kidney Injury
SeaStar Medical has activated the first clinical site for its NEUTRALIZE-AKI trial, which will assess the safety and efficacy of its Selective Cytopheretic Device (SCD) for treating acute kidney injury (AKI). The trial, expected to enroll up to 200 patients across 30 U.S. sites, aims to demonstrate the device's potential in reducing mortality and dialysis dependency. The SCD has previously shown promising results in clinical studies, garnering FDA Breakthrough Device Designation. The primary endpoint will focus on composite mortality and dialysis dependency over 90 days for patients receiving SCD therapy compared to standard care.
Read more →ICUSeaStar Medical Reports 2022 Financial Results and Provides a Business Update DENVER (
SeaStar Medical Holding Corporation reported its financial results for 2022, highlighting a focus on advancing its clinical programs, particularly for its Selective Cytopheretic Device (SCD) aimed at treating acute kidney injury (AKI) patients. The company is preparing to activate clinical sites for a pivotal trial while also pursuing regulatory approval for pediatric applications. However, their financial report noted a significant net loss and a steep decrease in cash reserves, presenting challenges that the company must navigate as it seeks to capture market attention with its innovative therapies.
Read more →ICUSeaStar Medical Holding Corporation Closes Initial $3.3 Million Tranche of $9.8 Million Private Placement DENVER
SeaStar Medical Holding Corporation has closed the initial $3.3 million tranche of a $9.8 million private placement with a single institutional investor. The investment is structured as a Senior Unsecured Original Issue 8.0% Discount Convertible Note, maturing in 15 months. The company can access additional financing contingent upon certain conditions. Despite the positive infusion of capital, the company faces several risks related to regulatory approval and market conditions.
Read more →ICUSeaStar Medical to Present at the Emerging Growth Virtual Conference on March 22, 2023
SeaStar Medical Holding Corporation (Nasdaq: ICU) is set to present at the Emerging Growth Virtual Conference on March 22, 2023. The company will be represented by CEO Eric Schlorff and CMO Kevin Chung, who will provide an overview of their innovative medical technologies aimed at reducing hyperinflammation's effects on vital organs. This virtual event is expected to attract a large audience of individual and institutional investors interested in growth companies.
Read more →ICUSeaStar Medical’s Selective Cytopheretic Device to be Featured at the 5th Chronic Kidney Disease Drug Development Summit
SeaStar Medical Holding Corporation (Nasdaq: ICU) will present its Selective Cytopheretic Device (SCD) at the 5th Chronic Kidney Disease Drug Development Summit in Boston on March 7, 2023. Dr. Kevin Chung, the Chief Medical Officer, will discuss the device's targeting of pro-inflammatory cells to address organ dysfunction caused by hyperinflammation. The SCD is currently undergoing a pivotal study, following FDA approval, which aims to establish its safety and efficacy for patients with acute kidney injury requiring continuous kidney replacement therapy. This innovation could significantly impact the treatment landscape for critically ill patients.
Read more →ICUForward-Looking Statements This presentation 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 s
SeaStar Medical presented its forward-looking statements regarding its SCD therapy, aimed at addressing hyperinflammation from conditions such as acute kidney injury (AKI). This therapy is poised for regulatory approval and has potential benefits demonstrated in clinical results. However, the presentation highlights several risks associated with the business combination, ongoing legal proceedings, and market competition that could affect operational success. The company remains focused on upcoming trials and milestones that could impact its market presence and shareholder value.
Read more →ICUSeaStar Medical Announces Details of the Selective Cytopheretic Device Pivotal Study in Critically ill Adults with Acute Kidney Injury
SeaStar Medical announced the launch of the NEUTRALIZE-AKI study, aimed at evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) for adults with acute kidney injury requiring continuous kidney replacement therapy. The study will enroll up to 200 patients across 30 U.S. clinical trial sites. Key endpoints include mortality rates and dialysis dependency, as the SCD seeks to mitigate hyperinflammation in critically ill patients. Previous studies indicated significant reductions in mortality associated with SCD treatment, highlighting its potential impact on critical care practices.
Read more →ICUSeaStar Medical to Hold Business Update Conference Call on February 15, 2023
SeaStar Medical, a medical technology company focusing on reducing hyperinflammation, will hold a conference call on February 15, 2023. The call will cover various business updates, notably the recent FDA approval for a pivotal trial of its Selective Cytopheretic Device (SCD) aimed at acute kidney injury. Additionally, updates regarding the Humanitarian Device Exemption submission for the use of the SCD in critically ill children will be discussed.
Read more →ICUSeaStar Medical Receives FDA Approval to Begin Study with Selective Cytopheretic Device to Reduce Hyperinflammation in Adults with Acute Kidney Injury
SeaStar Medical has received FDA approval to start a pivotal clinical study on its Selective Cytopheretic Device (SCD) aimed at reducing hyperinflammation in adults with acute kidney injury (AKI). The 200-patient trial is set to begin enrollment in March 2023, with interim results expected by the end of the year. The SCD previously demonstrated potential in critically ill patients, showing reduced mortality compared to standard care. The upcoming study aims to provide further evidence of the device's effectiveness and safety in treating this severe condition.
Read more →ICUDRAFT 3+LHA clean + AL Comments FEBRUARY 8, 2023 SeaStar Medical Receives FDA Approval to Begin Study with Selective Cytopheretic Device to Reduce Hyperinflammation in Adults with Acute Kidney Injury Patient enrollment i
SeaStar Medical has received FDA approval to initiate a pivotal clinical study of its Selective Cytopheretic Device (SCD) aimed at reducing hyperinflammation in adults with acute kidney injury (AKI). The study, which will enroll 200 patients, is set to begin in March 2023, with interim results expected in late 2023. The SCD has previously shown promise in a pilot study, demonstrating mortality reductions in treated patients compared to controls. This approval represents a significant step towards potential improvements in the critical care management of AKI.
Read more →ICUSeaStar Medical to Present at the Virtual Sequire Biotechnology Conference on February 2, 2023
SeaStar Medical (Nasdaq: ICU) will present an overview at the Sequire Biotechnology Conference on February 2, 2023, at 3:30 p.m. Eastern time. The presentation aims to highlight the company's innovative solutions that reduce hyperinflammation's impact on vital organs. Attendees can register for the event on the Sequire Biotechnology website, with an archived webcast available later on SeaStar Medical's site. This appearance signals SeaStar's commitment to engaging with potential investors through strategic platforms.
Read more →ICUSeaStar Medical Submits Investigational Device Exemption (IDE) Application to FDA to Study a Novel Therapy to Reduce Hyperinflammation in Adult Acute Kidney Injury Patients Building upon demonstrated clinical success, th
SeaStar Medical has submitted an Investigational Device Exemption application to the FDA for its Selective Cytopheretic Device, aiming to treat adults with Acute Kidney Injury. The planned pivotal study is set to enroll 200 participants, focusing on reducing hyperinflammation and evaluating mortality and dialysis dependency outcomes. The company received Breakthrough Device Designation for the SCD in 2022, which reflects significant regulatory support. Enrollment for this study is anticipated to begin in early 2023, with interim results expected later in the year.
Read more →ICUSeaStar Medical and Nuwellis Enter into a U.S. License and Distribution Agreement for SeaStar Medical s Selective Cytopheretic Device (SCD) for Pediatric Acute Kidney Injury (AKI) Approximately 4,000 children in the U.S.
SeaStar Medical and Nuwellis Enter into a U.S. License and Distribution Agreement for SeaStar Medical s Selective Cytopheretic Device (SCD) for Pediatric Acute Kidney Injury (AKI) Approximately 4,000 children in the U.S. with AKI require Continuous Kidney Replacement Therapy (
Read more →ICUSeaStar Medical Bolsters Operational Expertise with Appointment of Thomas R. Mullen as Vice President of Operations and Product Development
DENVER, COLORADO, Dec. 02, 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 announc
Read more →ICUSeaStar Medical Appoints Rick Barnett as Chairman of the Board of Directors
DENVER, COLORADO, Nov. 29, 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 announc
Read more →ICUSeaStar Medical’s Lead Product Candidate, the Selective Cytopheretic Device (SCD), Included in Consensus Statement for Pediatric Acute Kidney Injury in First Pediatric Acute Disease Quality Initiative (ADQI) Meeting
– 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,
Read more →ICUSeaStar Medical (Nasdaq: ICU) Announces Positive Interim Safety Findings from Ongoing Study Evaluating the Selective Cytopheretic Device (SCD) in Children
Data being presented at the American Society of Nephrology (ASN) Kidney Week 2022 Interim study data show that SCD treatment is safe to use in pediatric patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) The SCD is currently being eva
Read more →ICUSeaStar Medical (NASDAQ: ICU) Commences Trading on Nasdaq Capital Market and Outlines Corporate Strategy and Near-Term Catalysts
– Company advancing clinically proven platform therapy, the Selective Cytopheretic Device (SCD), to address the life-threatening consequences of hyperinflammation – SCD lead program in Acute Kidney Injury (AKI) with potential FDA approval for pediatric AKI targeted for Q1 2023 a
Read more →ICUSeaStar Medical Completes Business Combination with LMF Acquisition Opportunities LMF Acquisition Opportunities Renamed SeaStar Medical Holding Corporation SeaStar Medical Holding Corporation Common Stock and Warrants to
SeaStar Medical Completes Business Combination with LMF Acquisition Opportunities LMF Acquisition Opportunities Renamed SeaStar Medical Holding Corporation SeaStar Medical Holding Corporation Common Stock and Warrants to Commence Trading on Nasdaq Under New Ticker Symbol ICU an
Read more →ICULMF Acquisition Opportunities, Inc. Stockholders Approve Previously Announced Business Combination with SeaStar Medical, Inc. Transaction anticipated to close upon satisfaction of all closing conditions Denver, Colo. and
LMF Acquisition Opportunities, Inc. Stockholders Approve Previously Announced Business Combination with SeaStar Medical, Inc. Transaction anticipated to close upon satisfaction of all closing conditions Denver, Colo. and Tampa, Fl., October 18, 2022 -- LMF Acquisition Opportu
Read more →ICULMF Acquisition Opportunities and SeaStar Medical Announce Effectiveness of Registration Statement and Special Meeting of Stockholders to be Held
LMF Acquisition Opportunities and SeaStar Medical Announce Effectiveness of Registration Statement and Special Meeting of Stockholders to be Held October 18, 2022 to Approve Business Combination All stockholders of LMF Acquisition Opportunities as of September 23, 2022 are encou
Read more →ICUSeaStar Medical Appoints Dr. Sai Prasad Iyer, Ph.D as VP, Medical Affairs and Clinical Development
Denver, Colo. and Tampa, Fla., Sept. 19, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a speci
Read more →ICUSeaStar Medical Reports First Successful Treatment of Pediatric Patient with Hemophagocytic Lymphohistiocytosis (HLH) and Multi-Organ Failure with its SCD
DENVER, CO and TAMPA, FL, Aug. 01, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special pur
Read more →ICULMF Acquisition Opportunities, Inc. Announces Extension of Deadline to Complete Business Combination TAMPA, FL
LMF Acquisition Opportunities, Inc. Announces Extension of Deadline to Complete Business Combination TAMPA, FL, July 29, 2022 - LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (the "Company") announced today that its board of directors has elected to extend the date by which
Read more →ICUSeaStar Medical Submits Humanitarian Device Exemption Application to FDA for Use of Selective Cytopheretic Device in Children with Acute Kidney Injury
DENVER, CO and TAMPA, FL, July 20, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special pur
Read more →ICUSeaStar Medical Announces Publication of Clinical Trial Results Demonstrating its SCD Significantly Lowered Mortality Rates among Critically Ill ICU COVID-19 Patients by Safely and Effectively Stopping Inflammation Causing Cytokine Storms
DENVER, CO and TAMPA, FL, June 07, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, a medical technology company developing a platform therapy to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special purpos
Read more →ICUSeaStar Medical Appoints Kevin Chung, MD as Chief Medical Officer
DENVER, CO and TAMPA, FL, May 24, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Inc., a medical technology company developing a platform therapy to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (NASDAQ: LMAO) (LMAO), a special pu
Read more →ICUINVESTOR PRESENTATION 2022-05-03 Investor Presentation SeaStar Medical, Inc. LMF Acquisition Opportunities, Inc. 1
Investor Presentation SeaStar Medical, Inc. LMF Acquisition Opportunities, Inc. 1 May 3, 2022 Important Disclosures SeaStar Medical 2 This investor presentation (the "presentation") is for information proposes only to assist interested parties in making their own evaluation with
Read more →ICUSeaStar Medical Granted FDA Breakthrough Device Designation for a Novel Immunomodulatory Therapy for Acute Kidney Injury Patients
DENVER, CO and TAMPA, FL, May 03, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical, a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, and LMF Acquisition Opportunities, Inc. (Nasdaq: LMAO) (“LMAO”), a special pu
Read more →ICUSeaStar Medical to Become Publicly Listed on Nasdaq via Business Combination with LMF Acquisition Opportunities, Inc. SeaStar Medical is a medical technology company developing proprietary solutions to reduce the consequ
SeaStar Medical to Become Publicly Listed on Nasdaq via Business Combination with LMF Acquisition Opportunities, Inc. DENVER, CO and TAMPA, FL, April 22, 2022 -- SeaStar Medical, Inc. ("SeaStar Medical"), a medical technology company developing extracorporeal therapies to reduce
Read more →ICULMF ACQUISITION OPPORTUNITIES, INC. INDEX TO FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm F-2 Balance Sheet F-3 Notes to Financial Statements F-4 REPORT OF INDEPENDENT REGISTERED PUBL
LMF ACQUISITION OPPORTUNITIES, INC. INDEX TO FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm F-2 Balance Sheet F-3 Notes to Financial Statements F-4 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and Board of
Read more →ICULMF Acquisition Opportunities, Inc. Announces Separate Trading of its Class A Common Stock and Warrants, Commencing
LMF Acquisition Opportunities, Inc. Announces Separate Trading of its Class A Common Stock and Warrants, Commencing March 18, 2021 TAMPA, Fla., March 17, 2021 - LMF Acquisition Opportunities, Inc. (Nasdaq: LMAOU) (the "Company") announced that, commencing March 18, 2021, holders
Read more →ICULMF Acquisition Opportunities, Inc. Announces Pricing of Upsized $90 Million Initial Public Offering
LMF Acquisition Opportunities, Inc. Announces Pricing of Upsized $90 Million Initial Public Offering TAMPA, Fla., Jan. 25, 2021 - LMF Acquisition Opportunities, Inc. (Nasdaq: LMAOU) ("LMF Acquisition Opportunities" or the "Company") today announced the pricing of its upsized ini
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