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SeaStar Medical Holding Corporation

ICUFDA catalysts, PDUFA dates & pipeline intelligence
$3.47
▼ -0.02 · -0.57%

Financials

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52W LOW $2.0752W HIGH $7.35
Volume
8.10 K
Value Traded
747.94 K
Short % Float
2.85%
-25.59%Week
+12.58%1 Month
-29.49%3 Month
-5.93%6 Month
-99.85%5 Year
-99.85%All Time

Cash Data

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Key Stats

Market Cap
15.25 M
EPS (TTM)
-3.09
P/E Ratio
-
Ent. Value
8.42 M
Total Shares
4.41 M
Float Shares
4.27 M
Insiders
3.10%
Institutions
3.86%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

ICU Catalyst Timeline

Dated clinical, regulatory and corporate events for SeaStar Medical Holding Corporation

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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How ICU actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

No drug pipeline

SeaStar Medical Holding Corporation is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.

Clinical Trial Results

Readouts, endpoints and source filings for every ICU program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Selective Cytopheretic Device
Breakthrough
pediatric Acute Kidney Injury2026-03-30no device-related adverse events; survival rates of 69% (Day 28 and Day 60)Read MoreSeaStar 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 2026Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Messinger MichaelOfficer (Chief Financial Officer)Buy 750 2,500 held$3.27 08/18/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in ICU for Q2 2026.
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

ICU Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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Live calls and puts by strike: last price, volume and open interest for every expiry.
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Calls vs Puts by Expiry

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Competitive positioning

How ICU ranks across every disease it competes in

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See how ICU ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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ICU News

ICU
Oct 7, 2026
ICUFDA Updates
▲ +16.6%on this news

FDA Grants SeaStar Medical Breakthrough Device Designation for its SCD Therapy for the Treatment of Hyperinflammation in Adult Patients with Sepsis or a Septic Condition

SeaStar Medical has received FDA Breakthrough Device Designation for its Selective Cytopheretic Device (SCD) therapy aimed at treating hyperinflammation in adult patients with sepsis. This designation facilitates faster development and review processes for medical devices addressing critical health conditions. The SCD therapy has now achieved seven Breakthrough Designations, highlighting its potential effectiveness in treating severe inflammatory responses.

Read more →
ICU
Oct 5, 2026
ICUGeneral
▼ -24.3%on this newsshared move

SeaStar Medical Announces Exercise of Warrants for Approximately $3.3 Million Gross Proceeds

SeaStar Medical has announced the exercise of outstanding warrants, generating approximately $3.3 million in gross proceeds. The warrants, originally issued in 2025, will be exercised at a reduced price, allowing the company to issue new warrants for additional shares. The funds will support general corporate purposes, including working capital and capital expenditures.

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ICU
Oct 2, 2026
ICUConferences/Events
▲ +26.4%on this newsshared move

SeaStar Medical Announces Late-Breaking Presentation at ASN Kidney Week 2026

SeaStar Medical Holding Corporation announced that a late-breaking abstract on their post-approval SAVE Registry data has been accepted for presentation at the ASN Kidney Week 2026. The presentation will focus on improved outcomes in pediatric patients with sepsis-associated acute kidney injury. The event is scheduled for October 22, 2026, in Denver, CO.

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ICU
Oct 1, 2026
ICUFDA Updates

New ICD-10-PCS Codes are Now Available for the Use of SeaStar Medical’s SCD Therapy for Acute Kidney Injury (AKI)

SeaStar Medical has announced the availability of new ICD-10-PCS codes for its QUELIMMUNE therapy, aimed at treating acute kidney injury (AKI) requiring renal replacement therapy. These codes will facilitate hospital billing and improve tracking of clinical outcomes. The therapy has shown promising survival rates in clinical trials, indicating its potential effectiveness in critically ill patients.

Read more →
ICU
Sep 29, 2026
ICUConferences/Events

SeaStar Medical Announces Chief Medical Officer, Kevin Chung, M.D., to Present at the Pediatric Paracorporeal and Extracorporeal Therapy Symposium (PPETS) 2026

SeaStar Medical's Chief Medical Officer, Dr. Kevin Chung, will present at the 2026 Pediatric Paracorporeal and Extracorporeal Therapy Symposium. His talk will focus on QUELIMMUNE, an advanced therapy for pediatric patients with acute kidney injury. The presentation aims to share insights on medical device innovation and improving patient outcomes. The conference will feature discussions on emerging technologies in pediatric renal therapies.

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ICU
Sep 24, 2026
ICUGeneral

SeaStar Medical Congratulates H. David Humes, M.D., on Receiving the University of Michigan 2026 Distinguished University Innovator of the Year for Development of the SCD Therapy

SeaStar Medical announced that Dr. H. David Humes has been awarded the Distinguished University Innovator of the Year by the University of Michigan for his development of the Selective Cytopheretic Device (SCD) therapy. This therapy, commercialized as QUELIMMUNE, is the first FDA-approved treatment for critically ill pediatric patients with acute kidney injury. QUELIMMUNE has demonstrated a 50% reduction in mortality compared to standard care in clinical trials. The company is also advancing clinical trials for adult patients with acute kidney injury.

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ICU
Sep 10, 2026
ICUConferences/Events

SeaStar Medical to Present at the HC Wainwright 28th Annual Global Investment Conference

SeaStar Medical will present at the HC Wainwright 28th Annual Global Investment Conference from September 14 to 16, 2026. CEO Eric Schlorff will provide insights into the company's innovative treatments for critically ill patients. The presentation will be available online starting September 11, 2026, and will remain accessible for 60 days. SeaStar's QUELIMMUNE product is the only FDA-approved treatment for life-threatening Acute Kidney Injury in pediatric patients.

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ICU
Aug 12, 2026
ICUFDA Updates
▼ -5.7%on this news

SeaStar Medical Reports Second Quarter 2026 Financial Results and Provides Business Updates

SeaStar Medical reported a significant 82% increase in net revenue for its QUELIMMUNE therapy in Q2 2026, driven by the addition of three top-rated children's hospitals to its customer base. The company is advancing enrollment in its pivotal NEUTRALIZE-AKI trial for adult patients with acute kidney injury and has received ICD-10-PCS codes for billing its selective cytopheretic device therapy. Despite these positive developments, SeaStar reported a net loss of approximately $3.7 million for the quarter.

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ICU
Aug 6, 2026
ICUGeneral

SeaStar Medical to Report Second Quarter Financial Results on August 12, 2026

SeaStar Medical Holding Corporation will report its second quarter financial results on August 12, 2026. The company is known for its innovative treatments for critically ill patients, including its FDA-approved product QUELIMMUNE for Acute Kidney Injury. Additionally, they are advancing their Selective Cytopheretic Device therapy through a pivotal clinical trial for adult patients.

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ICU
Jul 14, 2026
ICUConferences/Events

SeaStar Medical Supports Advances in Critical Care of Pediatric Patients with Acute Kidney Injury (AKI)

SeaStar Medical is sponsoring key initiatives to enhance treatment for pediatric patients with acute kidney injury (AKI). The company is participating in the KidneyBee Summit 2026 and hosting a webinar on its QUELIMMUNE therapy, which has shown a 77% survival rate in clinical trials. This therapy aims to address the significant mortality associated with AKI in critically ill children.

Read more →
ICU
Jun 23, 2026
ICUFDA Updates
▲ +7.1%on this news

SeaStar 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.

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ICU
Jun 22, 2026
ICUConferences/Events

SeaStar 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 →
ICU
May 13, 2026
ICUGeneral

SeaStar 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.

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ICU
May 6, 2026
ICUGeneral
▲ +10.2%on this news

SeaStar 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 →
ICU
Mar 30, 2026
ICUConferences/Events
▲ +32.1%on this news· ran to +57% by day 3

SeaStar 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 →
ICU
Mar 26, 2026
ICUGeneral
▲ +22.4%on this news· ran to +63% by day 3shared move

SeaStar 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.

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ICU
Mar 18, 2026
ICUGeneral
▼ -5.2%on this news

SeaStar 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 →
ICU
Mar 9, 2026
ICUConferences/Events

SeaStar 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 →
ICU
Mar 5, 2026
ICUFDA Updates

SeaStar 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 →
ICU
Feb 9, 2026
ICUFDA Updates

SeaStar 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.

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About SeaStar Medical Holding Corporation

Denver, CO 17 employees seastarmedical.com
Headquarters3513 BRIGHTON BLVD, DENVER, CO, 80216
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