SeaStar Medical Holding Corporation (ICU) 銘柄情報

Extra buying op? Was expecting $1.00+ let’s go, til they crushed it at 3:30 today. Need $1 for Nasd. Compliance. May have to dig up $ for some more shares

SeaStar Medical Expands QUELIMMUNE Adoption for Critically Ill Pediatric Patients with Acute Kidney Injury (AKI)

July 8, 2025

SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today that the QUELIMMUNE therapy has been adopted for use by the nationally recognized Texas Children’s Hospital. The QUELIMMUNE therapy was approved by the U.S. Food and Drug Administration (FDA) in 2024 under a Humanitarian Device Exemption application for pediatric patients with AKI due to sepsis or a septic condition on antibiotic therapy and requiring Renal Replacement Therapy (RRT). Clinical data from the FDA application and subsequently published in Kidney Medicine showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors at Day 60 after ICU discharge.

“We are thrilled that Texas Children’s Hospital has begun adopting QUELIMMUNE as another potential means to save lives and help young patients avoid life-long dialysis,” stated Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Since QUELIMMUNE’s FDA approval, we have maintained a post-marketing registry, which has provided encouraging reports from multiple children’s hospitals, highlighting organ-sparing and life-saving outcomes for pediatric patients who previously had little hope of survival.”

SeaStar Medical introduced its Selective Cytopheretic Device (SCD) therapy under the brand name QUELIMMUNE to the pediatric market in mid-2024 based on the serious unmet need for organ-sparing and life-saving therapies in this patient population. The SCD therapy is designed to be broadly applicable as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body.

SeaStar Medical is currently conducting the NEUTRALIZE-AKI pivotal trial that is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. It has received FDA Breakthrough Device Designation for this indication and five others, including:

• Systemic inflammatory response in adult cardiac surgery

• Systemic inflammatory response in pediatric cardiac surgery to prevent post-operative adverse complications and outcomes

• Adult cardiorenal syndrome awaiting left ventricular assist device (LVAD) implantation

• End-stage renal disease (ESRD) requiring chronic dialysis

• Adult hepatorenal Syndrome (HRS)

About Acute Kidney Injury (AKI) and Hyperinflammation
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

About QUELIMMUNE
The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge.

In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.

About NEUTRALIZE-AKI Pivotal Trial
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

About the SeaStar Medical Selective Cytopheretic Device Therapy
The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.

About SeaStar Medical
SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

https://ih.advfn.com/stock-market/NASDAQ/seastar-medical-ICU/stock-news/96390374/seastar-medical-expands-quelimmune-adoption-for-cr

$ICU 💹

Jennifer is the only one who put up her own money for shares, the other two just took the freebies they loaded for themselves.

https://investors.seastarmedical.com/sec-filings/default.aspx
Insiders…

Looks like my entry on Friday was a great place to buy.

SeaStar Medical Announces Positive Nasdaq Listing Determination

July 2, 2025

Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that it has received confirmation from The Nasdaq Stock Market that the Company has evidenced compliance with the minimum $2.5 million stockholders’ equity requirement and all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the previously disclosed listing matter has been closed.

“We are very pleased to have this hurdle behind us and can now turn our full attention to commercializing QUELIMMUNE and our clinical development of potential organ-sparing and life-saving therapies for critically ill adult patients,” stated Eric Schloff, CEO of SeaStar Medical. “We will continue our diligent effort to manage our capital and create additional value to our stakeholders through expanded adoption of QUELIMMUNE and successful execution of our Selective Cytopheretic Device (SCD) therapy in our NEUTRALIZE-AKI pivotal trial in adult patient with Acute Kidney Injury (AKI) receiving continuous renal replacement therapy (CRRT).”

About Acute Kidney Injury (AKI) and Hyperinflammation

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions such as sepsis, severe trauma, surgery and COVID-19. AKI can cause destructive hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from this destructive hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, these patients may face complications including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

About QUELIMMUNE

The QUELIMMUNE™ therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are on antibiotics and being treated in the ICU with Renal Replacement Therapy (RRT). It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge.

In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE therapy.

About the NEUTRALIZE-AKI Pivotal Trial

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of the SCD therapy in 200 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

About the SeaStar Medical Selective Cytopheretic Device Therapy

The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing continuous renal replacement therapy (CRRT) hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.

About SeaStar Medical

SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for four therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy, a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.

For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

https://ih.advfn.com/stock-market/NASDAQ/seastar-medical-ICU/stock-news/96362773/seastar-medical-announces-positive-nasdaq-listing

$ICU

$ICU 💹

grabbed some on the a/h dip here.

https://seastarmedical.com/wp-content/uploads/2024/06/Pooled-Results-1024x457.jpg

INDICATION FOR USE
QUELIMMUNE (SCD-PED) is intended to treat pediatric patients (weight ≥ 10 kg and age ≤ 22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT).

Clinical Studies of the SCD-PED
QUELIMMUNE was evaluated in two multi-center, open-label, prospective clinical trials (SCD-PED-01 & SCD-PED-02) in pediatric intensive care unit (ICU) patients with AKI requiring CRRT.

QUELIMMUNE therapy demonstrated safety & probable benefit in this critically ill population.
Study Design & Endpoints:

Safety Results:

Secondary Outcomes:
QUELIMMUNE (SCD-PED) therapy demonstrated:

– 77% survival rate at Day 60

– No dialysis required in survivors (Day 60 after ICU discharge)

– 87.5% of survivors had normal kidney function (Day 60 after ICU discharge)


These data were published in the journal Kidney Medicine.

SeaStar Medical Reports Update on Nasdaq Listing Status

June 25, 2025

https://ih.advfn.com/stock-market/NASDAQ/seastar-medical-ICU/stock-news/96307086/seastar-medical-reports-update-on-nasdaq-listing-s

$ICU 💹

Jumped in on Friday with the carnage the offering presented. Bought both commons and warrants.

I see U later.

So today the DoD gave grant to AREVA which is part of GENEVA Foundation. This is a further study of the SCD beyond AKI.

AREVA Institute and SeaStar Medical Announce DoD Award of Prestigious Military Grant to AREVA Institute to Evaluate SeaStar Medical’s SCD Therapy to Advance Breakthrough Burn and Sepsis Research

https://investors.seastarmedical.com/news/news-details/2025/AREVA-Institute-and-SeaStar-Medical-Announce-DoD-Award-of-Prestigious-Military-Grant-to-AREVA-Institute-to-Evaluate-SeaStar-Medicals-SCD-Therapy-to-Advance-Breakthrough-Burn-and-Sepsis-Research/default.aspx

Pediatric registry updated

What happens to warrants in a buyout scenario? 
And why are the warrants increasing in price on days when the stock itself drops? 
ImhoMj

Anyone not in this is crazy stupid! Buyout of 7/8 very possible

Dr Sai Iyer a VP at SeaStar will be speaking this week at CKD Summit about the SCD and its possible role in kidney disease treatment
https://ckd3-summit.com/

Speaking of Sepsis--This paper came out--not yet peer review--but ANOTHER anecdotal story of 1 life saved by SCD. You can read thru the 17 page paper to see the condition the 10 year old boy was in:
https://www.researchsquare.com/article/rs-6221280/v1

Also did some opinion on what appears to be major takeaway from the paper. That post is found here
https://www.reddit.com/r/SeastarMedical/comments/1jbje74/evolving_treatments_in_neutropenic_septic_shock/

This is some incredible technology so far--so good

SeaStar and sepsis



Taken from here
https://www.tandfonline.com/doi/full/10.1080/0886022X.2025.2459349

Dr Chertow (Stanford) shouting out SeaStar NEUTRALIZE AKI trial

Dr Chertow (Stanford) Plenary Session today

Wow! Dr. Chertow highlighting #NEUTRALIZEAKI! pic.twitter.com/1ou4JTx1XJ— Kevin K. Chung, MD (@chungk1031) March 4, 2025

1 of 3 posters for 2025 AKI & CRRT San Diego

This thing feels like we could blink and it’ll be at $10. That fireside had insight

Fireside Chat--link--https://s201.q4cdn.com/298572669/files/doc_events/2025/Feb/27/SeaStar-Fireside-Chat-2.mp4

QUELIMMUNE Launch Update --27 FEB @ 4:30 PM EST

https://investors.seastarmedical.com/events-and-presentations/events/event-details/2025/Fireside-Chat--QUELIMMUNE-Launch-Update-with-Tim-Varacek-Senior-VP-of-Business--Commercial-Operations-2025-0W_9X-7lVn/default.aspx

SeaStar Medical & Dr Goldstein get shoutout in this new article Extracorporeal Blood Purification in European Pediatric Intensive Care Units





From here : https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2829833?

SeaStar partners with KHI and FDA

Half out at $3 + 30%

ICU $2.41 +'7% ...Lookong good run to $3.50s coming sooner or later .

The fireside chat for FRI is out NOW!!!!!!!!!!!!!!!



Some good info--some good explains in there. E N J O Y

Fireside "chat" w Dr Chung, CMO

FRI 31 JAN

https://investors.seastarmedical.com/events-and-presentations/events/event-details/2025/Fireside-Chat-Event-TEST/default.aspx

The clinical trials website was updated 27 JAN. The only change was the Mayo Clinic now being shown as recruiting

3 of the top 20 hospitals in the world are part of SeaStar Medical NEUTRALIZE-AKI trial

Mayo Clinic--Cleveland Clinic--Stanford Hospital (per 2024 Newsweek rankings)

https://investors.seastarmedical.com/news/news-details/2025/SeaStar-Medical-Activates-15th-Site-for-its-Adult-Acute-Kidney-Injury-Pivotal-Trial/default.aspx

INDEX CASE as defined by Dr Chung

The term "index case" is often used within the context of the first case encountered during an outbreak.

During a device launch, it is the first case that turns everyone into a believer, which then leads to wider adoption.

One "Index Case" at a time...@SeaStarMedical— Kevin K. Chung, MD (@chungk1031) January 15, 2025

Cleveland Clinic activated . Now recruiting for adult AKI RCT
B A M !!!!!!!!!!!!!!!

2.40s SeaStar Medical Projects Multibillion-Dollar Market Potential for its Selective Cytopheretic Device in Initial Target Indications
December 11 2024 - 6:30AM


SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, estimates a U.S. total addressable market for its proprietary, patented Selective Cytopheretic Device (SCD) in five clinical indications, subject to U.S. Food & Drug Administration (FDA) approvals, of $25 to $33 billion

Adding $2.15

Loading zone 2.05- 2.25

Investor conf call 11 DEC 2024
How to register--how to listen

https://investors.seastarmedical.com/news/news-details/2024/SeaStar-Medical-to-Hold-Business-Update-Conference-Call-on-December-11-2024/default.aspx

Noble Cap Mkt presentation 04 DEC 2024

https://www.channelchek.com/videos/seastar-medical-holding-corporation-noblecon20-presentation

$2.52 + 6% Keep on watch or add a few on dips. Last RS 1-25 on June 10th. First profit zone $3.53 to $5.01 

Take me to the ICU prepping for $4-$5 resistance. Wonderful low floater 

FINTEL target price update

There are 23 funds or institutions reporting positions in SeaStar Medical Holding. This is an increase of 7 owner(s) or 43.75% in the last quarter.

Total shares owned by institutions increased in the last three months by 9.34% to 165K shares.

https://fintel.io/news/seastar-medical-holding-icu-price-target-decreased-by-6111-to-714-376?

Ho hum--just ANOTHER BTD from FDA

Be so nice if Am Kid Found or _______ or ________ would step up/in and provide funding for trial to get ANY of these BTDs moving toward trials and possible approval

BIG NEWS FROM THE FDA
https://finance.yahoo.com/news/fda-grants-breakthrough-device-designation-140000778.html

SeaStar SCD gets a shoutout in this paper. About using extracorporeal renal replacement therapy BEYOND AKI

https://link.springer.com/article/10.1007/s00467-024-06533-z

Maxim Healthcare Summit--16 OCT presentation w CEO and CFO

RCT UPDATE--The clinical trial has been updated--07 OCT (last updated posted 09 OCT)
As far as positive or negative (IMHO) ; The Little Rock ,AR location was withdrawn, the Rochester, NY location was withdrawn, Bethlehem, PA was added

As far as "positives"-- Brooke Med AND JBSA (both @ Ft Sam Houston) were activated/recruiting

As far as "negatives"--the primary completion date was pushed from 11/ 2024 to 12/ 2025 . The study completion was pushed from 11/ 2025 to 09/ 2026 (dang)

For a quick overview of SeaStar SCD "device" potential--"device" MOA--upcoming catalysts--co personnel: scroll down past message board posts (hit "About" tab)

For more in depth--this is link to investor presentationSEPT 2024

https://investors.seastarmedical.com/overview/default.aspx