SeaStar Medical Holding Corporation (ICU) News

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

Dr Basu gave a fairly fast presentation. It did touch on extracorporeal therapy.

In the followup session a question was asked about how many PEDs have been treated by his hospital since FDA approval and if those results were aligned with results from studies.

His answer was they have treated across 5 different hospital sites (another 4-5 patients) and results are VERY similar. No adverse patient outcomes and a remarkable response in RRT free survival in the patients for whom the SCD was initiated in the setting of non-mechanical device assoc inflammation. They have used it in patients with cardiac assist devices and ECMO but less evident response profile.

Sepsis Alliance --followup to post below

So the Sepsis Alliance Summit begins tomorrow. It is 3 days --multiple topics. It is open to view to anyone--requires registration--but it is FREE. Link is below. Can browse various topics. See something of interest--a Dr you know--topic you are trying to get new info about??? Might be the place. NONE of the sessions are long.

https://learn.sepsis.org/sepsis-alliance-summit-2024?utm_source=SA+eBlast&utm_medium=SA+eBlast&utm_campaign=SA+eBlast

Sepsis Alliance Summit 25-27 SEPT



https://learn.sepsis.org/agenda-sepsis-alliance-summit-2024

Investor Slide Deck updated (SEPT 2024)

This is PDF download
https://s201.q4cdn.com/298572669/files/doc_presentations/2024/09/ICU-Investor-Presentation-090424-final.pdf

This is link to website to view without download.
https://investors.seastarmedical.com/overview/default.aspx

Sepsis Alliance Institute
SeaStar is 1 of the sponsors of this summit

On 25 Sept (3:40-3:55 PM)
SeaStar Medical Sponsored Session: Pediatric Sepsis, The Unique Fallout of a Global Killer

Rajit K. Basu, MD, MS, FCCM
Division Chief of Critical Care Medicine
Ann & Robert Lurie Children’s Hospital of Chicago

https://learn.sepsis.org/sepsis-alliance-summit-2024

Dr Basu is member of SeaStar SAB
He spoke in MAR at the ASKI & CRRT 2024 in San Diego

CEO on Smart Money Circle Show. Also has transcript

Maybe we’l enter long again, might linger down to 4 area we’l see

Are they in trouble here??

Trial site update

Still showing 9 sites activated

They did add 3 locations: Las Vegas, NV --UNLV Health, Rochester, NY--Univ of Rochester, Danville, PA--Geisinger Health . None are turned on/recruiting but are new sites since the 11 JUL update

Lawsuits! Glad we sold when we did

A Promising Medtech Player

https://beyondspx.com/2024/07/29/seastar-medical-holding-corporation-nasdaqicu-a-promising-medtech-player-navigating-challenges/

There is a med journal article that has been cited in SeaStar filings with SEC. It is COST AND MORTALITY ASSOCIATED WITH POSTOPERATIVE ACUTE KIDNEY INJURY Published by NIH and by Annals of Surgery--https://journals.lww.com/annalsofsurgery/fulltext/2015/06000/cost_and_mortality_associated_with_postoperative.27.aspx
While the article is from 2015 (so the $ figures are likely much higher??) there are some good takeaways/conclusions.

#1-- Our group has demonstrated that postoperative acute kidney injury (AKI), defined by (RIFLE) criteria based on even small increases in routinely measured serum creatinine (sCr) levels, is not only one of the most common postoperative complications but is also associated with an up to 10-fold increase in hospital mortality, decreased survival for up to 15 years after surgery, and an increased risk for chronic kidney disease (CKD)

#2-- Unadjusted median hospital costs for patients who did and did not develop AKI were $38,000 and $14,000

#3--Patients who developed postoperative AKI had significantly higher unadjusted hospital mortality (8.8% vs 0.6%) and 90-day mortality (11.3% vs 2.2%) than patients with no AKI

#4-- Given the financial and human costs associated with postoperative AKI, there is a critical need for strategies to better identify those patients at risk for postoperative AKI, to better manage those patients toward preventing AKI, and finally to treat AKI once it occurs.

ICU $6 to $9s this week keep on chugging

This is for the follow up study required by HDE approval in PED-AKI

https://clinicaltrials.gov/study/NCT06517810?spons=SeaStar%20Medical&rank=1

This "should" be a good way to know how many hospitals have voted and are using SCD (IF SeaStar keeps updated)

CMS approval details (trial reimburse Level B)

https://www.cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved/bb29239-1-nct05758077

CMO Dr Chung

The first of many. 👇🏼#SCDHDEinPEDs#PedsICU #QUELIMMUNE https://t.co/76zhdFgODL— Kevin K. Chung, MD (@chungk1031) July 23, 2024

ICU vice president

Very gratifying to be part of a team that delivers much needed care for our sick kids with AKI and sepsis. Congratulations to Drs. Humes, @slgold777 for leading the pediatric studies and your vision. Looking forward to hearing many success stories! $ICU #MedTwitter https://t.co/Ca2LmEmZTF— Sai Iyer Ph.D (@SaiIyerPhD) July 23, 2024

1st PED-AKI patient treated w Quelimmune (SCD) !!!!

https://investors.seastarmedical.com/news/news-details/2024/First-Pediatric-Patient-Treated-in-a-Commercial-Setting-with-SeaStar-Medicals-FDA-Approved-QUELIMMUNE-Therapeutic-Device/default.aspx

SeaStar distribution partner--Nuwellis--announces 1st sale of Quelimmune (SCD)

This innovative treatment offers new hope for this population that had not seen improvement in outcomes for the last 20 years.

Dr. Stuart Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital, and Principal Investigator of the multi-center studies that led to FDA clearance of QUELIMMUNE, expressed his enthusiasm for the introduction of QUELIMMUNE as standard of care


https://ir.nuwellis.com/news-releases/news-release-details/nuwellis-marks-first-commercial-sale-quelimmunetm-therapy

SeaStar receives CMS (medicare/medicaid) coverage for adult AKI trial.

https://investors.seastarmedical.com/news/news-details/2024/CMS-Grants-Category-B-Coverage-for-Adults-with-Acute-Kidney-Injury-Enrolled-in-SeaStar-Medicals-Selective-Cytopheretic-Device-Pivotal-Trial/default.aspx

Major barrier to enrollment removed!

Thank you ?@CMSGov?.🙏🏼

?@SeaStarMedical?

CMS Grants Category B Coverage for Adults with Acute Kidney Injury Enrolled in SeaStar Medical’s Selective Cytopheretic Device Pivotal Trial | SeaStar Medical https://t.co/x8E0E7FPyq— Kevin K. Chung, MD (@chungk1031) July 16, 2024

Looks like this one has finally taken a rest. Their sponsoring SPAC LMFA is getting it's turn now with a run up - w/ICU ownership in common, several million in warrants, 45M in assets, including 11 million in BTC.

Looking forward the the new 15MW btc mining facility announcement due any minute to test new 52w highs.

Both ICU and LMFA could easily be 3-5x these levels by year end.

Cheers!

More Offerings to come....they will try to finance it alone. No buyout or whatsoever. maybe a good thing.... nobody knows!

I like it…. I just want another of any holdings to rip higher and I can move over here for our long term climb. It’s going to happen not likely overnight but because I’m looking to significantly increase holdings it will likely happen sooner than later. I just took my 21 post split down to 16.50 avg, would love to double my position from here

RCT UPDATE: So the adult AKI trial sites was updated. The good news is 1 site --Univ Iowa hosp is turned on (recruiting). The other change is the JMS Burn Cntr (GA) was withdrawn. Univ Iowa hosp is a much larger facility(+ 800 bed) and Level 1 trauma center. The JMS Burn center is

SeaStar Medical Ships First QUELIMMUNE Product Order to U.S. Distribution Partner -
July 12 2024 - 8:30AM

SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports the initial commercial sale of QUELIMMUNE™-Pediatric to its U.S. license and distribution partner, Nuwellis, Inc. QUELIMMUNE is SeaStar Medical’s Selective Cytopheretic Device-Pediatric (SCD-PED), a patented cell-directed extracorporeal therapy that selectively targets the most highly activated neutrophils and monocytes responsible for hyperactive immune response. QUELIMMUNE is approved by the U.S. Food and Drug Administration (FDA) as a Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) to treat pediatric acute kidney injury (AKI) in patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy (KRT).
“It’s highly gratifying to ship our first commercial QUELIMMUNE product order to Nuwellis for these patients,” said Eric Schlorff, CEO of SeaStar Medical. “QUELIMMUNE is a best-in-class therapy that across two pediatric clinical studies has been shown to have a probable benefit of reducing mortality and decreasing dialysis dependency in these severely ill children. We expect prestigious pediatric hospitals to meet the HDE requirements this quarter, with a more robust commercial rollout in the fourth quarter of 2024.”

QUELIMMUNE consists of a SCD-PED cartridge and blood tubing set that are connected in-line to an existing hemodialysis delivery system’s extracorporeal continuous KRT circuit in a process that takes about 15 minutes. The Company expects that, on average, a full course of treatment for children with AKI will require three to seven days of treatment with the disposable SCD-PED cartridge being replaced every 24 hours.

Each year in the U.S., approximately 4,000 children with AKI require continuous KRT, with a mortality rate of approximately 50%. Many of those who survive experience long-term complications that can include chronic kidney disease and a lifetime of dialysis. Pooled analysis from two non-controlled studies, one of which was funded by the FDA office of Orphan Products Development, showed that children with AKI weighing 10 kilograms or more requiring continuous KRT treated with QUELIMMUNE had a 77% survival rate with no dialysis dependency at 60 days, and had no device-related serious adverse events or device-related infections.

SeaStar Medical is actively enrolling patients in the pivotal adult NEUTRALIZE-AKI clinical trial. The adult AKI population is 50 times greater than the pediatric population, which the Company believes represents a multibillion-dollar market opportunity.

Good post. Appreciated. Glty.

Hope you're maintaining a nice position