SeaStar Medical Holding Corporation (ICU) Quote

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As far as positive or negative (IMHO) ; The Little Rock ,AR location was withdrawn, the Rochester, NY location was withdrawn, Bethlehem, PA was added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

There it is. The Offering. Let's see which rules are involved and how deep we dive. Didn't had a look for now.....glta

Loving this action. Been holding both lmfa and icu after the reverse splits.

Remember, lmfa is a major stockholder in icu common and hold millions of the warrants (that have quintupled) through their spac that brought this public initially.

Cheers.

Nice writeup from across the pond
https://www.medicaldevice-developments.com/news/fdas-cber-approves-final-labelling-of-seastar-medicals-quelimmune-scd/

OBVIOUSLY there is some "misunderstanding" about the label requirements. Keep in mind that CBER is 1 center inside the FDA. But forget that --lets recall the FDA approvable letter and what was stated EXACTLY 21 FEB 2024

You are reminded that, as soon as possible and before commercial distribution of your
device, you must submit a Product Correspondence to this HDE submission with a copy of all
final labeling. Final labeling that is identical to the labeling approved in draft form will not
routinely be reviewed by FDA staff when accompanied by a cover letter stating that the final
labeling is identical to the labeling approved in draft form. If the final labeling is not identical,
any changes from the final draft labeling should be highlighted and explained in the Product
Correspondence.

Pretty easy to understand when ALL the facts are presented.

SeaStar Medical Finalizes FDA Labeling Requirement for QUELIMMUNE, Paving the Way for First Commercial Sales as Humanitarian Use Device - July 03 2024 - 8:30AM

SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has agreed to the final labeling for SeaStar Medical’s QUELIMMUNE™, the Selective Cytopheretic Device for pediatric patients, paving the way under the Humanitarian Use Device (HUD) designation to market the therapeutic device in the U.S. for the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT).

“We thank the FDA for diligently working through QUELIMMUNE’s labeling. We are now ready to make final changes to product labels for incorporation into the commercial kits,” said Eric Schlorff, SeaStar Medical CEO. “We expect to begin shipping this month and are excited to bring the potential lifesaving and quality-of-life benefits of QUELIMMUNE to critically ill children.”

Pediatric Acute Kidney Injury
QUELIMMUNE is approved under a Humanitarian Device Exemption (HDE) application, having met the applicable criteria with clinical results showing safety and probable clinical benefit to critically ill children with AKI who have few treatment options. Pediatric patients undergoing treatment with QUELIMMUNE are expected to require, on average, seven QUELIMMUNE daily therapies, with the disposable device being changed once every 24 hours.

Only about half of patients in the pediatric ICU with AKI who require KRT survive, with those surviving being at risk of long-term, life-threatening conditions such as chronic kidney disease. A pooled analysis from two non-controlled studies (one of which was funded by the FDA Office of Orphan Products Development) showed that children weighing 10 kilograms or more with AKI requiring continuous KRT who were treated with QUELIMMUNE had a 77% survival rate, no dialysis dependency at day 60 and no device-related serious adverse events or device-related infections. The U.S. addressable population of about 4,000 children falls within the 8,000-patient HDE criteria.

SeaStar Medical is also conducting a pivotal trial in adults with AKI who require continuous KRT. The applicable adult population is approximately 210,000 patients per year, or about 50 times larger than the pediatric population.

SeaStar Medical Announces 25-for-1 Reverse Stock Split

Source: GlobeNewswire Inc.

SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the Company’s 25-for-1 reverse stock split, which will become effective at June 7, 2024 at 5:00 PM EDT. The Company’s common stock will begin trading on a split-adjusted basis on The Nasdaq Capital Market (Nasdaq) effective with the open of the market on June 10, 2024. SeaStar Medical’s stock will continue to trade under the ticker symbol “ICU.”
Authorization for the reverse stock split was approved by the Company’s stockholders at SeaStar Medical’s 2023 Special Meeting of Stockholders held on September 6, 2023. The objective of the reverse stock split is to increase the market price for the Company’s common stock to, among things, enable the Company to regain compliance with the $1.00 minimum bid price requirement under applicable Nasdaq Listing Rules. The Company's common stock will trade under a new CUSIP number – 81256L203.

As a result of the reverse stock split, each 25 pre-split shares of common stock outstanding will automatically combine and convert to 1 issued and outstanding share of common stock. Stockholders of record who otherwise would be entitled to receive fractional shares will receive one whole share of common stock in lieu of such fractional share. The reverse stock split reduces the number of shares of common stock issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise or vesting of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants.

Stockholders of record will receive information regarding their share ownership following the reverse stock split from the Company’s transfer agent, Continental Stock Transfer and Trust Company. Continental Stock Transfer and Trust Company can be reached at 800-509-8856. Stockholders owning shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split and will not be required to take further action in connection with the reverse stock split, subject to brokers’ particular processes.

For additional information regarding the reverse stock split, please refer to SeaStar Medical’s Current Report on Form 8-K to be filed with the Securities and Exchange Commission.

About SeaStar Medical

SeaStar Medical is a medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Forward-Looking Statements

This press release 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 statements include, without limitation, the proposed reverse stock split and compliance with NASDAQ listing requirements. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:

LHA Investor Relations
Jody Cain
(310) 691-7100
Jcain@lhai.com

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Primary Logo

Do what?

Now it goes back to 2$

Gap closed. Waiting for 5 and below. If offering comes, maybe 3.
Imo

ICU NEW HOD