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SeaStar Medical Holding Corporation

SeaStar Medical Holding Corporation (ICU)

3.4583
-0.0717
( -2.03% )
Updated: 11:53:26

Your Hub for Real-Time streaming quotes, Ideas and Live Discussions

Key stats and details

Current Price
3.4583
Bid
3.43
Ask
3.53
Volume
95,669
3.25 Day's Range 3.58
3.25 52 Week Range 42.9225
Market Cap
Previous Close
3.53
Open
3.56
Last Trade
1
@
3.4583
Last Trade Time
11:53:27
Financial Volume
$ 324,468
VWAP
3.3916
Average Volume (3m)
2,060,145
Shares Outstanding
36,979,724
Dividend Yield
-
PE Ratio
-4.86
Earnings Per Share (EPS)
-0.71
Revenue
-
Net Profit
-26.23M

About SeaStar Medical Holding Corporation

SeaStar Medical Holding Corp is a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs. SeaStar Medical Holding Corp is a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs.

Sector
Surgical,med Instr,apparatus
Industry
Blank Checks
Headquarters
Wilmington, Delaware, USA
Founded
2022
SeaStar Medical Holding Corporation is listed in the Surgical,med Instr,apparatus sector of the NASDAQ with ticker ICU. The last closing price for SeaStar Medical was $3.53. Over the last year, SeaStar Medical shares have traded in a share price range of $ 3.25 to $ 42.9225.

SeaStar Medical currently has 36,979,724 shares outstanding. The market capitalization of SeaStar Medical is $127.58 million. SeaStar Medical has a price to earnings ratio (PE ratio) of -4.86.

ICU Latest News

SeaStar Medical’s Selective Cytopheretic Device Featured in Two Presentations at the 42nd Vicenza Course AKI-CRT-ECOS and Critical Care Nephrology

DENVER, June 11, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences...

SeaStar Medical Strengthens Board of Directors and Transitions to Commercial-Stage Company

DENVER, June 10, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) announces that three new members have joined its Board of Directors. Two new...

Article in Nature Scientific Reports Describes Mechanism of Action of SeaStar Medical’s Selective Cytopheretic Device in the Immunomodulation of Excessive Inflammation

DENVER, June 07, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences...

SeaStar Medical Announces 25-for-1 Reverse Stock Split

DENVER, June 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of...

Manuscript Published on Multiorgan Failure Patients Treated with SeaStar Medical’s Selective Cytopheretic Device Who Achieved Transplant Eligibility

SCD’s ability to improve clinical status of four critically ill pediatric and adult patients across multiple clinical conditions published in Transplantation Direct DENVER, May 22, 2024 (GLOBE...

SeaStar Medical Reports First Quarter 2024 Financial Results and Provides a Business Update

DENVER, May 14, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary...

SeaStar Medical Announces $3.6 Million NIH Grant Award to Study the Selective Cytopheretic Device in Adult Patients with Severe Chronic Heart Failure

DENVER, April 30, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of...

SeaStar Medical Reports 2023 Financial Results and Provides a Business Update

DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-1.8917-35.35887850475.356.33.2516869955.29702405CS
4-6.6667-65.843950617310.12512.53.2518398627.27156485CS
12-16.2292-82.43403174619.687520.6953.25206014511.86096147CS
26-9.0417-72.333612.542.92253.25405519619.10893662CS
52-9.4392-73.186276410212.897542.92253.25629770118.29723742CS
156-277.2917-98.7681923419280.753053.25404718620.11213447CS
260-277.2917-98.7681923419280.753053.25404718620.11213447CS

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ICU Discussion

View Posts
theswordman theswordman 2 days ago
Update @ clinical trials
Shows that 2 more sites are recruiting/enrolling patients since 29 APR

Shows update posted 12 JUN
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harry crumb harry crumb 4 days ago
Should be illegal all these scam stocks under 1$ an the RS, sec is crooked with this stupid rule, most. People cant even get shares to short to get their money back, sec you are criminals 100%
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scoobey-do scoobey-do 7 days ago
Who thinks ICU will open at $5.475 ($0.219 x 25) on Monday? Or higher? Or lower? It should be interesting.
Good luck everyone.
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theswordman theswordman 1 week ago
Click on banner for various day and notice the number of SeaStar SAB members that will be presenting in addition to Dr Humes key talk

https://www.irriv.com/courses/events/42nd-vicenza-course-on-aki-crrt/program



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theswordman theswordman 1 week ago
NASDAQ Reverse Split Timeline


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theswordman theswordman 3 weeks ago
Rather than a primary disease, acute kidney injury (AKI) is considered a window to a potentially serious underlying systemic disease, which may partially explain the high morbidity and mortality rates associated with the condition.

https://link.springer.com/article/10.1007/s00134-018-5329-z?utm_source=getftr&utm_medium=getftr&utm_campaign=getftr_pilot
👍️ 1
kbaz kbaz 3 weeks ago
Maybe. One with the Capacity to assist in Funding the final Upfront Study and Protocol for the SCD would fill the Gap that I was referring to. However, there's a Solid Chance that a Merger would be a Beneficial Fit longer term as $BAX has the Business Acumen that would give $ICU Dr's the ability to focus on their Strengths.
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theswordman theswordman 3 weeks ago
I see this as just 1 more company ( a la Fresenius DaVita etal ) that will be in line to have access to SCD for ANY off label use ASAP after full FDA approval.

All wondering IF the SCD use will end much of the routine dialysis at "dialysis centers"--and a shift in their business model. SeaStar will make sure any and all companies have equal access worldwide.
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kbaz kbaz 3 weeks ago
Hope y'all are getting your fill of this ICU on Reverse Split Fear... Dr. Chung is Legit and he just liked this post from President of BAXTER $BAX on Link'din..... Can somebody say Mystery Solved!!!
https://stockhouse.com/news/press-releases/2024/05/15/baxter-announces-mission-and-logo-for-proposed-kidney-care-company-vantive#:~:text=Baxter%20announced%20the%20mission%20and%20logo%20for%20its,for%20acute%20and%20chronic%20kidney%20diseases%20and%20beyond.
👍️ 1
theswordman theswordman 3 weeks ago
CMO tweet about latest SCD article

NOTICE: Multiple Clinical Conditions

NOTICE : multi-organ failure


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theswordman theswordman 3 weeks ago
Better understanding of sepsis--why it is hard to diagnose--hard to treat

https://www.aamc.org/news/sepsis-third-leading-cause-death-us-hospitals-quick-action-can-save-lives#:~:text=While%20sepsis-related%20deaths%20declined,100%2C000%20in%20the%20same%20age
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theswordman theswordman 3 weeks ago
CRS (cytokine release syndrome) is a double-edged sword, which may be both helpful in controlling tumors/viruses/infections and harmful to the host.

Often ICU mngmt speak--the SAB et al speak/present about "cytokine storm"
For a better understanding of CRS--Cytokine Release Syndrome; this article explains well--and also shows the many issues with fighting/controlling/stopping CRS with drugs alone.
https://www.nature.com/articles/s41392-021-00764-4



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theswordman theswordman 4 weeks ago
Increasing Eligibility to Transplant Through the Selective Cytopheretic Device

In this overview, we describe a case series of successful transition of pediatric and adult patients with multiorgan failure to successful transplant/device implantation procedures by treatment with the SCD in the following clinical situations: pediatric hemophagocytic lymphohistiocytosis, and adult hepatorenal and cardiorenal syndromes.

https://journals.lww.com/transplantationdirect/fulltext/2024/06000/increasing_eligibility_to_transplant_through_the.16.aspx
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theswordman theswordman 4 weeks ago
Few weeks old--CEO in Q & A session about kidney failure and bringing new devices to mkt

https://trfitzpatrick.com/p/expert-q-and-a-bringing-new-devices
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theswordman theswordman 1 month ago
This is one small step towards our methodical march towards commercialization and worldwide adoption of our platform technology across multiple indications. 👇🏼#NoShortcuts#CharlieMike $ICU@SeaStarMedical https://t.co/YT3H3A7cu8— Kevin K. Chung, MD (@chungk1031) April 30, 2024
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theswordman theswordman 1 month ago
UPDATE @ clinical trials.gov

Note the new activated sites (7 total) and an additional 5 sites they added and are working on activating.
2 of the "add'l" sites include Mayo and UCLA

Dr Chung stated We are just now ramping up due to contract negotiation issue that we have now corrected.
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theswordman theswordman 2 months ago
Every day in the US, more than 200 children are diagnosed with severe sepsis. April 21-27 is Pediatric Sepsis Week! Learn more at https://t.co/h3Gb8FfHyC For more information on SeaStar Medical's efforts in Pediatric acute kidney injury due to Sepsis, visit…— SeaStarMedical (@SeaStarMedical) April 24, 2024
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theswordman theswordman 2 months ago
21-27 APRIL is Pediatric Sepsis Week

https://www.sepsis.org/pediatric-sepsis-week/
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harry crumb harry crumb 2 months ago
Loading more here
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Fredric Fredric 2 months ago
Price moving nice
Was debating all day to buy
Finally pulled the trigger.
After hours n premarket will be the thing to watch.

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theswordman theswordman 2 months ago
Critical Care Nephrology. AKI--CRRT--ECOS Conf
11-13 JUN Vincenza ,Italy

https://www.extracorporeal-organ.com/copy-of-endorsement
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theswordman theswordman 2 months ago
24-27 APR--Extracorporeal Organ Support
Zagreb, Croatia--https://www.extracorporeal-organ.com/program

SEVERAL of the SeaStar SAB and DR Chung are presenting as seen on pg # 2-3
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theswordman theswordman 2 months ago
Articles - Healthcare Technology
NEW THERAPEUTIC DEVICE OFFERS HOPE IN THE FIGHT AGAINST PEDIATRIC SEPSIS

https://healthhq.world/issue-sections/articles/healthcare-technology/new-therapeutic-device-offers-hope-in-the-fight-against-pediatric-sepsis/
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theswordman theswordman 2 months ago
NOBLE CAPITAL MARKETS HEALTHCARE CONF

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scoobey-do scoobey-do 2 months ago
SeaStar Medical Reports 2023 Financial Results and Provides a Business Update April 17 2024 - 4:00PM

SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.
“It was exceptionally exciting to receive our first FDA approval for Quelimmune™, which is now available for treating critically ill pediatric patients suffering from acute kidney injury (AKI) and sepsis. We are proud to be the only company to develop and commercialize a therapeutic device that’s proven to save lives and decrease dialysis dependency in these extremely sick children,” said Eric Schlorff, SeaStar Medical CEO. “We are working closely with our distribution partner to commercialize Quelimmune Pediatric to leading U.S. children’s hospitals.

“In our NEUTRALIZE-AKI pivotal clinical trial, which is evaluating the safety and efficacy of our Selective Cytopheretic Device (SCD) in the significantly larger adult AKI patient population, enrollment now stands at 24 subjects and we have activated six clinical trial sites. Additional sites are advancing through the on-boarding process,” he added. “We anticipate conducting an interim analysis once we have reached the 90-day primary endpoint in 100 subjects, which we expect to occur in the second half of 2024.

“Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff. “The restatement primarily involved the accounting treatment of non-cash items and had minimal to no impact on our operating expenses, cash usage, cash position or future business potential. I would like to thank our finance team for their hard work in quickly completing this restatement.”

SeaStar Medical provides the following updates on its commercial and development programs, and corporate activities:

Pediatric Acute Kidney Injury

Only about half of patients in the pediatric ICU with AKI who require kidney replacement therapy (KRT) survive, with those surviving at risk of long-term life-threatening conditions such as chronic kidney disease. 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 kidney replacement therapy (CKRT) who were treated with Quelimmune had no device-related serious adverse events or device-related infections, a 77% survival rate and no dialysis dependency at Day 60.

In February 2024 SeaStar Medical received its first U.S. regulatory approval for the SCD Pediatric (SCD-PED) device for children with AKI and sepsis or septic condition weighing 10 kilograms or more who are being treated in the ICU with KRT. The SCD-PED is the first product approval in the Company’s newly branded Quelimmune product family. Quelimmune was 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. The U.S. addressable population of about 4,000 pediatric patients falls within the 8,000-patient HDE criteria.
The Company is working to commercialize Quelimmune with its distribution partner Nuwellis, which has deep relationships with nephrologists and intensive care physicians trained in pediatric extracorporeal therapy. Pediatric patients undergoing treatment with Quelimmune are expected to require on average seven Quelimmune units, with the disposable device being changed once every 24 hours.
In March 2024 the Company sponsored an industry symposium titled “New Therapies in Pediatric Acute Kidney Injury” at the AKI & CRRT 2024 conference. The symposium featured key opinion leaders in nephrology and AKI, who are members of the Company’s Scientific Advisory Board.
Adult Acute Kidney Injury

SeaStar Medical is conducting the pivotal NEUTRALIZE-AKI (NEUTRophil and Monocyte DeActivation via SeLective CytopheretIc Device - a RandomiZEd Clinical Trial in Acute Kidney Injury) clinical trial to evaluate the safety and effectiveness of the SCD in adults with AKI in the ICU receiving CKRT. The SCD has received FDA Breakthrough Device Designation for adult AKI. This designation is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints.

The NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD-ADULT in addition to CKRT as the standard of care, compared with the control group receiving only CKRT 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 SCD-ADULT therapy in AKI patients with sepsis and acute respiratory distress syndrome. A more complete description of the NEUTRALIZE-AKI trial design can be found in the journal Nephron.
The Company expects to receive regulatory approval for the SCD-ADULT in the second half of 2025 and to launch the product in the first half of 2026.
Additional SCD Indications

SeaStar Medical continues to explore the application of its SCD technology across a range of indications involving dysregulated immune processes where proinflammatory activated neutrophils and monocytes may contribute to disease progression or severity, in both acute and chronic indications.

In September 2023 the Company received Breakthrough Device Designation for the SCD for use in cardiorenal syndrome. This was only the ninth Breakthrough Device Designation granted by the FDA’s Center for Biologics Evaluation and Research (CBER) since the program’s inception in 2015. The Company plans to work in partnership with the University of Michigan to conduct additional clinical studies to gather further evidence to support FDA approval.
In October 2023 the Company received Breakthrough Device Designation for the SCD for use in hepatorenal syndrome. An ongoing pilot study in this indication at the University of Michigan is expected to provide valuable insight in the design and execution of a pivotal study.
In February 2024 the manuscript “New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation” Pitt, B., Iyer, S.P.N. and Humes, H.D. discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the SCD was published in the peer-reviewed European Journal of Heart Failure.
Corporate Developments

In January 2024 the Company appointed healthcare industry veteran David A. Green as Chief Financial Officer. Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
In January 2024 the Company announced a $9.0 million registered direct offering priced at-the-market.
In January 2024 a U.S. patent was granted with broad claims directed to methods of using the SCD to treat subjects with inflammatory conditions and to process activated leukocytes and platelets.
In February 2024 the Canadian Intellectual Property Office issued a patent with broad claims covering the SCD technology.
2023 Financial Results

Research and development (R&D) expenses for 2023 were $6.0 million, compared with $2.5 million for 2022, with the increase primarily driven by higher clinical trial and personnel expenses, partially offset by lower external services.

General and administrative (G&A) expenses for 2023 were $8.2 million, compared with $6.9 million for 2022, with the increase primarily due to higher insurance expense, higher costs associated with SEC reporting, increases in payroll-related expenses, higher legal and professional services fees, an increase in directors’ compensation expense and a legal settlement. The increase was partially offset by lower fees associated with an equity line of credit.

Other expense for 2023 was $12.0 million, compared with other expense of $0.6 million for 2022. The increase primarily resulted from an increase in interest expense, unrealized loss on convertible notes and loss on extinguishment of convertible notes, and a reduction in unrealized gains from declines in the fair value of derivative warrants liability. This was offset by a decline in the loss recognized in the change in fair value of the forward purchase agreement derivative liability and other income. The Company incurred a loss on changes in fair value of pre-merger convertible notes payable derivative liability in 2022, with no comparable liability in 2023.

The net loss for 2023 was $26.2 million, or $1.21 per share on 21.7 million weighted-average shares outstanding. This compared with a net loss for 2022 of $12.2 million, or $1.48 per share, on 8.2 million weighted-average shares outstanding.

The Company reported cash of $176,000 as of December 31, 2023, compared with $47,000 as of December 31, 2022. In January 2023 the Company announced a $9.0 million registered direct offering priced at-the-market.

About Hyperinflammation

Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.

About The Selective Cytopheretic Device

The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. Quelimmune is the official brand name for the SCD Pediatric that has received FDA HDE approval based on safety and probable efficacy.
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theswordman theswordman 2 months ago
CONF CALL REGISTRATION--The link is now live on webpage.
https://dpregister.com/DiamondPassRegistration/register?confirmationNumber=10187590&linkSecurityString=fc04ba1430

17 APR--WED @ 4 PM Eastern
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theswordman theswordman 2 months ago
kidney disease prevalence is increasing globally and it is now the seventh leading risk factor for mortality worldwide

https://www.nature.com/articles/s41581-024-00820-6

Failure to include kidney disease in this initiative misses the opportunity to address a major contributor to premature and preventable mortality.
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theswordman theswordman 3 months ago
SeaStar and SCD getting a shoutout TODAY in Extracorporeal Organ Support for Burn-Injured Patients issue of Medical Sciences by MDPI.

5.3. Cell-Directed Extracorporeal Therapy
The Selective Cytopheretic Device (SCD) (SeaStar Medical, Denver, CO, USA), is a technology that sequesters and modulates the most activated neutrophils and monocytes . The SCD is a biocompatible membrane that mimics capillary blood flow and sequesters activated leukocytes. The SCD is utilized in conjunction with CKRT, with the SCD downstream from the CKRT hemofilter in the circuit. The SCD requires the use of regional citrate anticoagulation to induce hypocalcemia within the SCD, which results in both the inhibition of the clotting cascade but also the inactivation of leukocytes. There are a number of smaller studies in critically ill medical patients which have shown promising results, but there are limited data including burn patients . A multicenter randomized controlled trial, NEUTRALIZE-AKI, is currently enrolling critically ill patients with AKI, who require CKRT .

https://www.mdpi.com/2673-1991/5/2/6
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theswordman theswordman 3 months ago
The AKI & CRRT 2024 (San Diego)--that webinar is NOW uploaded to SeaStar website for replay. It does include the Q & A portion also. Great info in this. Good questions.
https://s201.q4cdn.com/298572669/files/images/introducing_quelimmune__new_approved_therapy_for_pediatric_aki_due_to_sepsis-720p.mp4
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theswordman theswordman 3 months ago
C K D Summit--Dr Chung presentation--20 MAR/Boston

https://ckd3-summit.com/seminar/session-reserved-seastar-medical/
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theswordman theswordman 3 months ago
Dr Chung is presenting today (16 MAR) @ KDCT Conference (Kidney Disease Clinical Trialists)

The schedule/topics are linked here
https://www.kdctmeeting.com/scientific-program

It is the 3pm slot. Notice ALSO the 1 moderator (Sean Bagshaw)--ring a bell??
Session 9--Developing Core Outcome Sets In AKI Trials
👍️0
abrooklyn abrooklyn 3 months ago
SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

Source: GlobeNewswire Inc.

SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.
“We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients. Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We expect the pace of enrollment will accelerate as more medical centers come onboard. We anticipate conducting an interim analysis once we have reached our 90-day primary endpoint in 100 enrolled subjects, which we expect to reach in the second half of 2024.”

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 adults. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to continuous kidney replacement therapy (CKRT) as the standard of care, compared with the control group receiving only CKRT 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 SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. More information on the trial is available here.

In February 2024 the U.S. Food and Drug Administration (FDA) granted a Humanitarian Device Exemption (HDE) Approval Order to the Quelimmune™ pediatric device for use in children weighing 10 kilograms or more with AKI due to sepsis or a septic condition requiring kidney replacement therapy (KRT).

“Interactions with several key target hospitals are underway with plans to expand the commercial rollout with Nuwellis, Inc. during the second quarter,” said Eric Schlorff, CEO of SeaStar Medical. “As our therapeutic device is approved under an HDE, each hospital is required to secure institutional review board approval prior to purchasing the device for use in patients. We view Quelimmune as a tremendous win for children with AKI requiring CKRT given clinical results from our AKI pediatric trials that showed a 77% survival rate and no dialysis dependency at 60 days in those subjects, as well as for the healthcare system given the average cost of dialysis for a single patient with AKI who develops chronic kidney disease is about $100,000 annually.”

SeaStar Medical estimates the eligible population for its Quelimmune pediatric device to be approximately 4,000 children annually with AKI. About 20% of the top 50 children’s hospitals already have direct experience with the SCD. Pediatric patients undergoing treatment with the SCD are expected to require, on average, seven SCD units, with the disposable device being changed once every 24 hours. With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

The FDA’s HDE Approval Order was based on a pooled analysis from two non-controlled studies, SCD-PED-01 (funded by the FDA Office of Orphan Products Development) and SCD-PED-02. These studies showed that pediatric patients weighing ≥10kg with AKI requiring CKRT treated with the Quelimmune pediatric device had no device-related serious adverse events or device-related infections, a 77% survival rate, and no dialysis dependency at Day 60. The SCD-PED-01 (weight range ≥15 kg) and SCD-PED-02 (weight range ≥10 kg) studies demonstrated 75% and 83% survival rates, respectively.

SeaStar Medical also announces that its executive management team plans to hold a business update conference call in April to discuss progress with its AKI programs and opportunities in other indications, and to answer questions. Details regarding this call will be made available in the coming weeks.

About Hyperinflammation
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.

About The Selective Cytopheretic Device
The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. Quelimmune is the official brand name for the Selective Cytopheretic Device in pediatrics that has received FDA HDE Approval based on safety and probable efficacy.

About SeaStar Medical
SeaStar Medical is a commercial-stage, 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 SCD’s ability to treat hyperinflammation and the expected results of clinical trials and studies. 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, including the equity line of credit and forward purchase 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 assume 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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theswordman theswordman 3 months ago
SeaStar gets a shoutout in article

https://www.renalandurologynews.com/news/nephrology/acute-kidney-injury/more-severe-aki-predicts-adverse-outcomes-in-critically-ill-children/
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theswordman theswordman 3 months ago
Dr Batchinsky is a member of SAB. U.S. Army connections--along with CMO Dr Chung.This is something he is progressing: https://genevausa.org/news/story/geneva-scientist-invents-wearable-life-support-to-change-critical-care/
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theswordman theswordman 3 months ago
within 12 hours her course progressed to multiple organ failure, including anuric AKI, shock liver, respiratory failure, and refractory shock.

Our institution also requested the emergency use of an investigational extracorporeal device known as the SCD from SeaStar Medical.

https://journals.lww.com/ccejournal/fulltext/2024/03000/sequential_extracorporeal_therapy_of_pathogen.2.aspx
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harry crumb harry crumb 3 months ago
Now what, exited position last week on the pump, thank the stock gods, lol. So the news was sold and shorts are dominating now but seems decent support around this area
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theswordman theswordman 3 months ago
UPDATED--Looks NICE!!!
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frans frans 4 months ago
ICU up up now 0.8945
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macnai macnai 4 months ago
SeaStar will bob back up again after being raided by Pirates.
Big investors ie. institutions set off a selling panic among short-term investors by selling short and were able to buy back in bulk yesterday at much-reduced prices. They see the great future of this company and want to be in with decent size stakes.
My view ......take it or leave it.
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frans frans 4 months ago
that is NOT normal trading here now my 0.76
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frans frans 4 months ago
yes
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TheFinalCD TheFinalCD 4 months ago
stock market is full of surprises

many of which arent good
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frans frans 4 months ago
now 0.71 better bought it at 0.76
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TheFinalCD TheFinalCD 4 months ago
$ICU .52 what in TARNATION
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frans frans 4 months ago
what is going on here after FDA news ???
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theswordman theswordman 4 months ago
FDA APPROVAL LETTER
https://www.fda.gov/media/176511/download
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macnai macnai 4 months ago
Sellers pre-market will be weeping later today.
Hold and buy more if you can.
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Tom turtles Tom turtles 4 months ago
Wow....can you imagine when this has bad news ? FDA Approved and the stock plummets like a free falling boulder. In the .70's now pre-market. These criminals should be investigated. Didn't buy into any of the hype. Feel sorry though, for investors that did.
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theswordman theswordman 4 months ago
A Beacon of Hope

This isn't just a step forward in healthcare - it's a giant leap in the battle against a condition that has long challenged the pediatric intensive care community.
the Quelimmune device is set to become a standard of care for AKI in the ICU
hopeful for the impact this device will have on critically ill children with few treatment options

https://bnnbreaking.com/breaking-news/health/a-beacon-of-hope-fda-approves-innovative-device-for-pediatric-kidney-injury
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macnai macnai 4 months ago
Now is the TIME TO BUY
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