FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
SeaStar Medical Holding Corporation (ICU)
Company Research
Source: GlobeNewswire
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- 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 the receipt of a Breakthrough Device Designation from the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) for the Company’s patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis, also known as chronic dialysis. More than 480,000 individuals in the U.S. with ESRD are treated by in-center hemodialysis at least three times a week at a cost of approximately $100,000 per patient per year. “This is our first Breakthrough Device Designation award for the SCD in a chronic i
Show less
Read more
Impact Snapshot
Event Time:
ICU
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
ICU alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
ICU alerts
High impacting SeaStar Medical Holding Corporation news events
Weekly update
A roundup of the hottest topics
ICU
News
- SeaStar Medical Reaches Milestone of 100th QUELIMMUNE Commercial Device as Shipments Begin to its Third Hospital CustomerGlobeNewswire
- SeaStar Medical Reports Third Quarter 2024 Financial Results and Provides a Business UpdateGlobeNewswire
- Record Monthly Enrollment Achieved in SeaStar Medical’s Pivotal Adult AKI TrialGlobeNewswire
- SeaStar Medical Adds Second Hospital Customer for QUELIMMUNEGlobeNewswire
- Economic Analysis Supporting Significant Hospitalization Cost Reduction with SeaStar Medical’s QUELIMMUNE Pediatric Therapeutic Device Presented at ASN Kidney Week 2024 - UpdateGlobeNewswire
ICU
Sec Filings
- 11/19/24 - Form 4
- 11/19/24 - Form 4
- 11/15/24 - Form 4
- ICU's page on the SEC website