tw0122
6 months ago
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
theswordman
8 months ago
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As far as positive or negative (IMHO) ; The Little Rock ,AR location was withdrawn, the Rochester, NY location was withdrawn, Bethlehem, PA was added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)
theswordman
11 months ago
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.