Jul. 28 at 4:29 PM
$ICU
ONE-Of-ITS-KIND device!
SeaStar’s SCD cartridges were initially developed for ICU/critical care patients, but the company is expanding into chronic dialysis patients as a distinct new population that is not typically considered critically ill, yet suffers from chronic inflammation that could benefit from SCD therapy.
In Oct 2024, FDA granted Breakthrough Device Designation to SeaStar for use of the SCD in chronic hemodialysis patients — a separate, non-ICU population:
These patients:
Receive thrice-weekly outpatient hemodialysis,
Suffer from constant immune dysregulation and inflammation.
Despite not being “critical care” patients, they have:
High mortality rates (~15–20% annually),
Frequent hospitalizations
Massive cardiovascular risk
If Dr. Humes’ optimal protocol (2–3 cartridges per treatment day) is followed:
Monthly treatment for all U.S. dialysis patients:
36M–54M cartridges/year
$180B–
$270B in potential revenue
Even 10% U.S. adoption at monthly frequency =
$18B–
$27B/yr
