In This Article:
Release Date: May 14, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
-
SeaStar Medical Holding Corp (NASDAQ:ICU) achieved a fourfold increase in first-quarter revenue compared to the fourth quarter of 2024.
-
The company added a prestigious nationally recognized children's hospital to its list of Quelmmune customers and achieved 50% enrollment in the Neutralized AKI trial.
-
Two new breakthrough device designations were granted by the FDA, expanding pipeline indications for adult and pediatric cardiac surgery.
-
The company is seeing increased adoption of its quell immune therapy, leading to organ sparing and life-saving outcomes in pediatric AKI patients.
-
The adult AKI market presents a significant opportunity, with a potential $4.5 billion total annual market opportunity in the United States.
Negative Points
-
The process of adoption at medical centers can be lengthy, with time to activation varying from several months to approximately 8 months.
-
Sales are expected to be lumpy until more pediatric hospitals are activated and the cadence of patient presentation is better understood.
-
The enrollment rate for the Neutralized AKI trial has been slow at times, causing delays in reaching the enrollment goal.
-
The company faces challenges in maintaining the integrity of the trial, as specific data from interim analyses cannot be shared.
-
Operating expenses increased modestly due to increased spending for commercial launch and growing enrollment in the Neutralized AKI trial.
Q & A Highlights
Q: How many sites are currently activated for the adult clinical trial? A: We currently have 15 activated sites and plan to activate another 5 over the next 3 months. - Kevin Chung, Chief Medical Officer
Q: What is the total number of pediatric hospitals that you have as customers currently? A: We have 6 sites that are commercially active, with multiple others moving through the IRB process. - Tim Verrachek, Senior Vice President of Commercial and Business Operations
Q: What sort of pipeline growth have you seen in the 1st quarter compared to the 4th quarter? A: It's a combination of word of mouth and active engagement with hospitals. Existing sites share their positive experiences with Qualimmune therapy, which generates interest. The timeline for adoption varies based on the hospital's resources. - Tim Verrachek, Senior Vice President of Commercial and Business Operations
Q: Can you talk about the importance of the two additional breakthrough designations and how you're prioritizing the regulatory processes? A: Cardiac surgery is a significant target due to the high incidence of AKI complications. We plan to conduct additional clinical trials, potentially funded by grants and investigator-initiated studies. The commercial and medical affairs teams are assessing market needs for the five additional indications. - Kevin Chung, Chief Medical Officer and Eric Scharf, CEO