SeaStar Medical Provides Updates On Enrollment Of Adult Pivotal Clinical Study And Commercial Launch Of Quelimmune, FDA-Approved In Pediatric Patients
Portfolio Pulse from Benzinga Newsdesk
SeaStar Medical Holding Corporation (NASDAQ:ICU) provided updates on its acute kidney injury (AKI) programs, including the enrollment of 21 subjects in its NEUTRALIZE-AKI clinical trial for adult AKI patients. The trial aims to enroll up to 200 adults to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD) therapy. Additionally, the FDA granted a Humanitarian Device Exemption Approval Order for its Quelimmune pediatric device for AKI due to sepsis, with plans to expand commercial rollout with Nuwellis, Inc. in Q2. The company also plans a business update conference call in April.
March 12, 2024 | 12:57 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
SeaStar Medical's updates on its AKI programs and FDA approval for its Quelimmune pediatric device indicate progress in its product pipeline and potential for revenue growth.
The positive update on the enrollment progress of the NEUTRALIZE-AKI clinical trial and the FDA approval for the Quelimmune pediatric device highlight SeaStar Medical's advancements in its AKI treatment programs. These developments are likely to be viewed positively by investors, as they demonstrate progress in the company's product pipeline and potential for future revenue growth through commercial rollout plans with Nuwellis, Inc. The announcement of a business update conference call in April further indicates the company's proactive approach in communicating its progress and future plans, potentially boosting investor confidence.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100