Shares surge as FDA grants Humanitarian Device Exemption Approval
- SeaStar Medical shares rise 10% after FDA approval
- FDA grants Humanitarian Device Exemption Approval to SeaStar Medical
- Approval applies to pediatric selective cytopheretic device
- Quelimmune pediatric device can now be commercially marketed
- Initial commercial launch expected in the coming weeks
SeaStar Medical Holding shares jumped 10% to $1.60 following the announcement that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption Approval Order to the company’s pediatric selective cytopheretic device. This approval allows the Quelimmune pediatric device to be commercially marketed as a Humanitarian Use Device, targeting children weighing 10 kilograms or more with acute kidney injury due to sepsis or a septic condition requiring kidney replacement therapy. SeaStar Medical’s U.S. license and distribution partner Nuwellis is expected to launch the Quelimmune pediatric device for pediatric acute kidney injury in the coming weeks, with a full commercial program to follow. The FDA’s decision was based on clinical results demonstrating the safety and probable clinical benefit of the Quelimmune pediatric device for critically ill children with limited treatment options.
Factuality Level: 9
Factuality Justification: The article provides factual information about SeaStar Medical Holding’s shares increase after receiving FDA approval for their pediatric selective cytopheretic device. It includes details about the approval, the target population, the company’s plans for commercial launch, and the basis for FDA approval.
Noise Level: 3
Noise Justification: The article provides relevant information about SeaStar Medical Holding’s pediatric selective cytopheretic device receiving FDA approval. It includes details about the approval, the target market, and the company’s plans for commercial launch. The article stays on topic and supports its claims with information about the clinical results and the company’s partnership with Nuwellis. However, it lacks in-depth analysis, antifragility considerations, and accountability of powerful people. Overall, the article is concise and informative, with minimal noise.
Financial Relevance: Yes
Financial Markets Impacted: SeaStar Medical Holding
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The article pertains to the financial performance of SeaStar Medical Holding, as their shares were up 10% after receiving FDA approval for their pediatric selective cytopheretic device. There is no mention of an extreme event in the article.
Public Companies: SeaStar Medical Holding (not available), Nuwellis (not available)
Key People:
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