相关临床试验
2
1 进行中
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0
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0
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2017
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1
50.0%
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1
50.0%
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- Terumo Blood and Cell Technologies and Santersus AG announced an exclusive partnership to develop NucleoCapture blood purification technology combined with the Spectra Optia Apheresis System for sepsis treatment. - The FDA-designated Breakthrough Device selectively removes neutrophil extracellular traps (NETs) from blood plasma, targeting a key factor in sepsis progression that leads to organ failure. - Santersus will lead the pivotal NUC-CAP clinical study across the U.S., UK, and EU, while Terumo Ventures invests in the company's Series A financing round. - The technology has potential applications beyond sepsis, including Alzheimer's disease, systemic lupus erythematosus, and organ transplantation conditions.
- Santersus AG has received its second FDA Breakthrough Device Designation for NucleoCapture blood purification technology, this time for treating severe, treatment-refractory systemic lupus erythematosus. - The extracorporeal therapeutic apheresis device selectively removes cell-free DNA and neutrophil extracellular traps from patient plasma, providing a novel non-immunosuppressive treatment option. - NucleoCapture is indicated as an adjunct to standard therapy for patients with severe or life-threatening refractory SLE who have active disease despite current standard of care treatment. - The company is preparing to initiate pivotal clinical trials in both the U.S. and Europe while completing its Series A financing round to advance toward regulatory approval.