Clinical Trials
2
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2017
Completed
1
50.0%
Not yet recruiting
1
50.0%
No approval data available
- 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.
