Safety Milestone in Sepsis Treatment
CLINICAL EVALUATION
CycloPE® Shows Safety and Early Efficacy in Sepsis Study
PATH EX completed an international feasibility study in patients with sepsis to evaluate the safety and initial efficacy of the CycloPE® blood purification device. Conducted under ICH-GCP/ISO 14155 standards, the study was successful, showing no device-related safety concerns and demonstrating positive efficacy signals, providing the foundation for advancement toward a pivotal U.S. clinical trial.
Study Overview
- Study Type: Feasibility
- Patient Population: Critically ill patients with sepsis in the ICU
- Study Size: 15 patients enrolled
- Location: Leading international academic hospital
Key Findings
- No device-related safety concerns observed
- Positive signals of efficacy across multiple clinical parameters
- Study results support progression toward pivotal evaluation in the U.S.
Commitment to Standards
- The feasibility study was designed and executed in compliance with international standards (ICH-GCP and ISO 14155), ensuring the highest level of clinical and regulatory rigor.
