Clinical & Regulatory Momentum
Therapy attractiveness has been recognized rapidly by the FDA, propelling Adraxe into an expedited regulatory and clinical pathway for STOP therapy.
Read our latest publicationEfficacy Focus
Drastic Reduction in Time in Seizure
Our initial clinical models demonstrate drastically reduced time in seizure (number of seizures multiplied by average length) after 24 hours, continuing to improve over time.
FDA Recognition
Breakthrough Device Designation
Adraxe has achieved Breakthrough Device Designation, confirming the FDA's support for our novel approach and recognizing the significant unmet need for drug-resistant epilepsy patients.
Regulatory Path
TAP Program Acceptance
Accepted into the FDA's Total Product Life Cycle Advisory Program (TAP). This provides structured engagement with the FDA throughout the pivotal trial processes, enabling strategic alignment.