Products in Development
All products on this page are in development, not FDA cleared/approved
sEEG-based Drug Delivery System*
Diagnostic and therapeutic capabilities in one device
PRODUCT IN DEVELOPMENT
A novel platform integrating CED (Convection Enhanced Delivery) with sEEG (Stereoelectroencephalography)
Enables real-time monitoring of neural activity before and after drug infusion
Minimally invasive, low-profile system with procedural flexibility
Potential for clinical cost efficiency by eliminating OR and MRI
Software agnostic application
NEUROONE’S SEEG-BASED DRUG DELIVERY SYSTEM IS NOT FDA CLEARED/APPROVED. DEVICE FOR INVESTIGATIONAL USE IN LABORATORY ANIMALS OR OTHER TESTS THAT DO NOT INVOLVE HUMAN SUBJECTS. THE SYSTEM USES A MODIFIED VERSION OF THE NEUROONE EVO® SEEG SYSTEM, FDA CLEARED FOR USE FOR LESS THAN 30 DAYS (K222404).
Minimally invasive, ultra-thin profile designed to reduce brain trauma
Accommodates multiple trajectories
Intended for both pediatric and adult use
Bedside use (real-time MRI not required for device placement or infusion)
Allows for repeated infusions over a period of <30 days
Allows for multiple simultaneous injections (better coverage and reduced toxicity)
Multimodal system (ability to record, stimulate and deliver drugs)
SEEG - BASED DRUG DELIVERY SYSTEM
Technology
available in 3 sizes for R&D use and future clinical studies, if interested
Neural recordings anticipated to aid in the assessments of drug efficacy, dosing, toxicity, mechanisms of action and biomarkers across species
Potential to reduce drug failure rates and improve clinical outcomes
Potential to streamline drug discovery process
NeuroOne’s sEEG-based Drug Delivery System is not FDA cleared/approved. Device for investigational use in laboratory animals or other tests that do not involve human subjects. The system uses a modified version of the NeuroOne Evo® sEEG System, FDA cleared for use for less than 30 days (K222404).
Mini version
Devised for small animal models (rodents). Early stages of drug development and screening
Compact version
Devised for medium/large animal models. From discovery phase to preparation for clinical trials
Standard version
Devised for humans. Clinical trials and (if cleared/approved) commercial use
Percutaneously implanted
paddle lead for Spinal Cord Stimulation (SCS)
Next Gen Perc‑Paddle Lead
Combines paddle lead advantages with ease of use of traditional perc leads
Over 20 times thinner than traditional paddle leads
True percutaneous placement with a standard 14‑gauge needle
