Entering edit mode
2.0 years ago
Jo Ann
•
150
@jo_ann
Dr. Schwartz, Could you please clarify the availability and location of receiving TUG therapy. Are you associated with the Long Beach, CA, practice that does TUG or are you pursuing another route? I am confused since it was previously stated that TUG was being performed at the eye center in Long Beach, CA. Why does it still need the FDA approval and clinical trials if it is already being done in Long Beach. Are you doing something different but related to the Long Beach procedure? Can patients receive the TUG therapy at the Long Beach clinic at the present time? Please clarify. Thank you!
The use of the TUG device in Long Beach was under an IRB for clinical studies. Such studies may be performed as NSR (Non significant risk) if the IRB has reviewed pre-clinical work and agrees that the device is NSR. The other pathway is with an IDE (Exemption from the FDA to do studies) so that the FDA has data to review in the certification process. All of the work in Long Beach was under strict IRB approved studies. There have been no recent USA studies. It is hoped that enough funds can be raised to allow independent studies beyond the Long Beach facility.