These are the facts of where we are not your bulls-it facts! The clinical procedure for the Phase Ib study to treat NMIBC, titled "A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients with Non-Muscle Invasive Bladder Cancer at High Risk of Progression Who are Refractory to Therapy with Bacillus Calmette-Guerin ("BCG") and Who are Medically Unfit For or Refuse a Cystectomy" is to:
- Intravesically instill a sterile water based solution of TLD-1433 via catheter, through the urethra, into the bladder of a patient inflicted with NMIBC, who has failed standard of care and who is not indicated or refuses to have their bladder removed
- Allow the solution of TLD-1433 to absorb into any resident bladder cancer tumours for approximately sixty minutes
- Void the bladder and flush the bladder twice with sterile water to remove any excess TLD-1433 solution not absorbed by any bladder tumours
- Admit the patient into the operating room and administer a general anesthetic
- Insert a rigid cystoscope through the urethra of the patient into the bladder
- Fill the bladder with sterile water to provide shape to the bladder
- Insert the TLC-34XX DFOC device into the bladder via the cystoscope's working channel and connect it to the TLC-3200 PDT Laser System
- Deploy the DFOC in the bladder (like an umbrella) to strategically place optical detectors at twelve (12) predetermined locations along the bladder wall to precisely monitor the laser light to provide a uniform distribution of the laser light energy, in the correct dosage, to the bladder wall