Theralase has been very successful in executing on its strategic objectives by completing:
1. Health Canada Medical Device Licence (Class III) approval of its next generation TLC-2000 Therapeutic Medical Laser System
2. US Food and Drug Administration (“FDA”) 510(k) clearance of the TLC-2000
3. Health Canada Clinical Trial Application (“CTA”) approval of the lead PDC, TLD-1433
4. Princess Margaret Cancer Centre, University Health Network (“UHN”) Research Ethics Board (“REB”) approval
5. Demonstrated 6 month accelerated stability and 9 month long term stability of it lead anti-cancer PDC TLD-1433
6. Signed a Clinical Research Agreement (“CRA”) with UHN to conduct a Phase Ib clinical study for the indication of Non-Muscle Invasive Bladder Cancer (“NMIBC”)
7. Health Canada Investigational Testing Authorization (“ITA”) approval of the TLC-3200 medical laser and TLC-3400 Dosimetry Fibre Optic Cage (“DFOC”) technology
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