Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc.

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Post by floatinketuckyon Apr 01, 2022 8:03pm

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Post# 34569140

BTD AA and/or priority review

Operational Highlights:

FDA Fast Track. On November 23, 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with TLC-3200, to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with Bacillus Calmette-Guerin (“BCG”) – Unresponsive Non- Muscle Invasive Bladder Cancer (“NMIBC”) Carcinoma In-Situ (“CIS”), with or without papillary Ta or T1 tumors. FTD can lead to an Accelerated Approval (“AA”), Break Through Designation (“BTD”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.