Theralase Technologies Inc (TLTFF)

[RWC2587]

TORONTO, ON / ACCESSWIRE / November 25, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that the Food and Drug Administration ("FDA") has granted 510(k) approval for Theralase's next generation therapeutic laser, the TLC-2000 Therapeutic Medical Laser System.

The FDA has reviewed Theralase's 510(k) premarket notification and has determined that the TLC-2000 is substantially equivalent to the Theralase TLC-1000 therapeutic medical laser system for the indication of "Adjunctive Use in the Temporary Relief of Pain Associated with Knee Disorders" and has authorized Theralase to market the device throughout the United States.

This 510(k) approval allows Theralase the ability to commence marketing the TLC-2000 in the United States, effective immediately.

Roger Dumoulin-White, President and CEO, Theralase stated that, "Theralase has focused its resources on the successful completion of four major strategic objectives prior to yearend; specifically:

- Health Canada approval of the next generation TLC-2000 Therapeutic Medical Laser System
- FDA approval of the TLC-2000 (completed)
- Review Ethics Board approval of a Phase Ib clinical trial for Theralase's anti-cancer technology for the treatment of Non-Muscle Invasive Bladder Cancer
("NMIBC")
- Health Canada approval to commence the Phase Ib clinical trial for NMIBC.

Theralase has completed the first of these four strategic objectives and is now focused on completing the other three prior to yearend."