Theralase Technologies (TLT-V) Nov 25, '15 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.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology Division designs, manufactures and markets patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy Division researches and develops specially designed molecules called Photo Dynamic Compounds, which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
Additional information is available at www.theralase.com and www.sedar.com .
Theralase Technologies Inc. was recognized as a TSX Venture 50® company in 2015. TSX Venture 50 is a trademark of TSX Inc. and is used under license.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com |
