Theralase Technologies (TLT:CA) (TLTFF) , a Toronto-based manufacturer and marketer of a patented super-pulsed laser technology used to eliminate pain, reduce inflammation and accelerate tissue healing, announced that the Food and Drug Administration (FDA) has granted 510(k) approval for their next generation therapeutic laser, the TLC-2000 Therapeutic Medical Laser System.
Effective immediately, this milestone FDA 510(k) approval allows Theralase the ability to market the TLC-2000 in the United States. The FDA 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.”
“Theralase has focused its resources on the successful completion of four major strategic objectives prior to year end,” said Roger Dumoulin-White, President and CEO. These four major strategic objectives include:
● 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.
This milestone follows a number of positive updates from the Theralase. In October, Theralase announced plans to commence enrolling patients suffering from Non-Muscle Invasive Bladder Cancer (NMIB”) into a Phase Ib clinical study. This past September, Theralase completed a detailed report of how its TLC-3000B Laser System will be used to treat Non-Muscle Invasive Bladder Cancer (NMIBC). Furthermore, Theralase’s anti-cancer technology, where its TLC-3200 Oncology Laser System is used in conjunction with the PDC, TLD-1433, was submitted to Health Canada for clinical trial approval. With the first of the four stated objectives achieved, the company is focused on completing the other three prior to yearend.
The groundbreaking work being done at Theralase is ushering in the next generation of medicine. Their next generation therapeutic laser is one step closer to bringing patients much needed physical and financial relief that is currently missing in the medical field.
For more information about Theralase Technologies, visit www.theralase.com.
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