Theralase Technologies Receives 501(k) Approval for Next Gen Therapeutic Laser

Spotlight Companies |

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.

Disclosure: In the purview of Section 17(B) of the Securities Act of 1933 and in the interest of full disclosure, we call the reader's attention the fact that Equities.com, Inc. may be compensated by the companies profiled in the Spotlight Companies section. The purpose of these profiles is to provide awareness of these companies to investors in the micro, small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. Equities.com is not a registered broker, broker dealer, investment advisor, analyst, investment banker or underwriter. All profiles are based on information that is available to the public. The information contained herein should not be considered to be all-inclusive and is not guaranteed by Equities.com to be free from misstatement or errors. Readers are reminded to do their own due diligence when researching any companies mentioned on this website.

 

 

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Comments

Emerging Growth

Kiwa Bio-Tech Products Group Corp

Kiwa Bio-Tech Products Group Corp develops, manufactures, distributes and markets, cost-effective and environmentally safe bio-technological products for agriculture in China.

Private Markets

Lyft

Lyft matches drivers using their own personal vehicles with passengers who request rides through the smartphone app, and the passengers pay automatically through the app. When using Lyft, passengers have…

Uber

Uber connects riders with safe, reliable, convenient transportation providers at a variety of price-points in cities around the world. Uber makes money from charging their drivers 20% of the fare…