FDA Grants Approval for Next Generation Therapeutic Laser

Toronto, Ontario – 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 … Read More

Theralase Appoints Director of Clinical Education / Training and Clinic Director

Toronto, Ontario – November 24, 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 it has appointed Dr. Elizabeth Angelevski as the Director of Clinical Education / Training and Dr. Alex Peplow as the Clinic Director of Theralase. Dr. Angelevski graduated from Canadian Memorial Chiropractic College (“CMCC”) in 2009 and from McMaster University with a Bachelor of Science in Kinesiology (Honours) in 2005. She is a licensed chiropractor with an avid interest in sports injuries and rehabilitation. Dr. Angelevski will be responsible for: • Providing clinical overview to the marketing program for the next generation therapeutic laser • Training all healthcare practitioners on the safe and effective use of the next generation therapeutic laser • General management of the Theralase clinic Dr. Peplow graduated from York University in 2008 with a … Read More

Theralase Partners with University of Ulm ( Located in Germany)

Toronto, Ontario – November 12, 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 it has partnered with the University of Ulm (“Ulm”) to investigate the localization of its lead Photo Dynamic Compound (“PDC”) within cancer cells and shine more proverbial light on the Mechanism of Action (“MOA”) on how this PDC is so effective in the destruction of cancer cells when laser light activated. The scope of the current project between Ulm and Theralase is to investigate the localization (where do they locate in the cell) and the MOA (how they work on the cell) of Theralase’s lead PDC, TLD-1433, currently under investigation for the destruction of Non-Muscle Invasive Bladder Cancer (“NMIBC”). The head of the core facility “Confocal and Multiphoton Microscopy”, located in the Medical Faculty of Ulm, is … Read More

Theralase Anti-Cancer Technology Presented at International Laser Conference

Toronto, Ontario – November 10, 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 its latest anti-cancer technology research, combining Photo Dynamic Compounds (“PDCs”) with laser light to destroy cancer targets was recently presented at the 28th International Congress of Laser Medicine, Laser Florence 2015 from November 5th to 7th, 2015 and was the recipient of the best presentation award. The research entitled, “A Novel Family of Osmium Complex Photosensitizers for Multi-Wavelength Photo Dynamic Therapy (“PDT”)” conducted in collaboration between the Department of Medical Biophysics, University of Toronto, the Department of Chemistry, Acadia University and Theralase provided evidence that Theralase’s Osmium based PDCs when activated with various wavelengths of light were able to effectively destroy cancerous targets, pre-clinically. The research will be published by Medimond S.R.L. under their Monduzzi Editore International … Read More

Theralase Completes GMP Manufacture of Second Batch of Lead Drug

Toronto, Ontario – October 1, 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 it has completed manufacture of a second batch of its lead Photo Dynamic Compound (“PDC”), TLD-1433 in compliance with Good Manufacturing Practice (“GMP”) standards. This milestone demonstrates Theralase’s ability to consistently and reliably manufacture its lead light activated drug in the same purity and yield as the original GMP batch.   Consistency in manufacture of TLD-1433 is essential to prove to regulatory agencies that a drug intended for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”) can be reliably produced to GMP quality standards.   Theralase plans to evaluate TLD-1433 in a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy commencing in late 4Q2015.   … Read More

Theralase Submits Anti-Cancer Technology to Research Ethics Board for Approval

Toronto, Ontario – September 21, 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 it has submitted its anti-cancer technology to the Research Ethics Board (“REB”) of Princess Margaret Cancer Center, University Health Network (“UHN”) for approval.   The REB is responsible for reviewing the anti-cancer technology and assessing it from a clinical viewpoint. The anti-cancer technology consists of the Company’s lead Photo Dynamic Compound (“PDC”), TLD-1433, which is light activated by the proprietary Theralase TLC-3200 Oncology Laser System for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”). The REB, pending review, will authorize the UHN clinical team to commence enrolling patients, inflicted with NMIBC, into a Phase Ib clinical trial to study the effects of the technology as determined by the primary outcome measures of safety and tolerability, and as … Read More

Theralase Submits Investigational Testing Authorization to Health Canada for Approval

Toronto, Ontario – September 18, 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 it has submitted an Investigational Testing Authorization (“ITA”) for its anti-cancer technology to Health Canada for approval.   The ITA details information about the proprietary Theralase TLC-3200 Oncology Laser System, which Theralase plans to use to activate the Company’s lead Photo Dynamic Compound (“PDC”), TLD-1433, to destroy Non-Muscle Invasive Bladder Cancer (“NMIBC”).     Pending approval of the following applications, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at Princess Margaret Cancer Center, University Health Network (“UHN”) to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy:   Health Canada Clinical Trial Application (“CTA”) (Complete); Health Canada ITA (Complete); UHN Research Ethics Board (“REB”).   … Read More

Theralase Submits Clinical Trial Application to Health Canada for Approval

Toronto, Ontario – September 17, 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 it has submitted a Clinical Trial Application (“CTA”) for its anti-cancer technology to Health Canada for approval. Theralase’s anti-cancer technology utilizes the proprietary Theralase TLC-3200 Oncology Laser System to activate the Company’s lead Photo Dynamic Compound (“PDC”), TLD-1433, to treat Non-Muscle Invasive Bladder Cancer (“NMIBC”). Pending approval of the following applications, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at Princess Margaret Cancer Center, University Health Network (“UHN”) to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy: – UHN Research Ethics Board (“REB”); – Health Canada CTA; – Health Canada Investigational Testing Authorization (“ITA”). Roger Dumoulin-White, President and CEO, Theralase stated, “The submission of … Read More

Theralase Completes Detailed Information on the TLC-3000B Laser System

Toronto, Ontario – September 15, 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 it has completed detailed information on how the TLC-3000B Laser System will be used to activate the Company’s lead light activated Photo Dynamic Compound (“PDC”), TLD-1433 in the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”). Pending Health Canada approval of a Clinical Trial Application (“CTA”) and Princess Margaret Cancer Center, University Health Network (“UHN”) Review Ethics Board (“REB”) approval, expected in late 4Q2015, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at UHN to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy. Completion of information pertaining to the laser technology used to activate TLD-1433 marks the fourth and final major milestone for the Company … Read More

Theralase Completes Clinical Protocol

Toronto, Ontario – September 11, 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 it has completed the Clinical Protocol and Investigator’s Brochure detailing the application of its lead light activated Photo Dynamic Compound (“PDC”), TLD-1433 in the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”). Pending Health Canada approval of a Clinical Trial Application (“CTA”) and Princess Margaret Cancer Center, University Health Network (“UHN”) Research Ethics Board (“REB”) approval, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at UHN to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy. Completion of the Clinical Protocol and Investigator’s Brochure marks the third major milestone for the Company to complete its submission of a CTA application to Health Canada. Key components required … Read More