Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
TORONTO, ON / ACCESSWIRE / May 27, 2016 / Theralase Technologies Inc. ("Theralase®" or the "Company") (TSXV: TLT) (OTC: TLTFF), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that for the three-month period ended March 31, 2016, total revenue increased from $369,136 to $411,448 for the same period in 2015, an 11% increase.
In Canada, revenue decreased 47% to $180,069 from $344,351, in the US, revenue increased 1,720% to $152,375 from $8,369 and international revenue increased 407% to $79,004 from $15,584. The decrease in Canadian revenue in 1Q2016 and the corresponding increase in US and international revenue is attributable to the Company systematically building its sales and marketing teams in the Canadian and US market and the learning curves associated with training and developing a new sales force.
With the recent TLC-2000 FDA 510(k) clearance and Health Canada approval, Theralase is focusing on recruiting a high performing sales and marketing team in Canada and the US with the mandate of dramatically increasing sales of the TLC-2000 across Canada and the United States in 2016. Once these strategic markets have been established and running independently, Theralase will focus on growing its international revenues through exclusive international distribution agreements.
Cost of sales for the three-month period ended March 31, 2016 was $131,764 (32% of revenue) resulting in a gross margin of $279,684 or 68% of revenue, compared to a cost of sales of $135,156 (37% of revenue) in 2015, resulting in a gross margin of $233,148 or 63% of revenue. Cost of sales is represented by the following costs: raw materials, subcontracting, direct and indirect labour and the applicable share of manufacturing overhead.
Selling and marketing expenses for the three-month period ended March 31, 2016 were $316,254 representing 76% of sales, compared with $184,488 or 50% in 2015. The increase is primarily due to increased spending in marketing and sales personnel, which will augment sales in future financial quarters with the launch of the TLC-2000. Selling expenses are expected to continue to increase in the future as the Company expands in Canada, the US and international markets. On-going investment in sales personnel, marketing events and advertising are necessary expenses to generate and increase revenues in subsequent financial quarters.
Administrative expenses for the three-month period ended March 31, 2016 were $623,314 representing a 36% increase from $456,123 in 2015. Increases in administrative expenses were attributable to the following:
General and administrative expenses increased 17% due to increased spending on investor relations and research scientist activities
Stock based compensation increased by 110% as a result of vesting of stock options to certain employees, directors and officers of the Company in Q22015
Administrative salaries increased by 58% as a result of hiring clinical and educational staff.
Research and development expenses totaled $477,588 for the three-month period ended March 31, 2016 compared to $545,645 in 2015 (12% decrease). Research and development expenses represented 34% of the Company's operating expenses for the period and represent direct investment into the research and development expenses of the TLC-3000 anti-cancer technology.
The net loss for the three-month period ended March 31, 2016 was $1,145,739, which included $171,878 of net non-cash expenses (amortization, stock-based compensation expense, foreign exchange gain/loss and lease inducements). This compared to a net loss for the same period in 2015 of $933,643 which included $165,531 of net non-cash expenses. The PDT division represented $840,449 of this loss (73%). The increase in net loss is due to increased investment in research and development of the TLC-3000, sales, marketing and administrative personnel, all related to the launch of the next generation TLC-2000 therapeutic medical laser system and the commencement of a Phase Ib clinical study for Non-Muscle Invasive Bladder Cancer ("NMIBC").
Theralase has been very successful in executing on its strategic objectives in 2015 and 1Q2016 by successfully completing:
Health Canada Medical Device Licence (Class III) approval of its next generation TLC-2000 Therapeutic Medical Laser System
US Food and Drug Administration ("FDA") 510(k) clearance of the TLC-2000
Health Canada Clinical Trial Application ("CTA") approval
Princess Margaret Cancer Centre, University Health Network ("UHN") Research Ethics Board ("REB") approval
6 month accelerated stability and 9 month long term stability of it lead anti-cancer PDC TLD-1433
A Clinical Research Agreement ("CRA") with UHN to conduct a Phase Ib clinical study for the indication of NMIBC
Theralase is currently completing sterilization, biocompatibility and mechanical testing of the TLC-3200 medical laser probes used to activate TLD-1433 that has absorbed into bladder cancer lesions and submit the information to Health Canada, via an Investigational Testing Authorization ("ITA") mid-June 2016 for approval on or about the end of June 2016.
Health Canada requires information and testing that supports:
Biocompatibility (the materials that enter the body are proven not harmful to tissue)
Mechanical testing (the materials demonstrate the characteristics of functional reliability, tensile strength and repeatability of operation)
Sterility (the materials that enter the body are demonstrated to be sterile)
Pending ITA approval from Health Canada, Theralase and UHN will immediately commence enrollment of patients inflicted with NMIBC into a Phase Ib clinical trial.
The Phase Ib NMIBC clinical study protocol will commence by instilling a low dose of TLD-1433 drug into the bladders of three (3) patients with subsequent light activation using the TLC-3200 medical laser. These three (3) patients will then be monitored for thirty (30) days to ensure safety and tolerability of the procedure. If no adverse events are reported, then an additional six (6) patients will be enrolled at a high dose, followed by light activation and follow-up monitoring for six (6) months.
The Phase Ib NMIBC clinical trial will evaluate TLD-1433 for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (where the PDC accumulates in the body and how it exits the body) and an exploratory endpoint of efficacy in a patient population defined by UHN uro-oncology department to enable drug approval.
If safety and tolerability of the procedure is demonstrated in these nine (9) patients, the Phase Ib study results will support Health Canada approval and a Phase IIb multi-center efficacy study for NMIBC will be commenced in Canada, the United States and Europe.
Mr. Dumoulin-White concluded that, "The Company has successfully executed on the majority of its strategic initiatives in 2015 and 1Q2016 and is anticipating ITA approval in or around the end of June 2016 to allow an immediate commencement of a Phase Ib clinical study for NMIBC, which will allow the Company to dramatically increase shareholder value in 2016 by demonstrating the safety, tolerability and as an exploratory outcome measure efficacy of next generation anti-cancer technology."
TORONTO, ON / ACCESSWIRE / May 2, 2016 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLT.V) (OTC: TLTFF), a leading biotech company focused on commercializing medical devices to eliminate pain and developing Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that it has increased its revenues by 40% year over year in its latest audited 2015 financial statements.
Total revenue for the year ended December 31, 2015 increased 40% from $1,380,604 to $1,945,246 from the same period in 2014.
In Canada, revenue increased 97% to $1,691,086 from $857,723, while US revenue decreased 24% from $283,784 to $214,744 and international revenue decreased 84% from $239,097 to $39,415.
The significant increase in Canadian revenue in 2015 and the corresponding decrease in US and international revenue is directly attributable to the Company's mandate of building its sales and marketing teams from scratch commencing with the Canadian market. The next generation TLC-2000 therapeutic medical laser system received Food and Drug Administration ("FDA") 510(k) clearance and Health Canada medical device license approval in December 2015, allowing the newly minted Canadian team to commence sales of this next generation technology.
Now that the TLC-2000 is able to be sold in Canada and the United States, the focus of the Company will be to commence recruitment of a high performing US sales and marketing team to increase sales of the TLC-2000 technology in the US in 2016. Once the Canadian and US markets have been established and running independently, Theralase will then focus its attention on growing its international revenues through exclusive international distribution agreements commencing in 2017.
The cost of sales for the year ended December 31, 2015 was $629,899 resulting in a gross margin of $1,315,347 (68% of revenue), compared to a cost of sales of $459,323 in 2014, resulting in a gross margin of $921,281 (67% of revenue).
Sales and marketing expenses for the year ended December 31, 2015 were $1,091,277 (56% of revenue), compared with $598,178 (43% of revenue) in 2014. The increase represents direct investment in the new sales and marketing teams, for launch of the next generation TLC-2000 therapeutic laser system, which will significantly increase sales in 2016 and 2017.
Administrative expenses for the year ended December 31, 2015 were $2,455,985 (170% increase) from $1,448,781 in 2014. Increases in administrative expenses for the year ended December 31, 2015 were attributable to the following:
- General and administrative expenses increased 172% due to increased spending on investor relations and research scientist activities
- Professional fees increased by 208% due to increased legal fees for additional trademark and international intellectual property patents to protect the Company's latest technological advances in both its therapeutic laser and anti-cancer divisions.
- Stock based compensation increased by 279% as a result of granting and vesting of stock options to certain employees, directors and officers of the Company in 2015.
Research and development expenses totaled $3,038,326 for the year ended December 31, 2015 compared to $1,455,301 in 2014 (205% increase). Research and development expenses represented 46% of the Company's operating expenses for the period and represent direct investment into commercialization efforts of the TLC-2000 therapeutic medical laser technology and development expenses of the TLC-3000 anti-cancer technology.
The net loss for the year ended December 31, 2015 was $5,225,975, which included $666,181 of net non-cash expenses (amortization, stock-based compensation expense, foreign exchange gain/loss and lease inducements). This compared to a net loss in 2014 of $2,587,542, which included $291,534 of net non-cash expenses. The Photo Dynamic Therapy ("PDT") division represented $3,676,181 of this loss (70%). The increase in net loss is primarily due to increased investment in research and development, sales and marketing personnel and administrative personnel all related to the launch of the TLC-2000 and the commencement of a Phase Ib clinical study for Non-Muscle Invasive Bladder Cancer ("NMIBC") expected in late 2Q2016.
Roger Dumoulin-White, President and CEO, Theralase stated that, "Theralase achieved a majority of its strategic initiatives for 2015"; specifically:
- FDA 510(k) clearance and Health Canada medical device license approval of the TLC-2000, allowing distribution of this cutting edge technology in both Canada and the United States
- Health Canada Clinical Trial Application ("CTA") of its lead PDC, TLD-1433
- University Health Network Research Ethics Board ("UHNREB") approval of the clinical trial
- Six (6) month accelerated stability testing of TLD-1433
The Company is currently completing the sterilization and mechanical testing of its TLD-3400 medical laser probes used to activate TLD-1433 in the bladder of patients inflicted with NMIBC. The testing is expected to be completed by the end of May allowing re-submission of an Investigational Testing Authorization ("ITA") to Health Canada at the beginning of June with an expected approval date in mid-June 2016. Pending ITA approval, Theralase and University Health Network will immediately commence enrolling patients in a Phase Ib NMIBC clinical study with primary outcome measures of safety and tolerability, secondary outcomes of pharmacokinetics (where the PDC accumulates in the body and how it exits the body) and an exploratory outcome measure of efficacy.
Mr. Dumoulin-White concluded that, "The Company has successfully executed on the majority of its strategic initiatives in 2015 and is anticipating ITA approval in mid-June 2016 to allow an immediate commencement of a Phase Ib clinical study for NMIBC, which will allow the Company to dramatically increase shareholder value in 2016 by demonstrating the safety, tolerability and as an exploratory outcome measure efficacy of next generation anti-cancer technology."
RONTO, ON / ACCESSWIRE / April 22, 2016 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX V: TLT) (TLTFF), a leading biotech company focused on commercialization of medical devices to eliminate pain and development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that it has reached a milestone, demonstrating 6 month accelerated stability and 9 month long term stability of it lead anti-cancer PDC, TLD-1433.
Stability studies are an essential component of pharmaceutical development, allowing evaluation of a drug's stability under the influence of a variety of environmental factors such as: temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.
Demonstrating accelerated and long term stability of a drug to be used in human clinical testing is essential to prove that the potency and/or efficacy of the drug is not affected during prolonged shelf life.
Under accelerated and long term stability storage conditions, the drug is evaluated by High Performance Liquid Chromatography to separate, identify and quantify each chemical component to a very high degree of resolution to assess if any change occurs in the chemical composition over time.
Long-term stability is completed over three years, with reporting at 0, 3, 6, 9, 12, 18, 24 and 36 months. Accelerated stability is completed over six months, with reporting at 0, 3 and 6 months.
TLD-1433 has now demonstrated stability at 6 months under accelerated conditions and 9 months under long-term stability conditions, satisfying Health Canada guidelines, to allow use in treating patients in a clinical study.
The Company is currently pursuing an Investigational Testing Authorization ("ITA") of its proprietary laser system to activate the PDCs for the indication of Non-Muscle Invasive Bladder Cancer ("NMIBC").
Theralase is focused on commencing and successfully completing a Phase Ib clinical trial for patients afflicted with NMIBC utilizing its novel, next generation light activated, anti-cancer drug, TLD-1433 for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement of drug within tissue) and an exploratory endpoint of efficacy.
RONTO, ON / ACCESSWIRE / April 22, 2016 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX V: TLT) (TLTFF), a leading biotech company focused on commercialization of medical devices to eliminate pain and development of Photo Dynamic Compounds ("PDCs") to destroy cancer, announced today that it has reached a milestone, demonstrating 6 month accelerated stability and 9 month long term stability of it lead anti-cancer PDC, TLD-1433.
Stability studies are an essential component of pharmaceutical development, allowing evaluation of a drug's stability under the influence of a variety of environmental factors such as: temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.
Demonstrating accelerated and long term stability of a drug to be used in human clinical testing is essential to prove that the potency and/or efficacy of the drug is not affected during prolonged shelf life.
Under accelerated and long term stability storage conditions, the drug is evaluated by High Performance Liquid Chromatography to separate, identify and quantify each chemical component to a very high degree of resolution to assess if any change occurs in the chemical composition over time.
Long-term stability is completed over three years, with reporting at 0, 3, 6, 9, 12, 18, 24 and 36 months. Accelerated stability is completed over six months, with reporting at 0, 3 and 6 months.
TLD-1433 has now demonstrated stability at 6 months under accelerated conditions and 9 months under long-term stability conditions, satisfying Health Canada guidelines, to allow use in treating patients in a clinical study.
The Company is currently pursuing an Investigational Testing Authorization ("ITA") of its proprietary laser system to activate the PDCs for the indication of Non-Muscle Invasive Bladder Cancer ("NMIBC").
Theralase is focused on commencing and successfully completing a Phase Ib clinical trial for patients afflicted with NMIBC utilizing its novel, next generation light activated, anti-cancer drug, TLD-1433 for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement of drug within tissue) and an exploratory endpoint of efficacy.
ONTO, ON / ACCESSWIRE / December 29, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTC: TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that the University Health Network Review Ethics Board ("UHN REB") has approved the Clinical Study for evaluation of the Company's next generation anti-cancer drug, TLD-1433, in a Phase Ib clinical trial for patients inflicted with Non-Muscle Invasive Bladder Cancer ("NMIBC").
The Phase Ib NMIBC clinical trial will evaluate the anti-cancer technology for the primary endpoints of safety and tolerability, with an exploratory end point of efficacy, in a patient population who meets the inclusion / exclusion criteria of the study as evaluated by UHN's uro-oncology department.
Michael Jewett, MD, a Professor of Surgery in the Division of Urology at the University of Toronto, a member of the Department of Surgical Oncology at Princess Margaret Cancer Centre and of the Division of Urology at University Health Network stated that, "The role of the UHN REB is to clinically review all the documentation regarding the proposed Photo Dynamic Therapy ("PDT") treatment of patients inflicted with NMIBC, who meet the inclusion and exclusion criteria of the study. Now that UHN REB and Health Canada Clinical Trial Application ("CTA") approval have been received, pending Investigational Testing Application ("ITA") approval by Health Canada of the laser system used to activate the anti-cancer drug, UHN will commence enrolling and immediately treating patients inflicted with NMIBC according to the Clinical Protocol and Investigator's Brochure supplied by Theralase."
Roger Dumoulin-White, President and CEO, stated that, "The Company 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 (completed)
- FDA approval of the TLC-2000 (completed)
- Health Canada CTA approval (completed) and Health Canada ITA approval (pending)
- UHN REB approval (completed)
Theralase has now completed 3.5 of these 4 strategic objectives and will complete the final objective in due course to allow the Phase Ib clinical study to commence in early 2016.
The UHN REB approval represents the second to final step, which will allow the commencement of a very important clinical study in Theralase's history, which if successful will prove the safety, tolerability and hopefully the efficacy of the Company's next generation anti-cancer technology in the treatment of NMIBC."
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 commenced launch of its next generation therapeutic laser, the TLC-2000 Therapeutic Medical Laser System, in Canada.
The Canadian market represents over 128,000 healthcare practitioners, with the ability to purchase the TLC-2000, for their respective clinical practices.
David Smith, Director of Global Sales stated, "Health Canada approval of the TLC-2000 is a major accomplishment for the Company, allowing our sales team the ability to sell the safest and most effective therapeutic laser system ever designed to the Canadian healthcare market. Canada has the largest installed base of Theralase products, with approximately 800 installations and based on the performance of this next generation technology, I expect a high "trade-up" rate to the latest next generation technology. Now that Health Canada approval has been received, Theralase can execute on its strategic objective of increasing the revenue of the Company into the many millions of dollars commencing in 2016. The Company possesses the strategic plan, the personnel and the capital with which to execute on this objective."
Roger Dumoulin-White, President and CEO, stated that, "The Company has now completed two out of four of its key 2015 strategic objectives; specifically, FDA and Health Canada approval of its next generation TLC-2000 technology. Theralase is now well positioned to execute on generating significant revenue for the Company, by introducing this state-of-the-art technology to approximately 1.5 million healthcare practitioners located throughout Canada and the US, commencing in 2016. The remaining two strategic objectives involve Health Canada (Clinical Trial Application and Investigational Testing Authorization) and University Health Network (Review Ethics Board) approval of the Company's anti-cancer Photo Dynamic Therapy technology allowing commencement of a Phase Ib clinical trial to prove safety, tolerability and as an exploratory end point, efficacy, in a patient population diagnosed with high grade Non-Muscle Invasive Bladder Cancer that has failed standard of care."
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, released its third quarter 2015 financial results today.
Revenue for the three month period ended September 30, 2015 increased 186% from $134,036 to $383,791 from the same period in 2014.
In Canada, revenue increased 43% to $885,562 from $621,435, while US revenue decreased 42% from $234,167 to $136,382 and international revenue decreased 71% from $138,871 to $39,665.
The significant increase in Canadian revenue in 3Q2015 and the corresponding decrease in US and international revenue is attributable to the Company building its sales and marketing teams from scratch commencing with the Canadian market, in anticipation of the launch of the next generation TLC-2000 therapeutic medical laser system. Prior to the recently received Food and Drug Administration (“FDA”) approval of the TLC-2000, and the pending Health Canada approval, the sales and marketing teams successfully executed on closing sales for the existing TLC-1000 therapeutic laser technology platform.
Now that the TLC-2000 is FDA approved, Theralase will commence building its sales and marketing teams in the US with the mandate of dramatically increasing sales of the TLC-2000 across the United States in 2016. Once Health Canada approval is obtained, Theralase will be well positioned to dramatically increase sales of the TLC-2000, both in Canada and in the US. Once these markets have been established and running independently, Theralase will focus on growing its international revenues through international partnerships and distribution agreements.
The cost of sales for the nine month period ended September 30, 2015 was $357,750 resulting in a gross margin of $703,858 (66% of revenue), compared to a cost of sales of $311,455 in 2014, resulting in a gross margin of $683,018 (69% of revenue).
Sales and marketing expenses for the nine month period ended September 30, 2015 were $750,098 (71% of revenue), compared with $421,401 (42% of revenue) in 2014. The increase represents investment in the sales and marketing teams, preparing for launch of the next generation therapeutic laser system, which will augment sales commencing in 2016.
Administrative expenses for the nine month period ended September 30, 2015 were $1,619,210 (66% increase) from $976,568 in 2014. Increases in administrative expenses for the nine month period ended September 30, 2015 were attributable to the following:
General and administrative expenses increased 55% due to increased spending on investor relations and research scientist activities
Professional fees increased 155% due to increased legal fees for additional trademark and intellectual property patents to protect the Company’s latest technological advances in both its therapeutic laser and anti-cancer divisions.
Stock based compensation increased by 168% as a result of granting and vesting of stock options to certain employees, directors and officers of the Company in 3Q2015.
Research and development expenses totaled $2,629,163 for the nine month period ended September 30, 2015 compared to $1,021,717 in 2014 (157% increase). Research and development expenses represented 53% of the Company’s operating expenses for the period and represent direct investment into commercialization efforts of the next generation TLC-2000 therapeutic medical laser technology and research and development expenses of the TLC-3000 anti-cancer technology.
The net loss for the nine month period ended September 30, 2015 was $4,253,079, which included $438,539 of net non-cash expenses (amortization, stock-based compensation expense, foreign exchange gain/loss and lease inducements). This compared to a net loss for the same period in 2014 of $1,737,759, which included $157,748 of net non-cash expenses. The Photo Dynamic Therapy ("PDT") division represented $2,804,991 of this loss (66%). The increase in net loss is primarily due to increased investment in research and development for the anti-cancer technology, preparing for a Phase Ib clinical study for Non-Muscle Invasive Bladder Cancer ("NMIBC") in 4Q2015, and the addition of sales, marketing and administrative personnel related to the launch of the next generation TLC-2000 therapeutic medical laser system in 4Q2015.
Roger Dumoulin-White, President and CEO, Theralase stated that, “Theralase’s mandate is to invest in the next generation technologies, both in healing pain and destroying cancer, through strategic investment in research, development, personnel and infrastructure, in order to dramatically increase sales from a traditional sales base in the $2 million range to many millions of dollars, commencing in 2016.
Now that the TLC-2000 has been FDA approved, and as we await Health Canada approval, the Company will focus its energy and resources on successfully launching, increasing sales and growing market share of the next generation TLC-2000 laser technology in the US and eventually Canada, in 2016.
In the anti-cancer division, the Company is awaiting Health Canada, Research Ethics Board and FDA pre-Investigational New Drug Application approval in 4Q2015 to commence enrolling patients in a Phase Ib human clinical trial for the treatment of NMIBC in 4Q2015.
Mr. Dumoulin-White concluded that, "The Company is confident that the successful execution of these strategic initiatives will dramatically increase shareholder value."
nto, Ontario / ACCESSWIRE / November 26, 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 commenced launch of its next generation therapeutic laser, the TLC-2000 Therapeutic Medical Laser System, in the United States.
The United States market represents over 1.3 million practitioners with the ability to purchase the TLC-2000 Therapeutic Medical Laser System for their clinical practices.
David Smith, Director of Global Sales stated, “The FDA approval of the TLC-2000 represents a watershed moment for the Company to dramatically increase its customer base in the US and significantly increase corporate revenue through the sale of the safest and most effective therapeutic laser system ever designed to the largest consumer market in the world. I look forward to building the high performing team that will ultimately lead to these significant revenues for Theralase in 2016 and beyond.”
Roger Dumoulin-White, President and CEO, Theralase stated that, "Theralase has now gained access to the largest consumer market in the world with a technology that is far superior to competitive products in safety, but more importantly in efficacy. I look forward to welcoming the world to the next generation of therapeutic laser technology. The United States remains the largest medical device market in the world with a market size of approximately $110 billion, expected to reach $133 billion by 2016."
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."
TORONTO, ON / ACCESSWIRE / November 12, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTC:TLTFF), 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 Dr. Angelika Rueck, who will be conducting the research.
The heart of the facility consists of two laser-scanning microscopes capable of live cell imaging through detailed Fluorescence Lifetime Imaging Microscopy ("FLIM") and Phosphorescence Lifetime Imaging Microscopy ("PLIM").
More detail on the facility, led by Dr. Rueck, is available at:
http://fakultaet.medizin.uni-ulm.de/fileadmin/Forschung/research-infrastructure.pdf
Dr. Rueck was instrumental in assisting Theralase with microscopy analysis of its recent research entitled, "A novel class of ruthenium-based photosensitizers effectively kills in vitro cancer cells and in vivo tumors."
https://globalmedicaldiscovery.com/key-drug-discovery-articles/a-novel-class-of-ruthenium-based-photosensitizers-effectively-kills-in-vitro-cancer-cells-and-in-vivo-tumors/
Under the current research agreement, Dr. Rueck will determine the localization and MOA of TLD-1433 through the following phases:
Phase 1 - Intracellular localization of TLD-1433 and cytotoxicity (cell kill) will be investigated in two (2) different urothelial carcinoma tumour cell lines (HT1376 and T24) and one (1) normal human urothelial cell line as a function of time.
Phase 2 - FLIM and PLIM will be completed to more fully understand how TLD-1433 affects cancer cell metabolism and to identify the MOA of mediated cell death by this PDC.
Phase 3 - Cell metabolism in the three cell lines, in the presence and not of TLD-1433 will be analyzed.
Roger Dumoulin-White, President and CEO, Theralase stated that, "It is indeed a great pleasure to work with a scientist as renowned in her field as Dr. Rueck. Her research will be instrumental in helping Theralase to unlock the exact mechanisms of our PDCs in cancer cells and provide MOAs as to why the Theralase PDCs are so effective in the destruction of cancer cells. I look forward to reporting out on Dr. Rueck's research in due course."
TORONTO, ON / ACCESSWIRE / November 10, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLT.V) (TLTFF), 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 Proceedings Division, a leading international scientific academic publisher based in Bologna, Italy.
PDT combines light, oxygen and a PDC to cause the accumulation of cytotoxic Reactive Oxygen Species ("ROS") inside a cell resulting in localized cell death. To fully realize the potential of PDT, PDCs with favourable physical, chemical and biological properties are required to achieve maximum selectivity and efficacy.
The collaborative research demonstrated that three of the Company's tunable Osmium (II) biquinoline-based PDCs were able to absorb light at wavelengths throughout the green, red, and near infrared spectrum, allowing selective activation to destroy cancerous targets in a wide range of tissue depths ranging from thousands of an inch to inches.
In-vitro (Petri dish) and in-vivo (animal model) PDT using these three PDCs was successful in these wavelength ranges providing similar efficacy and immune mediated responses as Theralase's Ruthenium based PDCs, allowing the potential to destroy the primary tumour and prevent recurrence.
These findings suggest that this family of Osmium-based PDCs are potent PDT agents for the oncological treatment of solid tumors.
Roger Dumoulin-White, President and CEO, Theralase stated that, "The presentation of Theralase's latest research at international congresses and subsequent publication in international journals allows the Company to validate its technology against international competition and exemplifies the significance of this scientific work. Theralase is awaiting Health Canada and Food and Drug Administration ("FDA") approval of its TLC-3000 anti-cancer technology to commence enrolling patients in late 4Q2015 in either Canada, the United States of America or both to determine the safety, tolerability and efficacy of this technology in the destruction of Non-Muscle Invasive Bladder Cancer."
TORONTO, ON / ACCESSWIRE / October 1, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX Venture: TLT) (TLTFF), 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.
Theralase has completed and submitted all required documentation in 3Q2015 to Health Canada and University Health Network to evaluate the light activated drug for the lead indication of NMIBC.
Roger Dumoulin-White, President and CEO, Theralase stated that, "Theralase continues to execute on its strategic initiative to advance its anti-cancer technology to commence destroying NMIBC this year. Theralase has now demonstrated control of its manufacturing process to produce high grade TLD-1433 in large quantities. Pending successful completion of a Phase Ib and Phase II clinical study in NMIBC, Theralase now possesses the ability to rapidly ramp-up production of TLD-1433 in commercial quantities to supply oncology institutions, who treat this deadly disease."
TORONTO, ON / ACCESSWIRE / September 15, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX Venture: TLT) (TLTFF), 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 required to complete its submission of a REB application to UHN and a CTA application to Health Canada.
Key components required to submit a REB application to UHN and a CTA to Health Canada for a new drug / device combination include:
1. GMP manufacture of the drug (Complete);
2. Good Laboratory Practice toxicology analysis of the drug (Complete);
3. Completion of the Clinical Protocol and Investigator's Brochure (Complete);
4. Completion of detailed information regarding the device used to activate the drug (Complete).
Information regarding the TLC-3000B Laser System includes: safety information, medical device description, specifications, risk analyses, standard operating procedures and recommended maintenance procedures that a uro-oncologist would follow to administer a Photo Dynamic Therapy ("PDT") treatment using light activated TLD-1433 to a patient inflicted with NMIBC.
Roger Dumoulin-White, President and CEO of Theralase stated that, "The completion of the fourth and final component required to submit a REB to UHN and a CTA to Health Canada marks a new milestone in Theralase's pursuit of the destruction of NMIBC. Pending approval of these two submissions, Theralase will commence enrolling and treating patients in a Phase Ib clinical study for NMIBC at UHN."
TORONTO, ON / ACCESSWIRE / September 9, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLTFF) (TSX Venture: TLT), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that its latest research demonstrates that its lead Photo Dynamic Compound ("PDC"), TLD-1433, in addition to being indicated for the treatment of Non-Muscle Invasive Bladder Cancer ("NMIBC"), may also be effective for the treatment of Muscle Invasive Bladder Cancer ("MIBC").
The latest research involved testing the Photo Dynamic Therapy ("PDT") of TLD-1433 in an orthotopic rat bladder tumour model.
Procedure:
- 1.5 million AY27 rat bladder cancer cells per milliliter were instilled in the sensitized rat bladder for one hour to allow the cancer cells to attach.
- Tumours required two to three weeks to grow to an appropriate size.
- TLD-1433 was intravesically infused into the rat's bladder at either 0.6 mgmL-1 (representative of human low dose) or 6.0 mgmL-1 (representative of human high dose).
- After one hour incubation, TLD-1433 was removed and the bladder was washed three times with sterile water to remove any unabsorbed TLD-1433 mirroring the proposed human clinical treatment.
- An optical fiber was inserted into the center of the rat bladder to deliver green laser light for PDT, at a dose of 90 Jcm-2 again mirroring the human treatment.
- Experiments were performed with drug only and light only controls to exclude any possibility that drug or light alone led to cell kill.
- The rats were sacrificed two days post-PDT and their bladders were sent to the histopathology lab for analysis.
Results (Representative of Human Low Dose):
- Five tumours treated with 0.6 mgmL-1 TLD-1433 (representative of human low dose) followed by PDT showed a strong response to the PDT with complete destruction of the tumour, with large areas of hemorrhage, necrosis (cell kill), and inflammation present throughout the whole depth of the tumour.
- Blood vessels of the submucosa, the muscle layer, and urothelium distal from the tumour area were unaffected by the PDT.
- Drug or light only controls showed no effect on the destruction of the tumour.
To view the images, click here.
Representative image of drug only control (A), light only control (B), and PDT treated (C) tumours. Upper row shows zoomed in view, with lower row showing full bladder thickness images. In all cases, the scale bar represents 100 µm. In the control tumours, tumour nuclei are well defined and closely packed. Two days after PDT treatment, the tumour mass shows widespread hemorrhage and inflammation, with an absence of cancer cells. The dark spots in the treated tumours are neutrophils responding to the widespread cell death and inflammation. Full thickness sectioning shows a completely necrotic (cell kill) tumour. The urothelium and the deeper muscle layers adjacent to the tumour are intact.
Results (Representative of Human High Dose):
Three tumours treated with 6.0 mgmL-1 TLD-1433 (representative of human high dose) followed by PDT showed a strong PDT specific response with complete destruction. TLD-1433 mediated PDT was able to induce full depth tumour necrosis (cell kill) across 2 to 3 mm deep tumours. Furthermore, TLD-1433 was able to induce full depth tumour necrosis in MIBC tumours, showing the wide versatility of TLD-1433 to treat bladder cancer across various progression stages.
To view the images, click here.
Representative images of control (A) and PDT treated tumours (B). Top row shows the macro image of the tumour, with the arrowhead pointing to the tumour. Bottom row shows histological sectioning of the tumours from the first row. All scale bars represent 1 mm. The control tumour shows unabated growth, reaching a thickness of 2 to 3 mm of highly packed proliferating cells. The tumour PDT treated with 6 mgmL-1 TLD-1433 shows full depth necrosis of the whole 2 to 3mm deep tumour. This necrosis is evident even at macroscopic observation, with the full tumour showing a deep red color.
To view the images, click here.
Representative image of MIBC in control (A) and PDT treated (B) bladders. In all images, the scale bar represent 0.5 mm. In the control, the highly proliferative cancel cells have infiltrated the deeper muscle layer in multiple locations. In the PDT treated bladder with 6.0 mgmL-1 TLD-1433, the tumour had invaded the muscle layer, but has become completely necrotic (cell kill) due to PDT treatment. The muscle and urothelial tissue flanking the tumor remains healthy and do not show signs of inflammation or necrosis.
Roger Dumoulin-White, President and CEO, Theralase stated that, "This is a very significant finding as there are 75,000 Americans and 8,000 Canadians diagnosed with bladder cancer every year. Of these individuals 70% present with early stage disease (NMIBC) with the other 30% present with more advanced cancer (MIBC). If this research can successfully be translated clinically, then not only will TLD-1433 be able to successfully treat NMIBC, it may also be indicated to successfully treat MIBC, without any impact to healthy tissue."
TORONTO, ON / ACCESSWIRE / September 8, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX Venture: TLT) (TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has completed manufacture of its lead Photo Dynamic Compound ("PDC"), TLD-1433 in compliance with Good Manufacturing Practice ("GMP") standards. This milestone is critical for a Clinical Trial Application ("CTA") submission to Health Canada.
Pending Health Canada approval of the CTA, Theralase would commence enrolling patients inflicted with Non-Muscle Invasive Bladder Cancer ("NMIBC") into a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy.
Completion of the GMP manufacturing of TLD-1433 is a major milestone for the Company and is a prerequisite for a CTA application. Supporting data includes a Chemistry, Manufacturing, and Control ("CMC") analysis detailing pertinent specifications of the drug.
Key components required to submit a CTA to Health Canada for a new drug / device combination include:
1. GMP manufacture including CMC information for the drug;
2. Good Laboratory Practice ("GLP") Toxicology Analysis of the drug;
3. Completion of the Clinical Protocol and Investigator's Brochure;
4. Completion of detailed information regarding the device used in conjunction with the drug.
Roger Dumoulin-White, President and CEO, Theralase stated that, "Theralase is executing on its strategic initiative to advance our anti-cancer technology to commence destroying NMIBC this year. Theralase has now completed the first major milestone of the CTA application and is well on its way to completing all the remaining steps of the CTA application in 3Q2015 in order to allow commencement of a Phase Ib clinical study in late 4Q2015."
TORONTO, ON / ACCESSWIRE / September 3, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLT.V) (TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has expanded its Photo Dynamic Compound ("PDC") pipeline by demonstrating the efficacy of its Osmium based PDC platform.
The latest research has been selected for presentation at the 28th Annual International Congress on Laser Medicine and Surgery scheduled from November 5 to 7, 2015 in Florence, Italy. The abstract will publish in the peer-reviewed journal "Laser in Medical Science" with the complete paper to publish in the peer-reviewed journal "Laser Therapy". The International Congress on Laser Medicine and Surgery focuses on translating the latest research from the laboratory bench to the bedside in the field of medical laser technology.
The year 2015 has also been declared "Year of the Light" by the United Nations Educational, Scientific and Cultural Organization ("UNESCO").
The latest research to be presented involves the pre-clinical analysis of three of Theralase's Osmium based PDCs intended for multi-wavelength Photo Dynamic Therapy ("PDT").
Theralase is currently pursuing one of its Ruthenium based PDCs (TLD-1433) in the destruction of Non-Muscle Invasive Bladder Cancer ("NMIBC") and pending regulatory approvals will be able to commence a Phase Ib clinical study in 4Q2015. Based on the latest research, these three Osmium based PDCs represent an opportunity to expand the Company's platform of PDCs for numerous cancer indications.
PDT involves the strategic combination of light, oxygen and a PDC to cause the accumulation of cytotoxic ("cell killing") Reactive Oxygen Species ("ROS") in a specific cancer cell, resulting in cancer cell death at the location of activation. The full potential of PDT is best realized with PDCs with favourable physical, chemical, and biological properties to achieve maximum selectivity and efficacy in the destruction of cancerous targets.
The latest research details that three of Theralase's tunable Osmium based PDCs possess these preferential characteristics and in addition possess the ability to absorb light in the green, red and Near InfraRed ("NIR") wavelengths allowing them to be "light activated" from 0.01" to 4" in tissue depth. These characteristics allow extreme versatility in the destruction of different cancers, located at various tissue depths.
The PDCs demonstrated that they were optically stable for two weeks at 4? and were very resistant to photobleaching, indicating that they are able to remain active during the entire time required to destroy the cancerous cells.
In vitro PDT (Petri dish) analysis of these three PDCs showed high cell kill across multiple cancer cell lines in the green, red and NIR wavelengths, demonstrating their versatility to destroy numerous cancer targets.
In vivo efficacy was demonstrated in a subcutaneous mouse model using cancer cells. The PDC was injected directly into the tumour, followed by light delivery in the NIR spectrum. This PDT treatment caused complete destruction of the tumour and the mice remained tumour-free for over twelve months. An important observation was that NIR PDT resulted in 100% protection against re-challenge with the cancer cells, if reinjected twenty days after the initial treatment. These findings suggest that this family of Osmium-based PDCs exhibit the same strong characteristics as the Ruthenium based PDCs and are therefore potent PDT agents for the oncological treatment of solid tumours.
Roger Dumoulin-White, President and CEO, Theralase stated that, "Theralase has now demonstrated that both of its patented and patent pending PDC platforms (Ruthenium and Osmium based) are highly effective in the destruction of cancer cells and both platforms protect the recipient against further cancer cell challenge, providing an "immune protection" defense against recurrence. This discovery allows Theralase to pursue additional cancer indications with our full complement of Ruthenium and Osmium based PDCs, expanding our drug platform in the destruction of cancer. Next steps include completing the research and development of its anti-cancer technology to allow enrollment of patients in a Phase Ib human clinical trial for the treatment of NMIBC in 4Q2015, prior to expanding the pipeline into other cancer indications."
TORONTO, ON / ACCESSWIRE / July 16, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX VENTURE: TLT) (TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has appointed Michael Borovec as the Director of Investor Relations for the Company.
Michael possesses over 10 years' experience in investor relations and capital markets. He successfully completed the Canadian Securities Course, as well as his Series 7, 22 and 63 US licences in 2001. Michael graduated with a Business Management degree from Humber College in 1999 and an International Politics degree from York University in 2005.
Roger Dumoulin-White, President and CEO, Theralase stated, "Michael has a strong working knowledge of the financial markets, security regulations and investor relations, with a demonstrated track record in serving as a corporate spokesman in the investor community. Michael's main role with the organization will be to provide strategic corporate updates to the investment community, on a timely basis, in order to provide investors with the latest news about Theralase and our opportunities for growth. Michael will also be responsible for laying the groundwork for the Company to graduate to the Toronto Stock Exchange and eventually the NASDAQ stock exchange.
While the prices are this low, I picked up another 10K yesterday.
I sent a message to Theralase about TLC2000 approval and I got this back. Theralase Inc - Healing at the Speed of Light
"Hi, thanks for your message. As of now we are still waiting for approval from Health Canada but expect to have it very soon. You'll be sure to see announcements on our Facebook page as soon as it's available."
Thanks
I bought another 14k. Just wondering what they are talking about on stock house. Something about time lines are being pushed further. I assume if this is true it's HC.
Did TLT announce a big delay? I missed something.
TORONTO, ON / ACCESSWIRE / June 11, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX Venture: TLT) (TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has released commercial versions of its next generation therapeutic laser to its team of Key Opinion Leaders ("KOLs") and Territory Sales Managers ("TSMs") for evaluation only purposes. Formal Health Canada approval is expected in early July 2015, allowing commercial sale of the TLC-2000 in Canada.
The patented TLC-2000 next generation therapeutic laser sets a new standard in cold laser therapy with its patented Cell SensingTM technology. This technology "senses" the exact location of injured tissue in a body and then automatically adjusts for a patient's physical characteristics to deliver an optimized dose of laser light energy to heal the injury faster and more effectively than any other laser product on the market.
Roger Dumoulin-White, President and CEO of Theralase stated that, "Over the last year, the KOLs have been instrumental in providing guidance to forge the specifications, functions and graphical user interface of the next generation TLC-2000 from a healthcare practitioner's point of view. By releasing commercial versions to the KOL team now, they are able to provide one last evaluation of the product prior to launch. The products afforded to the TSMs allow them the opportunity to become familiar with the operation of the product and the graphical user interface so that they can properly present and explain the intracacies of the technology to potential customers. It also allows them the opportunity to solicit interest in the new product to build a 'pre-sales' book of potential purchasers. Theralase will fill these orders and commence actively selling the next generation technology immediately after receipt of Health Canada approval."
Another goof vid
TORONTO, ON / ACCESSWIRE / June 10, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX Venture: TLT) (TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that its next generation therapeutic laser, the TLC-2000, has recently received safety approval from the Canadian Standards Association ("CSA").
CSA conducted an in-depth review of the Company's technical testing results and approved the product in accordance with the latest international medical standards, including Canadian and US standards. The CSA safety approval paves the way for formal Health Canada approval anticipated in early July 2015.
The patented TLC-2000 next generation therapeutic laser sets a new standard in cold laser therapy with its patented Cell SensingTM technology. This technology "senses" the exact location of injured tissue in a body and then automatically adjusts for a patient's physical characteristics to deliver an optimized dose of laser light energy to heal the injury faster and more effectively than any other laser product on the market.
Roger Dumoulin-White, President and CEO of Theralase stated that, "In order to develop cutting edge technology that is superior to any existing technology on the market and in the process creating a new industry standard takes: vision, knowledge, perseverance, capital and luck. Thankfully, Theralase was blessed to have all five in the creation of the next generation TLC-2000 therapeutic laser system over the last few years. I join my entire organization into welcoming the debut of the next generation cold laser therapy product to Canadian healthcare practitioners within the next 30 days."
New testimonial.
TORONTO, ON / ACCESSWIRE / May 29, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLT:TSXV) (TLTFF: OTC Pink(R)), a medical laser company dedicated to commercializing technology to heal pain and destroy cancer, released its first quarter 2015 financial results today, demonstrating an increase of 2% in revenue year over year.
In 2014 and early 2015, Theralase has made dramatic strides in both its Therapeutic Laser Therapy ("TLT") and Photo Dynamic Therapy ("PDT") anti-cancer divisions.
In the TLT division, Theralase has completed the design and initial manufacture of its next generation TLC-2000 therapeutic laser technology and is currently awaiting final Health Canada approval to launch in Canada. The TLC-2000, with patented Cell Sensing(TM) technology, is able to determine the precise location of injured tissue in a patient based upon their physical characteristics and automatically deliver an optimal dose of healing laser light energy safely and effectively to heal the damaged tissue faster and more effectively than any other laser system on the market.
In the PDT division, Theralase has significantly advanced its anti-cancer technology, focused initially on the treatment of Non-Muscle Invasive Bladder Cancer ("NMIBC"), and is gearing up for enrollment of patients in a Health Canada Phase Ib clinical study.
To meet this goal, Theralase has:
- Assembled an illustrious Medical and Scientific Advisory Board ("MSAB") in 4Q2014
- Presented its anti-cancer technology to Health Canada during a Clinical Trial Application ("CTA") meeting that occurred in 1Q2015
- Commenced the manufacturing process of its lead Photo Dynamic Compound ("PDC") TLD-1433 to Good Manufacturing Practice ("GMP") certification standards for completion of a Drug Master File ("DMF") slated for 3Q2015
- Commenced toxicology analysis of its lead drug, TLD-1433
- Commenced compiling the clinical protocol and investigator's brochure
Completion of these key objectives will result in submission of a CTA package to Health Canada in 3Q2015 and pending approval, enrolling patients that meet the inclusion / exclusion criteria into a Phase Ib clinical study for NMIBC in 4Q2015.
Total revenue for the three-month period ended March 31, 2015 increased 2% to $368,304 from $361,179 year over year.
The net loss for the three-month period ended March 31, 2015 was $933,643 (including $165,531 of net non-cash expenses) compared to a net loss of $344,074 in 2014 (including $15,897 of net non-cash expenses).
The net loss is a reflection of the ongoing commitment of Theralase to invest in the next generation of therapeutic laser technology and state-of-the-art anti-cancer treatment technology, partially funded from existing therapeutic laser sales.
Selling and marketing expenses increased 51% to $184,488 from $122,278 for the same period in 2014, primarily due to increased spending in associated marketing costs.
Administrative expenses increased 89% to $456,123 from $240,373 for the same period in 2014. The increase in administrative expenditures was due to increased spending on investor relations activities and medical advisory fees.
Research and development costs increased 276% to $545,645 from $197,792 for the same period in 2014. The increase was due to increased expenditures and investment into the commercialization of the TLC-2000 therapeutic laser technology and research and development of the TLC-3000 anti-cancer technology.
Roger Dumoulin-White, President and CEO of Theralase stated, "2015 will be a very strategic year for Theralase, as it launches the next generation TLC-2000 with Cell Sensing(TM) technology both in Canada and the United States and commences enrolling patients in a Health Canada Phase Ib clinical study for NMIBC."
TORONTO, ON / ACCESSWIRE / May 28, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSX VENTURE: TLT) (TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has granted an aggregate of 4,200,000 stock options to directors and officers at an exercise price of $CAN 0.50 vesting over three years and expiring five years from date of issue.
These stock options were granted to directors and officers in compliance with the Company's 2004 Stock Option Plan approved by the shareholders of the Corporation at the Annual General and Special Meeting held on November 14, 2014.
These stock options were granted as a means of rewarding directors and officers for future service to the Corporation, including:
1) Launch of the patented TLC-2000 biofeedback therapeutic laser system with Cell SensingTM technology in 2Q2015 and
2) Commencement of the Health Canada Phase Ib human clinical study for the treatment of Non-Muscle Invasive Bladder Cancer with its patented and patent pending anti-cancer Photo Dynamic Therapy in 4Q2015.
Where is LONG TERM GERMS?! I look forward to his BS!
Point, you are like a Super Hero of the Titan Medical blog!!! Great article!!!