TLC-2000: Biofeedback Laser Technology
Theralase continues to make progress on commercializing its next generation therapeutic laser - the patented TLC-2000. The TLC-2000 biofeedback technology targets tissue at depth with higher precision than its competitors enabling exact doses of energy to be delivered to injured tissue for enhanced efficacy and accelerated healing. The TLC-2000 is also a learning device that remembers the most optimized protocols based on an individual patient's optical tissue profiles.
Theralase continues to develop the beta prototype of the TLC-2000 biofeedback therapeutic laser system, which will lead to the final prototype prior to commercialization. Theralase is currently conducting clinical trials of the technology at the University of Buffalo (Buffalo, New York) to demonstrate the efficacy of the TLC-2000 in the areas of myofascial pain. These clinical studies, if proven successful, could help secure a new Current Procedural Terminology (CPT) code for reimbursement of laser treatments in the US.
TLC-3000: Cancer Therapy
The proprietary TLC-3000 medical laser system has been custom designed by Theralase for the activation of Theralase's patented Photo Dynamic Compounds (PDCs), resulting in the successful destruction of cancer cell lines in-vitro. In 2009, in vitro experiments conducted at the Ontario Cancer Institute at Princess Margaret Hospital University Health Network demonstrated complete destruction of brain tumour cells (9L) following administration of the Company's patented PDCs and subsequent activation with the Company's TLC-3000 light source. In early 2010, the Ontario Cancer Institute at Princess Margaret Hospital University Health Network demonstrated complete destruction of breast cancer cells following administration of the Company's patented PDCs and subsequent activation with the Company's TLC-3000 light source. This completes Milestone 1 - In-Vitro Pre Clinical Study of the cancer research project, which is the successful destruction of cancer cell lines in vitro.
The Company commenced Milestone 2 - In-Vivo Small Animal Pre Clinical Study in Q2 2010, which is the evaluation of a variety of cancer cell lines in an in vivo small animal model. Theralase received the necessary approvals on its Animal Utilization Protocol by the UHN Ethics Review Committee in Q3 2010, allowing hands-on evaluation of the PDCs in a small animal model.
Theralase's research team at the world renowned Ontario Cancer Institute located at Princess Margaret Hospital, University Health Network (UHN) evaluated the toxicity of the patented PDCs on small animals, by choosing an escalating dose analysis. In Q1 2011, Theralase announced that its patented PDCs were as safe as any PDC presently approved on the market by a factor of 10. Now, that toxicity in a small animal in-vivo model has been successfully completed, Theralase plans to demonstrate efficacy of the PDCs in the destruction of tumours in a small animal in-vivo model.
These small animal pre-clinical trials represent the next strategic step forward in the Company's cancer therapy research program. Successful completion of this milestone, will lay the groundwork for exploring the use of these PDCs in the destruction of cancers in larger animals, including: horses, cats, dogs and eventually humans.
Successful achievements in its current research will enable Theralase to commence Milestone 3 - In-Vivo Companion Animal Application, which is the treatment of cancer in companion animals such as cats and dogs. One in eight companion pets develop cancer in their lifetimes. This presents a significant opportunity for the Company.
Success in Destruction of Listeria Monocytogenes Bacteria
The patented Theralase PDCs have shown an ability to destroy listeria monocytogenes bacteria in vitro when light activated, in new research performed at the Princess Margaret Hospital, University Health Network. Future applications of the PDC technology in bacteria destruction may involve: food safety through food processing equipment sterilization, hospital treatment room sterilization, medical equipment sterilization, bacterial load elimination in wounds and other bacteria destruction applications.
Theralase in developing and commercializing this new application of our PDC technology plans to work with a variety of organizations, including: food processing organizations, academic institutions, hospitals, practitioners and medical equipment manufacturers interested in bacterial destruction applications.
Theralase and George Brown College Join in Government-Funded Research to Combat Food Contamination
In Q2 2011 the Company announced that it is partnering with George Brown College's Centre for Hospitality and Culinary Arts to conduct applied research in the use of patented photodynamic compounds (PDCs) activated by its proprietary laser technology to destroy microbial pathogens associated with food contamination. This food safety approach, believed to be the first of its kind, is supported by the National Sciences and Engineering Research Council of Canada (NSERC). PDCs are light sensitive molecules that have the ability to attach themselves to specific cell types, in this case food pathogens such as bacteria, and are able to destroy these cells upon light activation.
In the wake of many outbreaks of consumer food contaminations associated with microbial pathogens such as Listeria monocytogenes (Listeria) and Escherichia coli (E. coli) and their various strains, Theralase initiated the study to determine the feasibility of using our patented PDCs for sanitation in the food service, food manufacturing and medical industries. Given their history and pedigree in culinary arts and additional focus on food applied research, the George Brown College Centre for Hospitality and Culinary Arts is a perfect partner for applied research in new and innovative sanitation protocols and techniques using the company's patented lasers and photodynamic compounds.
The 14-week food safety feasibility study will determine the specific areas in food processing facilities where pathogen contamination is not being adequately addressed by current processes and procedures. The contamination danger is a fundamental and ongoing concern of the food industry. Food safety is an increasingly important public health issue as food recalls are a costly exercise that can easily tarnish a company's reputation of quality.
The results of the study are expected later this year and will be followed by further lab testing and a pilot project at a commercial food processing facility.
Theralase and Equine Guelph at the University of Guelph Join in Research to Determine the Efficacy of Low Level Laser Therapy in Equine Animals
The Controlled randomized clinical trial will examine the systemic effect of low level laser therapy (LLLT) in the healing of distal limb wounds in horses. It will determine the optimal clinical use of non-invasive low level laser therapy; confirm its anti-inflammatory properties in equine patients, and any resulting faster wound healing. Theralase looks forward to working with Guelph to gather even more clinical data and to develop new applications for the equine sector.
It is believed that the systemic effect of low level laser treatment may positively affect clinical outcomes, such as the level of inflammation and wound healing time in horses. The research partnership will examine whether low level laser treatment induces healing faster compared to routinely managed wounds.
Theralase has been working with the equine sector for a number of years to treat muscle and tendon injuries that are common in equine athletes. Equine tissues are highly vulnerable to repetitive stress and injuries can be career ending if not treated properly. Veterinarians and trainers across North America use the Theralase line of therapeutic laser products to rapidly heal equine injuries on a cellular level.