Theralase’s Photo Dynamic CompoundsFOR IMMEDIATE RELEASE |
Tuesday, November 29, 2011
Theralase’s Patented Photo Dynamic Compounds (PDCs) Effective in Destruction of Cancerous Tumours in a Live Animal Model
Monday, November 28, 2011
Theralase Announces Q3 2011 Financials
Toronto, Ontario – November 28, 2011 Theralase Technologies Inc. (TSX-V: TLT) announced its third quarter 2011 financials today.
Revenue remained relatively constant year over year with total revenue for the three month period ending September 30, 2011 at $453,212, compared to $424,879 for the same period in 2010, an increase of 6.7%.
Selling expenses increased for the three month period ending September 30, 2011 to $237,409 compared to $177,944 for the same period the previous year, an increase of 33.4%. The increase is primarily due to increases in the sales and marketing costs associated with the new Territory Sales Managers (TSMs) hired for the United States sales and market expansion.
Administrative expenses remained constant at $280,587 for the three month period ending September 30, 2011 compared to $283,908 for the same period the previous year, with the minor reduction primarily due to decreased expenditures on administrative staff.
Research and development costs remained relatively constant at $225,439 for the three month period ending September 30, 2011 compared to $228,720 for the same period in 2010. The expenditures are primarily due to the development costs associated with the patented TLC-2000 biofeedback therapeutic laser system, scheduled to be commercially launched in 2012 and costs associated with the research and development of Theralase’s patented Photo Dynamic Compounds (PDCs) being developed for cancer, virus and bacteria destruction.
Roger Dumoulin‐White, President and CEO of Theralase Technologies Inc. stated, “The net loss for the three month period ended September 30, 2011 was $423,929 which included $16,122 of non-cash expenses (amortization, stock-based compensation expense, foreign exchange gain/loss and lease inducements). The company expenses the future product development costs of the patented TLC‐2000 biofeedback therapeutic laser system and TLC‐3000 Photo Dynamic Compound (PDC) technology from existing TLC‐1000 therapeutic laser product sales, resulting in the overall net loss. This investment in our future will secure our position as an international leader in medical laser technology both in the therapeutic tissue healing space as well as the tissue destruction space for decades to come.”
During the quarter, Theralase announced that its patented 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.
As well, during the quarter, Theralase announced it has successfully expanded its cancer destruction applications. This new research expands the application of Theralase’s patented PDC technology in the cancer field and introduces the potential for a successful impact on two devastating forms of cancer; specifically, brain and colon cancer. Theralase’s research has demonstrated a significant kill rate of greater than 99% in specific human brain and colon cancer cells lines. These results now lay the groundwork for further preclinical trials, which if proven successful may lead to human clinical trials. Theralase plans to aggressively pursue commercialization of its ground-breaking PDC technology through the accelerated FDA regulatory approval process. Theralase also plans to continue its research and development to optimize its PDCs, from the same platform, to destroy a variety of life threatening cancers.
Theralase also recently announced the launch of a new version of the high performance Theralase TLC-1000 therapeutic medical laser series, known as the Theralase TLC-900 series, which effectively eliminates the controller and allows the practitioner to operate the laser probes independently. This TLC-900 system allows the practitioner the ability to benefit from the high performance Theralase laser system technology, albeit with less features and versatility than the TLC-1000 series, but at an overall cost savings.
Subsequent to the end of the quarter, Theralase completed a non‐brokered private placement which raised gross proceeds of $420,000 by issuing 1,050,000 Units to investors at a price of $0.40 per Unit. Each Unit consists of one common share in the capital of the Company and one‐half of one non‐transferable common share purchase warrant. Each whole Warrant entitles the purchaser to purchase one additional common share in the capital of the Company until October25, 2013 at a price of $0.60 per Warrant Share. The securities issued under the Private Placement including any shares issued upon exercise of the Warrants are subject to a mandatory four month hold period, imposed by the TSX Venture Exchange, expiring February 25, 2012.
The company intends to utilize the proceeds of the offering to provide additional working capital to further develop the Company’s prospects in a number of areas; specifically:
· Support of small animal cancer trials at the Ontario Cancer Institute, Princess Margaret Hospital, University Health Network
· Research and development of Photo Dynamic Compounds used in conjunction with the patented Theralase laser technology in the destruction of bacteria in the area of food safety
· TLC‐1000 therapeutic medical laser USA sales and marketing expansion
· TLC‐2000 therapeutic medical biofeedback laser commercialization
Theralase is preparing for significant growth in the 4th quarter of 2011 and in 2012 as the Company expands its sales and marketing efforts in the US and internationally, launches its new controllerless laser series and prepares for the launch of its patented TLC‐2000 biofeedback therapeutic laser in 2012.
The complete consolidated financial statements and MD&A for the three and nine months ending September 30, 2011 can be found at www.theralase.com and www.sedar.com.
There is an earnings conference call and corporate update scheduled for November 30th, 2011 at 9:00am ET. The call in number is 1-866-440-8936, the conference ID is 8791351#. The call will be hosted by Roger Dumoulin-White, President & CEO of Theralase Technologies Inc.
About Theralase Technologies Inc.
Theralase Technologies Inc. founded in 1995, designs, develops, manufactures and markets patented, superpulsed laser technology utilized in biostimulation and biodestruction applications. The technology is safe and effective in the treatment of chronic pain, neural muscular-skeletal conditions and wound healing. When combined with its patented, light-sensitive Photo Dynamic Compounds, Theralase laser technology is able to specifically target and destroy cancers, bacteria and viruses, as well as microbial pathogens associated with food contamination. For further information please visit www.theralase.com
This press release contains forward-looking statements which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information
Roger Dumoulin-White
President & CEO,
416-447-8455 ext. 225
Kristina Hachey
CFO
416-447-8455 x224
Greg Bewsh
Director of Investor Relations,
416-447-8455 ext. 262
Thursday, November 17, 2011
Theralase Introduces Low Priced Laser Series
Theralase Introduces Low Priced Laser SeriesFOR IMMEDIATE RELEASE |
Wednesday, November 16, 2011
YOU ARE INVITED TO AN INTRODUCTORY WORKSHOP ON COLD LASER THERAPY
 YOU ARE INVITED TO AN INTRODUCTORY WORKSHOP ON COLD LASER THERAPY | |||||
This 2 hour session is for DCs, PTs, RMTs and MDs interested in introductory information on cold laser therapy for injury healing. The session includes presented material and an interactive workshop. Thinking of adding cold laser to your practice? Take advantage of this great opportunity.
Reserve your spot today. Limited to the first 25 registrants. | |||||
Monday, November 14, 2011
UNDERSTANDING THE MECHANISMS OF LOW LEVEL LASER THERAPY (LLLT)
| THERALASE WHITE PAPER NOW AVAILABLE! UNDERSTANDING THE MECHANISMS OF LOW LEVEL LASER THERAPY (LLLT) | |
Low Level Laser Therapy (LLLT) is a rapidly growing modality used in rehabilitation and physical therapy. A number of safe and beneficial therapeutic effects of LLLT have been reported in numerous clinical conditions; however, despite many reports of positive findings from experiments conducted in-vitro, in animal models and in randomized controlled clinical trials worldwide, the use of this scientifically grounded, non-invasive, anti-inflammatory and regulatory modality has yet to find mainstream adoption by medical doctors. | |
Current Research in Low Level Laser Therapy - Free Webinar Nov 16
CURRENT RESEARCH IN |
Wednesday, November 2, 2011
Low Level Laser Therapy (LLLT): Why More is Less and What is Best
LLLT is a fast growing field of medicine recognized by every major industrialized nation in the world, offering painless, non-invasive and highly effective drug-free solutions. Able to treat a plethora of neural muscular skeletal conditions, LLLT is often the only solution that is available to the highly trained practitioner to control disease when conventional therapies have come up lacking.
Unfortunately, LLLT is yet to achieve universal recognition by the medical community due to the confusion in the marketplace caused by the many poorly designed clinical studies in the published literature promulgated by researchers who lack the formal training in the rigors of proper scientific and clinical study methodologies. These unscientific and poorly designed clinical studies do more harm than good for the LLLT field, as the large number of patients who could substantially benefit from this modern miracle called LLLT are denied the service because their attending practitioners remain unconvinced of the technology. I have used many different laser devices over the past 20 years in my career and I must say that no two lasers are created equal. The best therapeutic laser I have used is one from one of the oldest and most respected cold laser manufacturers in the world; namely, Theralase Inc., based out of Toronto, Canada. The Theralase TLC-1000 laser system is Health Canada, FDA and European Union approved as a class 3B superpulsed therapeutic medical laser device. The Theralase’s advanced LLLT proprietary technology encompasses potent and complementary bioregulatory mechanisms achieved using visible red 660 nm and near infrared superpulsed (NIR) 905 nm laser light.
The Theralase superpulsed laser has the distinction of being one of the fastest in the world - delivering pulses at 200 billionths of a second, producing average powers of 100 mW and peak powers up to 50,000 mW per diode. These unique parameters result in a higher concentration of light energy (I₀), or photon density at tissue depth versus any known competitive technology, without the risk of burning tissue.
While continuous wave (CW) and standard pulsed lasers (PW) are limited to less than 1 to 2 cm of therapeutically effective depth of penetration, the Theralase superpulsed (SP) NIR laser technology is able to demonstrate therapeutic effect at up to 10 cm below the tissue surface. This allows Theralase’s superpulsed technology to target deep tissue structures such as: bones, tendons, ligaments and cartilage. In the literature, Theralase’s 905 nm superpulsed technology has been proven to be more effective than a 905 nm CW laser treatment1, thus it is the superpulsing of the Theralase technology which creates this difference.
In conjunction with its 905 nm superpulsed technology, Theralase combines 660 nm continuous wave technology leading to a synergistic therapeutic effect operating via direct photochemical and photophysical cellular events. The therapeutic optical windows of 660 nm and 905 nm laser light utilised by Theralase’s LLLT technology correspond with the absorption and the action spectra optical windows of the key mitochondria chromophores, such as cytochrome c oxidase and the cellular membrane lipids. Moreover, it is apparent that 660 nm and 905 nm light have an impact on the mitochondrial chromophores via independent and nitric oxide mediated photochemical and photophysical mechanisms.1,2,3 Hence the combination of 660 nm and 905 nm light is proven to have an additive biologic effect compared to any individual wavelengths. This biologic effect is further amplified by these two wavelengths activating and targeting the proximal and distal therapeutic mechanisms, in tissues, which induce bioregulatory responses that effectively modulate local and systemic pathologic manifestations in the Theralase LLLT treated patients.
According to Brown et al., mitochondria produce and consume nitric oxide (NO) and NO stimulates mitochondrial biogenesis, apparently via the upregulation of nucleotides like ATP and transcriptional factors like nuclear factor kappa B (Nf-kB).⁽⁴⁾
Therefore, it can be strongly suggested that the Theralase LLLT induced NO can reprogram cellular function, mainly via oxidative stress and changes of mitochondrial temperature gradient due to a process similar to selective photothermolysis, and thus initiate a cascade of local and systemic therapeutic signalling1. These signal transduction pathways may lead to increased cell activation and traffic, modulation of regulatory cytokines, growth factors and inflammatory mediators and expression of protective anti-apoptotic proteins.⁽⁵⁾⁽⁶⁾
The results of these molecular and cellular changes in animals and humans integrate such benefits as: increased healing in chronic wounds, improvements in sports injuries and carpal tunnel syndrome, pain reduction in arthritis and neuropathies, amelioration of damage after heart attacks, strokes or nerve injury and alleviation of chronic inflammation and toxicity.⁽⁷⁾⁽⁹⁾
There is certainly more than one reaction involved in the primary mechanisms of LLLT and there is reason to believe that all of these processes occur simultaneously when a tissue is irradiated. Experimental data clearly supports the use of 660 nm and 905 nm laser light as the best choices, based on their role in the modulation of redox mitochondrial function, changes in the properties of terminal enzymes and the cellular signalling that are critical steps in the bioregulatory mechanisms of LLLT.
In closing, I must report that there is a perplexity in the literature pertaining to the direct photoacceptor or the light absorbing chromophore for near infrared light (NIR). Manufacturer’s marketing materials are particularly rich with assumptions about the prime molecular photoacceptor and mechanisms of the light within the 800 to 880 nm range; however, the clinical literature shows no strong evidence that cytochrome c oxidase has strong absorption in the 800 to 880 nm range. Therefore, although photobiological effects in the 800 to 880 light range are ascribed to light absorption by mitochondrial cytochrome c oxidase, the low absorbance in this region makes scientists highly question it.⁽⁷⁾⁽⁹⁾
Class 3B versus Class 4 Lasers
There is a slew of false information in the public domain regarding the effectiveness and cellular mechanisms activated during class 4 laser light irradiation. Many class 4 laser manufacturers are intentionally or unintentionally misleading healthcare practitioners into believing that higher power and longer near infrared wavelengths equate to deeper tissue penetration and better clinical efficacy. Nothing could be further from the truth. Particularly disturbing are claims made by manufacturers of Class 4 laser technologies emitting in the 808, 880, 970 and 980 nm wavelengths.
Unfortunately, all of these claims turn out to be fancy sales gimmicks, as they have not the standing in the clinical or scientific journals to support their claims. The clinical and scientific facts are clear that because of the very high absorption of NIR laser light by water at wavelengths greater than 950 nm, 99% of the energy produced at this wavelength or above is absorbed before penetrating the dermis of the skin, leading to a high risk of thermal damage and a low depth of penetration. Promoting that a laser is a class 4 laser states absolutely no information about the wavelength of the device, but simply informs the purchaser about the risk of thermal tissue damage. A CO2 laser (wavelength = 10,600 nm), for example, is a common class 4 laser that is absorbed in the first 10 microns (0.0004 inches) of tissue, thus primarily in the epidermis. The same holds for the excimer (XeCl, wavelength = 308 nm) laser which is also absorbed in the epidermis. At 970 and 980 nm, the depth of penetration is less than 300 microns (< 0.01 inches), thus total absorption is achieved within the dermis of the skin. For any given wavelength, the tissue properties are determined by the scattering and absorption coefficients of the specific tissue structures resident in the tissue. These scattering and absorption coefficients determine the penetration depths and ultimately govern the overall depth of penetration of a laser beam. Now a Class 4 laser typically has higher incident power and larger treatment area, but the depth of penetration is superficial and is restricted to a few hundred microns at best (i.e.: the top layer of the dermis). Even with higher incident powers and large treatment areas there is no biochemical effect due to lack of cellular mechanism activation; therefore, the thermal effects of a class 4 laser are the only mechanism of action remaining. Once the thermal effects of tissue have been exceeded, tissue damage is imminent.
Certain manufacturers use the limited knowledge of their customers to claim that a Class 4 laser has greater efficacy than a class 3B laser. This is unsubstantiated rubbish. Laser classification is only used according to IEC-825 guidelines to determine the possible risk for eye and skin damage and has nothing to do with the efficiency in treatment. Laser classification is determined by not just a question of optical output power, but also wavelength, divergence of the beam, emission area, pulsing parameters, exposure rates, et cetera. Regarding Class 4 high power lasers, it has not been proven in the scientific and clinical literature that high power is better than low power, in fact the opposite has been proven to be true. As I have mentioned above, there is a therapeutic “optical” response window between 600 and 950 nm and a biphasic dose response curve governed by the Arndt-Schulz law, within which the positive bioregulatory effects occur.
The use of LLLT in animals and humans almost exclusively involves light in the range above 600 nm and below 950 nm with the maximum effective “optical window” ranging from 650 nm to 930 nm.⁽¹⁰⁾
As an example, a class 4 laser emitting 880 and 970 nm laser light at 10 W average power with a beam surface area of 10 cm² producing a radiant exposure of 1000 mW / cm², thus exceeding the safe exposure limits known as the Maximum Permissible Exposure limits (“MPE”), which range from 200 mW to 500 mW / cm² depending on wavelength. Therefore, these devices need to be treated as thermal invasive devices, period!
The use of class 4 lasers have a high potential of delivering non optimal treatment doses of energy due to their lack of penetration and excessive MPE; thus presenting a greater risk of burning patients, particularly with dark hair follicles. Let’s say that you wish to deliver energy to a tissue surface of 1 cm² with a dose of 10 joules/cm² of energy. With a 10 Watt laser this takes one second of treatment time. If however you wished to deliver 2 to 4 joules of energy to the same surface area, which is a more common therapeutic dose, this would take 0.2 to 0.4 seconds. Most Class 4 manufacturers treat up to 5 minutes with their technology, thus they have exceeded the therapeutic dose of tissue not only in wavelength by being outside the optical window, but also in power by exceeding the MPE by 20 times and the therapeutic dose by 500 times. This logic suggests that too much power and the wrong wavelength simply equates to the expense of more money without the requisite return in better clinical effects. I therefore regard lasers with output powers exceeding 500 mW as unnecessarily strong and downright dangerous to conduct LLLT treatments.
Class 4 lasers for phototherapy is not new and not innovative, as such lasers have been on the market for years but have been approved strictly for surgical applications; such as: general surgery and tissue ablation for port wine stains, spider veins, et cetera. Just advertising the advantage that a laser is class 4 and hence, is a better instrument then a class 3B laser is akin to claiming that the Chrysler 600 is a better vehicle than the Mercedes Benz 500, just because the number is higher.
The above criticism is directed towards the gross generalizations and false claims of vendors of Class 4 lasers who purport their use for therapeutic purposes, not against the use of class 4 lasers for their eligible claims in laser surgery and tissue ablation. One thing remains certain, current scientific and clinical research proves that class 3B lasers are best suited for therapeutic applications and class 4 lasers are best suited for tissue destruction.
Bibliography:
1) In vivo effects of low level laser therapy on inducible nitric oxide synthase. Moriyama Y, Nguyen J, Akens M, Moriyama EH, Lilge L. 3, March 2009, Lasers Surg Med, Vol. 41, pp. 227 -231)
2) Primary and secondary mechanisms of action of visible to near-IR radiation on cells. T, Karu. 1, Mar 1999, Photochem Photobiol, Vol. 49, pp. 1-17
3) Mechanisms of Low Level Light Therapy, T.N, Hamblin M.R and Demidova. [ed.] SPIE. 2006. Vol. 614001
4) Nitric oxide and mitochondria. GC. Brown. 12, Jan 2007, Front Biosci, Vol. 1, pp. 1024-1033
5) Novel effects of nitric oxide. Davis KL, Martin E, Turko IV, Murad F. 2001, Annu Rev Pharmacol Toxicol, Vol. 41, pp. 203-236
6) Nitric oxide prevents axonal degeneration by inducing HIF-1-dependent expression of erythropoietin. Keswani SC, Bosch-Marcé M, Reed N, Fischer A, Semenza GL, Höke A. 12, Mar 2011, Proc Natl Acad Sci, Vol. 108, pp. 4986-4990
7) Cellular Cromophores and Signaling in Low Level Light Therapy. T, Hamblin M.R. and Demidova –Rice. [ed.] SPIE. 2011. Vol. 6428, pp. 642802-1
8) ((Powers L, Blumberg WE, Chance B, Barlow CH, Leigh JS Jr, Smith J, Yonetani T,Vik S, Peisach J. The nature of the copper atoms of cytochrome c oxidase as studied by optical and x-ray absorption edge spectroscopy. Biochim Biophys Acta. 1979 Jun 5; 546(3):520-38
9) Beinert H, Shaw RW, Hansen RE, Hartzell CR. Studies on the origin of the near-infrared (800-900 nm) absorption of cytochrome c oxidase. Biochim Biophys Acta. 1980 Jul 8; 591(2):458-70)
10) (Biostimulatory windows in low-intensity laser activation: lasers, scanners, and NASA's light-emitting diode array system. Sommer AP, Pinheiro AL, Mester AR, Franke RP, Whelan HT. 1, Feb 2001, Clin Laser Med Surg, Vol. 19, pp. 29-33)
Tuesday, November 1, 2011
THERALASE INTRODUCES TLC CONTROLLERLESS SERIES
COST EFFECTIVE THERALASE TLC CONTROLLERLESS SERIES is now available in 3 different power levels*
Theralase has just made the TLC-1000 more affordable by introducing the "Controllerless Series". Both patients and therapists are provided the same super-pulsed dual wavelength technology with high patient efficacy and low hands-on treatment time as the TLC-1000, but without the controller.
MULTIPLE PROBE
Near Infrared Laser Diode: 5x905 nm:
High*
• Average power: 100 mW
• Peak power: 50,000 mW
Medium*
• Average power: 75 mW
• Peak power: 37,500 mW
Low*
• Average power: 50 mW
• Peak power: 25,000 mW
Visible Red Laser Diode: 4x660 nm:
• Average power: 25 mW
Treatment area size: 20 cm2
TRIPLE PROBE
Near Infrared Laser Diode: 1x905 nm:
• Average power: 100 mW
• Peak power: 50,000 mW
Visible Red Laser Diode: 2x660:
• Average power: 25 mW
Treatment area size: 3 cm2
SINGLE PROBE
Near Infrared Laser Diode: 1x905 nm
(collimated):
• Average power: 100 mW
• Peak power: 50,000 mW
Treatment area: 0.1 cm2
Please call for special introductory pricing
www.theralase.com
Toll Free: 1.866.843.5273
Tel: 1.416.447.8455
102-29 Gervais Dr. Toronto Ontario
M3C 1Y9 Canada
Theralase has just made the TLC-1000 more affordable by introducing the "Controllerless Series". Both patients and therapists are provided the same super-pulsed dual wavelength technology with high patient efficacy and low hands-on treatment time as the TLC-1000, but without the controller.
MULTIPLE PROBE
Near Infrared Laser Diode: 5x905 nm:
High*
• Average power: 100 mW
• Peak power: 50,000 mW
Medium*
• Average power: 75 mW
• Peak power: 37,500 mW
Low*
• Average power: 50 mW
• Peak power: 25,000 mW
Visible Red Laser Diode: 4x660 nm:
• Average power: 25 mW
Treatment area size: 20 cm2
Near Infrared Laser Diode: 1x905 nm:
• Average power: 100 mW
• Peak power: 50,000 mW
Visible Red Laser Diode: 2x660:
• Average power: 25 mW
Treatment area size: 3 cm2
Near Infrared Laser Diode: 1x905 nm
(collimated):
• Average power: 100 mW
• Peak power: 50,000 mW
Treatment area: 0.1 cm2
Please call for special introductory pricing
www.theralase.com
Toll Free: 1.866.843.5273
Tel: 1.416.447.8455
102-29 Gervais Dr. Toronto Ontario
M3C 1Y9 Canada
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