Tuesday, October 23, 2012

The Top Ten Features to Look For in a Cold Laser



Wednesday, October 31, 2012 1:00 PM - 2:00 PM EDT

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Learn the most important parameters to consider when comparing laser devices.
Navigate the laser marketplace as a more informed consumer.
Increase your knowledge of the latest in laser technology.
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Monday, October 22, 2012

Theralase Photo Dynamic Compounds Destroy Cancer


Toronto, Ontario – October 22, 2012, Theralase Technologies Inc. (TSX-V: TLT) announced today the successful results of preclinical studies (in-vitro and in-vivo) demonstrating significant destruction of various brain and colon cancer cell lines. The new proprietary Theralase treatment sharply delayed the tumour progression, when attacked by the Theralase patented light activated Photo Dynamic Compounds (PDCs), signifying a new and broadly promising approach to cancer treatment. When treated with the Theralase PDCs, cancerous mice survived cancer-free for more than 100 days post-treatment, a highly significant milestone.

The scientific data supporting this breakthrough was presented and well received recently at the 9th International Symposium of Photodynamic Therapy and Photodiagnosis in Clinical Practice held in Brixen, Italy. The Theralase presentation was made by Dr. Lothar Lilge, Senior Scientist, Ontario Cancer Institute / Princess Margaret Cancer Centre, University Health Network (UHN) and confirms the significance of the successful research conducted by Theralase in collaboration with UHN scientists, validating this scientific work on the international stage.

Dr. Lothar Lilge stated that, "These preclinical results demonstrate that the Theralase Photo Dynamic Compounds appear to be highly effective (100% cancer cell kill) when used to destroy various cancer cell lines in-vitro; specifically, brain glioma (U-87 and F-98) and in-vivo; specifically, colon cancer (CT-26WT), in the treatment of subcutaneous cancer tumours in Balb/c mice. Mice enrolled in the study, presented with subcutaneous cancerous lesions of approximately 6 mm in size prior to treatment, which is standard for these preclinical models. The statistically significant improvement in survival times make these results even more encouraging, as a number of mice are still alive today living cancer free, 100 days post treatment. Moreover, we believe that tested PDCs may have potential for Type I (oxygen independent) PDT effect; hence, their clinical use would represent a significant gain in cancer therapy.”

Dr. Arkady Mandel, Chief Scientific Officer at Theralase Inc. stated that, "We were delighted with the extremely promising results of our latest cancer studies, which demonstrate significant anticancer destruction of Theralase’s PDCs in all tested in-vitro studies and  in difficult to treat in-vivo cancer models, without significant optimization. With optimization, the ability of the Theralase PDCs to target and destroy cancerous tumours could be even more enhanced. There are a number of obvious advantages for the use of Theralase’s PDCs in the destruction of cancer that have been established by this body of work, such as: the Photo Dynamic Therapy (PDT) effect has been achieved at lower concentrations compared to aminolevulinic acid, also known as ALA (ALA is a currently approved FDA PDC) and with lower dark toxicity (PDC alone with no light) compared to methylene blue (another PDC), the Theralase PDCs have potential for Type I (oxygen independent) PDT effect and lastly were able to induce tumour necrosis (cell death) in mice that allowed prolonged survival, cancer free, in excess of 100 days of observation. New evidence from experimental and clinical studies increasingly points to a lack of oxygen content or hypoxia in solid tumours to be strongly associated with tumour propagation, malignant progression and resistance to therapy and it has thus become one of the central issues in tumour physiology and cancer treatment. Therefore, with the latest scientific data in hand, Theralase’s PDT has the potential to become more expeditiously integrated into the mainstream of cancer treatment.”

Roger Dumoulin-White, President and CEO of Theralase stated, “This new research extends the opportunity of Theralase’s patented PDC technology to have a successful impact on two additional devastating forms of cancer; specifically, brain and colon cancer. Our research has demonstrated a kill rate of effectively 100% in specific human brain and colon cancer cells lines. With the high mouse survival rate, which is approximately equivalent to 11 years “cancer free” in humans, being observed in this study, these results lay the groundwork for further preclinical work for these specific cancers. If the preclinical work is proven successful, this would lead to human clinical trials as early as 2013. Theralase plans to aggressively pursue commercialization of its ground-breaking PDT technology through the FDA regulatory approval process and is on track to commence FDA Phase 1 human clinical trials as early as this time next year. Theralase plans to continue its research and development at an accelerated pace to optimize and expand its growing patent portfolio of PDCs that are able to destroy a variety of life threatening cancers.”

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. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing. Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technology.

 For further information please visit www.theralase.com , regulatory filings may be viewed by visiting www.sedar.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                                          
rwhite@theralase.com

Kristina Hachey
Chief Financial Officer
416-447-8455 ext. 224
khachey@theralase.com 

Arkady Mandel
Chief Scientific Officer
416-447-8455 ext. 242
amandel@theralase.com

Greg Bewsh
Director of Investor Relations,
416-447-8455 ext. 262
gbewsh@theralase.com   

Wednesday, October 17, 2012

Theralase Photo Dynamic Compounds Effective in Destruction of Drug Resistant Bacteria


Toronto, Ontario – October 17, 2012 -- Theralase Technologies Inc. (TSX-V: TLT) announced today that its Photo Dynamic Compound (PDC) technology has been proven effective in the destruction of  staphylococcus aureus and its multi drug resistant strain, methicillin resistant staphylococcus aureus, also known as MRSA.

MRSA is a bacteria strain that has grown resistant to antibiotics and hence has the potential of causing invasive infections, which are extremely difficult to treat in 25% of the population infected. In 2005, the Centers for Disease Control and Prevention reported that 94,000 individuals were hospitalized as a result of MRSA infections and there were 18,650 deaths as a result, costing the US healthcare system an additional $45 billion a year.

The scientific data supporting this discovery was presented yesterday at the 9th International Symposium of Photodynamic Therapy and Photodiagnosis in Clinical Practice held in Brixen, Italy. The presentation by Dr. Lothar Lilge confirms the significance of the research conducted by Theralase’s and University Health Network’s (UHN) scientists.

Dr. Arkady Mandel, Chief Scientific Officer of Theralase Inc. stated that, “Theralase unveiled to the scientific community its advanced sterilization platform technology that is able to deliver an 8 log or 99.999999% kill rate, which is comparable with complete sterilization of life threatening infectious microorganisms, such as staphylococcus aureus and MRSA.  Theralase’s new PDC technology would therefore be well suited to preventing hospital acquired infections, as well as infections found in nursing homes, schools or bacterial contaminations in food processing facilities. Quite simply, once MRSA bacteria have been detected, they could be quickly destroyed utilizing Theralase’s patented Photo Dynamic Compounds and proprietary light sources.”

Dr. Lothar Lilge, Senior Scientist, Ontario Cancer Institute / Princess Margaret Cancer Centre, UHN stated, “Theralase’s PDCs in conjunction with light exposure were shown to achieve essentially complete sterilization, even at low concentrations, against staphylococcus aureus and MRSA in an in vitro laboratory setting. The effective dose of tested PDCs was not toxic for human tissues even after 4 hours of incubation demonstrating their suitability and safety to sterilization applications. As an added benefit, the Theralase PDCs maintained their sterilizing activity even in low oxygen conditions demonstrating a Type I photosensitization effect that may open up new opportunities for the safe and effective destruction of many strains of deadly organisms and tumours that thrive in low oxygen environments, such as cancer.”


Dr. Arkady Mandel went on to say, “The dramatic increase of antibiotic resistance in bacteria has led me to investigate whether Theralase’s PDCs would be effective in the destruction of MRSA, as an alternative to antibacterial pharmaceutical drugs. Our successes to date will allow Theralase’s PDCs to be used in the future to combat difficult to heal invasive infections. The Theralase PDCs in these studies have been chosen for their low dark toxicity to human tissue and for their high cancer and bacteria targeting properties. The Theralase PDCs are extremely promising for the development of advanced disinfection and sterilization strategies for controlling and eliminating hospital and community acquired infections, such as MRSA.

Roger Dumoulin-White, President and CEO of Theralase stated, “Based on our recent successes with our PDC technology in destroying MRSA, Theralase is actively pursuing early commercialization of this technology through strategic partnerships to co-develop the technology for particular sterilization applications. As an added benefit, due to the very low concentrations of PDCs required for sterilization, the costs of administering this technology will be very cost effective. The early commercialization of our patented PDC technology with strategic partners will dramatically improve the financial revenues of the organization. These scientific studies thus highlight Theralase’s commitment to advancing its exclusive patented technologies for the ultimate goal of greater commercial opportunities for the Company.”

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. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing. Theralase is currently developing patented Photo Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technology.

For further information please visit www.theralase.com, regulatory filings may be viewed by visiting www.sedar.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 & Chief Executive Officer
416-447-8455 ext. 225
rwhite@theralase.com                

Friday, October 12, 2012

Theralase Effective in the Treatment of Tobacco Addiction


Toronto, Ontario – October 12, 2012 -- Theralase Technologies Inc. (TSX-V: TLT) announced today that the Theralase therapeutic laser system, has been proven clinically effective in the treatment of tobacco addiction. 
 
The Theralase technology was clinically evaluated on over 500 subjects, who were heavy smokers, to validate if they were able to reduce their smoking by at least 25%, 30 days after receiving the Theralase laser treatment. The results of the clinical study demonstrated that 405 (73.8%) subjects had reduced their consumption of tobacco products by 25% or more, with 373 (92.0%) completely eliminating use and 32 of those subjects (8.0%) showing a reduction of at least 25%. 
 
Smoking is one of the most preventable illnesses that plague the American population. In 2009, the Centers for Disease Control and Prevention estimated that smoking accounted for $96 billion a year in direct health care costs and an additional $97 billion a year in lost productivity. Smoking addiction is a complex condition, which can disrupt a person’s life, leading to severe health concerns, deterioration of major organs, incurable diseases and eventually pre-mature death. In fact, more deaths are caused each year by tobacco use than by all deaths from human immunodeficiency virus (HIV), illegal drug use, alcohol use, motor vehicle injuries, suicides and murders combined, with cigarette smoking causing 1 out of every 5 deaths in the United States each year.
 
Roger Dumoulin-White, President and CEO of Theralase stated that Due to the complexity of smoking addiction and the poor success rate that alternative cessation methods have had, this independent clinical study was commissioned to enroll 549 subjects, from a homogeneous, cosmopolitan population of heavy smokers. The treatment group consisted of a relatively equal representation of male and female subjects with an average age in the mid to late forties. A Theralase therapeutic laser system was applied to specific ear and body acupuncture points to determine if the subject could reduce their smoking consumption by 25% or more 30 days after treatment. The results of the clinical study demonstrated that at the 30 day follow-up end point, 405 (73.8%) subjects had met the outcome criteria and had reduced their consumption of tobacco products by 25% or more, with 373 of those subjects (92.0%) completely eliminating use of tobacco products and 32 of those subjects (8.0%) showing a reduction of at least 25%. This non-pharmacologic and non-invasive therapeutic modality exceeds the effectiveness of other therapeutic options currently available for smoking cessation treatment, including nicotine patch, nicotine gum and other pharmaceutical alternatives.”

Dr. Arkady Mandel, Chief Scientific Officer of Theralase said, “Due to the significant reduction in the consumption of tobacco products by 405 (73.8%) subjects by 25% or more at the 30 day follow-up end point, the Theralase laser technology may find itself as a first line approach to combatting long term tobacco addiction in the not too distant future. Theralase laser acupuncture treatments may represent a safe and effective alternative for reducing the amount of tobacco products consumed by smokers”.

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. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing in both humans and animals. Theralase complies with all FDA, Health Canada, CE and international regulatory approvals to produce clinically effective, safe and high quality products. Theralase also develops patented Photo Dynamic Compound (PDC) technology focused at targeting and destroying cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technologies.

For further information please visit www.theralase.com, regulatory filings may be viewed by visiting www.sedar.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, please contact:

Roger Dumoulin - White,                                                                                
President and CEO                                                                                            
416-447-8455 ext. 225                                                                                     

Kristina Hachey
Chief Financial Officer
416-447-8455 ext. 224
khachey@theralase.com                                                                                

Greg Bewsh
Director of Investor Relations
416-447-8455 ext. 262

Arkady Mandel
Chief Scientific Officer
416-447-8455 ext. 242
amandel@theralase.comlase.com

Wednesday, October 10, 2012

Clinical and Business Rewards of Using Laser in Practice


Tuesday, October 23, 2012 1:00 PM - 2:00 PM EDT


Webinar Registration

Below are a few items that will be covered in the Webinar:
Clinical outcomes from laser treatments in Dr. Lemasurier's Practice
Increasing patient volume  and patient satisfaction
Time management - juggling modalities in practice
Advertising and marketing your laser
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By clicking the "Register Now" button you submit your information to the Webinar organizer, who will use it to communicate with you regarding this event and their other services.

Tuesday, October 9, 2012

The Healing Potential and Mechanism of Action of Low Level Laser Therapy: a brief overview


By Dr. Sean Miller, DC
October 8, 2012 – The chiropractic profession has always been in the habit of setting new standards for natural approaches to patients’ health, not following them. Low level laser therapy fits extremely well into the chiropractic model of using various safe, effective, and natural methods to help our patients achieve their optimum function.
A key feature of low level laser therapy that aids well for chiropractors and other natural medicine practitioners is low level laser therapy’s proven ability to help decrease pain and speed the healing of tissue. A study from the Australian Journal of Physiotherapy of 61 patients presenting with chronic low-back pain concluded that low level laser therapy combined with exercise was more effective long term than exercise alone. The amazing thing about this study is that the patients who had laser therapy were still experiencing significant pain relief 6 weeks after therapy was provided (1). Decreasing pain is a great benefit for our patients; however, pain is a symptom, and as chiropractors, we pride ourselves at addressing the cause of our patients’ complaints. It is thought that the low level laser stimulates the targeted cells to increase mitochondrial production of ATP, which speeds healing through increased cellular efficiency and energy (2). In summary, if the mitochondria in your cells are little power plants, low level laser therapy helps increase the output of the power plant. In a paper on PubMed from Lasers in Surgery and Medicine, the authors observed accelerated healing of cutaneous wounds and burns, as well as increased action potential of crushed sciatic nerves on the rats that received low level laser therapy (3). In another study from Laser in Surgery in Medicine, a low level laser was looked at from a microscopic level, and the authors concluded that, “5 J/cm [632.8 nm low level laser] stimulates
mitochondrial activity, which leads to normalization of cell function and ultimately stimulates cell proliferation and migration of wounded fibroblasts to accelerate wound closure.” (4) Increasing our patients’ cellular efficiency and, in turn, healing ability through use of low level laser therapy marriages perfectly with chiropractic care, which aims to do the same through restoring proper posture, biomechanics, and neurological function. If you are considering purchasing a laser, I recommend assessing each company before making a decision, as lasers are a relatively expensive addition to your practice. If you are considering low level laser therapy for a current complaint or just want to try it, I encourage you to do so, because after seeing and feeling the effects, you will start to realize that low level laser is here to stay.
Dr. Miller maintains an active practice in Avon, Colorado near Beaver Creek ski resort and runs a health blog with a growing following. He can be contacted through his website: www.seanmillerhealth.com
Sources:
1. G.E. Djavid, R. Mehrdad, M. Ghasemi, et al. In chronic low back pain, low level laser therapy combined with exercise is more beneficial than exercise alone in the long term: a randomized trial. Aust J Physiother. 2007;53(3):155-60.
2. Yu. A. Vladimirov, A.N. Osipov, and G. I. Klebanov. Photo-biological principles of therapeutic application of laser radiation. Biochemistry, 2004;69(1):103-113.
3. S. Rochkind, M. Nissan, M. Villareal, L. Barr-Nea, D.G. Rees. Systemic effects of low-power laser irradiation on the peripheral and central nervous system, cutaneous wounds, and burns. Laser Surg Med. 1989;9(2):174-82.
4. D.H. Hawkins and H. Abrahamse. The role of laser influence in cell viability, proliferation, and membrane integrity of wounded human skin fibroblasts following helium-neon laser irradiation. Laser Surg Med. 2006;3*(1):74-83.

Is TENS Just a Placebo for Chronic Pain?


From :Pain-Topics.org News/Research UPDATES

Recently reported research found that transcutaneous electrical nerve stimulation (TENS) was significantly helpful in reducing chronic pain intensity and disability while improving perceived health status for up to 1 year. However, these outcomes were comparable to those produced by sham/placebo TENS. Does this mean that TENS is worthless as a pain-treatment modality, or is there a need to reconsider the role and value of meaningful placebos in pain management?
TENS is an easy to use, noninvasive, analgesic intervention that may result in less pain, increased functionality, and decreased use of pain medication. Although TENS has been in use since the early 1970s, short-term results of this therapy have been inconclusive for treating chronic pain, and long-term randomized placebo-controlled studies with treatment periods of more than 3 months had not been executed. Therefore, researchers in The Netherlands designed a study to explore the long-term (1 year) time course of TENS treatment effects compared with a sham-TENS placebo [Oosterhof et al. 2012].
Writing in the September edition of Pain Practice they report a randomized placebo-controlled trial enrolling 163 patients with chronic pain who had been referred to a multidisciplinary pain center at a university hospital. Patients were being treated for peripheral neuropathic pain, osteoarthritis and related disorders, or injury of bone and soft tissue, and usual care for their conditions had failed in the past to satisfactorily ameliorate their pain.
Prior to randomization, all patients had their pain medication optimized by the attending anesthesiologist or pain practitioner; however, at baseline, the mean pain intensity among all patients was still moderate (about 62mm on a 100mm scale). Identical TENS devices were used for the actual and sham treatments, and self-applied by subjects for several hours each day. Sham units showed a fake output reading on the LCD display, but no current was delivered to the electrodes. The main endpoints of interest were the proportion of patients satisfied with treatment results and willing to continue treatment at the end of 1 year, pain intensity, pain disability, and perceived health status.
Results indicated that, throughout the time-course of the study, there was no significant difference (P=0.79) in the proportion of patients satisfied with actual vs. sham-TENS therapy; at the end of the year, an intention-to-treat analysis showed that 30% (24/81) of patients in the TENS group and 23% (19/82) of the sham-TENS group were satisfied with treatment results. These 43 patients in both groups experienced a mean overall improvement of 62.7%, and there were no significantly different between groups (P=0.74). Also, for patients still satisfied after 1 year, there were no differences in pain intensity or disability, perceived health status, or pain medication use between the TENS and sham-TENS groups; although, these measures in both groups had improved significantly from baseline.
COMMENTARY: Limitations & Possibilities
As noted above, TENS therapy has been in existence for nearly 4 decades. The TENS unit is a small, portable device delivering mild electrical current to nerves through electrodes connected to the skin at or near the sites of pain.
The approach has been used for various types of pain, although exact mechanisms of its analgesic effects are still under examination. Basic science studies suggest that TENS activates endogenous pain-control chemicals (eg, endorphins, enkephalins, dynorphins, GABA, serotonin) and their receptors. Along with that, the high and low electrical frequencies produced by a TENS unit inhibit pain signals along affected nerves, ostensibly blocking the impulses from reaching pain-perception areas in the brain.
In the Oosterhof et al. [2012] study, for those patients who appeared to respond to a TENS intervention and were satisfied with the therapy, there were stable improvements in pain and other measures over the 1-year period, whether they were assigned real or sham TENS units. However, as the authors concede, there was no third group for comparison receiving standard care without TENS to control for regression to the mean or the natural course of chronic pain, so they could not claim to have found a true placebo effect induced by the sham-TENS procedure.
During the year, 44 patients in the TENS group were lost to followup, with 18 dropping out due to dissatisfaction with treatment results. In the sham-TENS group, there were only 32 lost to followup, with 14 dissatisfied with results. Also, 93% of subjects in the actual TENS group but only 70% in the sham-TENS group believed they had received a real TENS unit, which should have decreased favorable placebo effects but did not.
The intervention was relatively safe, with the only adverse effect being that roughly half of all patients experienced skin problems caused by the electrodes, but only 4 (2 in each group) discontinued for this reason. Apparently, this was not due to actual electric current and the researchers noted that this problem can normally be overcome by changing the type of electrode.
The researchers note quite importantly that among those patients still satisfied with either actual or sham TENS after 1 year there was an average decrease of more than 50% in pain intensity, which is both statistically and clinically significant. Even among those who stopped treatment earlier, there was about a 28% improvement in pain, which may be clinically noteworthy since this went beyond the pain relief afforded them by usual medical care.
As one limitation, there may not have been a sufficient number of subjects completing the trial. The study design required 35% of patients in the TENS group and 15% in the sham-TENS group being successfully treated after 1 year to have 80% power for detecting significant difference between groups. Since these targets were not achieved, the lack of differences between groups might have been statistically a false negative, or Type II error.
Aside from that, in this long-term study by Oosterhof and colleagues [2012] it appeared that TENS might have functioned similar to placebo or, conversely, the sham/placebo treatment may have had genuine medical efficacy. As the researchers note, this may support the contention that “placebo effects are genuine psychobiological events, which can be robust in both laboratory and clinical settings.”
Along these lines, the researchers observe that, in neuropathic pain trials, placebos have had durable long-term effects that pose difficulties in distinguishing between treatment and placebo effects. Furthermore, other researchers [eg, Quessy and Rowbotham 2008] have noted that this problem is magnified in trials in which long treatment periods under blinded conditions are required and in which the analysis assigns trial dropouts as treatment failures, as in the Oosterhof et al. study.
TENS for Chronic Pain
Other research has investigated TENS for chronic pain. A Cochrane Systematic Review by Nnoaham and Kumbang [2008] compared “no treatment” controls with sham-TENS or active TENS using different electrical frequencies. Of 124 studies identified in their searches, only 25 RCTs (N=1,281) could be evaluated. At that, there was such a high degree of heterogeneity (differences and inconsistencies) across studies that a data meta-analysis was not possible.
Overall, in 13 of 22 sham/placebo controlled studies there was a positive analgesic outcome in favor of active TENS treatments. For multiple-dose treatment comparison studies, 8 of 15 were considered to be in favor of TENS therapy. Results were based on short-term low-volume TENS treatment: The duration of treatment was <4 weeks in about 80% of the studies, and in 70% of the trials treatment occurred <10 hours per week with 60% of the participants having <10 total sessions of TENS. The authors note that these limitations may explain why some of the studies failed to detect any differences between active TENS and sham controls.
Nnoaham and Kumbang conclude that published literature on TENS lacks the methodological rigor or robust reporting needed to make confident assessments of this therapy for chronic pain management. However, they assert that, even if the effect of TENS on chronic pain is a weak one, its potential to augment the effect of other pain treatment modalities should be explored. Indeed, in the much longer-term Oosterhof et al. study, TENS therapy was additive to analgesic effects of pain medications that all patients were taking.
TENS for Low-Back Pain
We have previously discussed in an UPDATE [here] evidence reviews and guidelines that found TENS ineffective for treating chronic low-back pain; although the evidence had some strong limitations that challenged its internal and external validity. Similarly, in 2008, a Cochrane Systematic Review by Khadilkar et al. examined 4 high quality RCTs of TENS for chronic back pain (585 patients) and found conflicting and inconsistent evidence, in comparison with placebo, to support the use of TENS. However, these studies were so disparate in design (clinical heterogeneity) that the researchers could not do a data meta-analysis and had to rely on qualitative observations that are prone to bias.
In response to the lack of clear and convincing evidence in support of TENS for chronic back pain, last summer the U.S. Centers for Medicare and Medicaid Services (CMS) announced it would no longer cover most uses of TENS for this pain condition [see MedPage Today article here]. They noted that reimbursement for TENS in treating low-back pain in particular will be available only when patients are participating in a randomized, controlled trial of the technology’s clinical effectiveness.
In the announcement they wrote, “TENS is not reasonable and necessary for the treatment of [chronic low back pain].” The CMS had conducted a review in the wake of a 2010 report by an American Academy of Neurology panel that, on the basis of only 5 trials, found the treatment was not effective [discussed in the abovementioned UPDATE]. Although, the CMS also acknowledged that some individual studies have shown that TENS can reduce pain and improve patients' physical function.
While the CMS plans to withhold coverage of TENS for chronic back pain, it will continue to fund RCTs of TENS for 3 years. The trials must directly address TENS’ clinical efficacy and be designed and powered to yield clear-cut answers. At present, the CMS emphasized that Medicare will still reimburse for TENS prescribed for treatment-resistant pain conditions other than low back pain, such as for chronic or severe postoperative pain.
When is a “Placebo” of Meaningful Value?
There are some interesting and remarkable parallels of research outcomes for TENS, as described above, with acupuncture for chronic pain in regard to the prominent influence of placebo effects as a possibly important component of therapeutic efficacy. Acupuncture was most recently discussed in an UPDATE [here], which noted that its benefits for treating musculoskeletal pain, osteoarthritis, and chronic headache were only weakly better than placebo, but that both placebo and true acupuncture conferred moderate benefits in reducing pain that went beyond and above the usual medical care patients had been receiving.
Both acupuncture and TENS have been available for a long time and there has been much research conducted to examine each modality; yet, the quality of most research has been surprisingly low and generally precludes an unbiased pooling of studies for more rigorous analyses. Despite this, it appears that both modalities have potential for offering select groups of patients nonpharmacologic options for pain relief and other health benefits; albeit, perhaps due largely to placebo components of the overall effects. And, as the Oosterhof et al. study demonstrates, the duration of those favorable effects can be long-lasting.
TENS is noninvasive and acupuncture is minimally invasive, both have relatively favorable safety profiles, and their benefit-to-cost ratios may be advantageous compared with some other therapies. Either therapy may be abruptly discontinued without adverse effects and, as the Oosterhof et al. study suggests, patients who do not benefit readily stop the treatment.
So, perhaps what is needed is a reconceptualization of the role of placebos in pain management and, when it comes to TENS or acupuncture, a recognition that a completely inert placebo version of these therapies may not exist.
As Andrew Avins, MD, suggested in an editorial discussed in our recent UPDATE on acupuncture, it may be time for an examination of why so many healthcare professionals feel threatened by the existence of placebo effects and, instead, consider how those effects might be harnessed for better pain care. Capitalizing on placebo effects may be perceived as bad science by some, but it may be welcomed as good medicine by patients who benefit.
Disclosure: We have no vested interests in or support from any manufacturers of electrical nerve stimulation devices, including TENS. Our only interest here is in arriving at sound practice decisions in pain management based on appropriately credible, reliable, and valid analyses of clinical evidence. — SBL
REFERENCES:
> Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database of Systematic Reviews. 2008;4(CD003008) [
abstract].
> Nnoaham KE, Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database of Systematic Reviews. 2008;3(CD003222) [
abstract here].
> Oosterhof J, Wilder-Smith OH, de Boo T, et al. The Long-Term Outcome of Transcutaneous Electrical Nerve Stimulation in the Treatment for Patients with Chronic Pain: A Randomized, Placebo-Controlled Trial. Pain Practice. 2012(Sep);12(7):513-522 [
abstract here].
> Quessy SN, Rowbotham MC. Placebo response in neuropathic pain trials. PAIN. 2008;138(3);479-483 [
abstract here].

Friday, October 5, 2012

Theralase Commences Equity Financing


TORONTO, ONTARIO-- Oct. 4, 2011 - Theralase Technologies Inc. (TSX-V:TLT) announced today that it has commenced raising funds from accredited investors in a non-brokered private placement (the "Private Placement") of up to 2,000,000 units (the "Units") at a price of CND $0.25 per Unit for gross proceeds of up to CDN $500,000.00. Each Unit consists of one common share in the capital of the Company and one-half of one non- transferable common share purchase warrant (a "Warrant"). Each whole Warrant entitles the holder to purchase one additional common share (a "Warrant Share") in the capital of the Company for 1 year after closing at a price of CDN $0.38 per Warrant Share. The securities issued under the Private Placement including any shares issued upon exercise of the Warrants are subject to a four month holding period, commencing upon closing.

The company intends to utilize the proceeds of the Private Placement 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 cancers, bacteria and viruses
·       TLC-1000 therapeutic medical laser USA sales and marketing expansion
·       TLC-2000 therapeutic medical biofeedback laser commercialization

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. Theralase technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal conditions and wound healing in both humans and animals. Theralase complies with all FDA, Health Canada, CE and international regulatory approvals to ensure effective, safe and high quality products. Theralase also develops patented Photo Dynamic Compound (PDC) technology focused at targeting and destroying cancers, bacteria and viruses when light activated by Theralase’s proprietary and patented laser technologies.

For further information please visit www.theralase.com, regulatory filings may be viewed by visiting www.sedar.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, please contact:

Roger Dumoulin-White,                                                                                  
President and CEO                                                                                            
416-447-8455 ext. 225                                                                                      

Kristina Hachey
Chief Financial Officer
416-447-8455 ext. 224
khachey@theralase.com                                                                                

Greg Bewsh
Director of Investor Relations
416-447-8455 ext. 262