Low Level Laser in the Treatment of Migraine and Traumatic Brain Injury in the Adult population

Pratibha Bansal M.D.,   Romanth Waghmarae M.D. DABA, FIPP. , Louis Banas B.S. , M.S. CLT ; Buffalo, New York,  June 2012

Note: Dr’s Bansal and Waghmarae are Board Certified Pain Management Physicians who have practicing Pain Management in Buffalo, New York for over 20 years.   Louis Banas is a laser specialist who has treated over 2500 hundred patients for chronic pain issues. He has treated over 60 adults for headaches of various types with significant success in most cases.   

Abstract:

Migraine headache due to trauma or otherwise is a major health concern worldwide with massive financial and social impact. Conventional treatments primarily focus on the prevention of further damage to the brain parenchyma, while failing to address the already existent symptoms. Previous clinical studies have shown that Low Level Laser Therapy (LLLT) can significantly reduce pain and induce temporary vasodilation in capillaries.  The authors demonstrate how LLLT can be used to improve the quality of life in patients by treating their current symptoms,. This case report illustrates the use of LLLT in the treatment of several patients with a severe headache and the clinical success achieved in the reduction of pain, as measured by VAS - achievable within 2-8 treatments.

Abstract:

Objective Information and Background.

The following case studies were followed at a Pain Management Clinic in Buffalo New York.  Pain Rehab is staffed with two board certified Pain Management Specialists who will see 300 to 400 patients weekly. Most patients were being seen do to traumatic injuries suffered at work, home or auto accident and in most cases had little or no relief with physical therapy, chiropractic, massage or surgery. Pain Rehab is very progressive in utilizing new and proven technology and reluctantly prescribes opiates and NSAIDS . All patients suffered from moderate to severe, debilitating pain on a daily basis. After a very positive evaluation of laser therapy on patients, a physical therapy clinic was added to the practice, therefore enabling this new modality to be readily available to their patients. Several patients suffering from chronic, debilitating headaches due to trauma or congenital defects were treated during a four month period. (It is important to note that headaches were just part of the overall pain complaints except for two patients noted in cases 4 and 7.) Over twenty patients were treated and only two patients out of twenty did not respond well. The treatments were performed by a laser specialist with four years of laser experience.  Listed below are a few of the significant, more interesting cases.

Case # 1.  A 28 y.o. female suffered severe whiplash in an auto injury and complained of daily, severe headaches with a vas value of 7-8 accompanied by blurred vision for a 12 month period. Laser was applied to bilateral temples and mastoid   for 2 minutes, delivering 15 joules to five sites, which included bilateral temple and mastoid sites and right cervical spine.  Patient was not able tolerate minimal cervical spine treatment. , including 6 joules per site for a 3 minute duration.  Note: Patient is African American and due to nerve damage or skin pigmentation could not tolerate prescribed dosage.   Treatment was given 3 times per week for two weeks at a reduced dosage for a total of six treatments.  Pain levels were substantially reduced and patient now only suffers 2-3 episodes per week with a vas value of 2-3.

Case #2 .  38 y.o. female, auto injury.  Previous physical therapy was unsuccessful. Patient complained of daily headaches 7-8 on the vas scale for two years.  Treatment included bilateral c-spine and right trapezium for 3 minutes time delivering 42.5 joules to each site, for a period of two weeks and levels increase to 72 joules for second week as patient healed and was more able to tolerate the procedure.  Patient received 12 treatments over a three week period and now experiences mild to moderate headaches once or twice per month.

Case 3#.  58 y.o. male was injured on the job and suffered a severe neck and left clavicle injury. Headaches were daily which were debilitating and patient reported a 7-8 level on the vas scale. Treatments of 8 sessions included 76.5 joules applied to left cervical spine and clavicle. 15 joules were applied to left cervical 1 area, after 10 treatments the headaches were entirely eliminated.

Case # 4. A 23 y.o. Female suffered from headaches 3-4 times per week since six years of age.  Patient has a high stress job as customer service representative. One treatment was applied at both temples delivering 15 joules in a two minute session. Patient was headache free for one week. 

Case#5.  A  57 y.o. female, auto injury 17 years ago and had damage to both frontal lobes. 28 Joules was applied to her forehead at two sites. Due to transportation difficulties her treatments are sporadic but after two treatments she now wakes up with minimal or no pain on most mornings.

Case #6.  A 52 y.o. male fell at work and hit back of head. Headaches occur on daily basis since accident 4 months ago.  Two treatments were performed two days apart delivering 25 joules to injured area. Patient states that headaches are significantly reduced and sleep patterns are substantially improved.

Case # 7. A 31 y.o. female former military P.A. presented herself with migraine headaches with a vas value of 7-8 on a daily basis. She has suffered with them since the age of 8.  The patient had seen several specialists including neurologists who were unable to help. The patient had military training as a physician’s assistant and realized she needed detoxing from drug overload which had been prescribed for the problem.   A single laser treatment was administered which included  48 joules at 2 sites on the forehead and 28 joules to four sites which included bilateral temple and mastoid areas.  The patient had significant relief for a 7 day period at which point she felt the change in medications was to blame. She returned for a single visit one day after the relapse and the  procedure was repeated.  The patient reported to be pain free within minutes after the procedure.  She feels she is completely healed.

Technical data:

The system utilized is the Theralase super pulsed Low Level Laser medical system. It  The system is equipped with a multiple probe hand piece (5 x 905 nm wavelength @0-100 mw average power per laser diode and 4 x 660 nm wavelength @25 mw . power per laser diode. (This allows for deep penetration of tissue when necessary with minimal heat transference to the tissue).

Healing pathways- Discussion

The majority of patients seen in this clinic have multiple injuries and headaches are a by-product of some type of trauma. Therefore, it may be safe to assume that vascular insufficiency is the main cause. A recently published a peer review paper concludes that the equipment used utilizes a 905 nm. Wavelength increasing Nitric acid up to 700 percent which expands capillary delivery of oxygenated blood. Currently Dr. Michael Whalen, working at Massachusetts General Hospital, is conducting controlled studies using a low level laser with the hopes of bringing this new technology into the forefront of neuroscience and medicine. These case studies give examples of how LLLT can be used to treat chronic migraines, specifically those that are a result of traumatic brain injuries. LLLT has been shown to reduce pain and inflammation, create a state of vasodilation by activating the nitric oxide pathway and further even promote angiogenesis.

ATP production.  Cold laser has the unique ability to generate the production of ATP Adenosine Tri-phosphate through a process called biostimualtion. Vacuoles (cytochromes and chromaphores) in the mitochondria of the cell absorb specific light wavelengths causing a cascade effect which rejuvenates damaged cells lacking this essential fuel molecule. Although this may be the main pathway for treating the traumatic injures, it is arguable that the nitric oxide production is the primary source of pain reduction.

Summary. LLLT is now becoming a valuable but slowly recognized modality for acute and chronic pain as well as wound care in the United States. It has been used extensively in Canada for over 12 years.

REFERENCES

1.            Faul M, X.L., Wald MM, Coronado VG, Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. 2010.

2.            Finkelstein E, C.P., Miller T and associates, The Incidence and Economic Burden of Injuries in the United States. Oxford University Press, 2006.

3.            Sahni, T., et al., Use of hyperbaric oxygen in traumatic brain injury: retrospective analysis of data of 20 patients treated at a tertiary care centre. Br J Neurosurg, 2012. 26(2): p. 202-7.

4.            Naeser, M.A. and M.R. Hamblin, Potential for transcranial laser or LED therapy to treat stroke, traumatic brain injury, and neurodegenerative disease. Photomed Laser Surg, 2011. 29(7): p. 443-6.

5.            Moriyama, Y., et al., In vivo effects of low level laser therapy on inducible nitric oxide synthase. Lasers Surg Med, 2009. 41(3): p. 227-31.

6.            Wu, Q., et al., Low-level laser therapy for closed-head traumatic brain injury in mice: effect of different wavelengths. Lasers Surg Med, 2012. 44(3): p. 218-26.

7.             Stephan, W. et al . Efficacy of super –pulsed 905 nm Low Level Laser Therapy in the Management of

Traumatic Brain Injury (TBI) World Journal of Neuroscience November 2012  www.scirp.org/journal/wjnsl

For further information, please visit www.theralase.com or call 1-855-494-7246

Cancer Risk Factors

Doctors often cannot explain why one person develops cancer and another does not. But research shows that certain risk factors increase the chance that a person will develop cancer. These are the most common risk factors for cancer:

• Growing older
• Tobacco
• Sunlight
• Ionizing radiation
• Certain chemicals and other substances
• Some viruses and bacteria
• Certain hormones
• Family history of cancer
• Alcohol
• Poor diet, lack of physical activity, or being overweight

Many of these risk factors can be avoided. Others, such as family history, cannot be avoided. People can help protect themselves by staying away from known risk factors whenever possible.
If you think you may be at risk for cancer, you should discuss this concern with your doctor. You may want to ask about reducing your risk and about a schedule for checkups.
Over time, several factors may act together to cause normal cells to become cancerous. When thinking about your risk of getting cancer, these are some things to keep in mind:

• Not everything causes cancer.
• Cancer is not caused by an injury, such as a bump or bruise.
• Cancer is not contagious. Although being infected with certain viruses or bacteria may increase the risk of some types of cancer, no one can "catch" cancer from another person.
• Having one or more risk factors does not mean that you will get cancer. Most people who have risk factors never develop cancer.
• Some people are more sensitive than others to the known risk factors.

The sections below have more detailed information about the most common risk factors for cancer.

Growing Older

The most important risk factor for cancer is growing older. Most cancers occur in people over the age of 65. But people of all ages, including children, can get cancer, too.

Tobacco

Tobacco use is the most preventable cause of death. Each year, more than 180,000 Americans die from cancer that is related to tobacco use.
Using tobacco products or regularly being around tobacco smoke (environmental or secondhand smoke) increases the risk of cancer.
Smokers are more likely than nonsmokers to develop cancer of the lung, larynx (voice box), mouth, esophagus, bladder, kidney, throat, stomach, pancreas, or cervix. They also are more likely to develop acute myeloid leukemia (cancer that starts in blood cells).
People who use smokeless tobacco (snuff or chewing tobacco) are at increased risk of cancer of the mouth.

Quitting is important for anyone who uses tobacco - even people who have used it for many years. The risk of cancer for people who quit is lower than the risk for people who continue to use tobacco. (But the risk of cancer is generally lowest among those who never used tobacco.)
Also, for people who have already had cancer, quitting may reduce the chance of getting another cancer.
There are many resources to help people stop using tobacco:

• Staff at the NCI's Smoking Quitline (1-877-44U-QUIT) and at LiveHelp (http://www.cancer.gov/livehelp) can talk with you about ways to quit smoking and about groups that help smokers who want to quit. Groups may offer counseling in person or by telephone.
• A Federal Government Web site, http://www.smokefree.gov, has an online guide to quitting smoking and a list of other resources.
• Doctors and dentists can help their patients find local programs or trained professionals who help people stop using tobacco.
• Doctors and dentists can suggest medicine or nicotine replacement therapy, such as a patch, gum, lozenge, nasal spray, or inhaler.

Sunlight

Ultraviolet (UV) radiation comes from the sun, sunlamps, and tanning booths. It causes early aging of the skin and skin damage that can lead to skin cancer.

Doctors encourage people of all ages to limit their time in the sun and to avoid other sources of UV radiation:

• It is best to avoid the midday sun (from mid-morning to late afternoon) whenever possible. You also should protect yourself from UV radiation reflected by sand, water, snow, and ice. UV radiation can penetrate light clothing, windshields, and windows.
• Wear long sleeves, long pants, a hat with a wide brim, and sunglasses with lenses that absorb UV.
• Use sunscreen. Sunscreen may help prevent skin cancer, especially sunscreen with a sun protection factor (SPF) of at least 15. But sunscreens cannot replace avoiding the sun and wearing clothing to protect the skin.
• Stay away from sunlamps and tanning booths. They are no safer than sunlight.

Protect yourself from the sun.

Ionizing Radiation

Ionizing radiation can cause cell damage that leads to cancer. This kind of radiation comes from rays that enter the Earth's atmosphere from outer space, radioactive fallout, radon gas, x-rays, and other sources.
Radioactive fallout can come from accidents at nuclear power plants or from the production, testing, or use of atomic weapons. People exposed to fallout may have an increased risk of cancer, especially leukemia and cancers of the thyroid, breast, lung, and stomach.
Radon is a radioactive gas that you cannot see, smell, or taste. It forms in soil and rocks. People who work in mines may be exposed to radon. In some parts of the country, radon is found in houses. People exposed to radon are at increased risk of lung cancer.
Medical procedures are a common source of radiation:

• Doctors use radiation (low-dose x-rays) to take pictures of the inside of the body. These pictures help to diagnose broken bones and other problems.
• Doctors use radiation therapy (high-dose radiation from large machines or from radioactive substances) to treat cancer.

The risk of cancer from low-dose x-rays is extremely small. The risk from radiation therapy is slightly higher. For both, the benefit nearly always outweighs the small risk.

You should talk with your doctor if you are concerned that you may be at risk for cancer due to radiation.
If you live in a part of the country that has radon, you may wish to test your home for high levels of the gas. The home radon test is easy to use and inexpensive. Most hardware stores sell the test kit.
You should talk with your doctor or dentist about the need for each x-ray. You should also ask about shields to protect parts of the body that are not in the picture.
Cancer patients may want to talk with their doctor about how radiation treatment could increase their risk of a second cancer later on.

Certain Chemicals and Other Substances

People who have certain jobs (such as painters, construction workers, and those in the chemical industry) have an increased risk of cancer. Many studies have shown that exposure to asbestos, benzene, benzidine, cadmium, nickel, or vinyl chloride in the workplace can cause cancer.

Follow instructions and safety tips to avoid or reduce contact with harmful substances both at work and at home. Although the risk is highest for workers with years of exposure, it makes sense to be careful at home when handling pesticides, used engine oil, paint, solvents, and other chemicals.

Some Viruses and Bacteria

Being infected with certain viruses or bacteria may increase the risk of developing cancer:

• Human papillomaviruses (HPVs): HPV infection is the main cause of cervical cancer. It also may be a risk factor for other types of cancer.
• Hepatitis B and hepatitis C viruses: Liver cancer can develop after many years of infection with hepatitis B or hepatitis C.
• Human T-cell leukemia/lymphoma virus (HTLV-1): Infection with HTLV-1 increases a person's risk of lymphoma and leukemia.
• Human immunodeficiency virus (HIV): HIV is the virus that causes AIDS. People who have HIV infection are at greater risk of cancer, such as lymphoma and a rare cancer called Kaposi sarcoma.
• Epstein-Barr virus (EBV): Infection with EBV has been linked to an increased risk of lymphoma.
• Human herpesvirus 8 (HHV8): This virus is a risk factor for Kaposi's sarcoma.
• Helicobacter pylori : This bacterium can cause stomach ulcers. It also can cause stomach cancer and lymphoma in the stomach lining.

Do not have unprotected sex or share needles. You can get an HPV infection by having sex with someone who is infected. You can get hepatitis B, hepatitis C, or HIV infection from having unprotected sex or sharing needles with someone who is infected.
You may want to consider getting the vaccine that prevents hepatitis B infection. Health care workers and others who come into contact with other people's blood should ask their doctor about this vaccine.
If you think you may be at risk for HIV or hepatitis infection, ask your doctor about being tested. These infections may not cause symptoms, but blood tests can show whether the virus is present. If so, the doctor may suggest treatment. Also, the doctor can tell you how to avoid infecting other people.
If you have stomach problems, see a doctor. Infection with H. pylori can be detected and treated.

Certain Hormones

Doctors may recommend hormones (estrogen alone or estrogen along with progestin) to help control problems (such as hot flashes, vaginal dryness, and thinning bones) that may occur during menopause. However, studies show that menopausal hormone therapy can cause serious side effects. Hormones may increase the risk of breast cancer, heart attack, stroke, or blood clots.

A woman considering menopausal hormone therapy should discuss the possible risks and benefits with her doctor.

Diethylstilbestrol (DES), a form of estrogen, was given to some pregnant women in the United States between about 1940 and 1971. Women who took DES during pregnancy may have a slightly higher risk of developing breast cancer. Their daughters have an increased risk of developing a rare type of cancer of the cervix. The possible effects on their sons are under study.

Women who believe they took DES and daughters who may have been exposed to DES before birth should talk with their doctor about having checkups.

Family History of Cancer

Most cancers develop because of changes (mutations) in genes. A normal cell may become a cancer cell after a series of gene changes occur. Tobacco use, certain viruses, or other factors in a person's lifestyle or environment can cause such changes in certain types of cells.
Some gene changes that increase the risk of cancer are passed from parent to child. These changes are present at birth in all cells of the body.
It is uncommon for cancer to run in a family. However, certain types of cancer do occur more often in some families than in the rest of the population. For example, melanoma and cancers of the breast, ovary, prostate, and colon sometimes run in families. Several cases of the same cancer type in a family may be linked to inherited gene changes, which may increase the chance of developing cancers. However, environmental factors may also be involved. Most of the time, multiple cases of cancer in a family are just a matter of chance.

If you think you may have a pattern of a certain type of cancer in your family, you may want to talk to your doctor. Your doctor may suggest ways to try to reduce your risk of cancer. Your doctor also may suggest exams that can detect cancer early.
You may want to ask your doctor about genetic testing. These tests can check for certain inherited gene changes that increase the chance of developing cancer. But inheriting a gene change does not mean that you will definitely develop cancer. It means that you have an increased chance of developing the disease.

Alcohol

Having more than two drinks each day for many years may increase the chance of developing cancers of the mouth, throat, esophagus, larynx, liver, and breast. The risk increases with the amount of alcohol that a person drinks. For most of these cancers, the risk is higher for a drinker who uses tobacco.

Doctors advise people who drink to do so in moderation. Drinking in moderation means no more than one drink per day for women and no more than two drinks per day for men.

Poor Diet, Lack of Physical Activity, or Being Overweight

People who have a poor diet, do not have enough physical activity, or are overweight may be at increased risk of several types of cancer. For example, studies suggest that people whose diet is high in fat have an increased risk of cancers of the colon, uterus, and prostate. Lack of physical activity and being overweight are risk factors for cancers of the breast, colon, esophagus, kidney, and uterus.

Choose a diet rich in fruits and vegetables.

Having a healthy diet, being physically active, and maintaining a healthy weight may help reduce cancer risk. Doctors suggest the following:

• Eat well: A healthy diet includes plenty of foods that are high in fiber, vitamins, and minerals. This includes whole-grain breads and cereals and 5 to 9 servings of fruits and vegetables every day. Also, a healthy diet means limiting foods high in fat (such as butter, whole milk, fried foods, and red meat).
• Be active and maintain a healthy weight: Physical activity can help control your weight and reduce body fat. Most scientists agree that it is a good idea for an adult to have moderate physical activity (such as brisk walking) for at least 30 minutes on 5 or more days each week.

Source: National Cancer Institute

Theralase Expands Board of Directors with Strong Financing Capabilities

Toronto, Ontario – February 1, 2013 -- Theralase Technologies Inc. (TSX-V: TLT) announced that effective today Mr. Matthew Perraton PFP, FMA, FCSI and Mr. Guy J. Anderson BA, CFP, CIM, FMA, FCSI, MBA have agreed to serve on the company's Board of Directors.

Mr. Perraton and Mr. Anderson join Mr. Donald Moore, Mr. Randy Bruder and Mr. Roger Dumoulin-White on the board and will be instrumental in helping Theralase secure the financing required to fuel Theralase’s growth over the next 5 to 10 years.

Mr. Perraton brings over 13 years of financial experience to Theralase, most recently as a Financial Planner for TD Waterhouse. Prior to his current position, Mr. Perraton held progressively higher positions with BMO Nesbitt Burns and Bank of Nova Scotia.

Mr. Perraton stated that, “I am delighted to join the board at Theralase, as I am absolutely convinced that Theralase is on the right path for shareholder value with both their therapeutic laser technology for healing tissue and their Photo Dynamic Compound (PDC) technology for destroying cancer. Their technology is far superior to anything I have seen on the market and properly financed I see great opportunities for Theralase in the near term”.

Mr. Anderson brings over 16 years of financial experience to Theralase, most recently as a Wealth Management and Personal Finance Advisor with the Investment Planning Counsel. Prior to his current position, Mr. Anderson held progressively higher positions with Franklin Templeton Investments Canada, T.E. Financial and Bank of Nova Scotia.

Mr. Anderson stated that, “I have followed the progress of Theralase over the last 4 to 5 years and have been amazed that the company has been able to advance such cutting-edge technology on a shoe string budget. I join Matt in saying that properly capitalized there is nothing that stands in the way of Theralase’s success. Their technology is not only the best on the market, but their management team has demonstrated an ability to survive in choppy markets and to advance the technology to the point that it is ready to grow in leaps and bounds”.

Roger Dumoulin-White, President and CEO, Theralase Technologies Inc. stated, “I am pleased that Matt and Guy have agreed to serve on our Board of Directors. They both have broad experience in financial management, regulatory compliance and strategic planning and both possess the vision and financial acumen to drive Theralase forward to achieve our full potential. I welcome Matt and Guy to the board and am confident that both will serve the company and the shareholders well during their tenure.”

Mr. Dumoulin-White also stated, “We are all saddened by the loss of our long time board member Mr. John “Jack” Murphy late last year  and we would like to take this opportunity to express our profound condolences to Jack’s family. He was a strong member of our team, an insightful director and always a pleasure to work with. His business judgment and knowledge will be sorely missed”.

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                    

416-694-7246 ext. 225                                  

rwhite@theralase.com

Kristina Hachey

Chief Financial Officer

416-694-7246 ext. 224

khachey@theralase.com 

Arkady Mandel

Chief Scientific Officer

416-694-7246 ext. 242

amandel@theralase.com

Greg Bewsh

Director of Investor Relations

416-694-7246 ext. 258

gbewsh@theralase.com   

Renowned Oncologist Dr. Michael Jewett Joins Theralase’s Medical and Scientific Advisory Board

Toronto, Ontario –January 29, 2013 -- Theralase Technologies Inc. (TSX-V: TLT) is pleased to announce that effective January 15, 2013, Michael Jewett MD, FRCSC, FACS has elected to join its Medical and Scientific Advisory Board.

Dr. Michael Jewett is currently 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 the University Health Network. He is well known for his contributions in the fields of technology assessment and image guided therapy, especially for minimally invasive treatment of kidney and bladder cancer. He is internationally known for his contributions in the fields of bladder, testis and kidney cancer fundamental and clinical research. For his valued contributions to the uro-oncology field, in 2008, Dr. Jewett was awarded the Wyeth/CIHR Rx&D Clinical Research Chair in Oncology. He also holds the Farquaharson Chair for Kidney Cancer Research.

Dr. Jewett has been the Principal Investigator/Co-Principal Investigator on over 60 Phase I-Phase III clinical trials and the Lead Principal Investigator of several Cooperative Group Trials. These clinical trials have primarily been focused on proving the safety, efficacy and clinical benefits of technology in the destruction of cancer, with the ultimate gain of achieving Health Canada or FDA clinical approval. 

He has recently served as Chairman of the Division of Urology at the University of Toronto and of Urology at the University Health Network, which incorporates the Princess Margaret Cancer Centre, one of the world's leading cancer centres. He is a recent Past-President of the Canadian Urology Association and a member of many urological and surgical oncology societies; including the Scientific Advisory Board of the Bladder Cancer Advocacy Network, the Medical Advisory and Research Board of Bladder Cancer Canada, and Chair of the CIHR funded Kidney Cancer Research Network of Canada. Dr. Jewett has been recognized for his lifetime achievements and contributions to Urology by the Canadian Urological Association, the American Urological Association, the Societe Internationale d’Urologie and the Society of Urologic Oncology.

Dr. Jewett stated, “I have been very impressed with the expertise of the Theralase team and with the significant opportunity their Photo Dynamic Compounds (PDCs) present in the field of bladder cancer treatment. I look forward to working with them closely in their quest to commercialize their PDC technology to the ultimate benefit of bladder cancer patients, when the unmet need remains so great”.

Roger Dumoulin-White, President and CEO, Theralase Technologies Inc. stated that, “We are elated to have someone of Dr. Jewett’s calibre join Theralase’s Medical and Scientific Advisory Board to lead our bladder cancer clinical research program. He has been actively engaged in clinical cancer research and will prove to be an invaluable resource for helping to design our clinical protocols, in conjunction with our research team, as we focus on our lead target, bladder cancer. With Dr. Jewett’s expert guidance, we are confident that we will be able to complete the steps necessary to commence FDA Phase 1 human clinical trials in 2013 with our lead Photo Dynamic Compound (PDC), where we will demonstrate that Theralase possesses a highly effective and safe alternative treatment option to patients, suffering from non-muscle invasive bladder cancer. Based on the clinical success of the PDC technology in FDA Phase 1 human clinical trials, Theralase is expected to be granted FDA “Fast Track” designation allowing an expedited priority review and approval process.”

According to the FDA, “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

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                    

416-694-7246 ext. 225                                  

rwhite@theralase.com

Kristina Hachey

Chief Financial Officer

416-694-7246 ext. 224

khachey@theralase.com 

Arkady Mandel

Chief Scientific Officer

416-694-7246 ext. 242

amandel@theralase.com

Greg Bewsh

Director of Investor Relations

416-694-7246 ext. 262

gbewsh@theralase.com   

Back Pain Is #1 Cause of Disability Worldwide

Global Burden of Disease 2010 highlights the pressing need to prevent, treat spinal and musculoskeletal disorders.

By Peter W. Crownfield, Executive Editor

A series of studies emerging from the Global Burden of Disease 2010 Project, a massive collaboration between the World Health Organization, the Institute for Health Metrics and Evaluation (the coordinating center), the University of Queensland School of Population Health, Harvard School of Public Health, Johns Hopkins Bloomberg School of Public Health, and the University of Tokyo, Imperial College London, clarifies the worldwide health burden of musculoskeletal conditions, particularly back and neck pain, in crystal-clear fashion, with low back pain identified as the number-one cause of disability worldwide and neck pain the number-four cause. Overall, musculoskeletal conditions represent the second leading cause of global disability.
Findings emphasize the shift in global health that has resulted from disability making an increasingly larger footprint on the burden of disease compared to a mere 20-30 years ago. In addition, while more people are living longer, the flip side is that they do so with an increasing risk of living with the burden of pain, disability and disease compared to generations past.
Dr. Scott Haldeman, who chaired the 2000-2010 Bone and Joint Decade Task Force on Neck Pain and Its Associated Disorders, and is currently president and CEO of World Spine Care, provided DC with an analysis of the Global Burden of Disease 2010 findings, highlighted as follows:

• Musculoskeletal conditions such as low back pain, neck pain and arthritis affect more than 1.7 billion people worldwide and have a greater impact on the health of the world population (death and disability) than HIV/AIDS, tropical diseases including malaria, the forces of war and nature, and all neurological conditions combined.
• When considering death and disability in the health equation, musculoskeletal disorders cause 21.3 percent of all years lived with disability (YLDs), second only to mental and behavioral disorders, which account for 22.7 percent of YLDs.
• Musculoskeletal conditions represent the sixth leading cause of death and disability, with only cardiovascular and circulatory diseases, neonatal diseases, neoplasms, and mental and behavorial disorders accounting for more death and disability worldwide.
• Low back pain is the most dominant musculoskeletal condition, accounting for nearly one-half of all musculoskeletal YLDs. Neck pain accounts for one-fifth of musculoskeletal YLDs.
• Low back pain is the sixth most important contributor to the global disease burden (death and disability), and has a greater impact on global health than malaria, preterm birth complications, COPD, tuberculosis, diabetes or lung cancer.
• When combined with neck pain (21st most important contributor to the global disease burden including death and disability), painful spinal disorders are second only to ischemic heart disease in terms of their impact on the global burden of disease. Spinal disorders have a greater impact than HIV/AIDS, malaria, lower respiratory infections, stroke, breast and lung cancer combined, Alzheimer's disease, diabetes, depression or traffic injuries.
• Current estimates suggest that 632.045 million people worldwide suffer from low back pain and 332.049 million people worldwide suffer from neck pain.

"The Global Burden of Disease Study provides indisputable evidence that musculoskeletal conditions are an enormous and emerging problem in all parts of the world and need to be given the same priority for policy and resources as other major conditions like cancer, mental health and cardiovascular disease," said Dr. Haldeman.
The seven studies from Global Burden of Disease 2010, as well as accompanying commentaries, appear in The Lancet.

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Efficacy of super-pulsed 905 nm Low Level Laser Therapy (LLLT) in the Management of Traumatic Brain Injury (TBI): A Case Study

RESEARCH

Below you will find my paper recently published in the World Journal of Neuro Science. I have treated over 65 patients for headache/migraine symptoms. The Department of Defense (DOD) has asked me to do anything I can to help resolve major healthcare problem (i.e Traumatic Brain Injury (TBI)) which is of course a major concern for the military.  Shortly after that conversation, a patient was presented to me with a TBI as a result of being hit with a lead pipe 3-4 times. His incapacitating headaches were eliminated in just three treatments. 

As a result of this publication and the positive clinical studies out of Massachusetts, four researchers at the University at Buffalo are preparing to start human trials for Alzheimer’s, Concussion (TBI) and Stroke.  We expect these studies to be done before year-end and if successful will be a major breakthrough in medicine, saving the health care system hundreds of billions of dollars. 

William Stephan, M.D. per 1^st Affiliation, Louis J. Banas, B.S., CLT per 1^st Affiliation, Matthew Bennett, M.D. per 2^nd Affiliation, Huseyin Tunceroglu, MSIV per 3^rd Affiliation

1^st Affiliation: William Stephan M.D., LLC, Buffalo, New York

2^nd.  Affiliation: University of Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York

Email: huseyint@buffalo.edu

Received 04 September 2012.

Abstract

Traumatic brain injury is a major health concern worldwide with massive financial and social impact. Conventional treatments primarily focus on the prevention of further damage to the brain parenchyma, while failing to address the already existent symptoms. Previous clinical studies have shown that Low Level Laser Therapy (LLLT)  can significantly reduce pain and induce temporary vasodilation in capillaries, which the authors hypothesize can be used to improve the quality of life in TBI patients by treating their current symptoms, which are predominately migraine-like headaches. This case report illustrates the use of LLLT in the treatment of a patient with a TBI and the great clinical success achieved in the reduction of pain, as measured by VAS - achievable within five treatments of 10 minutes in duration.

Keywords: Traumatic Brain Injury; Low Level Laser Therapy; LLLT; Chronic Migraines; Headaches

1. INTRODUCTION

Traumatic brain injury (TBI) typically occurs when there is any sudden trauma to the skull that induces damage to the brain. There are many causes of TBIs, but unfortunately no documented cures. According to Faul et al., the annual incidence of TBI in the United States is approximately 1.7 million incidents, which account for 30.5% of injury related deaths[1]. The direct and indirect costs of TBI totaled an estimated 76.5 billion dollars in the United States in 2000 [2]. Traumatic brain injuries play a major role in the health care of our nation, especially in our armed forces, where the men and women serving our country are at a higher risk to suffer a TBI.

Treatment is centered on preventing future insult to the brain, but very little can be done to treat the already existing symptoms. These symptoms, as described by the National Institutes of Health, range from mild to severe and include: headaches, nausea, vomiting, confusion, and blurry vision. Current theory on alleviating the symptoms of TBIs is based on reducing inflammatory and oxidative stress and increasing perfusion to support metabolic needs [3]. A study by Naeser et al. looked at the use of Near Infra Red (NIR) light for the treatment of TBI, stroke, and neurodegenerative disease. Their results were very promising, showing that nightly treatments with NIR LED over a period of months to years improved cognitive abilities [4]. Furthermore, they showed that the use of NIR light increased ATP production, caused vasodilation, and improved perfusion. We believe that the superpulsed 905 nm LLLT system employed in this case study operates through similar mechanisms of action and to support our hypothesis we present a case report of a patient with a traumatic brain injury that was treated with the superpulsed 905 nm LLLT system two years after the injury occurred.

2.   CASE REPORT

A 25 year old man with no pertinent past medical history presented as a new patient. His only complaint was chronic debilitating migraines since a traumatic brain injury which occurred in May of 2010. He was attacked and repeatedly hit over the head with a lead pipe, consequently requiring many sutures and leaving a scar on the brain as evidenced by the MRI performed subsequent to the incident. Since the attack, he has been experiencing excruciating migraines daily which he rates at ranging from 7/10 to 10/10 using a Visual Analog Scale (VAS) reference and physically describes them as: throbbing, squeezing sensations located primarily to the occipital region of his skull. He complains of being unable to have a peaceful night of sleep or to participate in play with his four children, the oldest being 9, due to the constant pain and agony he experiences.

After undergoing multiple previous treatment modalities, which included: medications, vitamin supplements, and chiropractic massage therapies, all of which were unsuccessful at alleviating his symptoms, he had all but given up hope. Willing to try anything to rid himself of the chronic pain, he agreed to undergo LLLT treatment. Using a Theralase® superpulsed LLLT medical laser system equipped with a multiple probe handpiece (5 x 905 nm wavelength @ 0 to 100 mW average power per laser diode + 4 x 660 nm wavelength @ 25 mW average power per laser diode), he was given a total of five treatments delivered over a two week period, with the 905 nm laser diodes set to 50 mW average power. The LLLT was targeted to a total of four areas on the scalp for two and a half minutes each: midline occipital region just below the lamboidal suture, superior aspect of the nape to target the Circle of Willis and over the mastoid processes bilaterally. We selected 905nm wavelength based on a previous scientific study that demonstrated that the 905 nm superpulsed wavelength employed by the system was able to increase inducible Nitric Oxide Synthase (iNOS) expression by 700%, as compared to numerous other wavelengths that showed little or no effect [5]. iNOS has been well documented in numerous clinical studies to cause temporary vasodilation by signaling endothelial cells located in capillary walls to become flaccid and relax. Additional studies have shown that 810 nm and 665 nm wavelengths may also be effective, but those specific wavelengths are not able to produce as much iNOS expression, when compared to 905 nm superpulsed technology [6]. An average power for the superpulsed 905 nm laser diodes was initially chosen to be 50mW based on personal experience, but further clinical investigations may uncover more clinically effective average power settings.

Immediately after the first treatment of only ten minutes in duration, the patient reported a 43% reduction in pain, reporting a VAS of 4/10 from a pre-treatment score of 7/10. He stated the throbbing and squeezing nature of his pain had immediately subsided and that all that was left was more of a dull achy pain. He continued with the treatments over the next week and with each new treatment his pain was further reduced. By the end of the course of 5 treatments, his pain had reduced by over 90% and all that remained was a minor ache that was barely even noticeable. Furthermore, he reported no side effects from the treatment except for a slight sensation of warmth over the area where the laser was placed. He was no longer experiencing constant pain; even his children noticed the difference saying that he looked happier. After two years, he was finally able to achieve a good night’s rest.

3.   DISCUSSION

Low Level Laser Therapy (LLLT) has been used in many acute and chronic conditions, but its effectiveness is yet to be fully documented by human clinical trials for migraine, stroke or TBI. Currently Dr. Michael Whalen, working at Massachusetts General Hospital, is conducting controlled studies using a low level laser with the hopes of bringing this new technology into the forefront of neuroscience and medicine. This case study gives one example of how LLLT can be used to treat chronic migraines, specifically those that are a result of traumatic brain injuries. LLLT has been shown to reduce pain and inflammation, create a state of vasodilation by activating the nitric oxide pathway and further even promote angiogenesis. The present theory is that by increasing blood flow to the brain, and subsequently, increasing oxygen delivery to the brain, the symptoms of a migraine can be mitigated. This case differs from previous studies performed using laser therapy to help patients with TBIs in that the type of laser and the settings used were unique. Specifically, unlike the LED light used by Naeser et al., the therapeutic laser we utilized only required five treatments over two weeks to be effective with immediate results after the first treatment.

It is currently unclear whether or not our patient will need maintenance therapy. He was interviewed at two weeks and 5 months post treatment, does carpentry work with his father   and remains symptom free. He is deeply appreciative of the care he was given and continues to enjoy family life which was impossible before LLLT. More research needs to be done, especially controlled double blind studies to further evaluate the full effectiveness and possible side effects of using LLLT in the treatment of TBIs and migraines, but the latest research has shown that LLLT is an extremely safe and effective technology for a wide range of neural and muscular skeletal conditions.

Note: Mr. Banas has successfully treated over 65 migraine patients not all of whom were victims of a TBI

but except for a few instances gave the a patients life changing , significant relief.

REFERENCES

1.            Faul M, X.L., Wald MM, Coronado VG, Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. 2010.

2.            Finkelstein E, C.P., Miller T and associates, The Incidence and Economic Burden of Injuries in the United States. Oxford University Press, 2006.

3.            Sahni, T., et al., Use of hyperbaric oxygen in traumatic brain injury: retrospective analysis of data of 20 patients treated at a tertiary care centre. Br J Neurosurg, 2012. 26(2): p. 202-7.

4.            Naeser, M.A. and M.R. Hamblin, Potential for transcranial laser or LED therapy to treat stroke, traumatic brain injury, and neurodegenerative disease. Photomed Laser Surg, 2011. 29(7): p. 443-6.

5.            Moriyama, Y., et al., In vivo effects of low level laser therapy on inducible nitric oxide synthase. Lasers Surg Med, 2009. 41(3): p. 227-31.

6.            Wu, Q., et al., Low-level laser therapy for closed-head traumatic brain injury in mice: effect of different wavelengths. Lasers Surg Med, 2012. 44(3): p. 218-26.