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.

For more information please visit www.theralase.com or call 1-855-494-7246 (PAIN)

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.