Q3 - September 2012THERALASEQUARTERLY NEWSLETTERAn update for clients, investors and employeesUPCOMING WEBINARSOctober 23, 2012 November 27, 2012Clinical and Business Rewards of Using Laser in Practice Current Research in Low Level Laser TherapyTo register To registerhttps://www2.gotomeeting.com/register/793806762 https://www2.gotomeeting.com/register/415407642UPCOMING SEMINARSTheralase’s Dr. Rhonda Mostyn will be presenting “Modern Science, Classic Healing: Therapeutic Laser Therapy andChiropractic” at Parker Seminars Toronto on Friday, September 21, 2012 at 11:00 am.CORPORATE UPDATESTheralase Creates Two Operating DivisionsOn August 16, 2012, Theralase announced that it is reorganizing its operations into two separate reportable operatingdivisions to better service and focus the companys resources for both independent markets. The Therapeutic LaserTechnology (TLT) division will be responsible for all aspects of the Companys burgeoning therapeutic laser business,which manufactures products used by healthcare practitioners predominantly for the healing of pain and the PhotoDynamic Therapy (PDT) division, which researches and develops Photo Dynamic Compounds (PDCs) for thedestruction of primarily cancer.It has become evident through the recent successes of both technology platforms that these two operating divisions haveunique requirements in terms of financing, staffing, logistics and resource allocation. Our intent is to manage and focusthe direction of each division to better execute on their respective strategic objectives. Theralases mandate is to buildboth the TLT and PDT divisions into separate $50 million annual recurring revenue models within the next 5 to 7 years.Photo Dynamic Therapy PDT divisionThere exists a substantial stream of research on the amount of systemic cytotoxic drugs and physical modalitiesassociated with different types of radiation therapy. Despite its many successes, and in spite of decades of advancedresearch with highly sophisticated instrumentation, it has not solved many of the basic mysteries of cancer. Worse yet,every gain seems to be more than offset by additional serious problems and contradictions.Theralase Inc., therefore, offers an innovative Photodynamic therapy (PDT) paradigm and patented approach for thenovel anti-cancer technology platform.
Photodynamic therapy (PDT) is a clinically approved, minimally invasive therapeutic procedure that can exert a selectivecytotoxic activity toward malignant cells. The procedure involves administration of a photosensitizing agent followed byirradiation at a wavelength corresponding to an absorbance band of the sensitizer. In the presence of oxygen, a series ofevents lead to direct tumor cell death, damage to the microvasculature, and induction of a local inflammatory reaction.Clinical studies revealed that PDT can be curative, particularly in early stage tumors. It can prolong survival in patients withinoperable cancers and significantly improve quality of life. Minimal normal tissue toxicity, negligible systemic effects,greatly reduced long-term morbidity, lack of intrinsic or acquired resistance mechanisms, and excellent cosmetic as well asorgan function-sparing effects of this treatment make it a valuable therapeutic option for combination treatments.However, contemporary PDT produces mostly superficial effects. Due to a limited light penetration through tissues, thedepth of tumor destruction ranges from a few millimeters to up to 1 centimeter. Theralase’s breaking-ground technologyoffers a complete illumination of this apparent disadvantage. Therefore, Theralase’s technology platform, which offers anumber of significant technological improvements and a barrier-breaking innovation, has the potential to become the firstPDT integrated into the mainstream of cancer treatment.Theralase Identifies the First Cancer Target for itsAdvanced Photo Dynamic TherapyOn July 18, 2012, Theralase announced that it has selected Theralase plans to aggressively pursue commercializationbladder cancer as the first clinical target in its Novel Photo of our ground-breaking PDC technology through theDynamic Compound (PDC) research. Theralase now has accelerated FDA regulatory approval process. Theralasea clear direction with which to proceed with FDA Clinical feels its technology will prove as effective in bladderTrials. Bladder cancer is the fifth most common cancer in cancer preclinical trials that will eventually lead to FDANorth America being the fourth most common in men and clinical approval.the eighth most common in woman. In North America, it isestimated that there will be over 77,000 new cases and Theralase Accelerates Intellectual Property Strategyover 15,000 deaths annually. On April 13, 2012, Theralase Technologies Inc. announced that it has filed a patent application for a newly developed Photo Dynamic Compound (PDC) to be added to its library of patented Photo Dynamic Compounds. It has been a stated objective to build on these important existing holdings and continue to expand the Intellectual Property footprint of the corporation. This filing represents a significant step in this regard and will specifically target new avenues in the destruction of cancers, bacteria and viruses. "I had indicated to our shareholders that we would quickly show evidence of our IP strategy," said Roger Dumoulin-White, CEO of Theralase Technologies. "WeThe Theralase light activated PDC drug has been proven firmly believe that our patents will be invaluable toto be superior to any currently approved FDA PDC drug Theralase as we continue to execute on our growth planon the market, tested in Theralase’s lab and we are working on the road to commercialization.”hard to help eliminate this devastating disease that candramatically affect so many families.
Mr. White added, “Further to our press release of March 28, 2012, I am pleased to say that the mice, with under the skincolon cancer tumours treated with Theralase’s patented anti-cancer PDC technologies have survived and flourishedforty-eight days post treatment; the mice continue to be cancer free. Based on recent successes in our research, we areconfident that Theralase is well positioned to expedite the required steps to initiate human trials in the near future.”Theralase Identifies Leading Anti-Cancer Drug CandidateOn March 14, 2012, Theralase Technologies Inc. announced that it is pursuing FDA Phase 1 approval for its patentedPhoto Dynamic Compounds (PDCs).Theralase has successfully identified the leading drug candidate, which will be used for safety and efficacy clinical testingin human cancer patients. In multiple preclinical studies, the leading drug candidate has been selected from Theralase’slibrary of PDCs and has repeatedly demonstrated: • extremely high efficacy, virtually 100% kill rate, in various cancer cell lines including brain and colorectal cancers • robust destruction of subcutaneous (under the skin) cancerous tumours in animals • extremely low toxicity • high stability, allowing for a long shelf lifeThe preclinical results were reviewed by SPIE (The International Society for Optics and Photonics) and were accepted bythe Conference Chairs for presentation at the SPIE Photonics Europe conference in Brussels, Belgium.Theralase will validate its extensive data with additional cancer animal models and toxicology analyses. This will providethe results required by the FDA to design a FDA Phase 1 clinical human study to commence in 2013 with scheduledcompletion in 2014.Roger Dumoulin-White, President and CEO of Theralase Inc. stated, "Achievement of this critical milestone representsirrefutable proof that the Theralase leading drug PDC candidate is effective in the destruction of cancer in live animalmodels. The treatment was well tolerated by the animals, eliminating their cancer without any adverse effects. TheTheralase leading drug candidate has been proven to be superior to any currently approved FDA PDC drug on themarket, tested in our lab.”Theralase Featured on "The Next Biggest Winner" Business TV SeriesTheralase was featured on "The Next Biggest Winner", a television series devoted to discovering undervalued companieswith the ability to grow significantly in shareholder value and become a big winner as an investment opportunity.The TV show, "The Next Biggest Winner," which showcases companies with significant growth potential scheduled anin-depth interview with Roger Dumoulin-White, President and CEO of Theralase Technologies Inc. on the iChannel,Tuesday, August 14th at 7:30pm. The iChannel has over 1.3 million affluent Canadian subscribers who look to its businessprogramming for new investment opportunities.To view the interview, please visithttp://www.thenextbiggestwinner.com/theralase-technologies-inc/
Therapeutic Laser Technology (TLT) divisionLow Level Laser Therapy (LLLT) is the drug-free, non-invasive and safe (FDA recognised) clinical application of light inthe range of 1mW – 500mW to a patient to promote tissue regeneration, reduce inflammation and relieve pain. Theralasetechnology is the only product on the market that activates all three known cellular pathways (ATP production, iNOSproduction and Na+ / K+ pump regulation) and provides a depth of penetration of four inches into tissue. Theralasetechnology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletalconditions and wound healing. The White Paper “UNDERSTANDING THE MECHANISMS OF LOW LEVELLASER THERAPY (LLLT)” may be accessed from the Theralase website and offers independent clinical studies tosupport the science.Theralase Establishes Middle East DistributionNetworkOn May 30, 2012, Theralase Technologies Inc. announced BioFinance is a leading life sciences investor conference inthat it had entered into an exclusive distribution Canada, which highlights more than 60 diverse life scienceagreement with Jordan based medical device distributor companies, and the investment opportunities that theyMediQu to market and sell the Theralase line of present. BioFinance 2012 also featured 17 investortherapeutic medical lasers into the Middle East, branded presentations that are aimed at addressing specificas Theralase Arabia. financing and management related issues relevant to life science industries.Under the terms of the agreement, MediQu willexclusively market and sell the Theralase therapeutic Theralase’s presentation took place Wednesday, May 30thmedical laser technology in Jordan, Lebanon, Syria, Iraq, at the St. Andrew’s Club and Conference Center. Mr.Saudi Arabia, Kuwait, United Arab Emirates, Bahrain, Roger Dumoulin-White, President and CEO of TheralaseQatar, Yemen, Oman, Egypt, Sudan, Libya, Algeria, presented on the strategic direction and recentTunisia, Mauritania and Morocco, in exchange for accomplishments of the company followed by a shortachievement of certain minimum performance criteria. Q&A period and one-on-one meetings with investors.MediQu is a large medical device distribution company in Theralase Closes Equity Financingthe Middle East that has partnered with Theralase to On April 13, 2012 Theralase Technologies Inc. stated that itestablish Theralase Arabia bringing to the table an has closed a previously announced private placement (theimpressive array of government, commercial and medical "Private Placement") of 3,000,000 units (the "Units") at acontacts including numerous major hospitals, medical price of Cdn $0.25 per Unit for gross proceeds of CDNclinics and doctors in the region. Theralase Arabia expects $750,000.00. Each Unit consists of one common share into exceed USD $5 million annually in the Middle East the capital of the Company and one-half of onewithin 3 to 5 years of launch. non-transferable common share purchase warrant (a "Warrant"). Each whole Warrant entitles the purchaser toTheralase Presents at BioFinance 2012 Life purchase one additional common share (a "WarrantSciences Conference Share") in the capital of the Company until April 13, 2013 atRoger Dumoulin-White, President and CEO presented a price of CDN $0.38 per Warrant Share. The securitiesthe latest corporate information at the BioFinance 2012 issued under the Private Placement including any sharesconference held in Toronto, Ontario from May 29 to 30, issued upon exercise of the Warrants are subject to a four2012. month hold period, expiring August 13, 2012.
The company intends to utilize the proceeds of the offering to provide additional working capital to further develop theCompanys prospects in a number of areas; specifically: • Support of small animal cancer trials at the Ontario Cancer Institute, Princess Margaret Hospital, University Health Network • Research and development of Photo Dynamic Compounds used in conjunction with the patented Theralase laser technology in the destruction of bacteria and viruses • TLC-1000 and TLC-900 therapeutic medical laser USA sales and marketing expansion • TLC-1000 therapeutic medical laser incorporating TENS (Transcutaneous Electrical Nerve Stimulation) • TLC-2000 therapeutic medical biofeedback laser commercializationOUTLOOKTheralase will continue to focus on increasing product sales of the TLC-1000 laser technology and the TLC-900controllerless laser series in the Canadian, US and international markets in 2012, supported by new independent scientificresearch confirming the effectiveness of Theralase’s proprietary and patented technology. Theralase will commercializeits patented TLC-2000 Biofeedback technology for launch in the first quarter of 2013, while researching and developingits patented TLC-3000 Photo Dynamic Compounds targeting the destruction of cancer, bacteria and viruses.The groundwork has been laid for significant growth. Our proven patented technology has no equal and our ability todramatically scale sales and marketing geographically as well as demographically will allow Theralase significant firstmover market advantage. Theralase is currently debt free as it utilizes its profits from the sale of its TLC-1000 andTLC-900 Therapeutic Medical Laser platforms to pay for its future growth in the form of the launch of the TLC-2000Biofeedback Therapeutic Laser Technology and the commercialization of the TLC-3000 Photo Dynamic CompoundCancer Destruction Technology.This newsletter contains forward-looking statements which reflect the Companys current expectations regarding future events. The forward-lookingstatements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligationto update these forward-looking statements.For more information, please contact:Roger Dumoulin-White Kristina HacheyPresident & CEO, Chief Financial Officer416-447-8455 ext. 225 416-447-8455 ext. firstname.lastname@example.org email@example.comGreg Bewsh Dr. Arkady MandelDirector of Investor Relations, Chief Scientific Officer416-447-8455 ext. 262 416-447-8455 ext. firstname.lastname@example.org email@example.com