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1. Q3 - September 2012
THERALASE
QUARTERLY NEWSLETTER
An update for clients, investors and employees
UPCOMING WEBINARS
October 23, 2012 November 27, 2012
Clinical and Business Rewards of Using Laser in Practice Current Research in Low Level Laser Therapy
To register To register
https://www2.gotomeeting.com/register/793806762 https://www2.gotomeeting.com/register/415407642
UPCOMING SEMINARS
Theralase’s Dr. Rhonda Mostyn will be presenting “Modern Science, Classic Healing: Therapeutic Laser Therapy and
Chiropractic” at Parker Seminars Toronto on Friday, September 21, 2012 at 11:00 am.
CORPORATE UPDATES
Theralase Creates Two Operating Divisions
On August 16, 2012, Theralase announced that it is reorganizing its operations into two separate reportable operating
divisions to better service and focus the company's resources for both independent markets. The Therapeutic Laser
Technology (TLT) division will be responsible for all aspects of the Company's burgeoning therapeutic laser business,
which manufactures products used by healthcare practitioners predominantly for the healing of pain and the Photo
Dynamic Therapy (PDT) division, which researches and develops Photo Dynamic Compounds (PDCs) for the
destruction of primarily cancer.
It has become evident through the recent successes of both technology platforms that these two operating divisions have
unique requirements in terms of financing, staffing, logistics and resource allocation. Our intent is to manage and focus
the direction of each division to better execute on their respective strategic objectives. Theralase's mandate is to build
both the TLT and PDT divisions into separate $50 million annual recurring revenue models within the next 5 to 7 years.
Photo Dynamic Therapy PDT division
There exists a substantial stream of research on the amount of systemic cytotoxic drugs and physical modalities
associated with different types of radiation therapy. Despite its many successes, and in spite of decades of advanced
research 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 the
novel anti-cancer technology platform.
2. Photodynamic therapy (PDT) is a clinically approved, minimally invasive therapeutic procedure that can exert a selective
cytotoxic activity toward malignant cells. The procedure involves administration of a photosensitizing agent followed by
irradiation at a wavelength corresponding to an absorbance band of the sensitizer. In the presence of oxygen, a series of
events 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 with
inoperable 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 as
organ 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, the
depth of tumor destruction ranges from a few millimeters to up to 1 centimeter. Theralase’s breaking-ground technology
offers a complete illumination of this apparent disadvantage. Therefore, Theralase’s technology platform, which offers a
number of significant technological improvements and a barrier-breaking innovation, has the potential to become the first
PDT integrated into the mainstream of cancer treatment.
Theralase Identifies the First Cancer Target for its
Advanced Photo Dynamic Therapy
On July 18, 2012, Theralase announced that it has selected Theralase plans to aggressively pursue commercialization
bladder cancer as the first clinical target in its Novel Photo of our ground-breaking PDC technology through the
Dynamic Compound (PDC) research. Theralase now has accelerated FDA regulatory approval process. Theralase
a clear direction with which to proceed with FDA Clinical feels its technology will prove as effective in bladder
Trials. Bladder cancer is the fifth most common cancer in cancer preclinical trials that will eventually lead to FDA
North America being the fourth most common in men and clinical approval.
the eighth most common in woman. In North America, it is
estimated that there will be over 77,000 new cases and Theralase Accelerates Intellectual Property Strategy
over 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. "We
The Theralase light activated PDC drug has been proven
firmly believe that our patents will be invaluable to
to be superior to any currently approved FDA PDC drug
Theralase as we continue to execute on our growth plan
on the market, tested in Theralase’s lab and we are working
on the road to commercialization.”
hard to help eliminate this devastating disease that can
dramatically affect so many families.
3. Mr. White added, “Further to our press release of March 28, 2012, I am pleased to say that the mice, with under the skin
colon cancer tumours treated with Theralase’s patented anti-cancer PDC technologies have survived and flourished
forty-eight days post treatment; the mice continue to be cancer free. Based on recent successes in our research, we are
confident that Theralase is well positioned to expedite the required steps to initiate human trials in the near future.”
Theralase Identifies Leading Anti-Cancer Drug Candidate
On March 14, 2012, Theralase Technologies Inc. announced that it is pursuing FDA Phase 1 approval for its patented
Photo Dynamic Compounds (PDCs).
Theralase has successfully identified the leading drug candidate, which will be used for safety and efficacy clinical testing
in human cancer patients. In multiple preclinical studies, the leading drug candidate has been selected from Theralase’s
library 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 life
The preclinical results were reviewed by SPIE (The International Society for Optics and Photonics) and were accepted by
the 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 provide
the results required by the FDA to design a FDA Phase 1 clinical human study to commence in 2013 with scheduled
completion in 2014.
Roger Dumoulin-White, President and CEO of Theralase Inc. stated, "Achievement of this critical milestone represents
irrefutable proof that the Theralase leading drug PDC candidate is effective in the destruction of cancer in live animal
models. The treatment was well tolerated by the animals, eliminating their cancer without any adverse effects. The
Theralase leading drug candidate has been proven to be superior to any currently approved FDA PDC drug on the
market, tested in our lab.”
Theralase Featured on "The Next Biggest Winner" Business TV Series
Theralase was featured on "The Next Biggest Winner", a television series devoted to discovering undervalued companies
with 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 an
in-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 business
programming for new investment opportunities.
To view the interview, please visit
http://www.thenextbiggestwinner.com/theralase-technologies-inc/
4. Therapeutic Laser Technology (TLT) division
Low Level Laser Therapy (LLLT) is the drug-free, non-invasive and safe (FDA recognised) clinical application of light in
the range of 1mW – 500mW to a patient to promote tissue regeneration, reduce inflammation and relieve pain. Theralase
technology is the only product on the market that activates all three known cellular pathways (ATP production, iNOS
production and Na+ / K+ pump regulation) and provides a depth of penetration of four inches into tissue. Theralase
technology is safe and effective in treating pain, inflammation and for tissue regeneration of neural muscular skeletal
conditions and wound healing. The White Paper “UNDERSTANDING THE MECHANISMS OF LOW LEVEL
LASER THERAPY (LLLT)” may be accessed from the Theralase website and offers independent clinical studies to
support the science.
Theralase Establishes Middle East Distribution
Network
On May 30, 2012, Theralase Technologies Inc. announced BioFinance is a leading life sciences investor conference in
that it had entered into an exclusive distribution Canada, which highlights more than 60 diverse life science
agreement with Jordan based medical device distributor companies, and the investment opportunities that they
MediQu to market and sell the Theralase line of present. BioFinance 2012 also featured 17 investor
therapeutic medical lasers into the Middle East, branded presentations that are aimed at addressing specific
as Theralase Arabia. financing and management related issues relevant to life
science industries.
Under the terms of the agreement, MediQu will
exclusively market and sell the Theralase therapeutic Theralase’s presentation took place Wednesday, May 30th
medical 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 Theralase
Qatar, Yemen, Oman, Egypt, Sudan, Libya, Algeria, presented on the strategic direction and recent
Tunisia, Mauritania and Morocco, in exchange for accomplishments of the company followed by a short
achievement 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 Financing
the Middle East that has partnered with Theralase to
On April 13, 2012 Theralase Technologies Inc. stated that it
establish Theralase Arabia bringing to the table an
has closed a previously announced private placement (the
impressive array of government, commercial and medical
"Private Placement") of 3,000,000 units (the "Units") at a
contacts including numerous major hospitals, medical
price of Cdn $0.25 per Unit for gross proceeds of CDN
clinics and doctors in the region. Theralase Arabia expects
$750,000.00. Each Unit consists of one common share in
to exceed USD $5 million annually in the Middle East
the capital of the Company and one-half of one
within 3 to 5 years of launch.
non-transferable common share purchase warrant (a
"Warrant"). Each whole Warrant entitles the purchaser to
Theralase Presents at BioFinance 2012 Life purchase one additional common share (a "Warrant
Sciences Conference Share") in the capital of the Company until April 13, 2013 at
Roger Dumoulin-White, President and CEO presented a price of CDN $0.38 per Warrant Share. The securities
the latest corporate information at the BioFinance 2012 issued under the Private Placement including any shares
conference held in Toronto, Ontario from May 29 to 30, issued upon exercise of the Warrants are subject to a four
2012. month hold period, expiring August 13, 2012.
5. The company intends to utilize the proceeds of the offering to provide additional working capital to further develop the
Company's prospects in a number of areas; specifically:
• Support of small animal cancer trials at the Ontario Cancer Institute, Princess Margaret Hospital, University Health
Network
• Research and development of Photo Dynamic Compounds used in conjunction with the patented Theralase laser
technology in the destruction of bacteria 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 commercialization
OUTLOOK
Theralase will continue to focus on increasing product sales of the TLC-1000 laser technology and the TLC-900
controllerless laser series in the Canadian, US and international markets in 2012, supported by new independent scientific
research confirming the effectiveness of Theralase’s proprietary and patented technology. Theralase will commercialize
its patented TLC-2000 Biofeedback technology for launch in the first quarter of 2013, while researching and developing
its 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 to
dramatically scale sales and marketing geographically as well as demographically will allow Theralase significant first
mover market advantage. Theralase is currently debt free as it utilizes its profits from the sale of its TLC-1000 and
TLC-900 Therapeutic Medical Laser platforms to pay for its future growth in the form of the launch of the TLC-2000
Biofeedback Therapeutic Laser Technology and the commercialization of the TLC-3000 Photo Dynamic Compound
Cancer Destruction Technology.
This newsletter 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.
For more information, please contact:
Roger Dumoulin-White Kristina Hachey
President & CEO, Chief Financial Officer
416-447-8455 ext. 225 416-447-8455 ext. 224
rwhite@theralase.com khachey@theralase.com
Greg Bewsh Dr. Arkady Mandel
Director of Investor Relations, Chief Scientific Officer
416-447-8455 ext. 262 416-447-8455 ext. 242
gbewsh@theralase.com amandel@theralase.com