Company
Theralase Technologies Inc. (TSXV: TLT) designs, develops
and manufactures patented, superpulsed laser technology used in a wide range of
biostimulation and biodestruction clinical applications. The Theralase
technology platform targets several diverse healthcare sectors:
Theralase Technologies Inc. is focused on a two‐part
strategy:
1. Production, marketing and distribution of the Theralase
Superpulsed Laser for sale to health care practitioners that are dedicated to the
treatment of chronic pain, sports injuries and wounds. In 4Q2013, launch the
patented TLC‐2000 biofeedback laser system internationally to provide a quantum
leap in therapeutic laser technology.
2. Commercialization of patented cancer technology through preclinical
research, human clinical trials and regulatory approvals in the direct
destruction of cancer.
Science
In 1917, Albert Einstein first published the principle of Light Amplification by Stimulated
Emission of Radiation, or quite simply lasers. In June 1960, Theodoro H. Maiman
constructed, using a ruby crystal, the first operational laser. In 1965,
doctors Sinclair, Knoll and Mester pioneered the way for therapeutic lasers;
lasers that do not cut or destroy tissue, but lasers that heal and have a
therapeutic curative effect on tissue. Approximately 3,000 clinical studies
worldwide have attested to the beneficial and curative effects of therapeutic
lasers. In the last twenty years, therapeutic lasers have dramatically
increased in power and effectiveness and decreased in cost and size.
Therapeutic laser therapy is a universal way of treating and
healing tissue structures, such as: muscles, tendons, ligaments, joints,
connective tissues, bones and skin. There are thousands of tissue conditions
that therapeutic medical lasers can be applied to, such as: pain relief,
muscular‐skeletal conditions, nerve rehabilitation, wound healing, anti‐aging
and addiction therapy.
Biodestructive laser therapy uses proprietary laser
technology to activate the Photo Dynamic key of specifically designed Photodynamic
Compounds (PDCs) that have an affinity to certain tissue types and when light
activated have the ability to destroy the target cell. There are thousands of
potential applications of this technology including the destruction of: cancer,
bacteria and viruses. Theralase has a worldwide exclusive patent to a platform
of PDCs that are unique in that they are activated via a Type 1 reaction that
is independent of oxygen, an important characteristic, as solid core tumors
(i.e. breast, bladder, lung, brain, prostate, et cetera) are hypoxic (low
oxygen) in nature.
Products
1) TLC‐1000
Biomedical Laser Platform (to be phased out by 2014)
The TLC‐1000 therapeutic laser technology is a non‐invasive,
superpulsed, dual wavelength, multiple diode laser system that has three
specifically designed probes; a multiple probe used for neural muscular
skeletal conditions, a dermatological probe used for facial and small area
treatments and an acupuncture probe used for stimulation of acupuncture and
trigger points. The TLC‐1000 is FDA, Health Canada and CE approved and is the
current lead product in the Company’s US sales and marketing expansion. In
addition, Theralase has product distributors in the Middle East and China.
Theralase provides turnkey support on its technology,
enabling customers to deliver safe, effective and profitable rehabilitation
treatments including customer service, clinical training, new applications,
marketing and patient referrals.
2) TLC‐2000
Biofeedback Laser Platform (Launch date: 4Q2013)
The Theralase TLC‐2000 biofeedback laser system is a quantum
leap forward in therapeutic laser technology. The TLC-2000 is able to measure a
patient’s optical profile in a matter of seconds and then deliver a precise,
clinical dosage of energy to their specific condition in a matter of minutes.
Clinically effective dosages specific to optical tissue profiles will be stored
in a HIPAA compliant central databank and be available real time to all
practitioners utilizing the TLC‐2000 therapeutic laser. The TLC‐2000 laser
system is also a learning device that remembers the most clinically effective
treatments performed by practitioners and transmits this information to the
central databank for the benefit of all users. Theralase is currently
commercializing the technology and plans to introduce the TLC‐2000 laser system
to the international medical market in 4Q2013. Theralase in keeping with its
mandate of world-class customer service will allow every Theralase customer,
the ability to trade up to the new state of the art TLC‐2000 laser system. In
order to allow all laser practitioners a common tool to use in the delivery of
precision therapeutic laser treatments, Theralase will allow purchasers of
competitive products the ability to trade up to the TLC‐2000, under certain
terms and conditions.
The TLC‐2000 will also be used to launch Theralase into a
new business model, the recurring revenue model; whereby:
Theralase will provide the technology, training, ongoing service
and ongoing marketing / customer referrals for a one time up-front fee, plus a small
portion of each treatment delivered. In this model, Theralase will partner with
medical practitioners by lowering the up-front cost of the equipment and
participating in each treatment delivered by the practitioner. The equipment
will be billed through the internet; thus, allowing real time payments and
control over non-payment by practitioners.
The Theralase TLC‐2000 biofeedback laser technology is
patented in the United States, five European countries and Canada.
Theralase therapeutic laser systems are manufactured in an
ISO‐13485 internationally certified medical manufacturing facility based in
Toronto, Ontario, Canada.
3) TLC‐3000
Photodynamic Compound (PDC) / Laser Technology Platform
This technology involves the research and development of Photodynamic
Compounds combined and activated by proprietary biomedical lasers for the
selective destruction of cancers, bacteria and viruses. The clinical
applications of this technology may possibly have a significant impact on one
of the most devastating diseases of our time.
Theralase has successfully completed Milestone 1 – in‐vitro Analysis in the R&D of this
technology and has successfully destroyed brain, breast and colon cancer cell
lines in an in‐vitro analysis in 2010.
Theralase has successfully completed Milestone 2 – Small Animal
in‐vivo preclinical analysis of the
PDC technology, which commenced in 2011 and was successfully completed in 2012.In
this phase, complete destruction of colon cancer in an orthotopic mouse model
was achieved with the mice now living cancer free for over 1 year post
treatment.
Theralase is currently pursuing Milestone 3a – Destruction
of bladder cancer in an orthotopic animal model.
Therapeutic Market
Therapeutic laser technology could potentially be used by
over 1 million healthcare practitioners and 300 million public consumers in the
US and Canada in the next 5 years.
The therapeutic laser market is extremely fragmented with no
one company seen as the industry leader. All companies claim to have the best
product in terms of efficacy, often without any scientific research support.
Theralase therapeutic lasers have been tested in gold standard blinded, randomised,
controlled clinical studies and have proven unequivocally that the Theralase
therapeutic laser system is clinically and statistically effective in reducing
pain and inflammation in a wide variety of patients. Many of Theralase’s clinical
studies have been peer-reviewed and accepted for publication in medical
journals as well as presented at international scientific conferences.
Strategic Opportunity
Theralase plans to introduce a new business mode in
therapeutic lasers, the recurring revenue model; whereby, Theralase will
provide the technology, training, service and customer referrals, in exchange
for an upfront fee and monthly usage fee. In this model, Theralase will partner
with the medical practitioner by lowering the up-front cost of the equipment
and participating in each treatment delivered by the practitioner. The
equipment will be billed through the internet; thus allowing real time payments
and control over non-payment by practitioners. Theralase expects to generate
annual recurring revenue of $48 to $60 million per year within the next 5 years
with 8,000 to 10,000 units in operation producing a minimum monthly revenue
stream of $500 per month per laser. This financial model has been successfully
employed by many Fortune 500 companies, including: cell phone, photocopier,
satellite and cable TV industries.
Cancer Market
Bladder cancer has been chosen as Theralase’s principal
cancer target for its lead PDC compound. Theralase PDCs have proved to be toxic
to bladder cancer cells when light activated (100% kill rate) at very low
effective concentrations.
$3.98 billion is spent annually for Bladder Cancer Treatment
in the USA. There are 73,000 new cases and over 15,000 deaths in the US each
year; worldwide 386,000 new bladder cancer cases occur annually.
Bladder cancer is the most expensive cancer to treat with a
recurrence rate of up to 80%. Standard treatment has remained relatively unchanged
with no new drugs approved since 1998.
Strategic Opportunity
Completion of a FDA Phase 1/2a clinical study in bladder
cancer within 3 years. Theralase would then move to sell all rights to the
bladder cancer PDC technology to a pharmaceutical company for a milestone
payment of between $113 to $362 million, research and development costs and would
include an annual royalty stream of $50 to 60 million for 17 years.
Sales
To roll-out the TLC‐2000 Biofeedback Laser Platform, Theralase
will implement a US and Canadian sales strategy which focuses on establishing
beach heads through physical locations in each of the 5 largest US states and 2
largest Canadian provinces by population; California, New York, Illinois,
Texas, Florida, Alberta and Ontario. A
1500 to 2000 square foot leased property will be secured in each of the major
cities of these territories and employ a full time receptionist, clinic manager,
multidisciplinary practitioners (revenue sharing basis) and a Territory Sales
Manager (TSM). The clinic manager will be responsible for clinic sales, while
the TSM will be responsible for product sales. The property will provide
multiple functions in one location; including: a multidisciplinary clinic used to
generate brand awareness and clinic sales to offset the overhead of the
facility, provide a training and teaching location for new practitioners,
provide a service depot for product warranty exchanges and provide a sales
location for the TSM to generate product sales and build a distribution network
of sales professionals to sell the Company’s products on a commission basis.
These 7 TSM’s will be supported by the Company with:
1) Affiliation with well-known teaching hospitals,
chiropractic, physical therapist and medical doctor teaching universities and colleges
to provide high-level clinical and testimonial support
3) Regional and national sales and marketing programs
focused on bringing healthcare practitioners to the clinic to learn about the
technology and become a “Theralase Certified Laser Center” in their area
4) National and regional marketing to patients about the
benefits of therapeutic laser technology including a presence at major
healthcare and industry conferences
5) Seminar and Webinar series to present Theralase’s technology
to healthcare practitioners
Key Employees and
Advisors
Roger Dumoulin-White, P.Eng,
President and CEO
Mr. Dumoulin-White founded Theralase in 1995 and has over 25 years as a
senior manager with private and public companies. As an award-winning
entrepreneur, he has pioneered Low-Level Laser Therapy for use in treating
pain, inflammation and for tissue regeneration of neural muscular skeletal
conditions and wound healing. He is responsible for developing patented Photo
Dynamic Compounds (PDCs) that are able to target and destroy cancers, bacteria
and viruses when light activated by Theralase’s proprietary laser technology.
Kristina Hachey, CGA, CFO
Ms. Hachey has over 16 years of experience in finance and financings in
public and private companies.
Arkady Mandel, MD, Ph.D., D.Sc.,
Chief Scientific Officer
Dr. Mandel has over 20 years of experience as a key founder of
therapeutic uses of lasers in dermatology and other areas of clinical medicine.
He is an experienced executive manager of research and development teams
dedicated to the field of biotechnology, drug development and photobiology. He
has published over 100 original scientific papers to his name, combined with
over 200 international patents attributed to his research. He is an editor of many
peer reviewed scientific and medical journals.
Lothar Lilge, Ph.D., Professor
in the Department of Medical Biophysics, University of Toronto, Senior
Scientist at the Ontario Cancer Institute / Princess Margaret Cancer Centre / University
Health Network
Dr. Lilge's research is focused on photodynamic therapy (PDT), optical
diagnostics, destruction of cancer and bacteria by light activated PDTs and the
use of light as a microscopic tool for biomedical research. He has published over
30 original scientific papers and is an editor of peer reviewed scientific
journals. Dr. Lilge is a much sought after speaker at many international
medical and scientific conferences.
Michael Jewett, MD, FRCSC, FACS,
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 a
member of Theralase’s Medical and Scientific Advisory Board. Dr. Jewett is
internationally known for his contributions in the fields of bladder, testis
and kidney cancer fundamental and clinical research. He 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 goal of achieving FDA or Health Canada clinical approval. He is a
recent Past-President of the Canadian Urology Association and a member of many
urological and surgical oncology societies worldwide. Dr. Jewett has published
over 175 original medical research papers.
James Andrews, MD, Founding
member of Andrews Sports Medicine and Orthopaedic Center in Birmingham,
Alabama. He is also a founder of the American Sports Medicine Institute (ASMI)
a non-profit institute dedicated to injury prevention, education and research
in orthopaedics and sports medicine. He is a member of Theralase’s Medical and
Scientific Advisory Board. Doctor Andrews is internationally known and
recognized for his skills as an orthopaedic surgeon as well as his scientific
and clinic research contributions in knee, shoulder and elbow injury prevention
and treatment. Doctor Andrews is Senior Consultant for the Washington Redskins
Professional Football team and Medical Director for the Tampa Bay Rays
Professional Baseball Team and the Ladies Professional Golf Association.
For further information, please call 1-866-843-5273 or visit www.theralase.com
