A final base shelf prospectus dated January 9, 2015 containing important information relating to the securities of Theralase
Technologies Inc. has been filed with the securities regulatory authorities in certain provinces of Canada. A copy of the final
base shelf prospectus, any amendment to the final base shelf prospectus and any applicable shelf prospectus supplement
that has been filed, is required to be delivered with this presentation.
This presentation does not provide full disclosure of all material facts relating to the securities offered. Investors should read the
final base shelf prospectus, any amendment and any applicable shelf prospectus supplement for disclosure of those facts,
especially risk factors relating to the securities offered, before making an investment decision.
Theralase Technologies Inc. (TSXV:TLT) (OTC Pink: TLTFF)
INVESTOR PRESENTATION – JANUARY 23 2015
Forward Looking Statements
Certain statements contained or incorporated in this presentation, which deal with the financial condition and operating
results of Theralase Technologies Inc. (“Theralase” or the “Company”), include information, analyses and projections as to
future corporate developments which are currently in the planning stage, and on the projected operating financial
performance of the Company, which constitute forward-looking statements. Such forward-looking statements, made with
special reference to the Company’s ongoing technologically complex healthcare and medical device research and
development efforts, which may include in-house and independent clinical trials, testing new medical technologies and
their applications, involve known and unknown risks and uncertainties that could cause actual events and results to differ
materially from those estimated or anticipated and which may have been implied or expressed in such forward-looking
statements. No conclusions as to the successful outcome of the ongoing and planned research and development projects
in which the Company is involved are intended or implied nor can they be foreseen or predicted prior to definitive
corporate announcements as to their outcome. Certain forward looking statements are identified by words such as
“believe”, “anticipate”, “estimate”, “expect”, “intend”, “plan”, “expect”, “project”, “may”, and “will” and the negative of
such expressions, although not all forward looking statements contain these identifying words, any statements that refer to
expectations, projections or other characterizations of future events or circumstances are forward looking statements.
Although Theralase believes that the expectations reflected in any forward looking statements made in this presentation are
reasonable, such statement are based on a number of assumptions which may prove to be incorrect, including, but not
limited to assumptions relating to the risks and factors set out in the Company’s final base shelf prospectus and prospectus
supplement (collectively the “Prospectus”), delivered with this presentation, copies of which are also available on SEDAR
under the Company’s profile at www.sedar.com. Accordingly, no assurances can be given that any of the events or
circumstances contemplated by any such forward looking statements will transpire or occur or, if any of them transpire or
occur or, if any of them transpire or occur, what impact they will have on Theralase’s results of operations or financial
condition. A more complete list of risks and uncertainties inherent to the Company’s industry can be found in the Prospectus.
Furthermore, the forward-looking statements contained in this presentation are made as of the date hereof. The Company
does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, whether
as a result of new information, future events, or otherwise, unless required by applicable laws. The forward-looking statements
contained in this presentation are expressly qualified by this cautionary statement and the cautionary statement under the
heading, “Forward Looking Statements” in the Prospectus).
All references to dollars herein are to Canadian dollars except as otherwise indicated.
2
Company Overview
Theralase Technologies Inc. (TSXV:TLT) is engaged in the development and
commercialization of patented, super-pulsed laser technology used in biostimulative and
biodestructive clinical applications.
The Company operates under two divisions:
Therapeutic Laser Technology (TLT) Division:
Effectively heals patients by eliminating pain, reducing inflammation and accelerating tissue
healing.
Company has 1 product in market and is launching its next-generation product in early 2015.
•TLC-1000, a cold laser technology used to heal a wide range of nerve, muscle and joint
conditions (generating approximately $1.5M / year)
•TLC-2000, (launching in early 2015), is a next generation patented biofeedback therapeutic
laser system.
Photo Dynamic Therapy (PDT) Division:
Developing light activated Photo Dynamic Compounds (“PDCs”) to destroy cancer and
bacteria.
TLT has 1 product in development:
•TLC-3000, which combines the application of the Company’s lasers with Photo Dynamic
Compounds in the destruction of Non Muscle Invasive Bladder Cancer (“NMIBC”).
3
Management Team
Roger Dumoulin-White – President & Chief Executive Officer
•
President and CEO of Theralase Technologies Inc. since 2004 (Theralase Inc. since 1994)
•
Before founding Theralase Inc., served as a Product Team Manager with Ford Electronics
Manufacturing Corporation, a division of Ford Motor Corporation (NYSE:F), where he
managed a $40 million a year business (subset of $400 million annual business), with
approximately 400 employees reporting to him (subset of 2,500 total employees)
•
Graduated from the University of Western (London, Ontario) with a bachelor degree in
Electrical Engineering (B.E.Sc)
Dr. Arkady Mandel – Chief Scientific Officer
•
One of the key founders of the therapeutic use of lasers in dermatology and other areas of
clinical medicine, as well as the originator and developer of phototherapy methods
•
Over 100 original papers and scientific monographs to his name, combined with over 200
international patents
•
Dr. Mandel earned his designation as a medical doctor from the Moscow State Medical
University
•
Doctor of Science accreditation majored in: biochemistry, microbiology, immunology,
biophysics, and photobiology
4
Scientific & Medical Advisors (TLT Division)
James Andrews, MD:
•
World renowned orthopaedic sports surgeon. Founder of the American Sports Medicine
Institute (“ASMI”) President and Chairman of the Andrews Research and Education Foundation
dedicated to prevention, education and research at the Andrews Institute. Mentored more
than 314 orthopaedic/sports medicine Fellows and more than 84 primary care sports medicine
Fellows who have trained under him through the Sports Medicine Fellowship Program.
Jeffrey Dugas, MD:
•
Orthopaedic sports surgeon. Member of American Academy of Orthopedic Surgeons
(“AAOS”), ASMI, International Cartilage Repair Society, Treats all types of orthopedic sports
injuries, including injuries of the shoulder, elbow and knee, including total joint replacement
surgery of the shoulder and knee.
Lyle Cain, MD:
•
Orthopaedic sports surgeon. Specializes in arthroscopy and treatment of sports related injuries,
as well as open and arthroscopic treatment of knee, ankle, shoulder and elbow injuries.
Performs surgical joint replacement for arthritis of the knee and shoulder. Certified to treat
cartilage injuries in the knee with articular cartilage implantation and meniscal transplantation.
Kevin Wilk, DPT:
•
Distinguished career as a clinical physical therapist for the past 29 years and as a leading
authority in rehabilitation of sports injuries and orthopaedic lesions. Provided significant
contributions to laboratory research, bio-mechanical research and clinical outcome studies.
5
Scientific & Medical Advisors (PDT Division)
Michael Jewett, MD:
•
Professor of Surgery (Urology) at the University of Toronto, Surgical Oncology at Princess Margaret Cancer
Centre, University Health Network (“UHN”). Clinical practice is in urologic oncology with research interests
in testicular cancer and superficial bladder cancer.
Lothar Lilge, Ph.D.:
•
Professor in the Department of Medical Biophysics, University of Toronto and Senior Scientist at the
Ontario Cancer Institute, Princess Margaret Cancer Centre, UHN. Research is focused on Photo Dynamic
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.
Ashish Kamat, MD:
•
Uro-oncologist. Internationally recognized expert in urologic oncology and an authority in the
management of urologic cancers. Expertise in bladder cancer, organ sparing and minimally invasive
techniques. Maintains an active research portfolio with a focus on efforts to develop novel therapies and
identifying predictors of response to therapy (e.g. intravesical immunotherapy), as a first step towards
personalized cancer therapeutics. Initiated, led and been active in several large studies including
multinational trials in bladder cancer, with findings published in high impact journals.
Michael O’Donnell, MD:
•
Uro-oncologist. Long history of focusing on bladder immunology and bladder cancer immunotherapy,
particularly the anti-cancer mechanisms of bacillus Calmette-Guerin (“BCG”) and its enhancement with
combination therapies. Recently headed a national trial of bladder cancer treatment utilizing BCG plus
interferon (a natural protein which induces healthy cells to combat disease) comprised of over 1,000
patients and holds several U.S. patents for his work.
Brian Wilson, Ph.D:
•
Senior Scientist and Head of the Applied Biophotonics group at Princess Margaret Cancer Centre, UHN
Professor in the Department of Medical Biophysics at the University of Toronto. Research focus of the
Applied Biophotonics group is the development and application of new therapeutic and diagnostic
techniques based on the use of lasers and other optical technologies.
6
Strategic Partnerships
Theralase has strategic relationships with a variety of world-class research institutions.
• PRINCESS MARGARET CANCER CENTRE - UNIVERSITY HEALTH NETWORK
• ONTARIO CENTERS OF EXCELLENCE – PHOTONICS
• VIRGINIA TECH UNIVERSITY
• ACADIA UNIVERSITY
• AMERICAN SPORTS MEDICINE INSTITUTE
7
TLT Division
Currently manufacture and sell the TLC-1000 cold laser
technology.
• Technology that allows light to penetrate into tissue to promote
cellular regeneration at the source of injury
• Used to heal a wide range of nerve, muscle and joint conditions
(i.e.: Low Back Pain, Knee Osteoarthritis, Shoulder Tendonitis)
• FDA and Health Canada cleared for Chronic Knee Pain
• Generating approximately $1.5 million per year
Market Potential
• U.S. pain market exceeds $99 Billion annually and is growing
rapidly 1
• 42% of this population is not well serviced by pharmaceutical
drugs and 46% is not well serviced by surgery 2
Solution
• Launch a technology that has the proven ability to eliminate pain
Opportunity
• Grow TLT division with new patented anti-pain technology via a
recurring revenue model and a direct sales force
1 Institute
of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care,
Education, and Research, 2011. The National Academies Press, Washington DC.
2 Peter
D. Hart Research Associates. Page 3. KEY FINDINGS. Americans in Pain.
8
TLC-1000 Advantages
The TLC-1000 has advantages to other competitors products
•
Highest peak power and lowest cost per milliWatt
Theralase Therapeutic Laser Comparison vs. Competitors *
Theralase
TLC -1007H
Microlight ML830
Erchonia
Quantum
MEDX
Meditech
Wavelength (nm)
905 and 660
830
635
635
785
830 / 840 / 660
Drive Platform / FDA
Approval
Super Pulse /
NHN
Continuous
Wave / NHN
Continuous
Wave / NHN
Continuous
Wave / ILY
Continuous
Wave / ILY
Continuous
Wave / ILY /
NHN
Indicated Use
Knee Pain
Hand and
Wrist Pain
Neck and
Shoulder Pain
Heat
Heat
Heat / Rotator
Cuff
Tendonitis
Average Power
(mW)
7 X 100 mW
6 x 25 mW
3 X 30 mW
2 X 5 mW
4 X 5 mW
16 X 5 mW
200 mW + 179
X 15 mW
Peak Power (mW)
50,000 mW
30 mW
10 mW
5 mW
5 mW
200 mW /0.9
mW
Total Actual Tested
Power
850
90
10
20
72
361
Photon Density Per
Laser Diode (W/cm2)
5000
3
1
0.5
0.5
20 / 1.8
Approximate List
Price (USD)
$17,600
$10,000
$14,000
$12,000
$8,000
$30,000
Approximate cost
per mW (USD)
$21
$111
$1,400
$600
$111
$83
9
* Information
on competitive devices on this slide is from generally available sources, that Theralase believes to be accurate, but has not conducted any independent investigation.
Next-Gen Technology - TLC-2000
The TLC-2000 is expected to launch in Q1-2015.
KEY PATIENT BENEFITS
• Dramatically improves efficacy over existing technology by targeting tissue
based on a patient’s physical characteristics (patient specific) – “Cell Sensing”TM
technology (Pending trademark applications: Europe: 13537626, US: 86/467,154,
Canada: 1,705,272)
PATENTED TECHNOLOGY
• Hold patents in Canada, U.S., Belgium, Italy, U.K., Germany, France & Spain
TLC-2000 ADVANTAGES
• Provides the repeatability and reproducibility required by the medical
community and insurance industry to enter the mainstream medical market
• Able to displace the competition with a more scientifically proven effective
technology
• Provides an attractive return on investment to healthcare practitioners
• Expected to be eligible for a unique reimbursable Current Procedural
Terminology (“CPT”) code in the U.S. for national reimbursement due to Cell
Sensing TM technology
• Allows Theralase the opportunity to migrate from capital equipment model to
recurring revenue model
10
TLC-1000 vs. TLC-2000
TLC-1000
TLC-2000
600 mW
1400 mW
Tablet computer, 10” full color touch screen, full keyboard
Wireless and Internet communication with live usage monitoring
Biofeedback patient specific “Cell Sensing TM” technology
Expected to be eligible for a unique CPT code
5 year warranty
5 year marketing program
5 year new and optimized protocols automatic download
Up to 4 multiple laser probes per system
Near Infrared (5 x 905 nm) + Visible Red (4 x 660 nm) laser diodes Total
Power per Laser Probe
Battery operating time
1 probe – 3 hrs
4 probes – 4.5 hrs
Built in electrical nerve stimulation
Medical grade power supply
CSA, CE, Health Canada, FDA Approvals (pending for TLC-2000)
Optional stand
11
TLC-2000 Growth
Roll Out Strategy
•
4 largest cities in Canada in 2015 (Toronto, Vancouver, Calgary, Montreal)
•
5 largest U.S. States in late 2015 / 2016 (New York, California, Florida, Texas,
and Illinois)
•
Internationally in 2016 / 2017 (Europe, South America, Asia Pacific)
Low Hanging Fruit
•
Trade-up 800 existing Theralase customers in Canada to TLC-2000 in 2015
•
Trade up 400 existing Theralase customers in U.S. to TLC-2000 in 2015 / 2016
•
Displace competitive products throughout Canada and the U.S. with TLC2000 in 2016
12
Business Model
Moving away from a capital equipment model to a recurring revenue model
Business Model Overview
•
•
Up Front /
Recurring
Revenue
•
•
•
•
•
•
Practitioner’s
Incentive
•
•
Clinics will commit to a 60 month lease = $150 to $600 per month depending on number of laser
probes and auxiliary equipment
Theralase plans to work with a capital lease partner in Canada and the US to provide upfront
capital to fund equipment
Lease will include: warranty, marketing, patient referrals and software updates for term of lease
At end of 60 month lease, practitioner has the following options:
Return equipment to lease company and all commitments are fulfilled
Pay 10% residual to lease company, keep technology and discontinue all support
Continue to pay monthly at $75 to $300 per month (depending on number of laser probes and
auxiliary equipment) to maintain ongoing warranty, marketing, patient referrals and software
updates.
Purchase latest Theralase technology and recommence lease process
12 treatments /month @ $50 per treatment will cover cost of lease (4 probes)
Clinic will retain all revenue > $600 per month (est. $10,000 / month, which is 200 treatments @
$50)
Illustrative Example: (Assuming Average Sale Price: $15,000)
 333 units sold equates to $5 M in revenue.
 666 units sold equates to $10 M in revenue.
13
U.S. Healthcare Demographics
TLT believes even a small amount of market penetration, can be a very
profitable business
Healthcare Practitioners*
2008
2017
% increase
Veterinarians
59,700
79,400
33.0%
Physical Therapists
185,500
241,700
30.3%
Medical Doctors
661,000
805,500
21.9%
Chiropractors
49,100
58,700
19.6%
Dentists
141,900
164,000
15.6%
Podiatrists
12,200
13,300
9.0%
Hospitals
5,795
5,795
0.0%
1,115,195
1,368,395
18.5%
0.10%
0.08%
Total
1,100 unit installed base
(target 2016)
* All statistics from the U.S. Bureau of Labor Statistics, Washington, DC,
Occupational Outlook Handbook, 2010 – 2011 edition
TLT believes < 0.1%
market penetration
could be a $16.5M
revenue business with
approximately 75% gross
margins
14
PDT Division
Anti Cancer Platform Technology (PDT Division)
•
Patented anti-cancer drugs known as Photo Dynamic Compounds (“PDCs”) localize inside cancer cells and
when light activated destroy certain organelles, resulting in natural cell death (apoptosis)
•
Proven ability to prevent the recurrence of cancer in-vivo, even after repeated exposures, providing an
immune-mediated (“memory response”) tumor rejection
•
Research is performed at the world renowned Princess Margaret Cancer Centre, University Health Network
(“UHN”)
Highlights
Efficacy
Low Toxicity
•
•
•
•
•
IP
0% toxicity at high concentrations (> 100µM) with no side effects leading to very high safety
profile
Ultra low toxicity (Negligible entry into blood stream for bladder cancer)
•
Excellent specificity and selectivity (quick evacuation from healthy cells / high light fluence
required for activation)
Water soluble, small molecule that readily penetrates cellular membrane (Organelle
localizing)
Activated at a variety of wavelengths allowing shallow and deep tumour destruction
•
•
Issued U.S. Patents: 6,962,910, 7,612,057, 8,148,360, 8,445,475
Pending U.S. Patent Applications: PCT/US14/30194, 13/863,089, PCT/US13/36595
•
Molecule
100% cancer cell kill at very low concentrations (< 0.8µM)
More effective at killing cancer cells than FDA approved drugs (668,000 x ALA, 198 x
PHOTOFRIN®)
Able to treat solid core hypoxic tumours (Type 1 and 2 activation), such as: breast, prostate,
lung and bladder
•
15
PDT Division
MARKET POTENTIAL
The National Institutes of Health estimated that for 2009, the overall annual cost of cancer was about $216.6
billion 3
Direct medical costs of cancer care in the United States alone were estimated as approximately $125 billion
in 2010.4
Bladder cancer is the fifth most expensive cancer in terms of total medical care expenditures, accounting
for almost 3.7 billion US dollars (2001 values) in direct costs in the US.5
OPPORTUNITY
•
Complete a FDA Phase I / II a human bladder cancer clinical study
•
Achieve FDA fast track and breakthrough status
•
Execution of a strategic partnering agreement with big pharma for destruction of bladder cancer (i.e.:
upfront payments , co-development funds, annual recurring revenue streams)
STRATEGY
•
2013 (complete): Destruction of cancer in a live animal mouse model. Demonstrated >99% efficacy for
a subcutaneous cancerous tumour
•
2014 (complete): Complete validation in orthotopic rat model at University of Toledo
•
2015 (pending): Good Manufacturing Practice (“GMP”) drug manufacture, dose toxicity study, drug
master file, clinical protocol, Health Canada Clinical Trial Application (“CTA”) and FDA Investigational
New Drug (“IND”) application, commence and complete FDA phase I / II a human clinical study
•
2016 (pending): Achieve FDA fast-track and breakthrough status. Execute strategic partnering
agreement with big pharma
3 National
Heart, Lung, and Blood Institute. NHLBI Fact Book, Fiscal Year 2012, Bethesda, MD, 2013
4.Projections
5
of the cost of cancer care in the United States: 2010–2020. Journal National Cancer Institute 2011;103:117-128
Pharmacoeconomics. 2003;21(18):1315-30.The health economics of bladder cancer: a comprehensive review of the published literature.
16
PDC Safety & Efficacy
HT1376 Human Bladder Cancer Line Safety and Efficacy of PDC *
Efficacy: PDC + Light
Safety: PDC + No light
120
45 J cm-2
90 J cm-2
80
60
40
20
45 J cm-2
90 J cm-2
100
Cell Kill (%)
Cell Kill (%)
100
120
80
60
40
20
0
0.00125 0.0025 0.005
0.01
0.02
Concentration (mM)
0.04
0
0.00125 0.0025 0.005
0.01
0.02
0.04
Concentration (mM)
Research performed at Princess Margaret Cancer Centre, University Health Network by Theralase research scientists under the direction of Dr. Lothar Lilge Ph.D., UHN
and Dr. Arkady Mandel Ph.D., M.D., D. Sc., Chief Scientific Officer of Theralase
*
17
PDC Efficacy vs. ALA and Photofrin® (FDA Approved Drugs)*
Mouse colon cancer (carcinoma)
Safety: PDC + No Light
100
80
60
40
20
0
ALA
TPDC
Cell Kill (%)
Cell Kill (%)
100
80
60
40
20
0
Efficacy: PDC + Light
0.00016 0.0003 0.0008 0.025
Concentration (mM)
ALA
14A
0.00016 0.0003 0.0008 0.025
Concentration (mM)
Human brain cancer (glioblastoma)
Rat brain cancer (glioma)
100
80
60
40
20
0
ALA
TPDC
Cell Kill (%)
Cell Kill (%)
100
80
60
40
20
0
0.0001 0.0002 0.0005 0.017
Concentration (mM)
0.0001 0.0002 0.0005 0.017
Concentration (mM)
Research performed at Princess Margaret Cancer Centre, University Health Network by Theralase research scientists under the direction of Dr. Lothar Lilge Ph.D. and
Dr. Arkady Mandel Ph.D., M.D., D. Sc., Chief Scientific Officer of Theralase
*
18
Destruction of Cancer in Live Animal with PDC *
PDC injection of 53 mg kg-1
4hr Post PDC Injection
(Pre Light Activation)
24hr Post Light Activation
20 Months Post Treatment
(No recurrence)
Tumour induced in
animal (BALB/c mice )
with tumour reaching
5.0  0.5 mm in size.
Mice have survived
20 months cancer
free after only 1 PDC
treatment
Research performed at Princess Margaret Cancer Centre, University Health Network by Theralase research scientists under the direction of Dr. Lothar Lilge Ph.D. and
Dr. Arkady Mandel Ph.D., M.D., D. Sc., Chief Scientific Officer of Theralase
*
Page
19
Support Groups for Translational Activities
Company
Role
Task
Status
Spharma (under
agreement with JSS
Medical, Montreal)
CRO
Regulatory
In Place
JSS Medical (Montreal)
CRO
Clinical
In Place
Sigma-Aldridge (SAFC)
(Madison, WI )
MFG
cGMP for API
In Place
TBD
TOX
GLP animal toxicology partner.
Q1-2015
20
Next Steps
Q4-2014 (Completed)
•
Enroll members to Medical and Scientific Advisory Board
•
Report on University of Toledo in-vitro and in-vivo data
2015 (Pending)
•
Conduct Health Canada CTA / FDA IND meeting (1Q2015)
•
Manufacture pre-GMP and GMP batches of lead PDC (TLD-1433) (2Q2015)
•
Toxicity analysis of lead compound in 2 different animal species (2Q2015)
•
Commence enrolling subjects into Health Canada / FDA Phase I / II a bladder cancer
clinical (Pending Regulatory Approval)
21
Ownership / Capitalization Table
OWNERSHIP TABLE as Jan 20, 2015
Holder Name
# of Common
Shares
% of Common
# of Fully
% of Fully
Shares
Diluted Shares Diluted Shares
Officers & Directors
S. Donald Moore (Director)
Roger Dumoulin-White (CEO)
Kristina Hachey (CFO)
Randy Bruder (Director)
Matthew Perraton (Director)
Guy Anderson (Director)
6,293,885
5,293,306
863,410
1,102,500
33,333
0
7.4%
6.2%
1.0%
1.3%
0.0%
0.0%
6,493,885
7,395,806
1,213,410
1,322,500
266,666
200,000
6.8%
7.8%
1.3%
1.4%
0.3%
0.2%
Total Officers & Directors
13,586,434
15.9%
16,892,267
17.8%
Public Float
71,734,859
84.1%
78,534,942
82.2%
TOTAL Shares
85,321,293
100.00%
95,427,209
100.0%
CAPITALIZATION TABLE
Description
# of Common
Shares Equivalent
Common Shares Outstanding
85,321,293
Options (Weighted Average Price $0.50)
5,095,000
Warrants (Weighted Average Price $0.25)
5,010,916
Total Fully Diluted Shares Outstanding
95,427,209
22
1945 Queen Street East
Toronto, Ontario, M4L 1H7, CANADA
Roger Dumoulin-White
President & CEO
1-866-THE-LASE (843-5273) x225
[email protected]
23
Appendix
24
Live Animal Survival *
Colon Cancer cells injected
Irradiation: λ=530 nm, 192 J
2013: $0 M
2014: $0 M
2015: $0 M
2016: $250 M
Investment
$10 M
ROI
2500% in 3 yrs
Investment vehicle
Survival of mice up to 20
Joint venture with bladder cancer asset placed into an incorporated company with 50/50 ownership split
months after one
between Theralase and investment partner
Theralase PDT treatment
Research performed at Princess Margaret Cancer Centre, University Health Network by Theralase research scientists under the direction of Dr. Lothar Lilge Ph.D. and
Dr. Arkady Mandel Ph.D., M.D., D. Sc., Chief Scientific Officer of Theralase
*
25
Bladder Cancer Treatment
U.S. Bladder Cancer Treatment Annual Spending
•
$3.7 Billion (2001) 5
Statistics
•
Estimates for bladder cancer in the United States for 2015 are:
•
Approximately 74,000 new cases of bladder cancer diagnosed (about 56,320 in men and
17,680 in women) 6
•
Approximately 16,000 deaths from bladder cancer (about 11,510 in men and 4,490 in
women) 6
•
430,000 new cases are diagnosed worldwide annually (2012) 7
•
Standard treatment unchanged with no new drugs approved since 2005 8
•
9th most common cancer, 4th in men, 8th in women 9
•
Most expensive cancer to treat with a 5 year recurrence rate 31 to 78% 10
•
85% of patients with bladder cancer present with NMIBC disease confined to the mucosa
(stage Ta and Tis) or submucosa (stage T1) 10
5
Pharmacoeconomics. 2003;21(18):1315-30.The health economics of bladder cancer: a comprehensive review of the published literature.
6 The
American Cancer Society
7
World Cancer Research Fund International, London, England
8
Cancer Research Institute 2015
9
American Society of Clinical Oncology
10
European Association of Urology, Recurrence, Progression, and Follow-Up in Non–Muscle-Invasive Bladder Cancer, 2009
26
Bladder Cancer Treatment
Current Standard of Care 11
Early stage disease (T0, Ta, T1): Trans Urethral Resection of the Bladder Tumour (TURBT) followed
by treatment with bacillus Calmette-Guérin (BCG) – 5 year survival rate of 88 to 98%.
Mid Stage disease (T2, T3a/b): Entire bladder removed along with nearby reproductive organs
and lymph nodes in a procedure called a radical cystectomy - 5 year survival rate of 46 to
63% depending on progression of disease.
Late stage disease (T4): Disease has spread to distant sites, such as the bones, liver and lungs
and is generally regarded as incurable - 5 year survival rate of 15%.
11
National Cancer Institute’s SEER database
27