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Pioneering Internal Radiation
Therapy with Cesium131
v092911
1
Forward Looking Statements
This presentation contains forward-looking statements. These statements relate to
future events or our future financial performance and involve known and unknown
risks, uncertainties and other factors that may cause our or our industry’s actual
results, levels of activity, performance or achievements to be materially different
from any future results, levels of activity, performance or achievements
expressed, implied or inferred by these forward-looking statements. In some
cases, you can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,”
“believes,” “estimates,” “predicts,” “projects,” “potential” or “continue” or the
negative of such terms and other comparable terminology.
These statements are only predictions based on our current expectations and
projections about future events. You should not place undue reliance on these
statements. Actual events or results may differ materially. In evaluating these
statements, you should specifically consider various factors, including the risks
outlined under “Risk Factors” in our Annual Report on Form 10-K filed with the
SEC on September 28, 2011. These and other factors may cause our actual
results to differ materially from any forward-looking statement. We undertake no
obligation to update any of the forward-looking statements after the date of this
presentation to conform those statements to reflect the occurrence of
unanticipated events, except as required by applicable law.
2
Corporate Highlights

Emerging market leader: internal radiation therapy of cancer

A superior solution for brachytherapy of cancer
 Exclusive patents: proprietary separation process for the Cesium131 isotope
 FDA approved for use in all body sites and tumor types
 Cesium131 products: safe and effective results compared with:
 external radiation and surgery
 internal radiation therapy with other isotopes

Multiple cancer indications in US and EU markets

Additional market expansion
 Current: Prostate, Lung, Brain, Head/Neck, Ocular, Colon and Gyn
 Pipeline: Breast, Esophageal, Pancreatic
 New GliaSite® product line for treatment of brain cancer
3
A Better Solution
Dr. Dattatreyudu Nori, professor and radiation oncologistin-chief at Cornell University says:
“Cesium131 brachytherapy is nothing less than a
new standard of care for treatment of prostate
cancer, giving patients an improved quality of life
and peace of mind.”
Medical News Today – UK, January 8th, 2006
4
Cesium131 Highlights

Offers superior results that beats the competition:

Delivers effective dose 2-6 times faster than Pd103 and I125

Minimally invasive
 High energy; and
 Short (9.7 day) half life
•
•
Cesium131 implantable seeds, placed in or around the tumor, or on the
surgical margins of a suture site
GliaSite balloon catheter and Lung Mesh / Suture are placed at time of
surgical tumor removal.
5
Cesium131
Brachytherapy “seeds”
LDR Brachytherapy for Prostate Cancer
Source: Oak Ridge Associated Universities
SAV I Catheter for
Breast Cancer
Source: Cianna Medical
6
Cesium131 Track Record

Over 7,000 prostate cancer cases treated with Cesium131

98% success (measured by freedom from biochemical failure)


New 5 year prostate cancer treatment data indicate strong efficacy
Leading medical institutions are currently securing patients for
treatment of the following cancer indications:







Prostate
Lung
Brain
Ocular
Colon
Head and Neck
GYN
7
Benefits of Prostate Seed-Implants
8
Source: Frost Sullivan Report 2004
Advantages of Cesium131
High Energy and Short Half Life Make Cesium131 the Isotope
of Choice for Treatment of Many Disease States
 Higher Initial Energy and Faster Delivery Time than Pd103 and I125



Dose is delivered in advance of absorption of delivery vehicles
Cancer cells have less opportunity to repopulate
Greater flexibility due to reduced total radiation to healthy tissues
 Uniform and Symmetrical Radiation Penetration


Improved dose distribution (homogeneity)
Improved placement positioning
 Single Application
Autoradiograph of an IsoRay seed (4.5 mm)
9
Brachytherapy Implant Comparative Analysis
ISOTOPE
HALF-LIFE
Cs131
9.7 days
Pd103
I125
17.5 days
60 days
AVG
THERAPEUTIC TOTAL DOSE
ENERGY
30.4 keV
20.8 keV
28.5 keV
ANISOTROPY
FACTOR
90% DOSE
DELIVERED
115 Gy
.969
33 days
125 Gy
.877
(TheraSeed®
200)
58 days
145 Gy
.930
(OncoSeed®
6711)
204 days
The above information is considered standard dosing information. Such information is governed by the FDA and is required to
accompany any product that is distributed to a customer and intended for use. Acquisition of this information can be obtained from the
company that manufactures each listed product.
10
GliaSite ® : Treatment of Brain Cancer
GliaSite® Balloon Catheter with
Therapeutic Isotope




GliaSite® is IsoRay’s newest product offering
•
The only FDA-approved balloon catheter for brachytherapy of brain cancer
Product launch preparations underway in the US
•
Reimbursement of the GliaSite® system with I125 is already established for both
in-patient and out-patient settings
European distribution agreement is completed
Received FDA clearance and CE Mark is in the final approval
process
•
New Liquid Cesium131 benefits expected to enhance market adoption rate, size
and profit margin
11
Cancer Facts
There were an estimated 1,479,3501 new cases of cancer
diagnosed in the U.S. in 2010:
Prostate - 217,730
Lung - 222,520
Head and Neck - 52,540
Brain - Primary (GBM)- 22,020
- Metastasis - 150,000
- Meningioma - 10,000
Eye and Orbit - 2,480
Breast - 209,000
Colon - 102,900
◦1- Cancer Statistics, 2010 Jemal et al., Cancer Management: A Multidisciplinary Approach 11th Edition (2008), American
Cancer Society 2010
12
IsoRay Market Potential

Head and Neck: 2,000 potential cases ($10,000,000.00)

Lung: 4,000 potential cases ($20,000,000.00)

Prostate: 13,000 potential cases ($65,000,000.00)

Ocular Melanoma: ~200 potential cases ( $350,000.00)

Brain Cancer (GBM): ~2,000 potential cases ($20,000,000.00)
Metastatic : ~15,000 potential cases ($150,000,000)
Meningioma : ~500 potential cases ($5,000,000)

Total~10,000
IsoRay
Market
Potential:$320
Breast:
potential
cases ($50,000,000.00)
Million*
*assuming the current reimbursement rates (which are subject to annual review and adjustment), remain constant
13
Corporate Strategy

Grow prostate cancer market share


Aggressively market the new GliaSite® system
•


revenue expansion in the brain cancer treatment market
Capture the lung cancer market
•

Leverage new positive 5 year data to increase adoption rates
Independent multi-center study now underway
Promote Cesium131 for treatment of colon, head and neck cancer
Develop breast and esophageal cancer market
 Evaluate use of Cesium131 in combination with the SAV-I void filling device and
others for treatment of breast cancer

Expand marketing and distribution in US and the EU
14
Near Term Milestones

Events to broaden prostate and other cancer markets
•
•

Independent publication of 5 year data for prostate treatment
Initiation of market use of Cesium131 for “dual therapy” in high risk
patients
•
New MD Anderson clinical comparison of Cesium131 with other isotopes
•
Initial Launch of GliaSite marketing and scientific presentations
•
Expand awareness of our Lung Mesh treatment
Submission for FDA approval of new liquid Cesium131
formulation
15
Near Term Milestones


Multiple GliaSite® Events
•
•
CE mark approval by notified body
US and EU launch of GliaSite® !
Expansion to new cancer treatments
•
•
•
Breast cancer : Integrate Cesium131 within the SAV-I catheter
Esophageal cancer : Utilize Cesium131 in combination with an
esophageal stent
Pancreatic cancer : Develop device for seed delivery
16
Financials
Year Ended June 30
US $
2011
2010
5,238,973
5,286,084
1,157,417
725,797
4,120,405
4,734,697
Operating Loss
(2,962,988)
(4,008,900)
Net Loss
(2,842,213)
(4,033,856)
(0.11)
(0.18)
Product Sales
Gross Income
OpEx
Loss per Share
Cash/Equivalents
$2,112,254
17
Summary
 Non-prostate
applications grew 139% from FY2010
to FY2011
 Positioned
to be the leader for brachytherapy
cancer treatment with a $320+ million potential
market share
 Multiple
 Strong
product and market indications for cancer
pipeline of near-term milestone events
18
ISORAY
WHERE THE FUTURE IS NOW
Thank You!
19
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