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January 29, 2018 | Author: Anonymous | Category: Science, Health Science, Urology
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www.isoray.com

Pioneering Internal Radiation Therapy with Cesium131

v092911

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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.

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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

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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

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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.

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Cesium131 Brachytherapy “seeds”

LDR Brachytherapy for Prostate Cancer

Source: Oak Ridge Associated Universities

SAV I Catheter for Breast Cancer

Source: Cianna Medical

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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

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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)

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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.

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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

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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

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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

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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

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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

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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

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ISORAY WHERE THE FUTURE IS NOW

Thank You!

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