Transcript Cancer Treatment Delivery System

_____________________________________________
A Feasibility Study for a
Non-Invasive, Non-Toxic Cancer
Treatment Delivery System
OVERVIEW
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○ New Product Concept
○ Cancer Treatment Delivery System
○ Market Analysis
○ Demand
○ Environment
○ Positioning
○ Marketing Strategy
○ Organizational & Technological Issues
○ Financial Analysis
○ Investment Opportunity
NEW PRODUCT CONCEPT
Cancer Treatment Delivery System
_____________________________________________
○ Non-Invasive
○ Unique pH Targeting System
○ targets malignancy
○ minimizes toxicity to healthy tissue
○ Loading and release characteristics
○ variable, selective
○ Optimally sized Microspheres
NEW PRODUCT CONCEPT
A Physician’s Perspective
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Steven J. Feigenberg, MD
Radiation Oncologist
NEW PRODUCT CONCEPT
Cancer Treatment Delivery System
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Hepatic Artery
Liver
MARKET ANALYSIS
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○ Demand
○ Scope of Problem
○ Environment
○ Competitor Analysis
○ Positioning
○ Marketing Strategy
DEMAND
Scope
of
Problem
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Percentage of All Causes of Death
in U.S., 2001
Accidents
4.2%
○ Cancer is the
Second Leading Cause
of Death in the U.S.
Other Causes
29.5%
Pneumonia &
Influenza
2.6%
Heart Disease
29.0%
Cancer
22.9%
Chronic Lung
Disease
Cerebrovascular
5.1%
6.8%
○ Over ½ million U.S.
Deaths are Cancer
Related
DEMAND
Scope
of
Problem
_____________________________________________
Trends in U.S. Cancer Death Rates, 1992 - 2001
Prostate
Hodgkin Lymphoma
Cervix Uteri
Stomach
Oral Cav & Pharynx
Breast (females)
Larynx
Lung & Bronchus (male)
Colon / Rectum
T estis
All Except Lung
All Cancers
Brain & ONS
Ovary
Leukemia
Myeloma
Non Hodgkin Lymphoma
Urinary Bladder
Corpus & Uterus, NOS
Kidney & Renal Pelvis
Melanoma of the Skin
Pancreas
Lung & Bronchus (female)
T hyroid
Esophagus
-4.0
-3.0
-2.0
-1.0
0.0
1.0
Liver & IBD
2.0
3.0
Unlike Nearly All other Cancers, the Death Rate for Liver
Cancer is on the Increase
DEMAND
Scope
of
Problem
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○ All Cancer
○ 1,368,030 new cases in
2004
○ 563,700 deaths in 2004
○ 5-year Relative Survival
Rate 65.5%
○ Liver Cancer
○ 18,920 new cases in
2004
○ 14,270 deaths in 2004
○ 5-year Relative Survival
Rate 8.0%
Liver Cancer represents only 1.4% of new cancer
cases, but accounts for 2.5% of all cancer deaths
ENVIRONMENT
Competitor
Analysis
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○ Complements
○ Substitutes
○ Traditional Non-Surgical Treatments
○ chemotherapy
○ radiation therapy
○ Novel Treatment Strategies
○ targeted chemotherapy
○ targeted radiation therapy
○ targeted hyperthermic therapy
ENVIRONMENT
Competitor
Analysis
_____________________________________________
Treatment Option
Targeting
System
Threat To
New Product
Radiofrequency Ablation
None
Medium-low to Medium
Cryosurgery
None
Low
Percutaneous Ethanol Injections
None
Low
External-Beam Radiation Therapy
None
Low
Interstitial Radiation Therapy
None
Low to Medium-low
ENVIRONMENT
Competitor
Analysis
_____________________________________________
Treatment Option
Targeting
System
Threat To
New Product
Hepatic Arterial Infusion of Chemotherapy
None
Low to Medium-low
Chemoembolization
None
Low to Medium-low
Targeted Hyperthermia Therapy (Thermo-Spheres) Antibodies
Medium-low to Medium
Targeted Chemotherapy (Dox-Spheres)
Antibodies
Medium to Medium-high
Targeted Radiation Therapy (SIR-Spheres)
Antibodies
Medium to Medium-high
MARKET ANALYSIS
Positioning
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○ SpHereTEK is uniquely positioned in the
Market of Novel Cancer Treatments
○ Its patented pH targeting system is unlike any other
○ Microsphere technology enables customized
treatment regimen (loading & release)
○ Treatment is only of the tumor and can include
○ chemotherapy
○ hyperthermia
○ radiation
○ Damage to healthy tissue is minimized
MARKET ANALYSIS
Marketing Strategy
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○ Long-term relationships would be developed
with Nationally Recognized Cancer Research
and Treatment Facilities
ORGANIZATIONAL ISSUES
Company
Structure
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Business
Development
Operations
Marketing
& Sales
Initial Structure
Finance
QA / Regulatory
Compliance
Business
Development
Marketing & Sales
QA / Regulatory
Compliance
Operations
Finance
As Business Develops
a more Hierarchical
Structure
Implemented
Mature Business
Structure
ORGANIZATIONAL ISSUES
Management Team
_____________________________________________
D. Rivera, BSE, MBA
Chief Executive
R. Marshall, BSc, MD, PhD
Medical Director
E. Trotzke, BSE, PhD
Project Manager
E. Hart, BSE, MS, MBA
Regulatory Affairs Mgr.
R. Mehta, BA, MBA, CPA
Comptroller
TECHNOLOGICAL ISSUES
Start Up Activities
_____________________________________________
Animal Testing
30 Months
Total Start-Up
Production
Protocol
FDA
Application
Phase II
Clinical Trials
Phase I Clinical
Trials
Phase III Clinical
Trials
FDA Approval Process
0
Months
6
9
15
21
30
FINANCIAL ANALYSIS
Projected Sales & Costs
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Sales
30.00 million
7.50 million
3.54 million
0.58 million
2.61 million
Operating Expenses &
Cost of Goods
4.25 million
5.9 million
20.76 million
FINANCIAL ANALYSIS
Projected EBIT
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9.2 million
Profit
1.6 million
0.03million
Loss
0.96 million
0.71 million
INVESTMENT OPPORTUNITY
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○ Cancer is Major Cause ○ Affiliation with Major
of Death in U.S. with
Research and
Liver Cancer on the
Treatment Centers
Increase
○ Profit Potential of
○ Most Current
over $9 Million in 5th
Treatments are NOT
Year
Curative
○ High Probability of
FDA Approval of IDE
○ Experienced
Management Team
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