_____________________________________________ A Feasibility Study for a Non-Invasive, Non-Toxic Cancer Treatment Delivery System
_____________________________________________OVERVIEW ○ 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 Steven J. Feigenberg, MD Radiation Oncologist
_____________________________________________ NEW PRODUCT CONCEPT Cancer Treatment Delivery System Liver Hepatic Artery
_____________________________________________ MARKET ANALYSIS ○ Demand ○ Scope of Problem ○ Environment ○ Competitor Analysis ○ Positioning ○ Marketing Strategy
_____________________________________________ DEMAND Scope of Problem Percentage of All Causes of Death in U.S., 2001 Cerebrovascular 6.8% Pneumonia & Influenza 2.6% Accidents 4.2% Heart Disease 29.0% Chronic Lung Disease 5.1% Other Causes 29.5% 22.9% Cancer ○ Cancer is the Second Leading Cause of Death in the U.S. ○ Over ½ million U.S. Deaths are Cancer Related
_____________________________________________ DEMAND Scope of Problem Unlike Nearly All other Cancers, the Death Rate for Liver Cancer is on the Increase
_____________________________________________ DEMAND Scope of Problem ○ All Cancer ○ 1,368,030 new cases in 2004 ○ 563,700 deaths in 2004 ○ 5-year Relative Survival Rate 65.5% Liver Cancer represents only 1.4% of new cancer cases, but accounts for 2.5% of all cancer deaths ○ Liver Cancer ○ 18,920 new cases in 2004 ○ 14,270 deaths in 2004 ○ 5-year Relative Survival Rate 8.0%
_____________________________________________ ENVIRONMENT Competitor Analysis ○ Complements ○ Substitutes ○ Traditional Non-Surgical Treatments ○ chemotherapy ○ radiation therapy ○ Novel Treatment Strategies ○ targeted chemotherapy ○ targeted radiation therapy ○ targeted hyperthermic therapy
_____________________________________________ Treatment OptionTargetingThreat To SystemNew Product Interstitial Radiation TherapyNoneLow to Medium-low ENVIRONMENT Competitor Analysis Radiofrequency AblationNoneMedium-low to Medium CryosurgeryNoneLow Percutaneous Ethanol InjectionsNoneLow External-Beam Radiation TherapyNoneLow
_____________________________________________ Treatment OptionTargetingThreat To SystemNew Product Targeted Radiation Therapy (SIR-Spheres)AntibodiesMedium to Medium-high ENVIRONMENT Competitor Analysis Hepatic Arterial Infusion of ChemotherapyNoneLow to Medium-low ChemoembolizationNoneLow to Medium-low Targeted Hyperthermia Therapy (Thermo-Spheres)AntibodiesMedium-low to Medium Targeted Chemotherapy (Dox-Spheres)AntibodiesMedium to Medium-high
_____________________________________________ MARKET ANALYSIS Positioning ○ 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 ○ Long-term relationships would be developed with Nationally Recognized Cancer Research and Treatment Facilities
_____________________________________________ ORGANIZATIONAL ISSUES Company Structure Business Development Marketing & Sales OperationsFinance QA / Regulatory Compliance Initial Structure Mature Business Structure Marketing & Sales Business Development Operations Finance QA / Regulatory Compliance As Business Develops a more Hierarchical Structure Implemented
_____________________________________________ ORGANIZATIONAL ISSUES Management Team R. Marshall, BSc, MD, PhD Medical Director E. Hart, BSE, MS, MBA Regulatory Affairs Mgr. E. Trotzke, BSE, PhD Project Manager D. Rivera, BSE, MBA Chief Executive R. Mehta, BA, MBA, CPA Comptroller
_____________________________________________ TECHNOLOGICAL ISSUES Start Up Activities Months Animal Testing Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials FDA Approval Process Production Protocol FDA Application 30 Months Total Start-Up
_____________________________________________ FINANCIAL ANALYSIS Projected Sales & Costs 3.54 million 7.50 million million million 2.61 million 0.58 million 5.9 million 4.25 million Sales Operating Expenses & Cost of Goods
_____________________________________________ FINANCIAL ANALYSIS Projected EBIT 1.6 million 9.2 million 0.96 million 0.03million 0.71 million Profit Loss
_____________________________________________ INVESTMENT OPPORTUNITY ○ Cancer is Major Cause of Death in U.S. with Liver Cancer on the Increase ○ Most Current Treatments are NOT Curative ○ High Probability of FDA Approval of IDE ○ Experienced Management Team ○ Affiliation with Major Research and Treatment Centers ○ Profit Potential of over $9 Million in 5 th Year
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