Integrascope Business Plan

Integrascope® Business Plan

YNano LLC

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7/2/10









Table of Contents
1. Executive Summary……………………. 2. Product Design………………………..... 3. Market Analysis....................................... 4. Commercial Options…………………… 5. Marketing Strategy……………………... 6. Manufacturing Plan…………………….. 7. Organization……………………………. 8. Corporate Values, Vision, Mission…….. 9. FinancialPlan…………………………... 3 6 7 14 15 18 19 20 21

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Integrascope® By YNano LLC 1. Executive Summary
YNano LLC will produce a diagnostic instrument with the strategic benefits of rapid measurement of infectious disease markers and overall patient health at low cost due to the employment of the patient sample as a key part of the diagnostic instrument. The Integrascope willinitially target developing nations with endemic Dengue fever followed by mass screening outreach markets for treatable infectious diseases where interventions can avoid disease spread and birth defects. Market Need There are an estimated 100 million cases of acute febrile Dengue fever a year world-wide with about 500,000 leading to severe hemorrhagy and hipovolemic shock. Dengue is endemic in 112countries with some outbreaks resulting in over 10,000 cases a day. This is significantly more widespread than 60 years ago when only 9 countries reported dengue outbreaks, and several of the countries currently reporting had not previously reported dengue or had not reported dengue in 20 years. Rapid, high sensitivity dengue detection poses many challenges due in part to the several days lag inantibody production. Also, it is vital to know if the patient had a prior Dengue infection due to the potential for a severe disease course with a high rate of mortality. The world-wide cost of treating patients is approximately $70 billion which includes the diagnostic costs (about 5% of the cost of care) primarily using clinical assessment based on WHO protocols and/or to a much lesser extentlaboratory instrumentation. Diagnosis of Dengue using clinical kits is difficult since antibodies for first time infections take several days to develop and since prior infection requires detection of a different type of antibody, and positivity rates are typically below 40%. The current penetration of diagnostic test kits is estimated at less than 10% and probably closer to 5% since only a few majorhospitals and centers have clinical laboratories that offer diagnostic tests to confirm the clinical infection. Moreover, it is more important to understand how to treat patients as soon as possible since their symptoms vary from the absence of symptoms, to mild fevers similar to a cold, or for the more severe cases hemorrhaging. There is no specific treatment of the disease, but instead patienthealth is supported based on understanding how the disease is progressing. Thus, there is an unmet need of at least 90% market share for an instrument that can provide rapid and useful clinical assessment to guide patient care and direct resources during an outbreak. Worldwide, there are about 300-400 million new cases of syphilis, gonorrhea, chlamydia and trichomoniasis and hundreds of thousands ofbirth defects caused by syphilis and rubella infections. These and many other curable infectious diseases can also be better managed by more extensive screening. There is a growing market for rapid clinical diagnostic products that can target several specific treatable infectious disease, especially during campaigns designed to lower incidence of transmission or improve infant health.

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The low cost, rapid in vitro diagnostic (IVD) market for infectious disease detection is currently approaching $1 billion and should grow at a rate above 10% per year. Product Development The Integrascope is a unique product design based upon a new diagnostic paradigm of using a patient’s sample as part of the diagnostic instrument in order to reduce cost and speed...